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In the News... CGM in space, diet and type 1 diabetes study, GLP-1 gel in development, and more!13 Sep 202400:08:05

It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: Dexcom CGM is worn in space, two over-the-counter CGMs are now available, a large new study looks at potential dietary causes of type 1, and researchers are looking at a gel version of GLP-1 medications.

Find out more about Moms' Night Out 

Please visit our Sponsors & Partners - they help make the show possible!

Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)

Omnipod - Simplify Life

Learn about Dexcom 

Edgepark Medical Supplies

Check out VIVI Cap to protect your insulin from extreme temperatures

Learn more about AG1 from Athletic Greens 

Drive research that matters through the T1D Exchange

The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:

Sign up for our newsletter here

Here's where to find us:

Facebook (Group)

Facebook (Page)

Instagram

Twitter

Check out Stacey's books!

Learn more about everything at our home page www.diabetes-connections.com 

Reach out with questions or comments: info@diabetes-connections.com

Episode transcription with links:

 

Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now.

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Astronauts on the Polaris-Dawn mission are wearing the Dexcom G6 CGM.

Polaris Dawn launched this week with astronauts wearing the G6 to better understand the effects of spaceflight on human health. The crew intends to conduct research to advance human health on Earth and the understanding of health during long-duration spaceflights.

“This health research-driven mission marks another first for Dexcom, with our industry-leading CGMs being worn by astronauts in outer space,” said Jake Leach, EVP and COO at Dexcom. “We are thrilled to play a role in building a future where people with diabetes are empowered to accomplish anything they set their minds to–including the possibility of exploring outer space–without being held back by their condition.”

Over five days in space, the Polaris Dawn crew plans to conduct around 40 scientific experiments. That includes several aimed at better understanding the effects of spaceflight on glucose health. Labront, a platform assisting health researchers in collecting and analyzing physiological data, is collaborating with Dexcom. It plans to provide advanced analytics for the data collected by the crew.

 

According to a news release, the mission expects to explore how microgravity, fluid shifts, and blood flow restriction exercises impact glucose regulation.

https://www.drugdeliverybusiness.com/dexcom-cgm-outer-space-polaris-dawn/

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There are now two OTC CGMs.. Dexcom launched Stelo a few weeks ago and now Abbott says Lingo is for sale. They’re both available on the companies’ websites, cost about the same, but you can opt to buy only one Lingo where Stelo comes in pairs. Lingo is meant for people without diabetes – it’s a health bio sensor. Abbott has another CGM called Libre Rio meant for people with type 2 who don’t take insulin. Not a lot of details about what the real difference are here – likely just in the software – No word on when Rio will be available.

https://www.cnbc.com/2024/09/05/-abbott-launches-its-first-over-the-counter-continuous-glucose-monitor-in-the-us.html

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Warning about flying with an insulin pump – And I want to be clear here because I’m sure you’ll see some scary headlines. This is really about pressure emergencies in planes. For the study, researchers tested 26 insulin pumps in a hypobaric chamber programmed to mimic the atmospheric changes during a normal commercial airline flight.

“The drop in cabin pressure during ascent may lead to a slight increase in insulin delivery as a result of the formation of air bubbles which displace excess insulin out of the cartridge,” Fan said in a meeting news release. “A slight reduction in insulin delivery is also possible during descent as the increasing air pressure dissolves the air bubbles, sucking insulin back into the pump.”

People on insulin pumps could be in real trouble in the event of rapid decompression of the cabin at altitude, researchers said. In that case, the pumps could deliver an insulin overdose -- dropping blood sugar levels so much that there’s a significant risk of hypoglycemia, results show.

These researchers recommend disconnecting and reconnect at take off and landing, but that’s not going to help if there is emergency rapid decompression. As always, be prepared with emergency glucagon and low snacks and supplies.

https://www.healthday.com/health-news/diabetes/flying-could-upset-insulin-pump-function-for-type-1-diabetics

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Lilly moves forward with it’s version of once weekly basal insulin. Clinical trials show it can help control both Type 1 and Type 2 diabetes as well as daily basal injections do. However, in those with type 1 diabetes, there was an increased risk for hypoglycemia

This is the same issue with Novo Nordisk’s Awiqli insulin – approved in Canada but not in the United States.

https://www.upi.com/Health_News/2024/09/11/weekly-insulin-injections-effective-diabetes-weekly/8711726068680/

https://www.medscape.com/viewarticle/once-weekly-insulin-looks-good-t2d-risk-seen-t1d-2024a1000gh8

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Eating what seems like really healthy foods could be associated with a higher risk of developing type 1 diabetes. New study shows that eating fruit, oats and rye in childhood is associated with a higher risk of developing type 1 diabetes (T1D). Eating berries, however, is linked to lower odds of developing the condition.

What triggers the immune system's attack is unknown but is thought to involve a combination of a genetic predisposition and an environmental trigger such as a virus or foodstuff.

T1D, the most common form of diabetes in children, is increasing worldwide. The number of cases worldwide is projected to double in just 20 years, from 8.4 million in 2021 to 17.4 million by 2040. Finland has the highest incidence of T1D globally, with 52.2 cases per 100,000 children under the age of 15 – more than five times higher than in the 1950s.

5,674 children (3,010 boys and 2,664 girls) with genetic susceptibility to T1D were followed from birth to the age of six. Food records completed by their parents repeatedly from the age of three months to 6 years provided information on the entire diet.

 

The 34 food groups covered the entire diet and, when they were all factored in, several foods were associated with a higher risk of developing T1D.

 

To the best of our knowledge, this is the first time a child's entire diet has been considered at the same time."

The results show that the more fruit, oats or rye children ate, the more their risk of T1D increased. In contrast, eating strawberries, blueberries, lingonberries, raspberries, blackcurrants and other berries appeared to provide protection against T1D. The more berries a child ate, the less likely they were to develop T1D.

Oats, bananas, fermented dairy products (such as yogurts) and wheat were associated with an increased risk of islet autoimmunity, whereas cruciferous vegetables, such as broccoli, cauliflower and cabbage, were associated with decreased risk.

It is, however, too early to make any dietary recommendations. The researchers are quick to point out that they don’t really know the “why” here. Could be the food itself, could be pesticides, and until the results are replicated they urge parents not to change their child’s diet.

https://www.news-medical.net/news/20240909/Eating-fruit-oats-and-rye-in-childhood-may-increase-type-1-diabetes-risk.aspx

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Researchers in France have developed a once-a-month hydrogel-based delivery system for semaglutide, significantly simplifying diabetes and weight management

Semaglutide, marketed as Ozempic, Rybelsus, and Wegovy, is a GLP-1 receptor agonist that helps to regulate blood sugar levels and promote weight loss. This medication is especially effective in managing type 2 diabetes and is available in both injectable and oral forms. Semaglutide enhances the body’s natural ability to control blood glucose and reduce appetite, providing a dual approach to treatment.

 

 

The new hydrogel delivery platform uses two innovative degradable polymers that are chemically bound to one another to form a gel, but allow slow, sustained release of soluble peptides over 1 to 3 months. How do you slow release a gel? With an injection. It goes under the skin. This is still in animal studies, so we’re a ways off from human clinical trials.

https://scitechdaily.com/new-semaglutide-hydrogel-say-goodbye-to-weekly-shots-for-diabetes-and-weight-loss/

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Edgepark Commercial

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Embecta has received clearance from the Food and Drug Administration for its first insulin patch pump.

The device can be used by people with Type 1 or Type 2 diabetes and worn for up to three days. It includes a 300-unit insulin reservoir.

Embecta said Tuesday it plans to develop a closed-loop version of the pump for automated insulin dosing that it will submit to the FDA in the future using the Tidepool Loop algorithm.

Earlier this summer, Insulet received FDA clearance to offer its Omnipod 5 pump to people with Type 2 diabetes. Diabetes tech firms have focused on Type 2 in recent years as insurance coverage improves.

https://www.medtechdive.com/news/embecta-gets-fda-nod-for-insulin-patch-pump/725904/

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An artificial intelligence (AI)–driven voice algorithm showed "excellent agreement" with the American Diabetes Association (ADA) risk test in detecting adults with type 2 diabetes (T2D), research presented at the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting revealed.

 

The AI model detected T2D with 66% accuracy among women and 71% in men, and there was 93% agreement with the questionnaire-based ADA risk score, demonstrating comparable performance between voice analysis and an accepted screening tool.

 

The Colive Voice project includes volunteers from all over the world; however, the current study was restricted to adults from the United States, both with and without T2D,

"This first proof of concept was limited to English speakers, and further research will need to enroll more diverse populations, in terms of languages and sociodemographic background," he said.

"This study represents a first step toward using voice analysis as a first-line, highly scalable T2D screening strategy," the authors concluded.

"The next studies will have to demonstrate the robustness of our approach in diverse populations and also include people living with prediabetes," Fagherazzi said. "If proven reliable, we expect such technology to be available in the next 5-10 years. Then, it could be deployed easily at scale in millions of smartphones worldwide and reduce undiagnosed diabetes cases."

https://www.medscape.com/viewarticle/ai-voice-analysis-diabetes-screening-shows-promise-2024a1000ggw

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Join us again soon!

Making it to the Big Leagues with T1D: Minnesota Twins draft pick Jaime Ferrer10 Sep 202400:30:39

Jaime Ferrer was diagnosed with type 1 at age three.. and this summer was drafted into Major League Baseball by the Minnesota Twins. I caught up with him to ask him your questions about works out, playing with a pump, how he managed the college recruitment process, and more. He’s a great kid and this was a fun one.

I should note that many of you know Jamie’s mother Mila Ferrer. She’s been blogging about her family’s experience for a long time, does a lot of work with Beyond Type 1 and is an advocate for the Latino diabetes community. I’ve had the pleasure of working with her on some of the past Beyond Type 1 projects.

Jaime was drafted by the Twins this summer and he’s currently practicing and playing with their minor league team Fort Myers Mighty Mussels. He is also part of the Tandem Diabetes Ambassador program.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Follow Jaime Ferrer on Instagram

Joint interview with Jaime and Mila Ferrer

Please visit our Sponsors & Partners - they help make the show possible!

Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)

Omnipod - Simplify Life

Learn about Dexcom 

Edgepark Medical Supplies

Check out VIVI Cap to protect your insulin from extreme temperatures

Drive research that matters through the T1D Exchange

The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:

Sign up for our newsletter here

Here's where to find us:

Facebook (Group)

Facebook (Page)

Instagram

Twitter

Check out Stacey's books!

Learn more about everything at our home page www.diabetes-connections.com 

Reach out with questions or comments: info@diabetes-connections.

Fast-tracking progress on a T1D treatment: All about Diamyd Medical23 Jul 202400:37:52

We're hearing more and more about prevention of type 1 diabetes. There’s some big news on that front – just last week Diamyd Medical got fast track designation for it’s medication to stave off T1D for people who carry a particular gene – a gene that about 40-percent of people with type 1 have. Diamyd is recruiting for some big clinical trials – we’ll find out who’s eligible, where you have to go and what you to have to do, and the reasons why there’s an awful lot of hope around this.

My guest this week is Elna Narula, US Site Relations and Patient Recruitment Lead at Diamyd Medical. Her daughter was diagnosed with type 1 more than 30 years ago. Elna was already working in healthcare and she became a diabetes educator.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

More info about Diamyd

Learn about the studies and recruitment here

Find out more about Moms' Night Out - registration is open for Denver and Philadelphia!

Please visit our Sponsors & Partners - they help make the show possible!

Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)

Omnipod - Simplify Life

Learn about Dexcom 

Edgepark Medical Supplies

Check out VIVI Cap to protect your insulin from extreme temperatures

Drive research that matters through the T1D Exchange

The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:

Sign up for our newsletter here

Here's where to find us:

Facebook (Group)

Facebook (Page)

Instagram

Twitter

Check out Stacey's books!

Learn more about everything at our home page www.diabetes-connections.com 

Reach out with questions or comments: info@diabetes-connections.

What does it mean to "Go Bionic?" - A deep dive into the newly-approved iLet system06 Jun 202300:56:17

The newly FDA-approved iLet Bionic Pancreas is the most hands-off automated insulin delivery system to be commercially available. At set up, all you enter is your weight and the only interaction with the pump is to announce meal size, no carb counting.

Stacey talks with Beta Bionics CEO Sean Saint. We go through this pump system in lots of detail, talk about future plans – yes we’ll talk dual chambered pump which is the original design here - and get a little philosophical about the idea behind a hands off system.. especially for those of us used to being much more in the driver’s seat.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

More about Beta Bionics: https://www.betabionics.com/

Our previous episodes about the iLet here: https://diabetes-connections.com/?s=ilet

One of many write ups of clinical trials with the iLet system: https://www.nejm.org/doi/full/10.1056/NEJMoa2205225

Stacey mentioned our episode with ConvaTec about infusion sets: https://diabetes-connections.com/the-seven-day-infusion-set-is-here-whats-next-from-convatec-infusion-care/

Please visit our Sponsors & Partners - they help make the show possible!

Take Control with Afrezza 

Omnipod - Simplify Life

Learn about Dexcom 

Check out VIVI Cap to protect your insulin from extreme temperatures

Learn more about AG1 from Athletic Greens 

Drive research that matters through the T1D Exchange

The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:

Sign up for our newsletter here

Here's where to find us:

Facebook (Group)

Facebook (Page)

Instagram

Twitter

Check out Stacey's books!

Learn more about everything at our home page www.diabetes-connections.com 

Reach out with questions or comments: info@diabetes-connections.com

 

 

In the News.. Lilly settles insulin lawsuit, iLet Bionic Pancreas approved, T1D Ninja Warrior winner and more!02 Jun 202300:07:24

It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: Lilly becomes the first of the big three insulin makers to settle a class action lawsuit over pricing, the FDA approved Beta Bionics' iLet system, oral meds trialed for T2D seem to work as well as Ozempic injectable, Lego adds a T1D "friend" to their line and a big win for an American Ninja Warrior competitor with T1D.

Please visit our Sponsors & Partners - they help make the show possible!

Take Control with Afrezza 

Omnipod - Simplify Life

Learn about Dexcom 

Check out VIVI Cap to protect your insulin from extreme temperatures

Learn more about AG1 from Athletic Greens 

Drive research that matters through the T1D Exchange

The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:

Sign up for our newsletter here

Here's where to find us:

Facebook (Group)

Facebook (Page)

Instagram

Twitter

Check out Stacey's books!

Learn more about everything at our home page www.diabetes-connections.com 

Reach out with questions or comments: info@diabetes-connections.com

Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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In the news is brought to you by VIVI Cap Keeps your insulin at the exact right temperature, even in extreme heat or cold.
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Our top story,
Eli Lilly has agreed to pay $13.5 million to end a six-year, class-action lawsuit accusing the company of overpriced its insulin. As part of the settlement, Lilly has agreed to cap out-of-pocket costs for its insulin at $35 per month for four years. That’s three months after Lilly said it would cut insulin prices to that level.
The lawsuit was filed in 2017, against insulin makers Lilly, Novo Nordisk and Sanofi. Plaintiffs claimed the companies joined in an “arms race” to raise list prices of their meds while the “real” price to pharmacy benefit managers remained constant or in some cases dipped.
Price increases of insulins that previously cost $25 per prescription were pushed up to $450, the suit said. The increases, taken in “lockstep,” were “astounding and inexplicable,” according to the class action lawsuit. Novo and Sanofi have yet to settle this case.

https://www.fiercepharma.com/pharma/eli-lilly-inks-settlement-long-running-insulin-pricing-lawsuit
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The FDA is changing its draft guidance for industry regarding Antidiabetic Drugs and Biological Products. It’s been 15 years since an update. Topics covered in the draft guidance include:
Hemoglobin A1c (A1C), a measure of average blood sugar, remaining an acceptable primary efficacy endpoint
The FDA now considering a reduction in the risk of hypoglycemia (low blood sugar) to be a clinically relevant outcome measure for diabetes drug clinical trials, when accompanied by either a reduction or maintenance of an acceptable A1C.
The use of data collected by continuous glucose monitoring (CGM) systems, which allow for nonstop, passive glucose monitoring, in clinical trials to potentially support hypoglycemia labeling claims. Recent advancements in CGM technology have led the agency to recognize the advantages of data collected from these systems in clinical drug development. The FDA will be accepting comments on the guidance until August 24, 2023.
https://www.appliedclinicaltrialsonline.com/view/fda-on-track-to-updates-diabetes-efficacy-endpoints-guidance
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The iLet bionic pancreas from Beta Bionics gets FDA approval for people with type 1 age 6 and up. This is a unique system in that it starts with only the user’s weight and requires meal announcements – no carb counting – to automate blood sugar. It will launch with the Dexcom G6 CGM. You’ll hear from the company CEO this Tuesday in our next episode where we do a deep dive into the system.
https://www.medicaldevice-network.com/news/beta-bionics-fda-insulin-pump/
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Researchers had observed an increased incidence of type-1 diabetes cases during the COVID-19 pandemic. Now, a new study has confirmed the link and established a temporal association between the development of type-1 diabetes in children and infection with the SARS-CoV-2 virus.
The new study published in Jama Network was the first research that used data, which indicated if the type-1 diagnosed children previously had COVID-19 infection.

The researchers found the likelihood to develop type-1 diabetes increased by 57% in children who had a confirmed COVID-19 infection, compared to those who did not have the infection.
https://www.medicaldaily.com/covid-19-infection-increases-incidence-type-1-diabetes-children-study-469854
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New oral medication from Pfizer seems to stack up well next to Ozempic for weight loss. New study looked at people with type 2 found danuglipron when given twice a day, lowered blood sugar in patients at all doses and reduced body weight at the highest dose after 16 weeks.

The weight loss with danuglipron is of a similar magnitude to that observed in the mid-stage data for Novo Nordisk's semaglutide, known as Ozempic when used for diabetes and Wegovy for obesity.
The treatments, including Pfizer's danuglipron, belong to a class of drugs that mimic the gut hormone glucagon-like peptide-1 (GLP-1), which works by suppressing appetite and were initially developed to treat type 2 diabetes.
Pfizer is also testing another oral diabetes drug, lotiglipron, which is given once daily and has said it plans to initiate late-stage development of only one of the two candidates.
The company believes an oral therapy could appeal to patients who want to avoid injections.
https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-diabetes-drug-reduces-weight-similar-novos-ozempic-2023-05-22/

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Artificial intelligence (AI) algorithms used to screen for and predict type 2 diabetes may be racially biased, which could perpetuate health disparities, according to a study published last week in PLOS Global Public Health.

Risk prediction models for type 2 diabetes have shown promise in bolstering early detection and clinical decision-making, but the researchers pointed out that these models can bias the decision-making process if risk is miscalibrated across patient populations.

The research team found that the Framingham Offspring Risk Score underestimated type 2 diabetes risk for non-Hispanic Black patients, but overestimated risk for their white counterparts.

The ARIC Model and PRT overestimated risk for both groups, but to a greater extent for white patients.

Research like this highlights that while data analytics and AI approaches may help find gaps in chronic disease management and care, racial disparities are still a major obstacle to achieving health equity for diabetes patients.

A 2021 study of city-level data revealed significant disparities in diabetes mortality rates across the United States.

The analysis sourced data from the 30 largest cities in the US and demonstrated that mortality rates were higher for Black individuals than for white individuals. Disparities were also found to be up to four times larger in some cities compared to others, with Washington, DC experiencing the highest rates of diabetes mortality inequities.

https://healthitanalytics.com/news/potential-racial-bias-found-in-type-2-diabetes-risk-prediction-models
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1 in 3 adults with Type 2 diabetes may have undetected cardiovascular disease. Elevated levels
However, mildly elevated concentrations of of two protein biomarkers that indicate heart damage may be an early warning sign of changes in the structure and function of the heart, which may increase the risk for future heart failure, coronary heart disease or death.

Researchers analyzed health information and blood samples for more than 10,300 adults collected as part of the U.S. National Health and Nutrition Examination Survey from 1999 to 2004. Study participants had reported no history of cardiovascular disease when they enrolled in the study.
One-third (33.4%) of adults with Type 2 diabetes had signs of undetected cardiovascular disease, as indicated by elevated levels of the two protein markers, compared to only 16.1% of those without diabetes.
https://medicalxpress.com/news/2023-05-adults-diabetes-undetected-cardiovascular-disease.html
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VIVI CAP
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MTV Documentary Films has acquired worldwide rights to Pay or Die, a film about Americans living with diabetes who face a cruel choice: pay the “extortionate” cost of insulin charged by pharmaceutical companies or risk death.

Scott Alexander Ruderman and Rachael Dyer directed and produced the documentary, which premiered in March at SXSW. MTV Documentary Films plans a theatrical release later this year, followed by a debut on streaming platform Paramount+.
Those personal stories in the film stretch across the country. “From a mother-and-daughter struggling to rebuild their lives after spending their rent money on insulin, to a young adult diagnosed with Type 1 diabetes during the COVID-19 pandemic, to a Minnesota family thrust into the national spotlight when their 26-year-old son dies from rationing his insulin, Pay or Die highlights this devastating struggle to survive while living with diabetes.”

https://deadline.com/2023/05/pay-or-die-mtv-documentary-films-acquisition-directors-scott-alexander-ruderman-rachael-dyer-news-1235382566/
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Katie Bone win the “American Ninja Warrior Women’s Championship” — not only claiming the title but a cash prize of $50,000. She donated $5,000 to the Juvenile Diabetes Research Foundation and Pumped NM.

Bone has not only appeared on three iterations of the competition series, but is also a nationally-ranked rock climber.

While not the youngest competitor anymore, she was the shortest standing at 5 foot, 2 inches. She’s been making waves since competing in “American Ninja Warrior Jr.” in 2020.

To train for the event during the pandemic, her father built a ninja course in their backyard.

During that competition, Bone, who was diagnosed with Type 1 diabetes at 11 years old, competed with both her insulin pump and glucose monitor on her arms.

Being on the show also presents Bone with the opportunity to be an ambassador for Type 1 diabetes awareness and representation.

Bone says Type 1 diabetes didn’t end her life, it just changed it.

“I hope I inspire a little kid to wear their pump on their arm,” Bone said. “It makes everything that you do that more amazing.”

In February, Bone competed at the USA National Women’s Team Climbing trials in Austin, Texas.

During her fourth climb, she fell.

“Katie heard four pops,” Tammy Bone said. “She tore her ACL and both sides of her meniscus. This was a moment she was preparing for all her life and it got put on pause.”

Bone had surgery and has been getting physical therapy in Colorado. The family returned Monday night to New Mexico after being away for three months.

Bone still has her eyes on the Olympics, though the road to recovery may take some more time.

“I don’t need easy, I just need possible,” she said.
https://www.abqjournal.com/2602750/17-year-old-new-mexico-ninja-warrior-katie-bone-takes-the-title-in-womens-championship-competition.html
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Today LEGO has revealed the first wave of Friends sets for 2023, bringing in a new cast of characters and an update to the branding with a new logo. A new LEGO Friends television series will also accompany the new sets. LEGO’s annual Play Well study revealed that 3 out of 4 children felt there were not enough toys with characters that represent them, so LEGO is aiming to bring more diverse representation to Heartlake City that’s inclusive of not just various ethnicities and genders, but also disabilities and neurodivergence. LEGO says the 2023 sets and series will feature characters with limb difference, Downs Syndrome, anxiety, vitiligo, and even pets with disabilities, including a blind dog and a dog with a wheelchair. She has a CGM printed on her arm and even has a printed phone tile showing her blood sugar. Her name is Hannah and she’s in 41744 Sports Center
https://www.brothers-brick.com/2022/10/27/lego-friends-reveals-5-sets-for-2023-with-diverse-characters-to-better-represent-children-news/
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On the podcast next week.. Beta Bionics CEO Sean Saint. Last week I MedT 780G

That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

 

The MiniMed 780G - A deep dive into Medtronic's most advanced system30 May 202300:48:47

This long-awaited Medtronic 780G is now FDA approved. It’s been out for two years in Europe and has features that are a bit different from other commercially available automated insulin delivery systems in the US, including a target range down to 100.

This week you'll hear from Heather Lackey, global medical education director for Medtronic Diabetes who also lives with type 1 and has used the 780G. We talk about what else this system can do – remember this is the one with the 7-day infusion set – and Stacey asks a lot of your questions.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

More info here: https://diatribe.org/medtronic-minimed-780g-approved-fda

Lackey mentions a study where even with no meal boluses for three months, people stayed mostly in range. Here's that study: The Official Journal of ATTD Advanced Technologies & Treatments for Diabetes Conference Madrid, Spain—February 19–22, 2020.  Diabetes Technology & Therapeutics. Feb 2020.A-1-A-250.http://doi.org/10.1089/dia.2020.2525.abstracts

Please visit our Sponsors & Partners - they help make the show possible!

Take Control with Afrezza 

Omnipod - Simplify Life

Learn about Dexcom 

Check out VIVI Cap to protect your insulin from extreme temperatures

Learn more about AG1 from Athletic Greens 

Drive research that matters through the T1D Exchange

The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:

Sign up for our newsletter here

Here's where to find us:

Facebook (Group)

Facebook (Page)

Instagram

Twitter

Check out Stacey's books!

Learn more about everything at our home page www.diabetes-connections.com 

Reach out with questions or comments: info@diabetes-connections.com

Rough Transcription:

Stacey Simms  0:00

Diabetes Connections is brought to you by The only Ultra rapid acting inhaled insulin by Omni pod five, the only tubeless pump that integrates with Dexcom G six mi Dexcom G seven powerful simple diabetes management.

This is Diabetes Connections with Stacey Simms.

This week, the long awaited Medtronic 780 G is now FDA approved. It's been out for two years in Europe and its features that are a bit different from other commercially available systems in the US, including a target range down to 100.

 

Heather Lackey  0:44

And it's just been proven to do so successfully without really increasing a lot of time below range. You know, what will the next system lead up? Will it be below 100? I don't know. But it's so nice to be waking up with glucose levels that are so much closer to someone without type 1 diabetes with this lower target.

 

Stacey Simms  1:05

That's Heather Lackey, global medical education director for Medtronic. She also lives with type one, we talk about what else the system can do remember if this is the one with the seven day infusion set, and I ask a lot of your questions. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Welcome to another week of the show. Always so glad to have you here. You know, we aim to educate and inspire about diabetes with a focus on people who use insulin. I'm your host, Stacey Simms, and we are getting some big FDA approvals. Along with the Medtronic 780 G, we got word that beta bionics islet will soon be commercially available. As I am recording this I do have an interview set up with the beta bionics CEO. If all goes to plan that will be our show next week. Real quick, while the original islet dual chambered pump was not what was in front of the FDA, the pump that has been approved has some really interesting features. It's unique in that there are no steps to the programming. When you get your pump, you're not putting in basal rates or insulin sensitivity factors or anything like that. All you do is put your weight in. But that is for next week. You can follow me on social media. We've already shared some information about the islet and I've done many episodes in the past if you want to listen to those to get an idea of what was approved, but this week, we're talking about the Medtronic 780 G, as you likely remember Medtronic at the very first of what we now call a ID systems automated insulin delivery systems with their mini med 670 G and that was approved in 2017. We've been hearing about the 780 G for a long time. It was submitted in 2021. I've talked a lot about the delays in the in the news episodes. It has been approved in Canada since last year. It was approved in Europe in 2020. We're gonna go through lots of features of the pump, but you should also know that the sensor used with this system The Guardian four is approved with no finger sticks for dosing, which to me is one of the most significant changes.

My guest to talk about all this is Heather lackey. She has been with Medtronic for more than 19 years. She delivers medical education strategy for insulin pump systems. She trains Medtronic education teams around the world. She lives with type one she was diagnosed at age 16. She was also a consultant on the movie Purple Hearts. She also popped up in a scene in that movie and yes, I asked her about that. Lots to get through.

But first Diabetes Connections is brought to you by Afrezza. Afrezza is the only FDA approved mealtime insulin that comes in a powder you inhale through your lungs. So why should you consider this unique alternative to mealtime injections. Afrezzais another option if you want to lower your use of needles or if you're experiencing skin reactions at your injection sites, and it is ultra rapid acting so you can take it right when your food arrives. Even unexpectedly. Find out more see if Afrezza is right for you go to diabetes dash connections.com and click on the Afrezza logo. Afrezza can cause serious side effects including sudden lung problems low potassium and it's not for patients with chronic lung disease such as asthma or COPD or for patients allergic to insulin. Tell your doctor if you ever smoked ever had kidney or liver problems history of lung cancer or if you're pregnant or breastfeeding. Most common side effects are low blood sugar cough and sore throat severe low blood sugar can be fatal. Do not replace long acting insulin with Afrezza, Afrezza is not for us to treat diabetic ketoacidosis please see full prescribing information including box warning medication guide and instructions for use on our frezza.com/safety.

Heather, thank you so much for joining me. I have a lot of questions for you about the new system but first welcome. I'm glad to have you here.

 

Heather Lackey  4:52

Oh thank you Stacey. It's my pleasure to be here and so nice to get to meet you. I listen to your podcast and just excited Good to be a part of this one.

 

Stacey Simms  5:00

Oh, well, I'm thrilled to have you. And I'm sure you don't mind if I say it has been a long time coming. Lots of people very excited about this improvement. Can we start by just talking about the seven EDG? What makes this different from the Medtronic pumps that have come before?

 

Heather Lackey  5:16

Yeah, well, the mini med seven add system is different in the fact of course, it let's say what it Phil has right still has automated basal insulin, and that insulin ID based on the sensor glucose values, but this system is set apart because it delivers does auto correction boluses, like every five minutes is needed. So we know that life with type 1 diabetes, as you well know, as a mom, someone with type one and be living with it, we know that life does not go as we expect all the time and as planned. And so many things affect our glucose outside of the three things that we've always tried to juggle for years, right? Food and insulin and exercise. But now that we really kind of identify that there's so many other things that are impacting our glucose, it really brings to light the fact that we don't get it right 100% of the time, when we dose insulin, we adjust food. And so that's where those auto corrections that are coming in real time, every five minutes, if needed, can really help. And what I love about the system is the auto corrections, you don't have to be sky high to get an auto correction. As a matter of fact, you don't even have to be high. before they begin. They're really kind of thinking like a pancreas than as soon as your glucose rises over 120 milligrams, as the basal is working as hard as it can and saying, Hey, I need help, then the auto corrections come into play. And they can start dosing a correction bolus every five minutes if needed.

 

Stacey Simms  6:59

So what is the difference between the auto basil and that bolus that you're talking about? Because you know, the automated systems that are out right now already adjusted basal every five minutes? What is actually happening when you say oh, and it's also giving a bolus?

 

Heather Lackey  7:14

Yeah, so the bolus happens every five minutes on top of the date. Right, facie, so let's say, again, the goal for many meds seven ad G, there were kind of two goals in play, right, we wanted to further improve time and range, you know, compared like with the mini med 670 G system without compromising any safety, because we all know we can drive down glucose, right, but you don't want to have a lot of lows. And we wanted to reduce the daily interactions with the system. And those daily interactions, right, the the alerts and the alarms and all of the safety pieces that were were added to mini med seven, add, those have all been now relaxed, and so less than erection and improvement in time and range without sacrificing hypoglycemia. So what's nice about the system is you not only are delivering the auto basil, like you said, right, we have auto basil and other systems that now if the auto basal cannot keep the glucose level in the target range, it predicts that the glucose level is going to go higher than it would like then that's when those auto corrections come. And they don't come once an hour, they come every five minutes. As soon as that since your glucose rises over 120 milligrams per deciliter. If the system says, Hey, I'm working as hard as I can with your basal, and I'm not able to keep your glucose at the target range that we want, right. And we'll talk about targets and here in just a minute, hopefully. But if we can keep your glucose at that target range, then I'm going to ask for some help. And that's where those auto corrections. And those are boluses. Right? boluses that happen every five minutes without the patient having to agree to them, or take any action on their part. They just happen automatically.

 

Stacey Simms  9:14

Alright, I have a few more questions about that. But I'll get back to that in a couple of minutes. Because I feel like most people will just see the results. And they they may not have too many questions about exactly what's going on there. But I want to get back to that bullets in a minute. But you mentioned range, and the seven EDG has a lower range than Tandem and Omnipod. Five have currently right it's correcting down to 100. Or that's a choice. You can adjust that.

 

Heather Lackey  9:37

Yeah, there's a couple of things that are different and new about this. And Minimates seven add definitely treats to a target, not a range. But you're right though the target is the lowest target at this moment that's available and so the auto basal target, you can set three settings Three different targets are available to where the person was diabetes , their healthcare provider can can really identify which target is best for them. But the three targets are 100 milligrams per deciliter, 110, and 120. Now 100 comes as kind of the default auto basal target. And that's because we know that this system was all of the copious data that we have. And all of the simulations that were done before this system was even launched, was using that 100 target. And that's what this system is built around to be the best target to you.

 

Stacey Simms  10:36

We should note that tide pool type pool loop, which was approved by the FDA a few months ago, can correct down to 87. But it is not available in any insulin pump, yet. It's a software program that was approved. So 100 for Medtronic is the lowest that you can actually use right now. But it's interesting, that's 101 10 and 120, where some other systems have, you know, an exercise mode that is a higher range, do you have any insight as to why those were chosen?

 

Heather Lackey  11:02

Well, those are that close to target to mirror a normal functioning, you know, system a system without diabetes . And the interesting thing is, is the 100 target is very much achievable without sacrificing time below range, right? So we're able to drive with the auto basal target being set at 100. And with having the auto corrections that are even delivering up to every five minutes, this is the system, you know, determined that those were needed. We have the algorithm that built to drive the system to 100. And it's just been proven to do so successfully without really increasing a lot of time below rage. You know, what will the next system lead us? Will it be below 100? I don't know. But it's so nice to be waking up with glucose levels that are so much closer to someone without type 1 diabetes. With this lower target.

 

Stacey Simms  12:03

Let's talk about the sensor because there are changes here too. Right. Tell me about the sensor that goes along with the 780G? Yeah, well,

 

Heather Lackey  12:10

the Guardian four sensor is the center that it works with the mini med 780G system. And the Guardian Force center was designed really to reduce the burden as daily finger sticks. That was the whole goal. Let's remove calibration from the system. And let's try to develop a system that doesn't require finger sticks. As we know, sometimes finger sticks still are needed with really with any of the systems and sensors. But the majority of the time when our patients are in the mark guard feature is they are using the SR glucose to bolus off that, you know, there's no real need for a fingerstick glucose. And interestingly enough, most patients bend upwards of you know, 95% or so in that smart guard feature. And so many patients will tell me, I am forgetting my glucose meter at home. And I had one patient that went on a trip, he went out of the country and he said, Look, I totally left insulin and glucose at home because I had kind of forgotten to take my meter bag with me. Wow, learning for sure.

 

Stacey Simms  13:27

Oh my gosh, yeah, my son goes without a meter quite often. Since you know his we use the Dexcom in the control IQ system from Tandem. But yeah, you don't want to forget your bag entire. That's not good

 

Heather Lackey  13:38

news. Okay, that's if that's now a burden that is taken off of you. And that's lovely. Yeah, no doubt. No need to be prepared, right?

 

Stacey Simms  13:47

Yep, absolutely. And I think it's worth pointing out that this is the only automated insulin system in the United States. That is one system, right? It's a glucose monitor infusions that insulin pump. That's all Medtronic and this system has that extended infusion set right so you're talking to sensor you were for seven days, and an infusion set for seven days, right. We'll get right back to my conversation with Heather but vs Diabetes Connections is brought to you by Omni pod. And when you're deciding that a random insulin pump, you got a lot to think about, especially if you've never used a pump before. It really can seem overwhelming. I remember that there are a lot of choices, and you want to make the right decision. And that's why I'm so excited to tell you about Omni pod five. Curious about trying an insulin pump or seeing what life without tubes is all about. Unlike traditional tube pumps, you can try Omni pod without being locked into a four year contract. You might even be eligible for a free trial, go to diabetes dash connections.com and click on the Omnipod logo for full safety risk information and free trial Terms and Conditions. Also visit omnipod.com/diabetes connections. Now back to Heather answering my question about this seven day infusion set

 

Heather Lackey  15:03

That's exactly right. One kind of new feature of the mini med seven add system is the extended infusion set. And that extended infusion set. It's been launched for a few months in a few different countries. But it comes now with de minimis 780G system, and really allowing people to just kind of have to think about changing a center and changing their infusions that just one day out of the week versus anymore. And so that system, you know, I have so many people that will go have our youth told us for years, you know, that we have to change our infusion set every three days. And why are we able to start to use that system now, and just been using that now for seven days. And the the, it's really simple to explain without getting into a lot of engineering details, but that infusions that is made with this advanced material. And what it does is it helps to reduce the insulin preservative, you know, kind of the loss that we would typically have, it helps to maintain the insulin flow. And it helps to maintain the stability of the unfolding. And so there's such a reduced risk of any kind of blockage or occlusions, with your infusion set whenever you use this new extended infusion set. And I always have to remind patients and people with that need us and their families, make sure you're only using the extended infusion set for seven days, and you're not using your current infusions that are that long, because the materials are different.

 

Stacey Simms  16:41

Yeah, good point. Can you use any insulin in those extended infusion sets?

 

Heather Lackey  16:47

So well, in the mini med 780G system, the insolence that are approved and on label are human log and Nova logs. So both of those are available to us with that set.

 

Stacey Simms  16:59

So no, Lusia if I ask, just checking, those are not approved at this time. Got it? Got it. I had a listener ask if the duration of insulin is adjustable, you know, is that a setting that people can kind of go in and tinker with?

 

Heather Lackey  17:13

Yeah, so active insulin kind of talks about the or is our duration and insulin kind of tuning knob that is in the programmable settings on the mini med 780G pump, the active insulin Time is of the two settings that are critical is one of the two, right the first setting is the auto label target, you know, looking at that 100 glucose target for most people with diabetes, but then also setting the active insulin time to two hours. And a lot of people will say, Look, I have never had active insulin or insulin on board. I've never thought that human log or Nova log was out of my body in just a couple of hours. And so it's interesting that Medtronic is recommending a two hour active insulin time. Why is that? And the real answer is this is what the algorithm was designed around, right, it's fine to have the ability to, you know, the algorithm is asking the patient, if you set the active insulin time to two hours, then that gives me the ability to calculate insulin, if I think it's needed, right, that doesn't always mean that you're just gonna get insulin stacked on top of, you know, each other dose on top of a dose every two hours. It just means that gives the algorithm the ability to give correction sooner. And whenever you're giving those auto correction. as frequently as every five minutes, it makes sense to be able to just kind of give the algorithm the freedom to make the decision if it's needed. And anytime I have someone that really wants to debate this, and understand how the algorithm works, I just always have to say, let's just look at the data. And you know, we're not stalking we're not having hypoglycemia in the 10s of 1000s of patients that we have data on.

 

Stacey Simms  19:06

Yeah, it's actually I wish I had a diabetes educator. Maybe this will be for another episode. You are obviously a diabetes educator. But it'd be fun to have somebody else from a different pump company because other pump companies will say no, no, no, exactly. As you're saying like you're stacking insulin. We set it this way for a reason. It's not adjustable for a reason. Is this two hour duration. A different setting from previous Medtronic pumps forgive me? I'm not as familiar with them.

 

Heather Lackey  19:29

You don't know. That's a great question. They see it the same accident one time. Honestly that has been a part of the bolus calculator settings, the bolus wizard and now the smartcard bolus feature that even since the paradigm days, right, when the bolus calculator was first presented, we're now looking at decades ago with the active insulin time. So it's the same setting we've had, but now it's kind of viewed in a different way than Then it has been in the past, right? In the past, it was very traditional, like you're saying and, and kind of how patients will think of it with, you know, whenever I'm in conversation with them, they're like, How can this be. And the simple fact is, with setting the accidents one time, as low as two hours, which is what we see the best control, the best time and range and the lowest time below range, right? So the fueler lows is actually set at two hours. And what that does is it just is a tuning algorithm knob. And it says, Hey, algorithm I'm going to allow you to give, if you determine that it's necessary, meet Insulet. And because you're looking at my rate of change, you're looking at how much insulin is on board, you know, how many grams of carbohydrate that I've entered, it takes all of this information into account and decide if action should be taken. And what lovely is the patient, the person with diabetes that mom, dad, the family, they don't have to make any of those decision, the system is doing it for them.

 

Stacey Simms  21:05

It should have probably started with this question. But what does the algorithm use as a starting base? You know, we're used to traditional insulin pumps where you sit with your educator or your doctor and you say, Here's my basal rate, here's my sensitivity factor or correction factor, or, as we're talking about here, duration, there is a pump in front of the FDA right now that just uses body weight. What is the 780? G use?

 

Heather Lackey  21:26

Yeah, that's a great question as well, algorithm really start with total daily dose of insulin, kind of as it is its starting point, right, the calculation. And that's why whenever you are new on the mini meds 780G system, people have to stay in manual mode. So the kind of the non auto basal in auto correction kind of piece of it. So they stay in manual mode for 224 hour days, right. So it's two days in manual mode. And then there's enough data as a starting point for this system to be able to, to say, Okay, this is a safe basal amount for you to begin with. In addition, if there's sensor glucose tracings, in that 48 hours of kind of that warmup period, to the smart guard feature, then those fasting sensor glucose level pump is looking to see like, how much insulin Do you require, whenever you're not announcing meals and, and so it see, okay, this is your center, glucose is in a fasting state. Now, how much auto Basil is being delivered. And that is kind of the two main pieces of information of how the system decides how much auto basil to begin with, and to deliver,

 

Stacey Simms  22:49

got it, can the user switch back to manual mode,

 

Heather Lackey  22:53

yet, they can, at any time, they can stop the smart guard feature, we know that the data is so overwhelmingly heavy weights heavy on the smart guard side. So we definitely see a major difference in time and range being improved. Whenever people are in this barcard feature versus in manual mode, right? They're always encouraged to say and

 

Stacey Simms  23:16

got it but the system doesn't like. And I hesitate to say it this way. But you'll know exactly what I mean, the system isn't kicking people out as much as one of the very early automated systems for Medtronic, right? That was a big complaint with the 670 was I got kicked out of auto mode.

 

Heather Lackey  23:30

That was a complaint. And we know that whenever the mini med six, seven ad system, the first hybrid closed loop system of its time was a pretty conservative algorithm, right? Because it was first of its kind, Medtronic really had to build on a number of safety precautions. And in many cases that led to those unwanted alerts and alarms and interactions with the pump to keep the system kind of in that auto mode, smart guard auto mode feature. And so with this, we the exits on mini med 780 G system. I mean, they're just not happening, right. And again, though, the number one of two goals of this system was to reduce the daily interactions with the system. So we can't have beats and alerts and alarms. And hey, you have to enter a BG all the time in order to stay in to the automation mode. This is a big difference that people especially those that have been on previous hybrid closed loop systems of all kinds, they're like this is really a pretty big change right? exits at night, exit in the daytime alerts at night. Those are some of the things that are really different from a user lens. Whenever I hear anyone asked my husband, you know, like what kind of from your standpoint In a view, what's the biggest change with you seeing your wife were the minimis 780G system for a while. And he just says, look, it just doesn't wake us up at night. And he just seems to be a little bit more pleased. A lot of surveys that have been conducted all throughout, you know, the countries where people are using and wearing many hats, 7080 G system, you know, it's like 94 95% of people are saying that they're satisfied with the impact on the their quality of life, they're happier with the quality sleep, that's one that's pretty high, ranked and desired by many. So for us to get a good night's rest and to feel confident to go to bed, lay our head down, not have lows or highs not have alerts and alarms. That's the system that we need. And that that's what people are enjoying.

 

Stacey Simms  25:54

One more question about manual mode, a listener had asked me is manual mode usable during the auto mode? In other words, if somebody really feels like they need to do an additional bolus, can they do it?

 

Heather Lackey  26:05

It can be done, but I would kind of ask why do they feel like it needs to be done? Right? Why would you need to go out to manual mode if you need to give an additional bolus. So carbs can be entered at any time that those are consumed? Right, we definitely want to announce our mills. And at any time in the smartguard feature, a patient can always look to see if if they what we kind of say a user initiated correction dose is needed. So you don't you know, I don't ever want people to feel like once I'm in the smart guard feature, guy can't take action. If I see glucose, where I don't want it to be or if I've eaten something that I didn't tell it, you know, go ahead and deliverable list, at least check to see if a bolus should be given. And maybe some of the feedback that patients had on mini med 670 G system where they felt like they had to enter in perhaps kind of ghost carbs or fake carbs when they weren't actually eating them to kind of trick the algorithm to giving more insulin, I think you'll find with now that control that we have able to control on this system like that active insulin times and the auto basal. I don't see that people at all are having to what we say automate the automation? Well,

 

Stacey Simms  27:27

yeah, we let me ask you a follow up on that. Because I don't know anybody who uses an AI D system who just puts in meal boluses and says, Great, I'm always in the range I want to be are you saying that's what's happening with the 780?

 

Heather Lackey  27:39

Well, I'm saying that anytime that you eat in any of the AIP systems, right, you can you can enter those grams of carbohydrate. But because many meds 780G system gives the autocorrection doses starting at anytime, and glucose is over 120 systems. If the auto basal can't handle that glucose response, then they're gonna get it. So because you start you intervene the system intervene early and intervene often, there's less of the need to take matters in your own hand. Right. So it's a different mindset. Really it?

 

Stacey Simms  28:18

Yeah, no, it's absolutely it sounds great. Well, we'll see. When you said meal announcements, to be clear, you're talking about carb counting and putting in the numbers of carbs you're eating, you're You're not just saying I am eating?

 

Heather Lackey  28:31

You're saying I Yes. You're you're entering grams of carbohydrate. Thank you for clarifying going

 

Stacey Simms  28:36

no, I'm just you know, I know it's coming. It's amazing to see how these things are changing. I just want to be clear as we go. Yeah. Well,

 

Heather Lackey  28:42

you know, that's kind of a segue Stacey to a lot of the different thoughts on do people have to now with autocorrection? Do people have to be so precise on the grams of carbohydrate that they're entering into those bits? Okay. Well,

 

Stacey Simms  28:59

let me give you Yeah, let me let's segue into that. Let me give you the best case use that I can make in my house or something like this. I have an 18 year old, he's a great kid. He's very responsible with diabetes. He is terrible about bowling before he eats. It's just it's just not happening. And so we have a lot of, you know, excursions that perhaps don't necessarily need to be happening. I would be thrilled at a more aggressive post meal bolused system. So talk me through what happens to scenarios for you. Somebody has an AD of just throw 85 carbs out there because this happened recently. So somebody has an 85 carb dinner, they bolus five minutes after they finish it. Or somebody has an 85 carb dinner and completely forgets to bolus how does the system handle those things? Oh, yeah.

 

Heather Lackey  29:45

Well, I'd love to show you my report. Because not only does it happen with an 18 year old, it happens with me more than I would like oh my goodness. I plan for 33 years. How am I forgetting to push the button,

 

Stacey Simms  30:01

I love it, you're human, you're human. I'm totally

 

Heather Lackey  30:04

human. So the 85 gram carb dinner, and they bill it five minutes later, right? We know that if you are not giving insulin before the meal, right, you're gonna have food most likely showing up to the party before the insulin arrives, right, so you're gonna have food, their glucose is gonna rise because of the food digest. And then here comes insulin. In that case, we would say, Look, if then, you know, if you're really bolusing, after the meal, you probably are going to need to reduce your meal Bolin, than we have some exact parameters for healthcare providers to kind of discuss with their patients. But you know, on average, it's like, look, probably just dose for, you know, maybe that path in your case, maybe it's not, because as you know, as those is that sensor, glucose starts to rise, the auto basal start to increase, it gets to the maximum, let's say, and then here comes the auto correction. And then you've got insulin, you know, from the bolus still showing up to the party at that point. So what's so great about this system is it knows like, okay, auto Basil is increasing, then there's some, you know, potential auto corrections, as soon as the bullet is given, the system goes, Okay, let's just, let's back off, right, let's see, what's gonna happen with the system before we really just push the pedal to the metal and start giving more correction. Right? So everything is done with the total safety in mind, right, which is something that's so great. Now for the 85 grams of carbohydrate, and they don't bolus at all, well, then that's really what are the auto corrections and the auto basil can shine, that's really where you're going to see sensor glucose is rising. And am I going to say they're never going to go high with an 85 gram carbon bill, I would say that wouldn't be, you know, really unlikely, depending on what what the nutrients are in that food, I would think it was going to be unlikely. And so glucose is going to rise, the system is going to to handle it as as well as it can. But what I can see time and time again, with when mills are skipped, that patients don't go as high and they don't say as high as long. But we have a study that actually support that patient who did zero pole was seeing for a period of time. So this is every single meal for this length of time. And I'd have to look at the report to know exactly the days, but their time and range was just right under that 70% of time and rain. Yeah. And so that's not at all what we are recommending, because we know that if you bolus and you're using the recommended settings, it doesn't matter if you're eight year old, or if you are a 18 year old, or if you're a 58 year old or if you're a 78 year old, we know that for everyone, you can have an upward time and range of 80% plus, right. So we know it's better. And we absolutely want to provide the charge that we should be announcing mil but it's so nice, whenever the occasional I forgot to bolus to you know,

 

Stacey Simms  33:29

sort of occasional

 

Unknown Speaker  33:32

got your back for some more than

 

Stacey Simms  33:36

excellent. I did get this question about the bolusing system, how much of a correction is given? Because on some of these other systems, it's a partial correction. I don't know if you can share that, you know, it's it may be part of the algorithm that you can't share. And then also, how does the system differentiate? Or does it between a missed meal and a random high? You know, a high that may come for another reason?

 

Heather Lackey  33:57

Yeah. Thank you good questions. Okay. So for the repeat the first one, if you don't mind, sure

 

Stacey Simms  34:03

how much of a correction is given, you know, like on the T slim, I think I may not be correct here, but it's something like, you know, once an hour can give 60% of the program to bolus. So is that something that the Medtronic keep some good and maybe proprietary? Well,

 

Heather Lackey  34:16

I can tell you this is the difference with the mini med 780G system is it gives a full correction, you know, if needed every five minutes and every correction bolus, right? It's like if you were giving a correction yourself with a pump, you're going to enter your glucose. The system does the same. It says look, this is where the glucose is. This is where I want it to be. And it's targeting 120 Whenever it's giving a correction dose of insulin, right. That's why after 120 it can start to deliver a correction dose and it looks at the difference and it sees how much insulin is going to be needed. And then it also applies other metrics as well like how much insulin is circulating in the body and And then it determine the safe amount that is going to be needed every five minutes. Got it?

 

Stacey Simms  35:06

Got it. Okay, great. And then the other question is about does the system differentiate between, you know, missing a meal or a high for another reason? And I could think of highs, you know, and teenagers for, you know, hormones or exercise, things like that, does the system differentiate? And I guess the follow up is, does it need to, or is a high, just a high,

 

Heather Lackey  35:24

you know, really high is the high and and that's what's so great about the the system anytime there is a rising rate of change, and you know, parameters are met, that the pump says, Wait a second, this is a rising rate. Oftentimes, it's a meal that's missed right? To meet the parameters. When the system sees that this is Matt, what it does is it allows a correction dose to be delivered even a little bit more aggressively. Right. So you know, it does have a mill detection module built in. It has mill detection technology built in, but it doesn't so much say, Oh, this is your sensor, glucose is rising now because of the meal. So I'm going to act this way. Versus your since your glucose is rising, because you have hormone releasing in the middle of the night and you're sleeping, right. Either way, this system is looking at the sensor glucose response. And if it's corrections need to be delivered in a more aggressive manner, or larger corrections need to be delivered either way, then the system is able to do that. You know,

 

Stacey Simms  36:40

we've mentioned several times that you live with type 1 diabetes. I mean, I know I can talk to you about the pump for probably another two hours. And I hope you'll come back on and we can talk more about it. But I want to ask you about your your journey. You were diagnosed as a teenager, what did you use what was the first diabetes technology, I assume it was a blood sugar meter. coming right back to Heather in just a second. But first Diabetes Connections is brought to you by Dexcom. And Benny has been using the Dexcom CGM for almost 10 years now, that first insertion was in 2013, just before he turned nine. I mean, it was great. Then if you've done finger sticks for a while you know how amazing it is to go from that to continuous glucose monitoring. But it is even better. Now. The Dexcom CGM systems just keep improving, continuing to get more and more accurate with no finger sticks or scanning required. The easy push button insertion has made it easy for Benny to do it himself. He has done every one since we switched to the GS six in 2018, which is really great for his independence back then, as a younger teen. Of course, we still love the alerts and alarms, and that we can set them how we want if your glucose alerts and readings for the G six do not match symptoms or expectations. Use a blood glucose meter to make diabetes treatment decisions. To learn more, go to diabetes connections.com and click on the Dexcom logo. Now back to Heather talking about what things were like she was diagnosed at age 16.

 

Heather Lackey  38:10

Yeah, you know, I was diagnosed in 1990. And of course, I had a meter. The old lancing device that I had was the one that you lay on the table and it's spring loaded and it like warm around like a hammerhead, and it would poke your finger. Right. So that was my first one. And you know, I was just on conventional insulin therapy, right, at least had disposable syringes. I wasn't sharpening a needle or have a glass of orange or anything like that. And you know, for me, Stacy, my parents were so great. My dad worked internationally. And they were just constantly talking to people like what, there's got to be something that right because I was doing everything I could, I mean, I really tried hard. And I have for, you know, three decades, tried hard to really kind of manage things. And they said, you know, there's got to be something better. And that was right at the end was actually before the end of the DCCT trial, when my parents were told, Hey, there's, we've got to get her on something better. We're starting to notice that these multiple daily injections are going to be a lot better. So went to went and started multiple daily injections. And at that point, this was in 1992. At that point, they they the healthcare team said you ought to consider a tump you're you're young your parents have insurance. You guys are certainly kind of wanting to have the best control you should consider a pump and Stacy for cash for seven years. The first seven years after I was diagnosed I did not want an insulin pump to save my life. I wouldn't even think about it until someone said hey, I had gained some weight in college, as many females and male do and I was trying to lose weight exercising to on the elliptical and or the treadmill, either one. And every time I would exercise, I would go low. And every time I would go low, I would have to have juice and peanut butter crackers, or whatever the case was, and I was having more calories than I had exercised off, you know, you can see the counter of your calories that you're burning. And I'm like, This is ridiculous, I'm going to continue to go low, and not be able to trim down my weight some, and I didn't have the right tools. And so that's the reason I started on a pump and then have been on a pump. For the last, I don't know, 2026 27 years, maybe when you

 

Stacey Simms  40:37

used to do a lot of patient training on insulin pumps, I know you still do some now, I'm even in your role here. What are their biggest concerns? You know, there's a lot of mechanical learning if you've never used an insulin pump before. But there's also as you mentioned, there's a reluctance sometimes. Can you share a little bit about what patients tell you?

 

Heather Lackey  40:54

I think the unknown is the biggest thing for patients, right? They don't know if it's surgical, they don't know if it how this goes in how you disconnect, how you're going to get live. The five emphases as I call it, you know, how do you sleep? How do you shower? How do you swim? How do you go in, you know, with exercise and do sports, what happens with intimacy and things like that, you know, those are unknown if you haven't met with a an educator or you haven't had a friend or even a health care provider that's kind of talked to you through that. So I think once people understand how insulin pumps and continuous glucose sensors kind of work inside of our life, and really how easy they are. The trainings are so much more simplified today, because the therapy is so much easier, right? And so I think once they start to see they're starting to put the pieces together, like the technology is working in the background, I don't have to work as hard. Here's the the, you know, two or three things that I have to do change my infusion set once a week, change the sensor once a week, and then I have to enter some grams of carbohydrate, however those grams of carbohydrate are calculated, then they start to understand this is not as big of a deal.

 

Stacey Simms  42:09

All right, I have to go back. You said the five S's and then I kind of heard you editing as you went, you can say six on this podcast. But what were the other ones we had sleep swim.

 

Heather Lackey  42:18

So fleet that were when boarding and zek?

 

Stacey Simms  42:22

That's great. I love that list. That's a great list. All right, before I let you go, I can't let you leave without talking about Purple Hearts, this Netflix movie that you were a consultant on, right? Tell me a little bit about what happened there. This is a character that has type one. And she marries a marine to get benefits health benefits. And it's a very romantic story. How did you come to be a consultant on that? And what was it like? Well, what was so interesting

 

Heather Lackey  42:46

about this, I mean, it was I mean, what a one and a life champ or V I mean, it was really great. The director, or producer, I think it was the director, she had reached out to Medtronic, specifically, because she was, you know, obviously going to be doing this movie, and the hurt. So her team had reached out to Medtronic. And she really wanted to one US product in the movie. But I guess her colleagues and friends and and others that he had talked to whenever she mentioned that this character was going to have type 1 diabetes. They were all like, Yeah, well, we, you know, we've learned that Medtronic pump for, you know, years and years. And so that's why she reached out, right, so reached out to our communications team and our marketing team. And those teams were so great to say, hey, look, they're going to be using a pump and sensor on the set, they might need to have some help. Just making sure that everything is used correctly. And you know, you're always in film, in movies, etc. Whenever I see things being used in an incorrect way. So yeah, so anyway, I was able to go out on the set. And then, you know, one thing just kind of led to another and they were like, well, you know, we're gonna need someone to train. You know, Sophia Carson is the actress. I mean, like, what an amazing thing to be able to beat her and all the other dudes amazing talent on that, that and they were like, Why don't you I mean that you do this? So why don't you just do this in the movie. And I was so happy that that tiny little piece was not cut it, it was such an important thing for my friends and family to be able to see so. And it really does kind of make people with type one I've heard over and over it was kind of cool for the film to kind of walk through people without type 1 diabetes. Like there's a trainee, you know, like, we have to get to understand how to use this equipment. And it's kind of the big day whenever you go on an insulin pump. The coolest thing about the scene that I was in with Sophia Carson, whenever she we finished the scene and she got on the system and we had everything is moving and working at and it was it was there. She was like, Heather, this is amazing that people go through this. And then she was like, gonna give you a hug like this is like I feel empowered having this system on me whenever I'm playing a character that has type 1 diabetes, so it was very organic and natural. And that wasn't anywhere in the script, you know. So it was just a true testament to how powerful technology is and people with diabetes. Five,

 

Stacey Simms  45:31

is there going to be a second one?

 

Heather Lackey  45:32

I have pushed. I have said, I hope that there is everybody wants to know what happened to those two characters. I don't know about it, but I would I would love to see a second movie as well.

 

Stacey Simms  45:45

That'd be great. Well, we will leave it there. Thank you so much for sharing so much of your time with me. I would love to have you back on to talk more about this system. We still have a lot of questions. I'm sure we just scratched the surface. But I really appreciate your time. Thanks so much for sharing so much information.

 

Unknown Speaker  45:59

Thank you Stacey. Have a great day.

 

Stacey Simms  46:05

You're listening to Diabetes Connections with Stacey Simms. Lutz where information with diabetes dash connections.com. I know we didn't get to all of your questions. I will definitely talk to the folks from Medtronic. Again, I thought Heather was really terrific. And she laid everything out. I loved her five S's. But you should also know that the 780 G she mentioned this. It's currently approved for users seven years old and above with type one, they have started taking pre orders that happened in the middle of May, and they will be shipping later this summer. throughout the US. If you have a 770 G, you will be eligible for a free upgrade through remote software. If you want to be notified more, you can go there's a link in the show notes and get their upgrade notification newsletter. So just go to diabetes connections.com Click on this episode's homepage. It'll give you all the information that you need. I'm taking a deep breath because as I have been telling you, my May was bananas. It was wonderful. It was busy and all the best ways. But I mean, I went to Ireland at the beginning of the month. Then I went to New Orleans for my daughter's graduation. Then we had a giant family reunion at my house. So hopefully as you're hearing this, nothing that busy has popped up for the month of June. What I do have on the calendar is the ADA Scientific Sessions conference toward the end of this month. I have never been to this. I've always tried to make it but it's never worked out. So I have immediate pass. I have my microphones packed Well, not yet, really. But I am going to be going and talking to all of these companies. I'll be putting stuff in the Facebook group. So please join Diabetes Connections, the group or sign up for our newsletter. And you can do that at diabetes dash connections.com Because I'm gonna be asking what you want here, who do you want me to talk to what questions you want me to ask. I'm going to try to do a whole bunch of interviews while I'm there and set up a whole bunch more. You can always email me Stacey at diabetes connections.com. I'm super excited about going to this event and really hoping to bring your questions to more of these folks. As I mentioned at the beginning of the show, I am scheduled to talk to beta bionics about the eyelet so that should be next week's episode. And of course we have in the news this Friday to fill you in if there are any more FDA approvals a there's more stuff in front of them. This has been a really interesting year so far, and we're not halfway through. Thank you to my editor John Buchanan, audio editing solutions. Thank you so much for listening. I'm Stacey Simms. I'll see you back here soon until the end. Be kind to yourself.

 

A better lancet in the age of CGM? Why PIP's CEO Josh Pittman says sticks still matter23 May 202300:32:41

When many diabetes tech companies are turning their attention to CGMs or closed loop systems, Josh Pittman has his eye on the basics: lancets. His company PIP, makes a new kind of smaller and thinner device for fingersticks. This week, we talk about why he thinks this is still necessary, why he's passionate about helping people overcome fingerstick fear and what his mother with type 2 taught him about why the basics are so important to long term care.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

 

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"Sixty seconds of help, every single day" - Neil Greathouse has a T1D social media ministry16 May 202300:48:29

On social media, Neil Greathouse is better known as “The Betes.” He posts daily about diabetes on social media. It’s a lot of work – and not his real job. I wanted to know why this is important to him. What is he hoping to accomplish?

There is so much to Neil’s story – he’s become a diabetes educator – and he’s an open book – he’ll share about going into DKA not too long ago, a failed marketing effort with a big diabetes company and much more.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

My first conversation with Neil, from 2017: https://diabetes-connections.com/neil-greathouse-t1d-instagram-inspiration/

Please visit our Sponsors & Partners - they help make the show possible!

Take Control with Afrezza 

Omnipod - Simplify Life

Learn about Dexcom 

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The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:

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Reach out with questions or comments: info@diabetes-connections.com

 

 

In the News.. Senate insulin price hearing, more evidence insulin can be stored at higher temps, cataracts cause in T2D rethought and more!12 May 202300:08:41

It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: The US Senate grills insulin makers about keeping the price where it is, two studies look at the impact of faster-acting insulins, a new study looks out temperature and insulin storage, researchers examine CGM access and health outcomes, and more

Check out Moms' Night Out with three new dates on the calendar!

Please visit our Sponsors & Partners - they help make the show possible!

Take Control with Afrezza 

Omnipod - Simplify Life

Learn about Dexcom 

Check out VIVI Cap to protect your insulin from extreme temperatures

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Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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In the news is brought to you by Moms Night Out - Treat yourself to some time away with other moms who get it. Our next stops this fall in Providence, RI and Frisco TX.
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Our top story this week, big Senate hearing on insulin.. The three insulin makers recently cut their list prices by around 70%. The Senate Committee on Health, Education, Labor and Pensions pressed industry leaders and all three – Lilly, Novo Nordisk and Sanofi - committed to “keeping their drugs affordable,”
But asked whether the companies would no longer raise prices on their existing insulins, only Lilly sai yes. The Sanofi and Novo Nordisk chiefs did not.
Sen. Markwayne Mullin, R-Oklahoma, called PBMs “the fox guarding the henhouse,” going after the executives for essentially “rebating themselves." He said the situation “isn’t working for America.”
“This committee is going to stay on this issue," Senator Bernie Sanders said Wednesday. "We need profound change in the industry and in PBMs."
https://www.fiercepharma.com/pharma/bernie-sanders-led-senate-committee-holds-pharma-chiefs-and-pbm-execs-feet-fire-insulin
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Not a big difference between fast-acting insulin aspart and standard insulin. New study using hybrid closed-loop insulin delivery system found that faster acting Fiasp did not offer any additional glycemic benefits compared with standard insulin aspart – Novolog - and participants had more cases of hyperglycemia with ketosis with the Fiasp.
The study cohort had a baseline HbA1c of 7.2% and a time in range of 63.9% at the start of the trial. Of the cohort, 76% was using a hybrid closed-loop insulin delivery system at enrollment.
There were no cases of severe hypoglycemia or DKA during either intervention.
https://www.healio.com/news/endocrinology/20230508/time-in-range-similar-with-fastacting-vs-standard-insulin-for-young-kids-with-diabetes
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On the other hand, people with type 2 diabetes saw more time in range with faster acting insulin. These were adults with type 2 on basal bolus MDI along with CGM. The insulins here with Lyumjev and humalog.
https://link.springer.com/article/10.1007/s13300-023-01400-w

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New study confirming that insulin doesn’t have to be refrigerated as strictly at package instructions. These researchers took 6 different bands and types of insulins and stored them – quote - unopened for 1–4 months in non-refrigerated conditions in a real-world setting during the summer in India, all compared with control samples of each insulin, which remained refrigerated.
Insulin vials were stored in watertight bags. Bags were placed in either an open plastic container stored on a high shelf or in a cupboard, or in clay pots with a separate water compartment. All storage containers were placed in shaded areas The temperature was measured every 15 min by electronic data loggers. The mean maximum temperatures were between 86 and 94 degrees. Most of the insulin stayed fine for two months and much of it for four months. Every study I talk about is linked up at this episode’s homepage at d-c dot com with more specifics.
https://www.thelancet.com/journals/landia/article/PIIS2213-8587(23)00028-1/fulltext?fbclid=IwAR1J2Y2JLZNHTvlPwtCo7t-wA60zhFMRvx2DEc7sujaFOX1pKc_-RbjhnL0
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Not so shocking conclusion that increasing access to CGMs – regardless of ethnicity and insurance status – can improve outcomes.
Despite higher rates of complications among T1D youths from lower-income backgrounds, diabetes technology is 50% lower among this group. Youths with public insurance have frequent interruptions to CGM access, which are associated with worsening HbA1C trends. Implicit biases and willingness to recommend diabetes technology to youths from underrepresented backgrounds are likely additional contributors to these disparities, according to authors.
Authors concluded the results demonstrated in the study suggest equitable access to CGM soon after T1D diagnosis could be a first step to improve HbA1C for all youths, but acknowledge this access alone is, “unlikely to eliminate disparities entirely.” The authors add broader societal strategies to address structural drivers of disparities in diabetes care are required.

https://www.contemporarypediatrics.com/view/equitable-access-to-glucose-monitoring-improves-hba1c-levels
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Interesting reminder that the seemingly obvious answer isn’t always the right one comes from cataract research..
Cataracts—the clouding of the lens of the eye—are the number one cause of blindness worldwide and are a common complication of type 2 diabetes. The current hypothesis behind diabetic cataract development is coined “the sugar hypothesis” and suggests that high blood sugar—a hallmark of diabetes—precedes cataract development. The working assumptions underlying the sugar hypothesis describe higher levels of glucose in the lenses of people with diabetes convert to a sugar alcohol molecule called sorbitol, which induces structural changes to the lens of the eye that precede cataract development. While unproven, researchers rarely investigate this theory further due to cataracts’ treatable nature.
Now, after some animal studies, it looks like the damage actually starts
before blood glucose rises above normal. The reseahres say it’s still too early to tell what’s going on but they hope ore study will bring the medical community a step closer to understanding the cellular mechanisms underlying the origins of diabetic complications during the pre-diabetic stage of the disease. Then, they say, they can search for ways to better prevent them.
https://scitechdaily.com/sweet-deception-sugar-hypothesis-of-diabetic-cataract-development-gets-an-eye-opening-reality-check/
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Very large study shows that GLP1 receptor agonists—a class of diabetes medications that include Trulicy and Ozempic —are associated with fewer major adverse cardiovascular events than another type of diabetes drug older veterans with no prior heart disease. The second drug type is DPP4 inhibitors with brand names like Januvia and Nesina.
Apparently, the clinical trials showing cardiovascular benefits for these drugs were conducted in people who already had heart disease, so these researchers wanted to see if it would help those who did not. 100-thousand US veterans were included in this study.
The median patient age was 67 years, and the median diabetes duration was 8.5 years. The researchers included variables such as age, sex, race, body mass index, blood pressure, laboratory values like hemoglobin A1c, and history of prior illnesses in the statistical analysis.

https://medicalxpress.com/news/2023-05-diabetes-drugs-adverse-cardiac-events.html
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Ascensia expands it’s Eversense PASS, a Payment Assistance and Simple Savings program designed to enhance affordability and access to the Eversense E3 CGM System. Under the new and improved program, more people with diabetes will be eligible for assistance paying for the system, which now includes increased savings for eligible first time users.
Eligibility for the program has now been extended to all commercially insured people with diabetes across the country, including those who do not have coverage for the Eversense E3 system from their insurance provider.
Eversense is an implanted CGM that lasts six months and has a removable smart transmitter.
https://www.prnewswire.com/news-releases/ascensia-diabetes-care-expands-payment-assistance-and-simple-savings-program-for-eversense-e3-cgm-system-301818639.html
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Right back to the news, but first, I want to tell you about Moms Night Out! In the 16+ years since my son was diagnosed with type 1, I have attended dozens of diabetes conferences and events. Now I’ve taken the best elements from those events and created a brand new experience. We’re going to have lots of diabetes technology for you to see and learn about, stress-relieving social time where you can meet other moms just like you, and speakers who will leave you feeling energized and ready to face the challenges of parenting a child with T1D. We had the first of these in January – I didn’t realize it was the first I actually expect it to be a one and done – but it went to so well and the reaction was so good from moms around the country that I deided to keep going. Our next stops are Frisco TX and Providence RI, back to Charlotte in Feb and more cities to come in 2024. Join us – check out the very top of diabetes-connections dot com or click on the event tab.
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Garmin today announced expanded region availability of the Dexcom Connect IQ apps. Available for a wide range of Garmin smartwatches, the Dexcom Connect IQ app3 provides people with diabetes with a secondary way to view their glucose levels, right from their wrist.
Connect IQ is the app platform for Garmin wearables, bike computers, and outdoor handhelds

https://www.garmin.com/en-US/newsroom/press-release/wearables-health/people-with-diabetes-can-now-view-dexcom-cgm-data-on-their-garmin-smartwatch-or-cycling-computer/
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On the podcast next week.. Neil Greathouse is a familiar face on social media – posting every day as “The Betes.” I’ll catch up with Neil to talk about what motivated this every day connection – he has a real job not in diabetes – and more. Last week I spoke with The Marvelous Mrs Maisel’s Austin Basis about managing T1D on set and off.

That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

"The Marvelous Mrs Maisel" actor Austin Basis manages T1D on (and off) the set09 May 202300:47:04

Actor Austin Basis has a juicy role in this final season of The Marvelous Mrs. Maisel; he plays Alvin, the head writer on the show within the show. Basis was diagnosed with type 1 at age nine back in the 1980s. It was a time before home blood glucose meters, let alone pumps and CGMs.

He shares how he manages T1D during auditions and on the set and of course we talk about Mrs. Maisel! I had questions about the fashion, the plot, all night shoots and how this final season ends.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

My first episode with Austin Basis from 2018: https://diabetes-connections.com/actor-austin-basis-and-the-kinetix/

Please visit our Sponsors & Partners - they help make the show possible!

Take Control with Afrezza 

Omnipod - Simplify Life

Learn about Dexcom 

Check out VIVI Cap to protect your insulin from extreme temperatures

Learn more about AG1 from Athletic Greens 

Drive research that matters through the T1D Exchange

The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:

Sign up for our newsletter here

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Reach out with questions or comments: info@diabetes-connections.com

 

 

"We're focused on bringing more access" Dexcom talks Medicare, G7 updates and more02 May 202300:37:06

Medicare has now expanded coverage for CGM use among people with type 2, in part because of studies by companies like Dexcom. We’ll talk about those findings and learn more about the US release of the G7.

Dexcom Chief Operating Officer Jake Leach gives us information on app updates, talks about CGM for people with type 2 and gestational diabetes, pump integration for the G7, smoothing – and what that means – and a lot more.

More info about CGM and Medicare:

From ADCES: http://www.radiomiw.com/press.html

Dexcom Medicare coverage info: https://www.dexcom.com/en-us/g6-g7-medicare

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Moms' Night Out is back! Three cities are on the schedule:  Learn more 

Please visit our Sponsors & Partners - they help make the show possible!

Take Control with Afrezza 

Omnipod - Simplify Life

Learn about Dexcom 

Check out VIVI Cap to protect your insulin from extreme temperatures

Learn more about AG1 from Athletic Greens 

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Reach out with questions or comments: info@diabetes-connections.com

 

 

In the News... FDA approves Medtronic 780G and Omnipod GO, oral insulin study, overnight hypo treatment trials, and more!28 Apr 202300:08:11

It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: after a long wait, the FDA approves Medtronics 780G and lifts their warning letter, Omnipod GO for people with type 2 gets approved, a look at insulin in pill form, a new way to treat overnight low blood sugars and lots more!

Please visit our Sponsors & Partners - they help make the show possible!

Take Control with Afrezza 

Omnipod - Simplify Life

Learn about Dexcom 

Check out VIVI Cap to protect your insulin from extreme temperatures

Learn more about AG1 from Athletic Greens 

Drive research that matters through the T1D Exchange

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Reach out with questions or comments: info@diabetes-connections.com

 

Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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In the news is brought to you by the T1D Exchange, make your voice heard and drive research that matters
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Buckle up there is a LOT going on
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Medtronic’s Minimed 780G AID system gets FDA approval. This is for people aged 7 years and older who have type 1 diabetes. Medtronic will begin taking preorders on May 15, 2023. Users of the current MiniMed 770G will be eligible for free remote software upgrades.
The 780G is currently available in 105 countries. It has been available in Europe since 2020 and in the UK since 2021. The biggest difference from other systems is that it can automatically administer bolus correction insulin doses every 5 minutes. It will also automatically adjust basal insulin The insulin pump's infusion set can be worn for 7 days, rather than 3 days as with the older system, and the glucose target level can be set as low as 100 mg/dL.
In the pivotal US trial, overall, patients who used the 780G spent 75% of the time in ideal glucose range (70-180 mg/dL) and 1.8% of the time below that range. Overnight, the figures were 82% and 1.5%, respectively. With the glucose target set at 100 mg/dL and active insulin time set to 2 hours, patients spent 78.8% of time in range without increased hyperglycemia.
https://www.medscape.com/viewarticle/991091
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U.S. Food and Drug Administration (FDA) lifted Medtronic’s warning letter sent in December 2021.
The resolution of the warning letter follows ongoing remediation actions from the company and proactive actions to continue to strengthen its quality systems. All regulatory restrictions associated with the warning letter have been resolved.
https://finance.yahoo.com/news/medtronic-diabetes-resolves-warning-letter-203000188.html
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FDA also approved Omipod GO, for people with type 2 who take daily injections of long acting insulin. Insulet says “Omnipod GO was designed to serve the more than three million people using basal insulin or transitioning to insulin therapy to treat their type 2 diabetes”
Omnipod GO is a standalone system that provides a fixed rate of continuous rapid-acting insulin for 72 hours. It’s tubeless and waterproof just like a regular Omnipod but it’s offered in seven different pre-programmed daily rates, ranging from 10 to 40 units per day, and operates without the need for a handheld device to control the Pod. It has been cleared for use with the following U-100 insulins: NovoLog®, Fiasp®, Humalog®, Admelog®, and Lyumjev®.

The product was developed to serve people with type 2 diabetes earlier in their treatment journey by starting them on Pod therapy for their insulin delivery, rather than daily injections. If a patient becomes insulin-intensive, meaning they require both basal and bolus insulin, the transition to another Omnipod product would be seamless.
Omnipod GO will have its US launch sometime next year.
https://www.businesswire.com/news/home/20230424006026/en/Insulet-Announces-FDA-Clearance-of-Omnipod-GO%E2%84%A2-a-First-of-its-Kind-Basal-Only-Insulin-Pod-Further-Simplifying-Life-for-People-with-Type-2-Diabetes
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Senseonics says the first pediatric study participant has received an Eversense 365-day CGM insertion.
The E3 180 day implantable CGM got FDA approval in February last year.
Dr. Francine Kaufman, Senseonics CMO, said expanding to a pediatric population represents a “priority” for the company. Positive results could further extend the company’s reach across the global diabetes community, she added.
The company also intends to utilize study data to submit for an integrated CGM (iCGM) designation in 2023. Senseonics holds an FDA investigational device exemption (IDE) to expand the trial to pediatric patients. These patients — between 14 and 18 years old — first enrolled in the second quarter of 2023.
https://www.drugdeliverybusiness.com/senseonics-first-pediatric-cgm-insertions/
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Baqsimi gets a new home. Amphastar Pharmaceuticals is buying the Glucagon nasal spray from Lilly in a deal worth up to $1.08 billion dollars. Launched in 2019, Baqsimi saw worldwide sales worth $139.3 million in 2022, the companies said. You may remember that Lilly had acquired Baqsimi from Locemia Solutions in 2015. The drug has an active compound glucagon, a form of a hormone produced in the pancreas that stimulates glucose production
https://www.reuters.com/markets/deals/eli-lilly-sell-low-blood-sugar-drug-amphastar-2023-04-24/
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The FDA recently cleared a new experimental drug for type 1 diabetes to begin a phase 2 clinical trial. If approved, the drug would be the first therapy to specifically address low blood sugar at night. We’ve talked about this.. Zucara Therapeutics is testing an oral medication currently known as ZT-01 will attempt to restore the body’s natural ability to respond to low blood sugar levels. Researchers will evaluate the ability of the drug to blunt hypoglycemia caused by insulin in type 1 diabetes.
This phase 2 clinical trial follows positive results from the company’s earlier phase 1 study which included 18 participants with type 1 diabetes who received the treatment. Of these 18, 16 (89%) had a meaningful increase in glucagon production after being given ZT-01, with no serious health events during the trial.
https://diatribe.org/drug-prevent-nighttime-lows-approved-enter-clinical-trials
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The T1D Exchange Registry is a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. The platform is open to both adults and children with T1D living in the U.S. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. The registry aims to improve knowledge of T1D, accelerate the discovery and development of new treatments and technologies, and generate evidence to support policy or insurance changes that help the T1D community. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy.
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Australian scientists have designed a new way to swallow insulin, in a pill form. The design also has potential uses for delivering other protein drugs, such as antibiotics and cancer treatments. Insulin is made of smaller versions of proteins called peptides. Previous attempts to develop an orally administered insulin have found that the severe pH levels in the gastrointestinal tract degrade the peptides, causing the drug to lose its function.
To get around this problem, the scientists encapsulated the insulin in a lipid-based nanomaterial placed inside an enteric capsule. In animal studies, long acting insulin was absorbed better than fast acting. They say long way to go, but an interesting start.
https://newatlas.com/medical/new-insulin-capsule-game-changing-diabetics/
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A new proof of principle study demonstrates the accuracy of Know Labs’ proprietary Bio-RFID™ sensor in quantifying different analytes in vitro, proving a 100% accuracy rate in these tests. The full study is currently undergoing the peer-review publishing process.

“Proof-of-principle studies are critical in demonstrating Bio-RFID’s accuracy for non-invasive methods of medical diagnostics. This was an essential step toward achieving our goal of delivering the first FDA-cleared, truly non-invasive glucose monitoring device to the market”
Know Labs’ technology platform, Bio-RFID, uses electromagnetic energy in the form of radio waves to non-invasively capture molecular signatures, which can be converted into physiologically meaningful information and insights. While the technology is proven to accurately measure several analytes inside and outside the body, the first application of this technology is aimed at non-invasive glucose monitoring.
This study did not include people but researchers say it’s an important step on the way.

https://www.businesswire.com/news/home/20230421005095/en/Know-Labs-Demonstrates-Accuracy-of-Non-Invasive-Bio-RFID-Technology-with-Proof-of-Principle-Study
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Moms Night Out – new cities include Providence, RI, Frisco, TX and Charlotte NC. more info here
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On the podcast next week.. Dexom's Jake Leach brings us up to date on some G7 updates as well as new Medicare coverage for people with type 2. Last week's episode was with the first US commercial pilot with type 1, Pietro Marsala.
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That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

Meet Pietro Marsala, the first US commercial airline pilot with type 1 diabetes25 Apr 202300:45:27

Long thought an impossible, development people with type 1 diabetes are now working as commercial airline pilots. The very first to be certified in the US , Pietro Marsala says he decided to forge ahead while working as a flight instructor, taking inexperienced student pilots up while he was in control.

Pietro will share what happened next, how a mountain of data gradually won of skeptics, his in flight diabetes routine and what he’s up to now. You might be a passenger on his next flight!

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Follow Pietro on Instagram: https://www.instagram.com/flytype1/?hl=en

FAA requirements for pilots who dose insulin: https://www.faa.gov/ame_guide/dec_cons/disease_prot/itdm

More about Pietro Marsala: https://www.healthline.com/diabetesmine/first-commercial-pilot-type-1-diabetes

 

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In the News...Does insulin use differ by gender? T1D & Covid update, fully implantable CGM studied, and more!19 Jul 202400:09:21

It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: A new study looks at insulin needs in men vs women, updates on stem cell transplants and a new look at COVID 19 and T1D plus a fully implantable CGM is announced. We'll also tell you about a T1D athlete drafted to the MLB. Lots more in this week's episode, full transcipt below. 

Find out more about Moms' Night Out 

Please visit our Sponsors & Partners - they help make the show possible!

Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)

Omnipod - Simplify Life

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Episode transcription with links:

 

Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now.

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In the news is brought to you by Edgepark simplify your diabetes journey with Edgepark

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Do men and women have different insulin requirements? A new study conducted across Europe says yes – women overall need less. Published in the Journal of Diabetes Science and Technology this looked at over 9,000 adults with type 1 diabetes using data from patients using the Diabeloop Generation 1 (DBLG1) hybrid closed-loop pump system.

In this study, women needed 14-percent less insulin overall than men. These researchers say these findings have important implications for the practical management of insulin therapy and highlight the necessity of considering gender as a crucial factor in diabetes treatment. The treatment guidelines provided by American and European Diabetes Societies do not currently have gender-specific recommendations for insulin-weight ratios.

The co-founder and Chief Scientific and Technical Officer for Diabeloop. “This study also highlights the capacity to discover new insights from big-data analysis of real-world data.”

*Insulin Requirements According to Gender and Weight in a Population of 9036 Adult Persons With Type 1 Diabetes Using Closed-Loop Insulin Delivery, https://doi.org/10.1177/19322968241252366).

https://www.theglobeandmail.com/investing/markets/markets-news/GetNews/27419187/diabeloop-study-reveals-significative-gender-differences-in-insulin-requirements-for-type-1-diabetes-patients/

 

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New drug therapy in those lucky diabetic mice boosted insulin-producing cells by 700% over three months, effectively reversing the disease.

Scientists at Mount Sinai and City of Hope have been able to grow new beta cells in the body, in a matter of months.

The therapy involved a combination of two drugs: one is harmine, a natural molecule found in certain plants, which works to inhibit an enzyme called DYRK1A found in beta cells. The second is a GLP1 receptor agonist. The latter is a class of diabetes drug that includes Ozempic,

The researchers tested the therapy in mouse models of type 1 and 2 diabetes.. The signs of the disease quickly reversed, and stayed that way even a month after stopping the treatment.

 

The results are intriguing, but of course being an animal study means there’s still much more work to be done before it could find clinical use. So far, harmine alone has recently undergone a phase 1 clinical trial in humans to test its safety and tolerability, while other DYRK1A inhibitors are planned for trials in humans next year.

https://newatlas.com/medical/diabetes-reversing-drug-boosts-insulin-producing-cells/

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Stem cell–derived beta-cell replacement therapy continues to show benefit in people with type 1 diabetes at a high risk for severe hypoglycemia. New info from Vertex shows that of a total 17 patients who received a full dose of their  investigational allogeneic stem cell–derived, fully differentiated pancreatic islet cell replacement therapy (VX-880), three, thus far, have achieved the primary study efficacy endpoint of elimination of severe hypoglycemic episodes with A1c < 7% at 1 year and the secondary endpoint of insulin independence.

Others are on the same trajectory, Piotr Witkowski, MD, PhD, professor of surgery at The University of Chicago, Chicago, said at the recent American Diabetes Association (ADA) 84th Scientific Sessions. In his presentation, Witkowski also provided details about the deaths of two study participants that the company had announced in January 2024, neither of which were related to the VX-880 product.

In fact, there have been no severe adverse events related to the product itself, with most due to either the infusion procedure or the immunosuppression. "These data highlight the curative potential of VX-880 in people living with type 1 diabetes and support further evaluation of VX-880 toward pivotal development," Witkowski said.

For now, patients selected for the study are those who experience frequent severe hypoglycemia deemed to be a greater risk to the patient than that of immunosuppression.

However, Ahn pointed out, "With VX-880, the obvious fly in the ointment is the need for immunosuppression which carries significant risk…There are multiple solutions being proposed, but we are still waiting for data as promising as the initial Vertex data is on that front."

https://www.medscape.com/viewarticle/stem-cell-derived-islets-continue-show-benefit-t1d-2024a1000cx1

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Still lots of COVID studies coming in about type 1. A German study suggests COVID 19 may speed up progression of existing but presymptomatic T1D in kids.

These researchers had been screening and following children in an early presymptomatic stage of type 1 diabetes for several years. They noticed an increase in the numbers of Incidence of clinical type 1 diabetes nearly doubled after the pandemic started.

"We know that the virus can infect the pancreatic islets so it could be causing damage or change in the beta cells that make insulin," said Ziegler when discussing possible mechanisms behind this association. "Second, there is generalized inflammation during the infection and there may be a stimulation of the immune response. Third, there could be metabolic stress from the infection that affects the beta cells that make insulin.

To dive into this topic, youth were identified in the German Fr1da-screening program from 2015 to 2023. All patients had presymptomatic diabetes defined as persistent, confirmed positive results for two or more islet autoantibodies. Their progression was monitored at 3- to 6-month intervals. Clinical type 1 diabetes was defined according to American Diabetes Association

 

COVID infection was either self-reported via the family or identified with SARS-CoV-2 antibodies were confirmed in blood samples collected at study visits.

 

Vaccination against COVID-19 may be one way to protect presymptomatic type 1 diabetes youth from progression, Ziegler added. She said her group is currently testing whether COVID-19 vaccination can reduce new-onset, presymptomatic type 1 diabetes in a clinical trial  of children with genetic risk factors for the condition.

https://www.medpagetoday.com/endocrinology/type1diabetes/111084

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The FDA says no – for now - to Novo Nordisk's weekly insulin.  This has been approved in Canada and should be available there shortly. But the FDA says it wants more information related to the manufacturing process and the type 1 diabetes indication to complete the review.

Novo said it does not expect to be able to fulfil the requests this year, and that it will work closely with the FDA regarding the next steps.

The regulator's decision follows its outside panel's vote against the use of the weekly insulin icodec, in patients with type 1 diabetes due to risks of low blood sugar.

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-declines-approve-novo-nordisks-weekly-insulin-2024-07-10/

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A couple of weeks ago we spoke to the attorneys taking on CGM monitronig in schools. They’ve helped a family in Connecticut and set a precdent.  A child with autism and diabetes was not getting reasonable accommodations under the federal Americans with Disabilities Act in a public preschool program. I’ll link up the press release from the DOJ but this family wasn’t getting any support and it just wasn’t safe. The lawyers here tell me the ruling and settlement is just going to help them going forward as they try to make schools complient with CGM as a reasonable  accomodatin.

https://www.justice.gov/usao-ct/pr/aba-therapy-provider-make-changes-comply-americans-disabilities-act

 

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Ozempic could lower the risk of dementia and a range of other mental problems compared with other existing treatments for patients with diabetes. What’s more, researchers found that Ozempic cut nicotine dependence in those patients.

 

This study relied on medical records from more than 100,000 U.S. diabetes patients, including more than 20,000 who were prescribed semaglutide between December 2017 and May 2021.

After a year, patients who took Ozempic had a 48% lower risk of developing dementia than those on Januvia. The risk in Ozempic patients was also 37% lower than those who took Glucotrol and 9% lower than those on Jardiance.

Notably, previous research has determined that diabetes patients are at a greater risk of developing dementia.

But the authors emphasized that the analysis is observational. The results need to be replicated in a controlled trial that assigns patients to randomly take Ozempic and the other drugs, according to Dr. Max Taquet, another Oxford clinical lecturer and senior study author.

https://www.cnbc.com/2024/07/16/healthy-returns-ozempic-may-lower-dementia-risk-nicotine-use.html

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Edgepark Commercial

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The Omnipod 5 with Dexcom G7 integration is now available through select pharmacies with full availability expected in the fall.

 

The System uses new Pods that are compatible with both Dexcom G6 and G7, but the prescription code will stay the same as the current Omnipod 5 Pods. This means the community will have similar insurance coverage and access to what they have with Omnipod 5 today.

 

If you're looking to start on Omnipod 5 and you're currently using Dexcom G7, your doctor will need to send a prescription for both the Omnipod 5 Intro Kit and Omnipod 5 Pods, compatible with Dexcom G6-G7, to ASPN Pharmacies.

 

You can learn more at https://www.omnipod.com/innovation/dexcom-g7.

 

If you are already using Omnipod 5, you will get the new Pods compatible with Dexcom G6 and G7 through your Pod refills. You do not need a new prescription. The week of July 29th, you will receive a free software update for the Omnipod 5 App to your Controller or compatible Android smartphone which is needed to use the System with Dexcom G7. Accept the update. We recommend you continue to use your current Omnipod 5 Pods and Dexcom G6 supplies until the new Pods compatible with Omnipod 5 with Dexcom G6-G7 are available at your preferred pharmacy.

 

We'll email our users when the new Pods are available in most pharmacies.

 

You can learn more at

https://www.omnipod.com/innovation/new-compatible-devices

 

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Big promises about long-term implantable blood glucose monitor from a company called Focus. They say they’re partnering with Glucotrack to quote - transform how people with diabetes interact with their condition.

They’re not calling this a CGM – rather it’s a CBGM, continuous blood glucose monitor because it will measure glucose levels in blood, not in interstital fluid like CGMs do. They company says this is a fully subdermal location, with no external wearable. In preclinical studies, the CBGM has a MARD of 4.7% at day 90. That is MUCH lower than CGMs on the market – Dexcom and Libre are in the low 8s right now. BUT.. it hasn’t been fully tested in people yet. Human clinical trials are set to start later this year.

https://www.drugdeliverybusiness.com/focus-collaborates-glucotrack-implantable-cbgm/

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Big congrats to Jamie Ferrer (Chy-may Fer-rare)

On Monday, Ferrer’s dream was realized when the Twins selected the Florida State outfielder in the fourth round (No. 126 overall) during Day 2 of the MLB Draft. Minnesota vice president of amateur scouting Sean Johnson said the club had its eyes on Ferrer since high school.

“Recently, I was in Orlando at a conference called, “Friends for Life with CWD [Children with Diabetes],” and we had an event that was a sports day. … Kids would come up to me and either them or their families would ask me how I dealt with this [or that],” Ferrer said. “And seeing their faces light up whenever I said I was diagnosed at three and I played college baseball. … You hear people tell you no and that you can’t do this because you have Type 1 diabetes … So why not inspire as many people as I can?”

 

“I’m super proud of being a Type 1 athlete, and it’s something that I’ll never shy away from talking about or showing off my insulin pump because it’s who I am and it’s something that I’ve had to deal with my entire life.”

https://www.mlb.com/news/jaime-ferrer-selected-no-126-overall-by-twins-in-2024-mlb-draft

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Join us again soon!

How "A Tad Too Sweet" founder Jisel Parra found her diabetes community18 Apr 202300:37:32

Jisel Parra had a rocky start with diabetes – as a teen her type 1 was initially misdiagnosed and she struggled with support and mental health. But she found ways to find community and gradually started to thrive with T1D. These days, Jisel runs A Tad Too Sweet, which makes trendy medical bracelets. She has a career outside of diabetes and has two children.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Please visit our Sponsors & Partners - they help make the show possible!

Take Control with Afrezza 

Omnipod - Simplify Life

Learn about Dexcom 

Check out VIVI Cap to protect your insulin from extreme temperatures

Learn more about AG1 from Athletic Greens 

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The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:

Sign up for our newsletter here

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Reach out with questions or comments: info@diabetes-connections.com

 

 

In the News... Abbott Libre reader recall, Medicare CGM coverage expands, T1D young adult study and more!14 Apr 202300:09:21

It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: Abbott recalls Freestyle Libre readers (not the sensors, see below for more information), Medicare expands CGM coverage for  more people with type 2, a new study looks at the transition for children with T1D to adults and why patients aren't being served well during that time, and much more!

Please visit our Sponsors & Partners - they help make the show possible!

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Omnipod - Simplify Life

Learn about Dexcom 

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Learn more about AG1 from Athletic Greens 

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Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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In the news is brought to you by Athletic Greens AG1 by Athletic Greens is daily nutrition made really simple.
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If you’ve got an Abbott Libre reader – check it for a huge recall. The company is issuing a class one – that’s the most serious -recall of all readers distributed in the U.S. from November 2017 to February 2023, totaling more than 4 million devices.

The recall is due to the potential overheating, sparking, or fire that may occur when the readers are charged with non-Abbott adapters or USB cables, or when they are damaged or exposed to liquids. Abbott-provided USB cables and power adapters limit the current to safely charge the battery, whereas third-party cables and adapters may allow much higher power, increasing the risk of fire.

Abbott has reported 206 incidents related to this issue, including at least seven fires and one injury, but no deaths. I’ve got the phone number to call and more information in the show notes at d-c dot com.
This recall only applies to those using the external reader device, not those using their smartphone.
Contact Information
Users with questions about this recall should contact Abbott Customer Service at 1-855-632-8658, available 7 days a week from 8AM to 8PM Eastern Time, excluding major holidays.

https://www.fda.gov/medical-devices/medical-device-recalls/abbott-recalls-readers-used-freestyle-libre-freestyle-libre-14-day-and-freestyle-libre-2-flash
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A big policy change coming next week - The Centers for Medicare and Medicaid Services will expand continuous glucose monitor coverage to more people with type 2 diabetes. That starts April 16th, this Sunday if you’re listening as the episode first drops.
The expanded coverage applies to people using a basal only routine, as well as others who have a history of what has been classified as “problematic hypoglycemia.” Bottom line for those with type 2 – check with your doctor to see if a CGM is now covered
October.https://diatribe.org/medicare-expands-cgm-continuous-glucose-monitor-coverage-type-2-diabetes

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Montana lawmakers are considering a bill that would require insurance companies to cover CGMs for people with Type 1 and Type 2 diabetes.
House Bill 758 has broad support from lawmakers, but it faces opposition from insurance companies and some providers. That opposition focuses on the cost, whether a CGM is medically necessary at all stages of diabetes, and the possibility that CGM manufacturers will raise their prices if there is an insurance mandate.
Blue Cross and Blue Shield of Montana, the state’s largest insurer, estimates the bill, if passed, would cost the organization nearly $5 million a year. The BCBS spokesperson also says ““These things are a convenience,”

https://khn.org/news/article/montana-potential-bill-insurance-covering-continuous-glucose-monitor/
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Short-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) was associated with an increased risk for heart failure hospitalization among patients with type 2 diabetes (T2D), according to a Danish registry study.

Among over 300,000 patients with T2D, short-term use of NSAIDs was associated with a relative 43% increased risk of a first-time heart failure hospitalization in the subsequent 28 days. NSAIDs increased the risk of heart failure even more in type 2 diabetics who were 80 or older (78%) or who had high blood sugar levels (68%), the results showed. Those who'd never used an NSAID before had the worst reaction, with their heart failure risk nearly tripling. However, heart failure was not associated with using NSAIDs in people with well-controlled diabetes and normal blood sugar levels.
https://www.medpagetoday.com/cardiology/chf/103936
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New study from Boston Children’s Hospital shows the transition from child to young adult managing type 1 is a pretty fraught time.
routine outpatient care for type 1 diabetes decreased between ages 16 and 24. At the same time, emergency room visits to treat the condition increased for that age group.

The study raises the concern that young adults lack a “medical home” with an endocrinologist and instead may be seeking routine care such as insulin prescription refills from an emergency department (ED), Garvey says. If anything, the research supports the idea that endocrinologists should have an integral role in diabetes management for young adults, she says, and illustrates how specialized care may prevent the need for acute care in hospitals.
The data here showed that annual endocrinologist visits declined from 2.3 per year at age 16 to 1.5 per year by age 24. This data stands out, Garvey says, because previous research has shown endocrinologists are the main providers of type 1 diabetes care for most young adults with the condition.
These researchers hope the study can serve as a launching point for endocrinologists to assess how they can help young adults better manage type 1 diabetes
https://answers.childrenshospital.org/self-care-of-diabetes/
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The past few years have seen numerous advances in the understanding of how type 1 diabetes develops and how to manage it, yet the global disease burden remains high, according to a review article published April 5 in The Lancet.
The authors cite data related to diabetes control in youth and adults from the T1D Exchange demonstrating that only 21% of adults with type 1 diabetes have an A1c (a blood test that reflects a 90-day sugar average) of 7.0 or lower.
While type 1 diabetes is the third most common disease of childhood, there should be greater awareness of adult onset of the disease. The paper references data from the UK Biobank indicating that up to 40% of type 1 diabetes diagnoses occur in people over age 30.
, the paper notes that racial and ethnic disparities persist and insulin pump usage is lowest at 18% among non-Latinx Black populations compared with 72% among non-Hispanic white people and 40% among Hispanic populations.
The paper also reports that inhaled insulin – brand name Afrezza - has demonstrated a fast onset of action, improving the ability to control glucose after meals.
https://medicalxpress.com/news/2023-04-global-diabetes-burden-high-advances.html
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A research team led by the University of Michigan Health Department of Neurology followed more than 120 patients who underwent bariatric surgery for obesity over two years after the procedure. They found that all metabolic risk factors for developing diabetes, such as high glucose and lipid levels, improved outside of blood pressure and total cholesterol, according to results published in Diabetologia.

Investigators also found that patients two years removed from bariatric surgery showed improvements in peripheral neuropathy, a condition marked by damage to the nerves that go from the spinal cord all the way to the hands and feet.
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Obesity is the second leading risk factor for peripheral neuropathy after diabetes, which affects more than 30 million Americans.
https://medicalxpress.com/news/2023-04-bariatric-surgery-reverse-diabetes-complications.html
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Athletic Greens
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As of April 12, 2023, Panbela Therapeutics has officially begun their Phase II double-blind, randomized study to assess the effectiveness and safety of CPP-1X-T for recent onset type 1 diabetes (T1D). The study will involve enrolling 70 patients across six different centers in the United States, with Indiana University leading the trial. The first patient has already been enrolled, which has led to a boost in the company’s stock prices.

Panbela Therapeutics is a clinical-stage biopharmaceutical company that specializes in developing innovative therapies for cancer patients and those with other urgent medical needs. They have recently completed a clinical trial of ivospemin, a treatment for locally advanced or metastatic pancreatic cancer. The company also acquired Cancer Prevention Pharmaceuticals in June 2022, a clinical-stage biopharmaceutical company that focuses on developing therapies to prevent cancer and rare diseases.

CPP-1X-T is one of the drugs that Panbela Therapeutics is currently developing. This drug has shown potential complementary activity with the FDA-approved treatment for pancreatic cancer and is being evaluated for the treatment of T1D in the Phase II clinical trial. The company’s shares have been fluctuating in recent months due to various factors, including the progress and results of their clinical trials.

https://beststocks.com/panbela-therapeutics-begins-phase-ii-clinical/

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Type 1 Diabetes Conference & Community
For people living with type 1 diabetes of all ages where they can find:

Information, Motivation, And Inspiration To Thrive With Type 1 Diabetes
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The book!
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On the podcast next week.. Jisel Parra was diagnosed as a teenager and it couldn’t have gone worse – they didn’t prescribe insulin initially, she struggled with getting the right and with her mental health.. but now she makes medical jewelry and tags with her company A Tad Too Sweet. I’m excited for you to hear her story. Last week, Dr. Bryce Nelson on Tzield.
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That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

"I want to make this a priority" - A doctor's perspective on Tzield12 Apr 202300:44:59

Dr. Bryce Nelson is one of the first doctors in the country to administer the new Tzield to delay the onset of type 1. He’s been involved with TrialNet, identifying those who have the genetic markets for T1D and says that research was exciting but frustrating because they had no treatment. Now, they're looking at a possibly new way of talking about T1D.

Dr. Nelson is the Chief of Endocrinology at Children’s Hospital of Richmond at VCU

Dr. Nelson takes us through the process of using Tzield – which was researched under the name teplizumab – from identifying the patient, to treatment to what happens next. His first patient, William Troutman, is a North Carolina teenager. William's mom joined me a few weeks ago to tell their side of the story.

Listen to our episode with Amanda Troutman: https://diabetes-connections.com/delaying-a-t1d-diagnosis-with-tzield-a-deep-sigh-of-relief-for-a-little-while/

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

 

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BD spinoff Embecta looks to build on 100 years of diabetes technology04 Apr 202300:26:44

This week… one of the oldest diabetes companies is looking ahead – Once part of BD, makers of needles and syringes, Embecta is now working on new technology like a patch pump. I’m talking to CEO Dev Kurdikar about moving the company forward, while still serving the patient community that relies on their established technology.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

 

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Managing "Overwhelming Chaos" - when a child is diagnosed with more than T1D28 Mar 202300:36:13

Dr. Maureen Michele is a pediatrician whose daughter had already survived a cancer diagnosis, when she was later diagnosed with 1 diabetes. In fact, Dr. Michele knew enough to test for T1D, so mom and daughter found out together, in the school bathroom. The family is now on the other side of what she calls this overwhelming chaos.. and what they’ve learned can help others..

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Maureen's Book: Reclaiming Life

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In the News... Sanofi buys Provention, Insulin price update, New surgery trialed for T2D and more!24 Mar 202300:08:15

It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: Insulin-maker Sanofi lowers its prices and also acquires Provention, clinical trials begin on an out-patient surgery that could help treat type 2 diabetes, a swimmer DQ'd for the tape on his CGM gets the systemic changes he'd pushed for and more!

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Episode Transcription:

Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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In the news is brought to you by Athletic Greens ● AG1 is way more than greens.
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Provention Bio’s been in a news a lot lately after the approval of Tzield to delay the development of type 1. Now French insulin-maker Sanofi has agreed to acquire it. The deal builds on an existing co-promotion agreement and gives Sanofi full ownership of the drug. Sanofi makes long acting Toujeo and Lantus.
Interestingly, Sanofi has said they’re gong to stop further work on type 2 diabetes and obesity drugs.
They also joined Novo Nordisk and Eli Lilly in dropping the price of insulin in the US.
https://www.reuters.com/markets/deals/frances-sanofi-acquire-us-based-provention-bio-29-bln-2023-03-13/
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Insulin pricing staying in the news as Senators Bernie Sanders and Cori Bush introduced legislation to cap the price at 20-dollars. They point out the recent prices cuts don’t apply to everyone and are still at the whim of the manufacturers.
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California signs up with Civica Rx to produce its own insulin and sell it at an affordable price. The $50 million investment will allow California to produce insulin to be sold at prices capped at $30 per vial and $55 for a box of five prefilled pens, Civica Rx said (PDF) in a release. The agreement is part of the state’s CalRx Biosimilar Insulin Initiative.
Utah-based Civica Rx is a nonprofit, social welfare manufacturer of generic drugs. This is a long way off.. Civica Rx still needs to gain approval for its biosimilar versions of Sanofi’s Lantus (gargline), Eli Lilly’s Humalog (lispro) and Novo Nordisk’s Novolog (aspart).
The cost of insulin would be same for all patients regardless of their insurance situation
https://www.fiercepharma.com/manufacturing/california-invests-50m-partner-civica-rx-insulin-manufacturing
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Millions of Americans with diabetes have cheered as drugmakers slashed the price of insulin, the lifesaving medication that treats the chronic disease.

But those lower prices, which came amid government pressure to cap insulin costs and more competition from generics and biosimilars, are only one part of the cost of treating the disease, which causes elevated blood sugar that can damage the heart, eyes and kidneys if untreated.

Over-the-counter medical supplies to monitor glucose levels and administer medications can make up the largest portion of a patient’s costs. A 2020 JAMA Internal Medicine report found that children and adults with private health insurance spent more out-of-pocket on diabetes-related supplies than on insulin A person with diabetes who uses insulin typically spends $4,882 a year on treatment if they have insurance. Of that, $3,992 is spent on supplies, according to an analysis by GoodRx, or more than 80% of the annual expense of managing the disease
https://www.usatoday.com/story/money/personalfinance/2023/03/19/cost-diabetes-supplies-worse-than-insulin/11472381002/
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New trial of a technique to slow the progression of type 2 diabetes. It’s a simple outpatient surgery conducted in the early stages of diagnosis.
The procedure targets the doo-oh-DEE-num duodenum, the first section of the small intestine just past the stomach. This organ plays a key role in digestion, including regulating insulin and blood glucose levels. In patients with type 2 diabetes, the cells that line the duodenum have become damaged, and the trial’s hypothesis is that removing these cells helps healthy ones to grow back, improving the regulation of blood glucose levels.

Patients in the clinical trial would undergo an endoscopy to insert a device into the doo-oh-DEE-num duodenum, which removes those dysfunctional cells with a series of electrical pulses. The procedure itself is only minimally invasive – it takes about an hour, it’s conducted under a general anaesthetic and the patient is discharged the same day.
Early results seem encouraging. Patients who have undergone the procedure in recent months have already seen their blood glucose levels drop. BTW if you live near L-A they’re still recruiting for this. You have to have a type 2 diagnosis and not yet need insulin injections.
https://newatlas.com/medical/diabetes-prevent-slow-progression-procedure-clinical-trial/
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Another study showing automated insulin delivery systems work well and are safe, this one the Tandem Control IQ in little kids. That’s only approved right now for kids as young as six.. this study looked at children ages two to six. The hybrid closed-loop system added an average of about 3 hours in ideal blood glucose range over the 13 weeks, compared to no change with standard care.
Standard care here meant either an insulin pump or multiple daily injections plus a separate Dexcom G6 CGM.
https://www.medscape.com/viewarticle/989673
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Follow up! Two years ago we told you about Ethan Orr, a Colorado high school swimmer disqualified at a state meet because of the tape over his CGM. Orr’s family filed a complaint with the department of justice and the US Attorney in Colorado took up the case. They weren’t seeking any financial damages, just a change in policy, which they got. The changes include allowing medical tape with documentation, a way to evaluate requests from students with disabilities who might need reasonable modifications of rules, and a way for refs or coaches to seek on the spot reasonable modifications.

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“I knew I’d have to fight my disease to swim, but I never imagined I’d have to fight discrimination to swim,” Ethan said, according to the news release from the law firm.
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Athletic Greens
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Today, JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization, presented the inaugural Mary Tyler Moore Awards to three women leaders in Congress who have been instrumental in the fight against T1D. U.S. Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH), co-chairs of the Senate Diabetes Caucus, were honored alongside Representative Diane DeGette (D-CO), co-chair of the Congressional Diabetes Caucus, for their longstanding support of the T1D community. The ceremony, held during JDRF's annual Government Day, honored the legacy of screen icon Mary Tyler Moore, who was diagnosed with T1D at the age of 33. As international chairman of JDRF from 1984 to 2017, Moore used her influence to bring government, scientists and people living with diabetes together to further T1D advocacy and innovation.

JDRF (PRNewsFoto/JDRF)
JDRF (PRNewsFoto/JDRF)
One of Moore's most significant achievements as JDRF international chairman was increased Congressional funding for the Special Diabetes Program at the National Institutes of Health that has accelerated the pace of type 1 diabetes research. This long-term investment in diabetes research has led to significant scientific breakthroughs including Tzield, the first disease modifying treatment for T1D which can delay the onset of the disease by over two years. JDRF Government Day volunteers, more than 175 T1D advocates from across the country, will encourage members of Congress to renew the Special Diabetes Program when they visit lawmakers later today on Capitol Hill.
https://finance.yahoo.com/news/jdrf-presents-inaugural-mary-tyler-110000226.html
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On the podcast next week..
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That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

"The most options possible" - Tandem Diabetes plans for a second integrated sensor and a smaller pump21 Mar 202300:43:39

When the FDA cleared the 3 FreeStyle Libre 2 and FreeStyle Libre 3 (iCGM) system sensors for integration it meant a big leap forward to interoperability. For the first time in the US, insulin pumps can work with two different sensors.. Libre and Dexcom. This week, Stacey talks to Dr. Jordan Pinsker, medical director for Tandem Diabetes Care, about the upcoming Libre integration, the Mobi pump that's in front of the FDA right now, and much more. Dr. Pinsker has extensive experience with automated systems – he’s been there since close to the beginning and we talk about the long process to bring them to market, how they’re changing lives and what is still yet to come.

More about the Libre approval: https://beyondtype1.org/freestyle-libre-aid-clearance/

More about Dr. Pinsker: https://www.tandemdiabetes.com/providers/bio/jordan-pinsker

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Please visit our Sponsors & Partners - they help make the show possible!

Take Control with Afrezza 

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Learn about Dexcom 

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T1D is an "All Day Game, Every Day" - Author & Advocate Ginger Vieira14 Mar 202300:34:44

Ginger Vieira is here to talk about her new book – she’s written on everything from pregnancy with diabetes to exercise to her new series of children’s books. But she’s such a well-versed advocate, I had to ask her about her work at the T1D Exchange and all about her use of Afrezza. Why does she love it so much and what does she want you to know about using inhaled insulin?

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

More about Ginger: https://www.gingervieira.com/

Diabetes Doodles: https://diabetesdoodles.com/

Please visit our Sponsors & Partners - they help make the show possible!

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In the News.. Insulin price update, Libre approved for AID systems, Medicare expands CGM coverage and more!10 Mar 202300:09:23

It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: learning more about Lilly's plan to lower the price of some insulins, Abbott's Libre 2 and Libre 3 get FDA approval to work with automated insulin delivery systems like Control IQ and Omnipod 5, Medicare expands coverage of CGMs for people with type 2, an old blood pressure medication shows promising results in a T1D study, and more!

 

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Episode transcription:

Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now

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In the news is brought to you by Athletic Greens

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Insulin prices

https://www.statnews.com/2023/03/06/eli-lilly-insulin-medicaid-rebates/

Drugmaker Eli Lilly & Co.

on Wednesday said it will cut prices of its most commonly prescribed insulins by 70% and cap monthly out-of-pocket costs at $35 at certain retail pharmacies for people who have private insurance.

 

Lilly will list its Lispro injection at $25 a vial effective May 1 and slash the price of its Humalog and Humlin injections by 70% starting in the fourth quarter.

 

The announcement comes amid growing federal pressure to lower the cost of insulin. The Inflation Reduction Act capped insulin prices for Medicare beneficiaries at $35 per month but did not protect people with private insurance or who don’t have coverage from higher prices.

Eli Lilly would’ve had to pay Medicaid about $150 for each vial of insulin used in the program if it hadn’t dramatically cut the list prices for some of its older products this week.

The company was about to run into a Medicaid penalty for raising the price of it’s drugs faster than the rate of inflation.

https://www.cnbc.com/2023/03/01/lilly-cuts-insulin-prices-70percent-cap-prices-at-35-per-month-for-private-insurance.html

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The FDA has cleared Abbott's Freestyle Libre 2 and Libre 3 continuous glucose monitors (CGM) for integration with automated insulin delivery (AID) systems. These devices have also been cleared for younger children, extended wear time, and for use during pregnancy.

 

The FDA on March 6 cleared Abbott’s Freestyle Libre 2 and Freestyle Libre 3 CGM for use with automated insulin delivery (AID) systems.

 

AID systems connect a CGM, insulin pump, and smartphone to automatically adjust insulin dosing in real-time in response to changing glucose levels. These systems have been demonstrated to help many people with diabetes improve their time in range and reduce the time spent thinking about managing glucose each day.

 

With this new clearance from the FDA, Libre 2 and 3 CGMs and the connected smartphone app will soon integrate with insulin pumps to adjust insulin dosing.

 

Freestyle Libre 2 and Libre 3 CGMs were previously cleared for use by people with diabetes ages 4 and older. Freestyle Libre 3, cleared in the United States in May 2022, is compatible with both iOS and Android smartphones. Among several upgrades made from Libre 2, Libre 3 no longer requires users to manually scan their device with their smartphone to see glucose levels – data is sent to the mobile app automatically.

 

In the announcement, Abbott said the device has also been cleared for an extended wear time of 15 days, for use by children as young as age 2, and for use during pregnancy by women with type 1, type 2, or gestational diabetes.

 

Current users of Libre CGMs should note that the devices available now cover people with diabetes ages 4 and older, can be worn for 14 days, and are not cleared for use during pregnancy. According to Abbott, the modified Libre 2 and 3 sensors will be available in the U.S. later this year.

https://diatribe.org/fda-clears-freestyle-libre-2-and-3-use-automated-insulin-delivery

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Medicare will cover continuous glucose monitors for a broader group of patients, starting in April, according to an updated policy published by the Centers for Medicare and Medicaid Services.

 

The policy change included broader language and also came earlier than expected, making it a “welcome surprise,” and could double the market for the devices, J.P. Morgan analyst Robbie Marcus wrote in a research note.

 

Dexcom and Abbott Laboratories had expected coverage to start in mid-year.

 

In an earlier draft of coverage guidelines, CMS had suggested covering the devices for people with diabetes who take daily insulin, or who have a history of problematic hypoglycemia. Now, the policy includes people with non-insulin treated diabetes and a history of recurrent level 2 or at least one level 3 hypoglycemic event.

 

“At first glance, it seems that the finalized CMS language is broader and no longer includes daily insulin language,” Marcus wrote.

 

The policy change could open up a bigger opportunity for broader coverage by commercial insurers over the next year or two, he added.

Currently, just 25% of people with Type 2 diabetes who are intensive insulin users (taking multiple shots per day) use a CGM. Covering people who take basal (daily) insulin could double the U.S. market opportunity of about 2 million people with Type 1 diabetes and 2 million people with Type 2 diabetes who are intensive insulin users, a group currently covered by CMS, Marcus wrote.

https://www.medtechdive.com/news/Medicare-CGM-coverage-Dexcom-abbott-ABT-DXCM/644019/

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Bigfoot Biomedical receives FDA clearance for the Android mobile app for Bigfoot Unity. The mobile app allows users to input and review therapy recommendations from healthcare professionals. Users can also access a glanceable display of their current glucose range and receive real-time alerts.

 

Last month Bigfoot sold its closed-loop automated insulin delivery (AID) system technology to Insulet. CEO Jeffrey Brewer said he has confidence in the makers of the omnipod to utilize Bigfoot’s “great asset” in its focus on simplicity and ease of use for pump users.

He said the limited rollout generated “great data” to support Bigfoot Unity in the type 2 population. That includes ease of use, especially for people who might not be tech-savvy.

 

The big focus for Bigfoot Biomedical, Brewer explained, remains the pharmacy channel. He said the company is currently in discussions with Express Scripts, Optum and CVS to utilize their wide reach. Brewer said that getting an agreement with one or more of those companies will enable a more broad launch this year.

By wrapping the insulin delivery around CGM, Bigfoot Biomedical believes it can address the type 2 market in a new way.

 

https://www.massdevice.com/bigfoot-biomedical-next-steps-diabetes-management/

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Although the use of diabetes technology has increased across all racial and ethnic groups, inequities persist, according to research published in the Journal of Endocrinology & Metabolism.

In the United States, race and ethnicity have been associated with inequities in diabetes treatment and outcomes. Non-Hispanic Black and Hispanic indi- viduals with type 1 diabetes (T1D) have higher hemoglobin A1c (HbA1c), higher rates of severe hypoglycemia and dia- betic ketoacidosis, and are more likely to visit emergency departments and hospitals than individuals with T1D who identify as non-Hispanic White.

 

Researchers used a version of Optum’s deidentified Clinformatics Data Mart to select Medicare Advantage beneficiaries with T1D between January 1, 2017, and December 31, 2020.

 

Investigators found that overall, use of an insulin pump, a CGM, both insulin pump and CGM, and either insulin pump or CGM increased during the 4-year study period

When evaluating the data by racial and ethnic group, investigators found that the prevalence of each outcome did increase; however, “within each annual cohort and outcome, there were significant differences between racial/ethnic groups,” with gaps in prevalence between White individuals and individuals of other races and ethnicities remaining “generally increase[ing] or remaining stable” between 2017 and 2020.

 

When evaluating data from the 2020 cohort, there were significant differ- ences noted in the use of insulin pump and/or CGM technology based on demographic and socioeconomic factors.

 

According to the researchers, the “persistent inequities” in diabetes technology access found in the current study have implications “not only for patients and providers, but also for health care systems and policymakers” and require multiple policy changes to improve equitable access.

 

 

https://www.drugtopics.com/view/racial-ethnic-inequities-persist-in-diabetes-care

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The CLVer study tested whether improved blood glucose control using a hybrid closed loop insulin pump (also known as an automated insulin delivery or AID system) and/or verapamil preserves beta cell function one year after diagnosis.. The trial showed that verapamil, but not better blood glucose control, improved beta cell function over the year-long study.

 

In October, the FDA approved the drug Tzeild (teplizumab) for people with diabetes antibodies but who did not yet have type 1 diabetes. This therapy was the first approved medicine to delay the onset of type 1 diabetes by an average of 2 years.

 

The CLVer study offers further hope for researchers by showing that another medication can have additional impact in type 1 diabetes, and lays the groundwork for further study. By seeing preserved c-peptide levels in the study participants, the trial demonstrated that taking verapamil improved beta cell function.

 

Additionally, although AID users had greater time in range of 78% compared to non-users’ 64%, which is a 3.4 hour/day difference, the trial found that AID did not provide a significant improvement in insulin secretion.

This study was partially funded by JDRF

 

“Safe, effective therapies are urgently needed to delay disease progression in people recently diagnosed with type 1 diabetes,” said Dr. Sanjoy Dutta, chief scientific officer at JDRF. “This is the second trial showing that verapamil, a cheap and widely used blood pressure medication, can preserve beta cells in the new onset period. The CLVer trial moves us one step closer to our goal of having disease modifying therapies widely available for people with type 1 diabetes.”

https://diatribe.org/impressive-results-show-verapamil-preserves-insulin-producing-cells-newly-diagnosed-type-1-diabetes

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Some advances in cell transplantation to treat type 1:

Vertex gets FDA clearence for their application to study VX-264, a stem cell-derived, pancreatic islet cell therapy encapsulated into an immunoprotective device with the potential to treat type 1 diabetes (T1D). The VX-264 program does not require the use of immunosuppression, which may broaden the population of people with T1D that this investigational therapy could reach. This clearance means they can begin clinical trials.

AND

Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, announced today that the first two patients in the second cohort of its active U.S. Phase 1/2 clinical trial for the treatment of type 1 diabetes (“T1D”) and hypoglycemia unawareness (the “T1D Study”) received their first islet transplant into the higher capacity 10-channel Cell Pouch™.   These patients will be monitored for safety and efficacy for three months after which a second dose of islets is anticipated to be transplanted in accordance with the protocol. Additionally, a third enrolled patient has now been implanted with the higher capacity Cell Pouch and awaits islet transplant in the coming weeks.

While they are working towards not using immunosuppression, the patients in the current trial do still require immunosuppression to start after implantation of the Cell Pouch SystemTM

 

https://www.businesswire.com/news/home/20230308005894/en/Vertex-Announces-FDA-Clearance-of-Investigational-New-Drug-Application-for-VX-264-a-Novel-Encapsulated-Cell-Therapy-for-the-Treatment-of-Type-1-Diabetes

https://finance.yahoo.com/news/sernova-announces-initial-islet-transplantation-120000700.html?guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAH6NwHdjldrxbueuanlpUGXou6yHP2dKNpYXN31GEMLWCyhkJkgwlhn9ScIDMTX5GGtf5V242uN3EvZzFtTd56z0YZaQgOss37DT2dksdasEONxWa7OOdgnWvDlwUd0-s2RPyMTPi1sw8z08CK6DUMLIrrA6dmCDZeozlwos_CDB

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Two classes of drugs prescribed off-label for some patients with Type 1 diabetes can provide significant benefits but also come with health concerns, according to a study by UT Southwestern Medical Center researchers. The findings, published in The Journal of Clinical Endocrinology & Metabolism, provide a rare view of real-world use of these medications, which are growing in popularity among patients with Type 1 diabetes as adjuvants to insulin.

Type 1 diabetes is universally treated with insulin injections. However, explained Dr. Lingvay, because only a fifth of patients with Type 1 diabetes in the U.S. achieve the blood sugar control that the American Diabetes Association recommends, doctors are increasingly prescribing medications known as glucagon-like peptide-1 receptor agonists (GLP-1RAs) and/or sodium-glucose cotransporter-2 inhibitors (SGLT2is) to help patients reach this goal.

Furthermore, both classes of medications have been shown in patients with Type 2 diabetes to decrease the risk of cardiac and renal events and help promote weight loss, effects that also would greatly benefit patients with Type 1 diabetes. However, the risk-benefit ratio of these medications has not been fully vetted in this patient population.

 

In fact, both classes of drugs have been associated with increased risk of severe hypoglycemia and DKA when used in patients with Type 1 diabetes. Because both positive and negative effects of GLP-1RAs and SGLT2is were shown in strictly regulated clinical trials, their real-world effects have been unclear.

 

To examine their efficacy, Dr. Lingvay, along with colleagues Khary Edwards, M.D., a former Endocrinology fellow at UTSW, and Xilong Li, M.B.A., Senior Database Analyst at UTSW, searched medical records for Type 1 diabetes patients treated at UT Southwestern who used any GLP-1RAs and/or SGLT2is for at least 90 days before Oct. 31, 2021. Their search turned up 104 patients: 65 who had used GLP-1RAs exclusively, 28 who had used SGLT2is exclusively, and 11 who had used both either concurrently or sequentially.

 

After a year of use, patients on GLP-1RAs had significant reductions in weight, glycated hemoglobin A1C (a three-month average measure of blood sugar), and total daily dose of insulin. SGLT2i users had significant reductions in hemoglobin A1C and basal insulin, a baseline dose delivered outside of meals.

 

However, SGLT2i users were about three times more likely than GLP-1RA users to experience DKA. Just over a quarter of patients taking either class of drugs stopped due to side effects such as gastrointestinal problems.

 

The study authors say these results suggest both types of drugs can be beneficial to patients with Type 1 diabetes, but close monitoring is required. Specifically when using SGLT2is, extreme caution is advised in selecting patients with the lowest risk of DKA, performing detailed education about the risk of DKA, and ensuring careful monitoring to prevent its occurrence.

 

https://www.utsouthwestern.edu/newsroom/articles/year-2023/february-type-1-diabetes.html

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Athletic Greens

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COVID-19 patients who took the diabetes drug metformin for two weeks after a diagnosis were less likely to develop long COVID-19 symptoms, according to results from a clinical trial.

 

The trial enrolled about a thousand participants who were symptomatic with a COVID-19 infection for less than a week. Participants were randomly selected to receive a placebo or one of three drugs: metformin, ivermectin or fluvoxamine.

About 6 percent of people who took metformin later developed long COVID-19, as determined by a medical diagnosis. In the placebo group, 10.6 percent of participants developed long COVID-19.

 

This meant that overall people who took metformin were 42 percent less likely to develop long COVID-19 compared to people who got the placebo.

 

The authors also note that the beneficial effect is potentially stronger for people who started taking metformin less than four days from symptom onset compared to people who started the medication four or more days after their first symptoms. The participants who received the two other drugs, ivermectin and fluvoxamine, did not see any benefits in terms of preventing long COVID-19.

https://thehill.com/policy/healthcare/3889797-diabetes-drug-proves-beneficial-in-preventing-long-covid-in-clinical-trials/

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Great article..

https://www.nytimes.com/2023/03/03/sports/baseball/garrett-mitchell-brewers.html

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On the podcast next week.. Ginger Vieira, author and diabetes advocate. Our last episode was with a family whose son was treated with Tzield to delay his T1D diagnosis.
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

 

Delaying a T1D diagnosis with Tzield: "A deep sigh of relief, for a little while"07 Mar 202300:40:45

Last fall, Tzield was approved to delay type 1 diabetes in people predicted to develop it. This week, I’m talking one of the first families to use what used to be called Teplizumab for their son, as a regular patient, outside the clinical trials. How exactly does this all work? Who’s eligible and how do you cover the enormous financial cost?

Amanda Troutman talks about why they went through this process with her son, William. Their whole family was tested for the genetic markers after their daughter, Jenna, was diagnosed in 2020.

As always, this podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Our previous episodes on Tzield: https://diabetes-connections.com/?s=teplizumab

More about the Troutman family: https://www.vcuhealth.org/news/north-carolina-teen-among-first-in-us-to-receive-new-diabetes-drug

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Navigating the insurance maze with T1D - consultant (and D-Mom) Emily Adams16 Jul 202400:45:16

This week, I think it’s fair to say that we all struggle with insurance issues. Diabetes – or any chronic condition – increases the hoops we jump through, the expense and the stress. I’m talking to Emily Adams an employee benefits consultant to get some advice about how to navigate. Emily thought she knew the system pretty well, but then her daughter was diagnosed with type 1 and she learned on a personal level how complex our system is.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

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"We want to continue to push it forward" Dexcom's Jake Leach on the G7 release28 Feb 202300:36:07

Dexcom’s G7 has been available in the US for less than two weeks, but the company continues to look ahead. Part of the future? Their Type Zero group – which created Tandem’s Control IQ – is working on a truly closed loop system.

Chief Operating Officer Jake Leach spoke to Stacey from the recent ATTD Conference. Of course we also asked a bunch of your G7 questions and had a more in-depth discussion about CGM monitoring for people without diabetes.

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SmartFusion™ is a new way to detect & predict infusion set failures21 Feb 202300:35:45

Infusion sets have always seems like the weak link of pumping for us. What good is the best algorithm and state of the art pump and CGM if the way it all attaches to the body is no good? New information shows infusion failures happen more than you may think. John Wilcox's company, DiaTech Diabetes, has an infusion set failure detection system. He’s going to explains what that is, how it works and what you can do with the sets you have right now to make them more effective

More here: https://diatechdiabetes.com/

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In the News... Dexcom G7 launch, cannabis and type 1, Insulet acquisitions and more!17 Feb 202300:07:05

It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: Dexcom G7 is now available in the United States, Insulet buys assets from Bigfoot and another California company, new studies about cannabis and type 1 and COVID and diabetes, different predictors of type 2 in women and men, plus scholarships for T1D students.

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Episode Transcription: 

Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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In the news is brought to you by T1D Exchange dedicated to improving outcomes for the entire T1D population
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Our top story. Today’s the day. February 17th is the day Dexcom’s G7 becomes available in the United States. Now.. whether you can get it still depends on your insurance, your doctor – a new prescription is needed – and the availability at your pharmacy. Whether you want to get it may depend on if you use a compatible pump system – the G7 will NOT work with Tandem’s CIQ or Omnipod 5 for several more months. The G7 will be accessible to all Medicare patients with diabetes who meet the eligibility criteria as of today.. so no wait there. Much more to come on the launch I’m sure..
https://investors.dexcom.com/news/news-details/2023/Dexcom-G7-Continuous-Glucose-Monitoring-System-Will-Be-Available-to-Medicare-Beneficiaries-at-Launch/default.aspx?fbclid=IwAR0cKhAv5C8TMZ8v8f98rlhnvBQ0JkFj3SLRyc7RdMeOAO3_Tpl95cKNX20
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People who’ve had Covid-19 have a higher risk of developing diabetes, and that link seems to have persisted into the Omicron era, a new study finds.

Mounting evidence suggests Covid-19 infections are tied to a new diagnosis of diabetes, though it’s not clear whether this relationship is a coincidence or cause-and-effect. Big study here, 23,000 adults who’d had Covid-19 at least once.
The raw data showed that people who’d had Covid-19 had higher risks of being diagnosed with diabetes, high cholesterol and high blood pressure after their infections.

But when the researchers adjusted those numbers to account for the benchmark diagnosis, only the risk of diabetes remained significantly elevated. Covid-19 increased the odds of a new diabetes diagnosis by an average of about 58%.

The new study is notable because it adds recent data, said Wander, who was not involved in the research. It also used strategies to try to address shifts in health care during the pandemic.

Another strength of the study was that it included people who were diagnosed between March 2020 and June 2022, so it was able to estimate the risk even after the Omicron variant swept through the US.
https://www.cnn.com/2023/02/14/health/covid-diabetes-risk-study/index.html
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Insulet making a couple of interesting acquisitions.. $25 million in assets from Automated Glucose Control LLC in California. And the same amount $25 million of assets from Bigfoot Biomedical. AGC and Insulet have had a partnership since 2016 which mostly involved the algorithm that led to Omnipod 5. Bigfoot has also claimed patents regarding more hands-off insulin delivery,
The acquisition effectively doubles Insulet’s IP portfolio, Eric Benjamin, the company’s executive VP of innovation, strategy and digital products, said in a press release.
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Dr. Halis Akturk and colleagues began noticing patterns among people with T1D in Colorado hospital emergency departments (ED) after cannabis was legalized in the state. They have since conducted several nationwide retrospective studies on those living with T1D that also use cannabis, including hospitalization records and T1D Exchange Registry participant surveys. They found that T1D participants had repeated return visits to the ED in the following weeks, and DKA was frequently misdiagnosed.
Based on that research, Dr. Akturk’s team has recently developed a key to differentiating between DKA and a new syndrome that mimics DKA, one they’ve named HK-CHS: Hyperglycemic Ketosis-Cannabis Hyperemesis Syndrome.
To treat HK-CHS, your care team will typically increase fluids, treat the high blood glucose with insulin, and balance your electrolytes, or anion gap. You will be advised to stop using cannabis until the symptoms resolve. These treatments will bring your blood glucose levels back into target range and get your gut moving again, which will ease the nausea and vomiting. Depending on your dose, frequency, and duration of use, symptoms may take several days to several weeks to resolve.
https://t1dexchange.org/cannabis-t1d-risks/
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About two thirds of people with type 1 diabetes in the United States have overweight or obesity, nearly the same proportion as Americans without diabetes, new nationwide survey data suggest. What's more, among people with overweight or obesity, those with type 1 diabetes are less likely to receive lifestyle recommendations from healthcare professionals than those with type 2 diabetes, and are less likely to actually engage in lifestyle weight management activities than others with overweight or obesity, with or without type 2 diabetes.
"the lack of evidence for safe, effective methods of diet- and exercise-based weight control in people with type 1 diabetes may be keeping doctors from recommending such methods," these researchers say.

"Large clinical trials have been done in type 2 diabetes patients to establish guidelines for diet- and exercise-based weight management, and we now need something similar for type 1 diabetes patients."
https://www.medscape.com/viewarticle/988199
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New research showing men and women have different risk factors when it comes to type 2 diabetes.
In healthy women, low serum level of the adipose tissue protein adiponectin was an independent strong predictor of type 2 diabetes and prediabetes in the future. In healthy men, instead, low serum level of the liver protein IGFBP-1, was an independent strong predictor of type 2 diabetes and prediabetes This means that these proteins, which are measures of insulin sensitivity in adipose tissue (adiponectin) and liver and muscle (IGFBP-1), can predict whether one has a high risk of getting type 2 diabetes in 10 years.
A previous study performed in Shanghai in 2016 showed gender differences in the same direction. In men with prediabetes the risk of future type 2 diabetes was significantly reduced if they increased their physical activity and muscle mass . In contrast, the same study showed that women with prediabetes must avoid increasing waist circumference and abdominal obesity or reducing large waist circumference to prevent type 2 diabetes.
https://medicalxpress.com/news/2023-02-women-men-shown-factors-diabetes.html

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Tempramed/ VIVI Cap
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2023 Diabetes Scholars applications are now open! If you're a high school senior living with type 1 diabetes in the US, you can apply to get money for college.
https://diabetesscholars.org/apply-now/?fbclid=IwAR2txFmkmxp9qoMf5ZkKX0f83oxj3aOr69rCXeqozRDxq7Dt94e9QdBQrjg
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On the podcast next week.. Diatech Diabetes is a medical device company based out of Memphis, TN committed to changing the way infusion set failure detection is done with our infusion set failure detection system, SmartFusion. The last episode is with Dr Phyllisa Deroze all about explaining to your child when you, the parent, have diabetes.
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.
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The T1D Exchange Registry is a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. The platform is open to both adults and children with T1D living in the U.S. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. The registry aims to improve knowledge of T1D, accelerate the discovery and development of new treatments and technologies, and generate evidence to support policy or insurance changes that help the T1D community. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy.

When a child becomes their parent's "Diabetes Helper" - a new book from Dr. Phyllisa Deroze14 Feb 202300:37:22

When you’re a parent with diabetes, your kids often learn about diabetes before they can read or write. They know you might beep or take shots or wear a CGM and they often become diabetes helpers in serious circumstances. This week, Dr. Phyllisa Deroze talks about why she wrote a new book “Diabetes Helpers.” Dr. Deroze began blogging at DiagnosedNOTdefeated.com almost immediately after being diagnosed with diabetes in 2011. The following year she founded Black Diabetic Info; a website dedicated to helping close gaps of cultural incompetence around diabetes information.

Amazon link to Diabetes Helpers

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Our previous episode with Dr. Deroze about how diabetes is misrepresented in media: 

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What "A Portfolio of Devices" Means for the Future of Tandem Diabetes07 Feb 202300:35:42

Tandem Diabetes has made some big moves recently, acquiring two new companies – one makes infusion sets, the other a patch pump called Sigi, and their tiny Mobi pump is in front of the FDA right now. We’re finding out how it may all come together from Tandem’s EVP and Chief Strategy Office Elizabeth Gasser. We talk about how these acquisitions have changed Tandem’s road map – you may remember they released that look into the future last year – G7 integration, software updates and a lot more.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

2022 Episode with Tandem, includes links to the original 5-year road map

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In the News... Dexcom G7 Release Date, Omnipod Eros Discontinued, Best Age to Screen for T1D and more!03 Feb 202300:08:16

It’s In the News, a look at the top stories and headlines from the diabetes community happening now. This week, Dexcom sets a US release date for the G7, we find out whether Tandem will be a Tidepool Loop partner now that Insulet and Medtronic are out, Omnipod Eros to be discontinued, a new study says there's a better age to test kids for type 1, a new smart insulin pen sensor can also be used to track dosing of GLP-1 medications, a new twist in the Faustman study of the TB vaccine to treat diabetes, the Sims 4 update brings CGMs to the game and more.

Links and transcript below

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Episode Transcription: 

Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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In the news is brought to you by VIVI Cap – confidence on the go that keeps your insulin protected in hot or cold
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Learning a bit more about the Tidepool pump partnership, at least who it won’t be. When Tidepool Loop approval was announced last month, it came without the original pump partners, Omnipod and Medtronic. CEO Howard Look said they do have a pump partner but that they’re not ready to announced yet. I spoke to Tandem for next week’s episode and they say its’ not them. Quote “That’s not part of our roadmap, it’s not an integration we’re working on.”
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Insulet announces it will discontinue the original Omnipod system. In a letter to healthcare professionals, the company says the system, referred to as Eros or Omnipod Classic will be discontinued at the end of this year. It’s no longer available to new patients and existing customers will be transitioned to Dash or Omnipod 5. I’ll link up the letter in the show notes.
“Dear healthcare professionals,
We have made the decision to discontinue the original omnipod insulin management system in the us after December 31 2023. This system is often referred to omnipod eros or omnipod classic.
Insulet will continue to support the omnipod system throughout this year to allow existing patients ample time to transition to newer omnipod technology such as Omnipod dash or Omnipod 5. please note this product is no longer available for new patients in the US. After December 31, 2023 Insulet will not be able to guarantee the availability of the omnipod system supplies. “
https://www.facebook.com/photo/?fbid=10225188520677483&set=a.1253748061199
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Civica continues to move ahead with more affordable insulin, announcing that Ypsomed will make and supply their pens. Civica plans to produce three insulin biosimilars priced at no more than $30 per vial and no more than $55 for a box of five pen cartridges. Contingent on FDA approval, Civica anticipates that its insulins will be available for purchase beginning as soon as 2024.

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New study shows screening kids at risk for type 1 diabetes only once – at age ten – is very effective in detecting the condition by the age of 18. These researchers also say “Almost no one” who is islet autoantibody negative at age 10 years despite a high familial risk for type 1 diabetes will develop clinical diabetes by the age of 18. Full study published in the Lancet.
https://www.medwirenews.com/diabetes/age-10-years-optimal-type-1-diabetes-screening-point/23957596
https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(22)00350-9/fulltext?fbclid=IwAR2kRNyGg6lnq3ZWsFkXnCvkeNiisg9mE2bbN_OnGiLrUpcHKXAaff3OkE4
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The nonprofit public health advocacy group the Physicians Committee issued a formal complaint that a recent CBS "60 Minutes" segment was a promotion for Novo Nordisk’s obesity drug, Wegovy, that was dressed up as a news segment.

The Washington, D.C.-based group has filed a complaint with federal bodies alleging that the CBS "60 Minutes" segment that aired on New Year’s Day breached the FDA’s “fair balance” rules for drug ads.

The Committee said in a release that the feature failed to talk about alternatives to the drug or about other weight-loss methods; that only experts “paid by Novo” were used in the program; and that the piece used overly promotional language.
This has caused Wegovy supply issues for Novo which, coupled with manufacturing problems, only deepened bumps in production last year for the drug and led to an official shortage of the drug in 2022.

A spokesperson for Novo Nordisk told Fierce Pharma Marketing: “Novo Nordisk did not provide any payment or sponsorship to CBS 60 Minutes for their reporting on obesity as part of a news segment that aired on January 1, 2023, and we did not control any of the content or have any role in identifying or selecting the doctors and patients featured in the news segment.”

https://www.fiercepharma.com/marketing/health-group-lambasts-novo-nordisk-60-minutes-paid-news-program-weight-loss-med-wegovy

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Some researchers have pulled out of a trial investigating the use of an old tuberculosis vaccine to treat children with Type 1 diabetes only months after they began enrolling participants. This is part of the Faustman study of the BCG vaccine. Some recent research suggests that the vaccine, first administered in 1921, also may protect against Covid-19 and respiratory diseases because of its broad effects on the immune system. The lead investigators of the pediatric trial are proceeding with the study, but N.Y.U. Langone’s abrupt withdrawal could potentially jeopardize its viability if they are unable to collect data on the children at the N.Y.U. site.
An earlier study by the scientists at Massachusetts General found that two doses of B.C.G. vaccine reduced blood sugar levels to near normal in a very small group of adults with Type 1 diabetes. Other studies of B.C.G., using different versions of the vaccine and following Type 1 diabetes subjects for varying periods of time, have yielded mixed results.
The lead investigator of the trial, Dr. Denise Faustman, director of the immunobiology laboratory at Massachusetts General Hospital, said that N.Y.U.’s withdrawal was a serious deviation from trial protocol that may call into question the final results.
https://www.nytimes.com/2023/01/20/health/diabetes-bcg-nyu.html
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A new smart insulin pen sensor can also be used to track dosing of GLP-1 medications. Brand names for GLP-1 medications include Trulicity and Ozempic. This device, called Mallya, attaches to the injector and connects it to a mobile app. It’s already cleared in Europe and should be available in the US in the next few months.
The device is compatible with most popular insulin pens, including Lilly’s Kwikpen, Sanofi’s Solostar, and the Novo Nordisk FlexPen. Biocorp also announced that it has partnered with Novo Nordisk, Sanofi, and Roche Diabetes Care to improve Mallya’s current design moving forward.
According to the Mallya website, the device’s lifespan is two years before a replacement is needed, and in no way does it change the way that users operate their insulin pen. The device can be charged via USB and, with average use of three to four injections per day, requires charging once a month. Also, for those who have different pens for multiple types of insulin, the app can connect multiple Mallya devices, one for basal insulin and another for bolus, for instance.

https://diatribe.org/fda-clears-smart-injector-pen-device-mallya
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Tempramed/ VIVI Cap
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New features popped up this week in the latest version of The Sims – after an update, players can opt for their characters to wear a CGM – Libre or Dexcom
Freestyle Libre in the Sims 4 game. Search for CGM or Libre
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The Jonas Brothers officially have a star on the Hollywood Walk of Fame.

On Monday, Nick, Joe and Kevin Jonas were honored during a ceremony on Hollywood Boulevard where their careers as musicians were celebrated. Their star was dedicated in the category of Recording and the trio was introduced by Monte and Avery Lipman of Republic Records, Ryan Tedder and writer and producer Jon Bellion.
While the brothers still maintain their own separate projects -- Nick Jonas is set to produce and star in the upcoming film "Foreign Relations," Joe Jonas recently starred in the film "Devotion," and Kevin Jonas hosts the ABC series "Claim to Fame" -- they continue to make music together and are slated to release new songs this year.
The group closed out Monday's ceremony by announcing big news about their upcoming new album, which will be released in May. They also said they'll be going on tour again.

XX
On the podcast next week.. Tandem Diabetes with an update on their road map announced last year. They’ve since acquired a patch pump company and one that makes infusion sets. A lot to catch up on! This past week’s long format episode is with Tidepool Loop, a deep dive into what was approved with CEO Howard Look
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

Tidepool Loop gets FDA approval - CEO Howard Look on what comes next31 Jan 202300:45:15

The US FDA has approved Tidepool Loop, an app designed to automate insulin dosing. Born out the do-it-yourself, "we are not waiting" movement, it has designs and features not in the first wave of commercial automated systems like Omnipod 5 and Tandem’s Control IQ. CEO Howard Look talks to Stacey about what was approved here and what Tidepool Loop is all about.

If you’ve followed this story closely, you’re going to be surprised to learn about a few changes that have happened along the road to approval.. and to learn the questions that Tidepool will have to answer next.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Learn more about Tidepool: https://www.tidepool.org/

Our previous episodes with Howard Look: 

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Beyond New Year's resolutions, making diabetes changes that stick24 Jan 202300:38:28

How are those New Year's resolutions going? By this time, it’s possible you’ve given up. But maybe it's just that you’ve set your goals a little too high.

This week, Stacey talks to Ben Tzeel, Founder of Your Diabetes Insider, Registered Dietitian, Certified Diabetes Care & Education Specialist, Certified Strength & Conditioning Specialist. Ben also lives with type 1. We’re going to talk about how to make the changes you want in a way that helps you stick with it. AND he’s going to share some of his experience in a trial where he ate – no joke – about four thousand calories at one meal!

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

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Episode Transcription Below (or coming soon!)

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*Learn more about OMNIPOD* *Learn more about AFREZZA* *Learn more about DEXCOM*
In the News.. Mark Cuban's pharmacy starts "insulin test," EOFlow patch pump, T2D drug updates & more!20 Jan 202300:07:59

It’s In the News, a look at the top stories from the diabetes community from the last seven days. This week: Cost Plus pharmacy starts putting out feelers about insulin, asking people to take part in a pilot program, EO Flow looks at the US market for their new patch pump, quite a few new studies about type 2 diabetes drugs, a study about slowing down type 1 in kids and much more!

Learn more about the T1D exchange and drive research that matters! www.t1dexchange.org/stacey

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Episode Transcription Below (or coming soon!)

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Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines of the past seven days.
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In the news is brought to you by The T1D Exchange - Help drive research that matters.
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Possible new player in the US Patch pump business. EO Flow has submitted a 510(k) application to the FDA for its EOPatch wearable, disposable insulin pump. EO Flow is based in California and has launched the pump in South Korea. The company also has FDA breakthrough device designation on an integrated artificial pancreas. The website says EOPancreas is a wearable disposable artificial pancreas system that integrates a continuous glucose sensor and an insulin pump in one small wearable module and autonomously controls insulin infusion. They’re looking for a US partner for the pump and hope to launch in 2024.

http://www.eoflow.com/eng/eopatch/eopatch_010100.html
https://www.drugdeliverybusiness.com/eoflow-submits-insulin-patch-pump-fda-clearance/
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Your time in range before getting a COVID vaccine may predict your body’s response. This was a small study, 25 patients with type 1 who received two doses of a COVID vaccine. Researchers followed the group two weeks before before and six months after the shots.
Main outcome measures: The primary exposure and outcome measures were pre-vaccination glucose control, and antibody response after vaccination, respectively. Patients meeting the recommended pre-vaccination glucose targets of TIR (≥70%) and TAR (≤25%), developed stronger neutralizing antibody titres (p < 0.0001 and p = 0.008, respectively), regardless of HbA1c. highlighting a role for well-controlled blood glucose in vaccination efficacy.
https://pubmed.ncbi.nlm.nih.gov/36611249/
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New study in kids with type 1 seems to show that the drug golimumab – brand name Simponi – can help preserve beta cell function. This is the Tiger study which included people ages 6 to 21 years old with T1D and given either the drug or a placebo for 52 weeks the off the drug for another year. The group taking the drug used less insulin and had a higher c peptide level in the time after the medication stopped, indicating that there was a difference.

https://diabetesjournals.org/care/article-abstract/doi/10.2337/dc22-0908/148228/Two-Year-Follow-up-From-the-T1GER-Study-Continued?redirectedFrom=fulltext
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New study confirming what a lot of you already know, Metformin failure in people with type 2 diabetes is very common, particularly among those with high A1c levels at the time of diagnosis.
An analysis of electronic health record data for more than 22,000 patients starting metformin at three US clinical sites found that over 40% experienced metformin failure. This was defined as either failure to achieve or maintain A1c less than 7% within 18 months or the use of additional glucose-lowering medications. "These results call into question the ubiquitous use of metformin as the first-line therapy and suggest a more individualized approach may be needed to optimize therapy," they add in their article published online in the Journal of Clinical Endocrinology and Metabolism.
The investigators identified a total of 22,047 metformin initiators from three clinical primary care sites: the University of Mississippi's Jackson centers, which serves a mostly African American population, the Mountain Park Health Center in Arizona, a seven-clinic federally qualified community health center in Phoenix that serves a mostly Latino population, and the Rochester Epidemiology Project, which includes the Mayo Clinic and serves a primarily White population.

https://www.medscape.com/viewarticle/986994
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The FDA has approved a label update for semaglutide that allows the drug to be used in addition to diet and exercise as a first-line option to improve glycemic control in adults with type 2 diabetes. The brand name here is Wegovy. With its initial FDA approval in 2019, semaglutide became the first and only glucagon-like peptide-1 (GLP-1) analog in pill form.
https://www.pharmacytimes.com/view/fda-approves-label-update-for-semaglutide-allowing-use-as-first-line-option-for-adults-with-type-2-diabetes
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Merk says it’s diabetes drugs Januvia and Janumet have become contaminated with a potential carcinogen.. and it can resolve the problem by the end of the year. The company submitted a report to the U.S. Food and Drug Administration (FDA) and other regulators. The impurity arose mostly during storage, as well as during manufacturing, Bloomberg News said. The FDA said in August certain samples of sitagliptin, a compound in Merck's diabetes drugs Januvia and Janumet, were contaminated with a possible carcinogen.
https://www.bloomberg.com/news/articles/2023-01-17/merck-mrk-ready-to-remove-cancer-linked-chemical-from-diabetes-drugs-in-2023
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Researchers studying new methods for improving blood sugar control in type 2 diabetes have discovered an old class of antipsychotic drugs may offer clues to a novel kind of treatment for hyperglycemia. While the researchers propose the old drugs could be directly repurposed to treat diabetes, they could also be slightly modified to more specifically target blood sugar control.
The class of drugs, known as (DPBPs), were developed back in the 1960s and are still used today. The researchers say they “They all improve blood sugar control by preventing the muscle from burning ketones as a fuel source.”
Because the DPBP drugs are already approved medicines the researchers hope to quickly move to proof-of-principal human trials. This would establish whether these preclinical findings are reproducible in human patients.

The new study was published in the journal Diabetes.
https://newatlas.com/medical/old-antipsychotic-drugs-new-class-diabetes-treatment/
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Another study showing an AID system works well for people with type 2. Scientists from University of Cambridge set up a small study, no surprise, the closed loop system did a lot better than standard injection therapy – people stayed in target range 66-percent of the time versus 32-percent with shots. That was an additional 8 hours a day of time in range.
https://www.medicalnewstoday.com/articles/type-2-diabetes-artificial-pancreas-may-soon-be-an-option
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Dexcom gives us a little more information about the G7. I interviewed Kevin Sayer for this week’s long format interview and he says the G7 will launch in the US during this first quarter.. so by the end of March. He also gave a more pessimistic view for interoperability with Tandem and Omnipod than we’ve heard – with Tandem end of summer early fall and Omnipod 5 next year. It’s up to those companies, not Dexcom.
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T1D Exchange
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On the podcast next week.. how are those new year’s resolutions going? If you haven’t kept them up, maybe you tried to do too much at once? Nutritionist Ben Tzeel joins me to talk about how to get back on track.
I mentioned last week’s episode with Dexcom CEO Kevin Sayer. We talk about the G7 launch and lots more, including their plans for the type 2 community and moving into “health”
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

"We've got a lot on our plate" - Dexcom's CEO talks G7 and beyond17 Jan 202300:40:19

We've got new information about Dexcom’s G7 launch and much more. CEO Kevin Sayer says it’ll be available in the US before the end of March. Sayer joins us from the J.P. Morgan Healthcare Conference in San Francisco. He talks about Dexcom’s pump partners, when the FDA will let them put in features they already have in Europe but not here, and answers a lot of your questions.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Stacey mentioned this link during the episode: www.dexcom.com/g6-medicare

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My son was diagnosed with T1D at age two. How was his first year away at college?09 Jul 202400:41:38

When my son was diagnosed with type 1 more than 17 years ago, the day he’d leave home seemed very far away, but also something we knew we needed to plan for. Well, Benny finished his Freshman year of college – he goes to school 300 miles away – and he’s here to talk about it. We answer your questions about how it went, how he managed, how I managed and what’s next.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Previous episodes with Benny

Previous episodes with Lea 

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Reach out with questions or comments: info@diabetes-connections.

"He's a Huge Inspiration To Me" - A Father & Daughter Face T1D Together10 Jan 202300:37:18

Dad and daughter, Randall and Emma Barker, were diagnosed at the same age (ten) and have a few other coincidences around their experiences with T1D. They have a close relationship and this week, they share their story.

The Barkers are here to talk about eye health – we get help from the American Diabetes Association's Dr. Laura Hieronymus to talk about treatment and prevention of complications, which Randall has. But we also talk about what it’s been like for Emma to watch her father live with type 1 and then be diagnosed herself and Randall shares his own feelings of guilt.. and pride. This is a good one.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

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In the News... More T2D predicted, Basal-only pump planned, Glucagon discontinued.. and more!06 Jan 202300:06:22

It’s In the News, a look at the top stories from the diabetes community from the last seven days. This week: predictions of a huge increases in cases of type 2, insulin prices are capped for those with Medicare, Omnipod commits to a basal-only pump for people with type 2, and more!

In the news is brought to you by Athletic Greens! Find out more: https://athleticgreens.com/stacey 

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Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines of the past seven days.
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In the news is brought to you by Athletic Greens! AG1 is way more than greens it’s daily nutrition made really simple
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New study says the number of young people in the United States with diabetes will increase by nearly 700% over the next 40 years. This was a projection study using numbers from the past 20 years and was published in the journal Diabetes Care. The CDC believes that "the increasing prevalence of childhood obesity," as well as "the presence of diabetes in people of childbearing age," could be two reasons for why the number of young Type 2 diabetics has increased so rapidly. There is some evidence that COVID 19 may also have something to do with more cases of diabetes but there isn’t enough data to know for sure.

https://www.wibw.com/2023/01/03/cdc-predicts-huge-spike-diabetes-among-young-adults-next-40-years/
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As of January first, the monthly out-of-pocket cost of insulin is capped at $35 for seniors on Medicare. That’s part of the Inflation Reduction Act in effect on Jan. 1. In August, Republicans blocked a provision in the bill that would have capped the out-of-pocket cost of the drug for everyone on private insurance. There was no provision for the uninsured. It’s not clear whether insulin pricing will come up again during this new congress.
https://www.nbcnews.com/health/health-news/insulin-cost-cap-people-diabetes-no-benefit-rcna58165
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Insulet is planning a basal only pump, looking at the type 2 market to compliment their Omnipod pump. The newly announced device is designed for patients with Type 2 diabetes who receive daily or weekly injections of basal insulin. Unlike Insulet’s other devices, it doesn’t have a controller, but has a built-in basal conversion rate. They hope to have it on the market by 2024. In an earnings call late last year Insulet announced a 42-percent increase in revenue in the US. They’ll plan a European launch of Omnipod 5 in mid-2023.
https://www.medtechdive.com/news/insulet-omnipod-5-q3-earnings-record-PODD/635811/
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Beta Bionics appoints a new Chief Medical Officer as the company quote - for the commercial launch of the iLet Bionic Pancreas System. As of right now, the iLet is still in front of the FDA but it sounds like it may be getting close to approval. Dr. Steven Russell is the new CMO here.. Dr. Russell has directed nearly all of the bionic pancreas clinical trials. The bionic pancreas – renamed the iLet a few years ago – operates using only the person’s body weight, no basal rates or other settings – and input about the size of meals, not carb counts.
https://www.newswire.com/news/beta-bionics-appoints-dr-steven-russell-as-chief-medical-officer-in-21920409
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Lilly’s Emergency Glucagon Kit is now out of production. They announced last year that they will discontinue the red box emergency kit at the end of 2022 in the US. The company says with newer options like Baqsimi nasal spray, Gvoke and Zegalogue pens, the demand isn’t there. If you do prefer the older kit – really the only way to do those mini-glucagon shots some people really like – there are still two options – Novo’s GlucaGen Hypo Kit – the orange box and a generic made by Amphastar.
https://diatribe.org/glucagon-options-expand-lilly-discontinues-emergency-kit
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Another move forward to islet transplantation. Houston Methodist Medical Center in Texas delivered islet cells and immunotherapy directly into a 3D-printed device named NICHE, which is similar to a bioengineered pancreas. It’s about the size of quarter and goes under the skin. There’s a tiny port that means the device can be refilled with medication. These researchers say they’re probably three years from human trials.
https://www.jpost.com/health-and-wellness/article-726001
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The US Food and Drug Administration has approved semaglutide brand name Wegovy for teenagers with obesity. When Wegovy was approved for use in adults with obesity in June 2021, it was labeled a "game changer." The results in teens – who also received what they call lifestyle intervention – were close to the results seen after bariatric surgery. Wegovy is a once weekly shot – it’s also sold with a lower dose as a type 2 treatment with the brand same Ozempic. Same drug, lower dose.
https://www.medscape.com/viewarticle/986403
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On the podcast next week.. A father and daughter who both live with type 1 – they were diagnosed at the same age – talk about their experience with eye health. What’s changed and what’s still the same for people with diabetes. And we get guidance and info about prevention and treatments available.
Last week’s show our 2023 prediction episodes!
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.
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Our 2023 Diabetes Technology Predictions (and a last look back at 2022)03 Jan 202300:47:53

Happy new year! What will 2023 bring for diabetes technology? We bring our best guesses to the table and we take a look back at what we said would happen last year. Stacey is joined by Chris Wilson on a Twitter Spaces Chat and you'll also hear from Mike Hoskins for a look back to 2022.

Mike is currently an editor at Healthline and formerly the managing editor at DiabetesMine. Chris Wilson, is a longtime advocate and information junkie who just marked 25 years with type 1. Chris will tell you that for much of his time with diabetes he didn’t have insurance and didn’t use a lot of the more advanced tech.. and now he really follows it all very closely, takes part in clinical trials and is designing his own pretty incredibly sounding DIY closed loop features.

None of the three have financial stakes in these companies, past some stocks that may be buried in mutual funds – we don’t’ own individual stakes in these companies. And their information is based on whatever is publicly available.

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Episode Transcription Below (or coming soon!)

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Wait Wait... Don't Poke Me! The Diabetes Game Show (2022)27 Dec 202200:39:40

It’s our annual game show: Wait Wait Don’t Poke Me! Taped earlier this year for the Mental Health Plus Diabetes Conference, this is a light hearted episode with games and trivia, all centered around diabetes.

Our guests are Rob Howe, Taylor Daniel and Mark Heyman.. three terrific diabetes advocates who will introduce themselves and share more about their diabetes connections.

There is a video version over on YouTube.

Hope you play along with our silly games at home.. and enjoy!

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Episode Transcription Below (or coming soon!)

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"Invisible Illness Reveals Invisible Strength" Yale lacrosse player Bri Carrasquillo explains Dexcom U20 Dec 202200:34:41

A student athlete diagnosed with type 1 just after her very first college season, Bri Caraquillo had reached her dream of playing lacrosse at Yale but had to figure it all out all over again after her diagnosis in May of 2020
Bri is part of the very first class of Dexcom U – a program that’s happening under the new NIL ruling . We’ll explain what that is, what it means for these student athletes and get advice from Bri about balancing it all.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

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*Click here to learn more about OMNIPOD* *Click here to learn more about AFREZZA* *Click here to learn more about DEXCOM*
In the News.. Tandem buys a patch pump, Insulin pump equity, Lilly loses a partner, and more!16 Dec 202200:07:58

It's In the News, a look at the top stories from the diabetes community from the last seven days. This week: Tandem buys the maker of Sigi Pump, a reusable, rechargable patch pump, Lilly uncouples from Ypsomed, big study finds widespread adoption of insulin pumps among people with type 1, but not among people of color, a big look at vegetables studies and why potatoes are basically messing things up.. and a lot more!

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Episode Transcription Below (or coming soon!)

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*Click here to learn more about OMNIPOD* *Click here to learn more about AFREZZA* *Click here to learn more about DEXCOM*

Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines of the past seven days.
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In the news is brought to you by T1D Exchange! T1D Exchange is a nonprofit organization dedicated to improving outcomes for the entire T1D population.
https://t1dexchange.org/stacey/
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Big new study about insulin pumps shows white patients are twice as likely to get one as Black patients, and better-educated, wealthier people are also more likely to be using one. Over 20 years, starting in 2001, these researchers saw a large increase in insulin pump use across all patients, but no change in distribution by race or socioeconomic status
The study was recently published in the journal Diabetes Technology & Therapeutics. Recent data found that Black people had higher rates of severe diabetes-related complications compared with white folks.
There is also a concern that these gaps will widen with the new automated insulin-delivery systems, worsening health inequality for subsets of youth with type 1 diabetes.

https://www.usnews.com/news/health-news/articles/2022-12-13/insulin-pumps-ease-diabetes-care-so-why-are-black-patients-less-likely-to-get-one
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Tandem Diabetes snaps up a patch pump.. buying the Swiss company that makes Sigi. The Sigi Patch Pump is not yet available, it has FDA breakthrough designation. This is a rechargeable pump, you get two you can switch out, and the infusion set is disposable. It’s set up to work with an AID system. We did an episode with SIGI earlier this year.. no word on what this might mean for Tandem’s Mobi pump.. which is a tubed pump that’s very small and was meant to compete with Omnipod.. before this news.

https://www.businesswire.com/news/home/20221213005314/en/Tandem-Diabetes-Care-to-Acquire-Insulin-Patch-Pump-Developer-AMF-Medical
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Eli Lilly has pulled out of a partnership with Ypsomed that would have given it a branded insulin pump to sell in the U.S.
Lilly struck a deal two years ago to commercialize YpsoPump under its own brand in the U.S. The partners have since worked to customize the pump, which has been sold in Europe since 2016, for the U.S. market.
Ypsomed plans to push ahead with the U.S. expansion without Lilly, outlining plans to file with the Food and Drug Administration in the second half of next year and commercialize the pump with a new partner.
This is the second pump partner Lilly has dropped. They had a prototype with a company called DEKA but quietly disbanded that partnership a few years ago.
https://www.medtechdive.com/news/lilly-LLY-ypsomed-insulin-pump-split/638492/
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New more aggressive targets for blood pressure and lipids are among the changes to the annual American Diabetes Association (ADA) Standards of Care in Diabetes.

The document, long considered the gold standard for care of the more than 100 million Americans living with diabetes and prediabetes, was published December 12
"In this year's version of the ADA Standards of Care — the longstanding guidelines for diabetes management globally — you'll see information that really speaks to how we can more aggressively treat diabetes and reduce complications in a variety of different ways," ADA Chief Scientific and Medical Officer Robert A. Gabbay, MD, PhD, told Medscape Medical News.

Other changes for 2023 include a new emphasis on weight loss as a goal of therapy for type 2 diabetes; guidance for screening and assessing peripheral arterial disease in an effort to prevent amputations; use of finerenone in people with diabetes and chronic kidney disease; use of approved point-of-care A1c tests; and guidance on screening for food insecurity, along with an elevated role for community health workers.
https://www.medscape.com/viewarticle/985482
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I love this story.. A new report says eating a diet rich in vegetables may not reduce the risk of type 2 diabetes. Why? Because usually, potatoes are included a as veggie in these studies, including fried potatoes, potato chips, and mashed potatoes increase the risk. In the study, participants who consumed the most vegetables — minus potatoes — had a 21% reduced risk of diabetes than those without substantial amounts of vegetables in their diet.

The vegetable most closely associated with a reduction in diabetes risk were green leafy vegetables and cruciferous vegetables.

The new study assessed the effects of both vegetables and potatoes separately. They concluded that potatoes’ neutral — or even negative effect — on diabetes had masked the true benefit of vegetable consumption.

https://www.medicalnewstoday.com/articles/potatoes-and-diabetes-risk-cooking-method-matters
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Back to the news in a moment but first..
The T1D Exchange Registry is a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. The platform is open to both adults and children with T1D living in the U.S. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. The registry aims to improve knowledge of T1D, accelerate the discovery and development of new treatments and technologies, and generate evidence to support policy or insurance changes that help the T1D community. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy.
The registry is now available on the T1D Exchange website and is simple to navigate, mobile and user-friendly. For more information or to register, go to www.t1dregistry.org/stacey
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The U.S. Food and Drug Administration has approved the first pill to improve control of diabetes in some cats. The drug called Bexacat (bexagliflozin tablets), is not insulin and is not meant for cats who have the type of diabetes that requires treatment with insulin. Rather, it is what is called a sodium-glucose cotransporter 2 (SGLT2) inhibitor.
As part of the approval, the FDA requires that Bexacat labels include a boxed warning about the importance of patient selection. Only certain cats should take the drug, determined through careful screening.
Bexacat also shouldn't be used in cats who are being treated with insulin or in those who have previously been treated with insulin.
Typically cats with diabetes are treated with diet and insulin therapy, including twice-daily injections given 12 hours apart.

https://www.usnews.com/news/health-news/articles/2022-12-09/cats-now-have-an-fda-approved-pill-to-treat-their-diabetes
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On the podcast next week.. yale lacrosse player Bri Carrasquillo was diagnosed just after her freshman year. Now she’s part of Dexcom U – a new program for college athletes with type 1.
Last week’s show was G7 with Dexcom’s Jake Leach Listen wherever you get your podcasts
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

G7 Approved! Dexcom's Jake Leach answers your questions (and looks ahead)13 Dec 202200:36:23

This week.. after a year of deliberations, the US FDA approves the newest product from Dexcom, the G7. This is a much smaller device, with all-in-one sensor and transmitter, shorter warm up time and many more new features.

Stacey talks with Dexcom’s Chief Operating Officer Jake Leach. They do a lighting round of questions to learn more about what was – and was NOT – approved here. It’s not exactly what’s already on the market in Europe.. and we look ahead to what’s next.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Previous episodes on the G7: https://diabetes-connections.com/?s=g7

Watch the interview on our YouTube channel: https://www.youtube.com/@diabetesconnections

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Episode Transcription Below (or coming soon!)

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*Click here to learn more about OMNIPOD* *Click here to learn more about AFREZZA* *Click here to learn more about DEXCOM*
In the News.. Dexcom G7 approved, Mark Cuban pharmacy looks at insulin pricing, T1D teens & blood pressure, and more!09 Dec 202200:09:33

It's In the News.. a look at the top news stories in the diabetes community over the past seven days. This week, The US FDA gives the green light to Dexcom's G7 CGM, Mark Cuban's Cost Plus Pharmacy puts out a survey all about insulin, new studies looking at teens with type 1 and blood pressure as well as CGM and hospitalizations at the VA and much more!

Previous episodes on Dexcom's G7: https://diabetes-connections.com/?s=g7

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Episode Transcription Below (or coming soon!)

Please visit our Sponsors & Partners - they help make the show possible!

*Click here to learn more about OMNIPOD* *Click here to learn more about AFREZZA* *Click here to learn more about DEXCOM*

Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines of the past seven days.
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In the news is brought to you by T1D Exchange! T1D Exchange is a nonprofit organization dedicated to improving outcomes for the entire T1D population.
https://t1dexchange.org/stacey/
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Our top story is big news.. Dexcom’s G7 gets FDA approval. This device with a shorter, half hour warm up time, with the sensor and transmitter all in one piece was approved for people age 2 and up with all types of diabetes. It was approved as an iCGM as expected, which is good news for the automated systems the G6 currently works with.. much more to come of course, we’ve done a lot of episodes on the features and design of the G7 so I’d urge you to listen to those if you haven’t yet and of course we’ll follow up with a new episode with Dexcom as soon as they’ll talk to me!
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In other news.. Illinois Attorney General files a fraud lawsuit, accusing Eli Lilly, CVS Pharmacy, Novo Nordisk and several other pharmaceutical companies of artificially inflating the cost of insulin by over 1,000% since the late 1990s. The complaint singles out Eli Lilly in particular, noting the price for a dose of its analog insulin Humalog rose by 1,527% between 1997 and 2018. "Remarkably, nothing about these medications has changed," the complaint states. "Today's $350 insulin is the exact same drug defendants originally sold for $20."

The suit also notes that 13% of Illinoisans, about 1.3 million people, live with diabetes, making the pharma companies' alleged monopoly scheme a public health threat. There are several other state and class action suits against the insulin makers going through the courts right now. So far none have landed more than a glancing blow.
https://www.courthousenews.com/illinois-attorney-general-sues-over-sky-high-insulin-prices/
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A new contender, though, might be entering the arena. Mark Cuban’s Cost Plus Pharmacy put out a tweet this week asking for feedback on adding insulin to their lower-cost inventory. Quote - Insulin users: we are evaluating a future insulin test program and would like your feedback. If we offered a 90-day supply of a fast-acting insulin (up to 12 vials/8 packs of pens) for $170 incl. shipping, what would you think?” There’s a feedback form and I’ll link that up in the show notes.
https://forms.office.com/Pages/ResponsePage.aspx?id=nlWlyavTPES7xglhq5HvDwx1m5bO2mRDq1ekDvUshMtUNUZBM0dDUTA3RVpUOEY1WVNWVDE4U0JTMiQlQCN0PWcu
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People with diabetes who used glucose lowering drugs prior to getting COVID-19 seem to have fewer COVID-19 related adverse outcomes during hospitalization. The mediations have already been shown, albeit in conflicting findings, to have possible benefits regarding morbidity and mortality among patients with diabetes who become infected with COVID-19. These meds include orals like Metformin as well as injectables like sglt2 inhibitors like Jardiance and Invokana GLP-1 agonists like Ozempic and Trulicity.
https://www.ajmc.com/view/glucose-lowering-drugs-may-reduce-risk-of-covid-19-related-adverse-events-in-patients-with-diabetes
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New research about opioids and diabetes. This study says people
People with diabetes who underwent surgery had a significantly increased rate of prolonged opioid use (POU) compared to people without diabetes who underwent surgery. 56% higher for people with type 2 and more than 200% higher for those with type 1. This was a big, retrospective, observational study of more than 43,000 people who had operations at a single diverse healthcare system in 2008-2019.
The researchers say this shows that in a real-world setting healthcare providers are generally not accounting for individual risk factors when prescribing postoperative opioids.
https://www.medscape.com/viewarticle/985068
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Teens with Type 1 diabetes (T1D) who took bromocriptine, a medication used to treat Parkinson's disease and Type 2 diabetes, had lower blood pressure and less stiff arteries after one month of treatment compared to those who did not take the medicine, according to a small study published in Hypertension, an American Heart Association journal. People with type 1 are at higher risk of high blood pressure and those diagnosed with T1D as children have even higher risks for heart disease. Therefore, researchers are interested in ways to slow down the onset of vascular disease in children with T1D.
The study's small size is a limitation. However, the researchers note that further research into bromocriptine's impact on vascular health in a greater number of people with Type 1 diabetes is warranted; they are planning larger trials.
https://medicalxpress.com/news/2022-12-parkinson-medication-blood-pressure-teens.html
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CVS is facing a fraud charge with a lawsuit accusing them of deceptive fundraising in a campaign it held for the American Diabetes Association. Prior to each customer’s transaction, a checkout screen prompts the customer with several options for pre-selected dollar amounts, as well as an opt-out option, allowing donations to the diabetes association.
Yet, the plaintiff alleges, CVS did not forward donations to the diabetes association, but instead applied the donations toward a legally binding $10 million obligation CVS made to the diabetes association. In November, Edward L. Powers, a lawyer for CVS, filed a motion to dismiss the case, challenging the plaintiff and his lawyer on their interpretation of the alleged $10 million “debt.”
CVS says they agreed to fundraise from customers and turn over the donations to the diabetes association. After more than three years of fundraising, CVS would make up the difference between the cumulative customer donations and $10 million, according to the motion. The group bringing the suit disagrees and says everyone who made a campaign donations” are entitled to damages.

https://www.bostonglobe.com/2022/12/05/metro/tweet-draws-attention-lawsuit-accusing-cvs-fundraising-fraud-checkout-cvs-has-filed-motion-dismiss-suit/
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Wearing a CGM can keep you out of the hospital.. according to a new study focusing on Veterans Affairs clinics in the US. Wearing a CGM was associated with a lower risk for all-cause hospitalization and mortality in adults with type 1 and type 2 diabetes. This was even though the people with type 2 who received CGM were actually unhealthier [than non-CGM users] according to the researchers, who called the mortality reductions, dramatic.
During a presentation at the World Congress on Insulin Resistance, this researcher said:
“All of this data suggests that we may need to look at these types of outcomes in a much more serious fashion, because there may be some additional benefits that we didn’t appreciate. If true, then maybe CGM use may become more like the SGLT2 inhibitors, and we’ll start using them in a much more comprehensive way.”

https://www.healio.com/news/endocrinology/20221202/cgm-use-lowers-hospitalizations-may-reduce-mortality-in-type-1-and-type-2-diabetes
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Back to the news in a moment but first..
The T1D Exchange Registry is a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. The platform is open to both adults and children with T1D living in the U.S. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. The registry aims to improve knowledge of T1D, accelerate the discovery and development of new treatments and technologies, and generate evidence to support policy or insurance changes that help the T1D community. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy.
The registry is now available on the T1D Exchange website and is simple to navigate, mobile and user-friendly. For more information or to register, go to www.t1dregistry.org/stacey
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outed by celebrities, raved about by TikTok users, and advertised by med spas, a new class of drugs for treating diabetes and obesity has exploded in popularity for its weight-loss effects, leading to rippling shortages across several of the medications.

Amid the surge in demand, Eli Lilly and pharmacies have started to tighten access to the latest of this type of drug, tirzepatide, focusing on giving it to people with type 2 diabetes, the only population it’s authorized for so far. But that’s left another set of patients scrambling — people with clinical obesity who turned to the medication as one of their few options for treatment.

The class of drugs are GLP-1 receptor agonists, which mimic the effects of a hormone that can help people feel full. Within this group, Novo Nordisk’s obesity drug Wegovy and diabetes drug Ozempic have been in short supply for months due to manufacturing issues and increased demand. Lilly’s diabetes medication Trulicity has also been in tight supply, according to the drugmaker. That leaves tirzepatide, sold under the name Mounjaro. Lilly said in a statement that the drug is currently not in shortage, but that the company is continuing to monitor availability of competitor therapies and “supply with a focus on access for people with type 2 diabetes.”

Related: Patients seeking novel weight loss drugs find a ‘wild west’ of online prescribers
In October, Lilly made changes to a discount program for the drug, now requiring people to attest they have type 2 diabetes. The coupons allowed patients to get the drug for $25 a month when it would otherwise cost about $1,000. Some pharmacies are also now checking if people have a diabetes diagnosis before filling prescriptions.
https://www.statnews.com/2022/12/07/eli-lilly-tightens-access-tirzepatide-mounjaro-diabetes-obesity/
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On the podcast next week.. yale lacrosse player Bri Carrasquillo was diagnosed just after her freshman year. Now she’s part of Dexcom U – a new program for college athletes with type 1.
Last week’s show was One Drop is making a CGM? We’ll talk to CEO Jeff Dachis about that. Listen wherever you get your podcasts
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

One Drop is the newest player in the CGM market06 Dec 202200:35:16

Jeff Dachis founded One Drop in 2014, after his own type 1 diagnosis. Known for its sleek meter design and more recently for on-demand telehealth services, One Drop is moving into something new. Jeff shares how that includes what they’re calling a continuous health sensor. We’ll talk about what that term means, how it could help people with diabetes and what Jeff is still really passionate about.

More about One Drop: https://onedrop.today/blogs/press-releases/ada2022-cgm-biowearable-sensor-t2d

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

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In the News... AID using Libre 3, Tzield cost, protein trigger research for T1D and more!02 Dec 202200:08:42

It's In the News.. a roundup of the top diabetes stories and headlines of the past seven days. This week: the first AID system to use Libre 3 is released, we learn more about Teplizumab, now brand name Tzield, to prevent T1D and how much it may cost. Couple of new research projects about what triggers type 1, a personal story about retinopathy and a player with T1D takes the stage at the World Cup.

Check out Stacey's book: The World's Worst Diabetes Mom!

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Episode Transcription Below (or coming soon!)

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*Click here to learn more about OMNIPOD* *Click here to learn more about AFREZZA* *Click here to learn more about DEXCOM*

Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines of the past seven days.
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In the news is brought to you by T1D Exchange! T1D Exchange is a nonprofit organization dedicated to improving outcomes for the entire T1D population.
https://t1dexchange.org/stacey/
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And by my new book “Still The World's Worst Diabetes Mom: More Real Life Stories of Parenting a Child With Type 1 Diabetes” available on Amazon in paperback and for kindle.
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The first automated insulin delivery system using the FreeStyle Libre 3 is now authorized in Germany. The mylife YpsoPump and the FreeStyle Libre 3, combined with the mylife CamAPS FX algorithm from CamDiab
Ypsomed already launched mylife Loop in partnership with CamDiab in early summer 2022 in several countries. That was with the Dexcom G6. The company now says By enabling the FreeStyle Libre 3 sensor to work with mylife Loop, people with diabetes now have the option of choosing between two sensors, the Dexcom G6 and the FreeStyle Libre 3, and of customising their loop.
with other European countries to follow in 2023. The mylife Loop offering is currently available for Android, iOS will follow in the second half of 2023.
I spoke with Ypsomed last year, they are partnering with Lilly and plan to bring their pump the US. Right now oly the Dexcom G6 is approved for AID use, so we’ll see if we get the same kind of flexibility.
https://www.drugdeliverybusiness.com/ypsomed-camdiab-insulin-dosing-abbott-freestyle-libre-3/
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Really interesting but very early work on protein known as Befa. It’s produced by gut bacteria and triggers the division of cells that make insulin. Reserachers at Univesrty of Utah are working on understanding more about how Befa works.. hoping it could help them figure out a way to stimulate beta cell prdocution. The researchers’ findings were recently published in the journal Cell Metabolism. The finding suggests that bacterial warfare in the gut can have collateral beneficial effects on the body, boosting the population of cells that can make insulin throughout the lifespan. In the future, Guillemin’s team imagines possible therapeutic applications for the finding. For example, proactively fortifying the microbiomes of high-risk infants with BefA-producing bacteria could prevent them from later developing type 1 diabetes.
https://scitechdaily.com/profound-implications-new-research-details-the-microbial-origins-of-type-1-diabetes/
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A new serological test may be pivotal in the search for viral triggers of diseases like diabetes and celiac disease. PepSeq is a technology that allows scientists to test antibody binding against hundreds of thousands of protein targets at one time, instead of testing one at a time. This protocol is laid out in detail in an article published earlier in November in Nature Protocols.
It's said to be an important step forward as concerns about bioterrorism, zoonotic diseases and the next pandemic are never far away. Understanding these pathogens will help scientists develop vaccines and track their movement and evolution.

"This can help us to better understand the epidemiology of infectious diseases, and it is also empowering us in our search for potential viral triggers for non-infectious diseases like diabetes and celiac disease," Ladner said.
https://medicalxpress.com/news/2022-11-serological-viral-triggers-diseases-diabetes.html
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The recent approval of teplizumab – brand name is now Tzield, for the delay of type 1 diabetes by the US Food and Drug Administration is expected to advance efforts to increase screening to cost-effectively identify those at risk for the condition who would be eligible to receive the new treatment. The anti-CD3 monoclonal antibody was approved November 17. In a clinical trial, teplizumab delayed the onset of clinical (stage 3) type 1 diabetes by approximately 2 years, and longer in some cases.. more than 4 years.
It is administered by intravenous infusion once daily for 14 consecutive days and is expected to cost in the region of $200,000 for the course of treatment.

During an investor call on November 18, Provention Bio chief commercial officer Jason Hoitt said that among the company's "strategic initiatives" were "advancing awareness and screening for autoantibodies in at-risk individuals, and ultimately, routine screening during pediatric well visits for the general population," as well as "[healthcare provider] belief in teplizumab and desire to prescribe it for their patients."

Without broad population-based screening, first-degree relatives of people with type 1 diabetes are likely to be the first to be screened and those with stage 2 identified for receipt of teplizumab. Today, that population is estimated at about 30,000 in the United States, Hoitt said, adding, "with this approval we hope that more stage 2 patients can be readily identified so the course of the disease can be changed."
https://www.medscape.com/viewarticle/984748
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A new way to test for pancreatic cancer is being considered a breakthrough. Pancreatic cancer is commonly considered the deadliest of all cancers in part because with few symptoms and invasive testing, it’s so difficult to detect. Bluestar Genomics, which has developed a new non-invasive “liquid biopsy” test that uses a blood test.

Pancreatic cancer is eight times as common in patients over the age of 50 with a recent diagnosis of type 2 diabetes. Sometimes, new cases of type 2 diabetes may actually be a consequence of early, undetected pancreatic cancer. Bluestar has breakthrough designation from the FDA. It’s too soon for doctors to recommend this for everyone with type 2 but those recently diagnosed should ask their doctors.
https://www.diabetesdaily.com/blog/theres-a-new-test-for-pancreatic-cancer-heres-why-it-matters-for-type-2-diabetes-706202/
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Not really news but a lot of social media chatter about a lame diabetes joke this time during Wednesday, the reboot of the Adams Family. Hearing great things about the show but not the diabetes joke. Good time to mention Diatribes d-stigamtize campaign . I’ll link up the website, it’s an effort to collect stories and to come up with action to fight diabetes stigma.
https://www.dstigmatize.org/
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Back to the news in a moment but first..
The T1D Exchange Registry is a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. The platform is open to both adults and children with T1D living in the U.S. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. The registry aims to improve knowledge of T1D, accelerate the discovery and development of new treatments and technologies, and generate evidence to support policy or insurance changes that help the T1D community. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy.
The registry is now available on the T1D Exchange website and is simple to navigate, mobile and user-friendly. For more information or to register, go to www.t1dregistry.org/stacey
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Big shout out to friend of the show – and friend of mine – Mike Hoskins. Mike wrote for diabetesmine for many years and still works at the parent company, Healthline. He recently shared a lot of information and feeling about his diabetic retinopathy diagnosis. He goes into detail of what the treatment has been lie, saying that others sharing that with him has helped make it all a bit easier. Its’a wonderful article and I’ll link it up in the show notes.
https://www.healthline.com/health/my-diabetic-retinopathy-diagnosisXX

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Many of you have probably been following Jodan Morris for many years, but just in case.. the 28-year old professional soccer player was diagnosed at age 9. He’s now part of the U.S. Men's National Team that beat Iran this week and moves ahead to the World Cup knock out rounds this weekend. He plays out of Seattle and has started a foundation, Jordan Morris Foundation, to support kids living with Type 1 Diabetes.
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On the podcast next week.. One Drop is making a CGM? We’ll talk to CEO Jeff Dachis about that. Last week’s show was with therapist JoAnne Robb.
Listen wherever you get your podcasts
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

In the News... Generic GLP-1, All-in-one sensor and infusion set, 365-day CGM, T1D & Roblox and more!05 Jul 202400:09:02

It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: The Eversense CGM could soon be approved for one year of continuous use, the first generic GLP-1 medication is launched, a new company tauts and all-in-one sensor and pump infusion set, a new diabetes accessory in the Roblox game, and more!

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Episode transcription with links:

Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now.

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In the news is brought to you by Edgepark simplify your diabetes journey with Edgepark

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The first ever generic GLP-1 medication will soon be available in the US. It’s a generic of Victoza, originally approved by the FDA in 2010 for diabetes, is part of the same class of drugs that includes Ozempic and Mounjaro.

Liraglutide is Glucagon-like peptide-1 receptor agonists (otherwise known as GLP-1s or GLP-1 RAs) are a class of incretin drugs that mimic the body’s natural hormones to help treat diabetes and obesity.

However, the popularity of the drugs has spiraled out of control at times, leading to shortages and supply chain issues in the US and abroad.  The arrival of a GLP-1 generic drug provides reasons to be hopeful for doctors and patients alike, but there are also caveats.

Couple of caveats - liraglutide is injected once daily (vs. weekly) and many doctors say it doesn’t work as well for as many people as semaglutide and terzepatide. No confirmation on the price Two other generic options are being developed and could launch in December 2024. Patents for newer GLP-1 medications like Ozempic and Wegovy won’t expire until several years down the road

https://www.healthline.com/health-news/victoza-generic-glp1-drug-available

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Senseonics plans to launch a 365-day sensor in the U.S. in the fourth quarter of this year. A one-year Eversense CGM could be a game changer for the company.

 

In 2024, Senseonics expects to more than double U.S. new patient starts and increase the global installed base by around 50%. The growth is built on the current 180-day version of Senseonics’ implantable Eversense CGM.

Eversense’s 180-day sensor can need calibrating twice a day, something Senseonics CEO Tim Goodnow said “has been a competitive disadvantage.” Users calibrate the 365-day sensor once a week.

Senseonics is in talks with insulin pump manufacturers about integrating its Eversense CGM with their devices but has yet to commit to a timeline for finalizing an agreement.

https://www.medtechdive.com/news/senseonics-365-day-cgm-2025-sales/719717/

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People who take Ozempic or Wegovy may have a higher risk of developing a rare form of blindness, a new study suggests. Still, doctors say it shouldn’t deter patients from using the medicines to treat diabetes or obesity.

 

Last summer, doctors at Mass Eye and Ear noticed an unusually high number of patients with non-arteritic anterior ischemic optic neuropathy, or NAION, a type of eye stroke that causes sudden, painless vision loss in one eye.

 

The condition is relatively rare — up to 10 out of 100,000 people in the general population may experience it — but the doctors noted three cases in one week, and each of those patients was taking semaglutide medications.

The risk was found to be greatest within the first year of receiving a prescription for semaglutide.

 

The study, published Wednesday in the medical journal JAMA Ophthalmology, cannot prove that semaglutide medications cause NAION. And the small number of patients — an average of about 100 cases were identified each year — from one specialized medical center may not apply to a broader population.

The ways that semaglutides interact with the eyes are not entirely understood. And the exact cause of NAION is not known either. The condition causes damage to the optic nerve, but there is often no warning before vision loss.

 

For now, patients who are taking semaglutide or considering treatment should discuss the risks and benefits with their doctors, especially those who have other known optic nerve problems such as glaucoma or preexisting visual loss, experts say

https://www.reuters.com/business/healthcare-pharmaceuticals/wegovy-ozempic-linked-with-sight-threatening-eye-disorder-study-2024-07-03/

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We got some updates at ADA about the over the counter CGMS Dexcom Stelo and Abbot’s Libre. Dexom plans a late august launch of stelo, which you’ll order from their website – it won’t be physically in stores.

Abbott also plans to sell its wellness-oriented Lingo device this summer through an e-commerce website. That’s a sensor that’s been available in other coutnires for a while, but was recently okayed in the US. It’s not meant for people with diabetes. The Libre Rio is designed or adulst with type 2 who don’t use insulin. No timing yet on that product’s launch.

Neither Abbott nor Dexcom have disclosed pricing for the upcoming products.

https://www.medtechdive.com/news/abbott-dexcom-over-the-counter-cgm-launch/719928/

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Insulet is looking to expand the label for its Omnipod 5 insulin pump for people with Type 2 diabetes. The company said Friday it recently filed with the Food and Drug Administration.

Insulet presented study results at the American Diabetes Association’s 84th Scientific Sessions that evaluated Omnipod 5 in people with Type 2 diabetes who were taking basal insulin or multiple daily injections. The results showed “substantial improvements in blood glucose outcomes and overall quality of life,” said study chair Francisco Pasquel, an associate professor of endocrinology at Emory School of Medicine.

Omnipod 5 is currently cleared in the U.S. for people with Type 1 diabetes. Insulet hopes to expand the pump to people with Type 2 diabetes, with an expected launch in early 2025.

The FDA has not yet cleared any automated insulin delivery systems for people with Type 2 diabetes, Insulet said. The company has a basal-only insulin pump, called Omnipod Go, that was cleared for people with Type 2 diabetes last year, but it does not connect to other devices.

Even though Omnipod 5 is not currently indicated for Type 2 diabetes, doctors prescribe it for their patients with full reimbursement since the pharmacy channel doesn’t distinguish between Type 1 or Type 2 patients, J.P. Morgan analyst Robbie Marcus wrote in a research note on Sunday.

https://www.medtechdive.com/news/insulet-omnipod-5-type-2-diabetes-study/719644/

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In the keynote address at the American Diabetes Association annual conference, FDA Commissioner Dr. Robert Califf expressed concerns about the rising rates of diabetes in the U.S.

Though revolutionary medications and technologies for diabetes and weight loss continue to emerge, these treatments are vastly underused.

The silver lining lies with type 1 diabetes therapies, which are showing great promise in clinical trials.

“For the larger epidemic of type 2 diabetes, we’re failing right now,” Califf said. “I don't say that lightly.”

A huge problem, Califf said, is access. While most health insurance plans cover medical devices and medications for diabetes, without insurance, costs add up quickly. Ozempic, for example, costs nearly $1,000 per month without insurance. Studies have found that regardless of insurance status, roughly 26% of Americans skipped or delayed treatment due to cost.

https://diatribe.org/diabetes-management/fda-commissioner-says-were-failing-people-type-2-diabetes

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Embecta presented two abstracts at the American Diabetes Association Scientific Sessions last weekend making the case for its insulin patch pump for Type 2 diabetes. The company submitted the device for Food and Drug Administration clearance in late 2023.

The diabetes device company developed a patch pump with a larger insulin reservoir that can hold up to 300 units.

Embecta, which is better known for making equipment such as pen needles and insulin syringes, has been developing its first patch pump. The company found that a device with a larger insulin reservoir could provide longer wear times and fewer disposable patches.

https://www.medtechdive.com/news/embecta-insulin-patch-pump-volume-american-diabetes-association/719779/

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Pump/CGM sensor in one

The niaa signature patch pump, shown with a watch displaying current blood sugar level

The niaa signature patch pump has a manual bolus button and is part of an in-development AID system.

Swiss technology maker Pharmasens demonstrated a new semi-reusable tubeless patch pump and glucose sensor in the same compact device, called the niia signature, which the company says can be worn for five days.

 

The top of the device, which includes Bluetooth connectivity and the electronic and mechanical parts to control the pump, separates from the disposable 300-unit reservoir along with the adhesive used to attach the device to the body via a steel cannula. A small button on the device allows manual bolusing. The company says an AID system will manage the device, controlled by smartphone.

 

PharmaSens' simpler basal-bolus patch pump, the niia essential, was submitted for FDA approval in late December. Availability of the niia signature AID system has yet to be announced.

https://diatribe.org/diabetes-technology/diabetes-technology-display-ada-2024

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Edgepark Commercial

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New international consensus statement offers guidance on the care and monitoring of people who are at high risk for type 1 diabetes (T1D). This is all about screening and testing for islet autoantibodies.

These individuals are classified as: At risk or Stage 0 (single autoantibody or transient single autoantibody), Stage 1 (two or more autoantibodies with normoglycemia), and Stage 2 (two or more autoantibodies with dysglycemia but without symptoms and not yet meeting diagnostic criteria for Stage 3 clinical T1D).

The document was presented on June 24, 2024 in a 90-minute symposium at the American Diabetes Association's annual Scientific Sessions and published simultaneously in both Diabetes Care and Diabetologia.

"This is not guidance around who to screen or when to screen. This is guidance for the hundreds of thousands of people around the world who have participated in screening, mostly through research programs, and have been identified with positive autoantibodies and need care in the clinical setting," panel co-chair Anastasia Albanese-O'Neill, PhD, APRN, CDCES, of Breakthrough T1D, told Medscape Medical News.

 

The recommendations also include when to start insulin, and how to provide education and psychosocial support to individuals and family members of those given the early-stage T1D diagnosis.

https://www.medscape.com/viewarticle/experts-advise-early-risk-monitoring-type-1-diabetes-2024a1000bpo

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Roblox has added a diabetic option, complete with insuli pen and Dexcom

You can find it in the marketplace

JDRF – now breakthrough t1d – started a world in roblox a couple of years ago as well

Roblox is a super popular online game that a lot of kids play.

https://www.roblox.com/games/5823990610/Breakthrough-T1D-World

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FFL next week!

Join us again soon!

Getting back to "Diabetes Sanity" - Therapist & T1D mom JoAnne Robb29 Nov 202200:41:47

We’re in the holiday eating season right now.. difficult enough to manage without diabetes. What can we do to take off some of the pressure this time of year while still enjoying holiday meals and parties and treats?

JoAnne Robb is a therapist who has three children.. two with type 1. We talk about a lot more than food and holidays.. and as you can hear, she feels pretty strongly about some of the advice that’s out there right now.

More info about JoAnne, including her upcoming webinar, Let Them Eat Cake? https://www.diabetessweettalk.com/

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Check out Stacey's book: The World's Worst Diabetes Mom!

Join the Diabetes Connections Facebook Group!

Sign up for our newsletter here

Episode Transcription Below (or coming soon!)

Please visit our Sponsors & Partners - they help make the show possible!

*Click here to learn more about OMNIPOD* *Click here to learn more about AFREZZA* *Click here to learn more about DEXCOM*
When your sibling has T1D: Stacey's daughter Lea shares her story22 Nov 202200:47:31

Stacey talks a lot about her son with type 1 but, as many of you know, she also has a daughter who doesn’t have diabetes. What’s it like to grow up with a sibling who gets more attention for something you can’t do anything about?

Lea was five when her little brother was diagnosed – she’s now 21 and she has a lot to say.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Check out Stacey's book: The World's Worst Diabetes Mom!

Join the Diabetes Connections Facebook Group!

Sign up for our newsletter here

Episode Transcription Below (or coming soon!)

Please visit our Sponsors & Partners - they help make the show possible!

*Click here to learn more about OMNIPOD* *Click here to learn more about AFREZZA* *Click here to learn more about DEXCOM*
In the News... Teplizumab approved, Twitter mess for Lilly, Medtronic 7-day infusion set launches, and more!18 Nov 202200:11:41

It’s in the News.. the top diabetes stories of the past seven days. This week, the first drug to prevent T1D for any length of time is approved, Eli Lilly takes a financial hit from a Twitter impersonation stunt, Medtronic's 7-day pump infusion set is ready for consumers, Dexcom's G7 gets great reviews from older folks and educators for ease of use, a new study about light at night and diabetes and more!

Learn more about the T1D Exchange: www.t1dexchange.com/stacey 

Check out Stacey's book: The World's Worst Diabetes Mom!

Join the Diabetes Connections Facebook Group!

Sign up for our newsletter here

Episode Transcription Below (or coming soon!)

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Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines of the past seven days.
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In the news is brought to you by T1D Exchange! T1D Exchange is a nonprofit organization dedicated to improving outcomes for the entire T1D population.
https://t1dexchange.org/stacey/
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And by my new book “Still The World's Worst Diabetes Mom: More Real Life Stories of Parenting a Child With Type 1 Diabetes” available on Amazon in paperback and for kindle.
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Our top story  this week, the US U.S. Food and Drug Administration approves teplizumab, the first drug to delay the onset of type 1 diabets. We’ve been following this for a long time and I’ll ink up our previous interviews with Provention Bio, the company that makes it. The brand name will be Tzield (teplizumab-mzwv) and it’s an injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.

 

Tzield is administered by intravenous infusion once daily for 14 consecutive days. Lots of questions here and we’ll follow up with an interview and more as soon as I can.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-can-delay-onset-type-1-diabetes

https://diabetes-connections.com/delaying-a-t1d-diagnosis-the-fda-considers-teplizumab/

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Our top story this week – the kerfuffle over on Twitter where a couple of accounts spoofed Ely Lilly. The insulin makers stock tanked 6% over just one day late last week, wiping billions of dollars from its market cap. On Nov.10, someone pretending to be Lilly’s corporate account tweeted: “We are excited to announced insulin is free now.” You may know that Twitter under new owner Elon Musk was verifying any account with any name for just 8-dollars. Another verified but fake Lilly account tweeted profanities and taunted people who use insulin with higher pricing, again, also fake. Other major insulin makers Sanofi and Novo Nordisk were also caught up in the crossfire, with their stock prices dipping and questions over the high cost of insulin back in the headlines.
In the understatement of the year, Lilly CEO David Ricks said – quote – “it probably highlights that we have more work to do to bring down the cost of insulin for more people”
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Mice with diabetes appeared cured after transplantation of insulin-secreting pancreatic islet cells, according to a Stanford Medicine study. The animals’ immune systems were coaxed to accept the donated cells prior to transplantation through a three-pronged process that could be easily replicated in humans, the researchers said. No immune-suppressing treatments were necessary after the transplant to prevent rejection of the foreign islet cells. The technique, which builds on earlier work at Stanford Medicine, may open the door to a new type of organ transplant that doesn’t require an immunologically matched donor or years on immune-suppressing medication. The difference here is that they do two transplants.. first doing a partial blood stem cell transplant which makes the new pancreas cells recognized as the body’s own and less likely to be rejected. Long way to go here, but promising idea.
https://med.stanford.edu/news/all-news/2022/11/islet-transplant-diabetes.html
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The first and only 7-day infusion set is ready to go.. after approval more than a year ago – in September of 2021, Medtronic says customers can now order the Medtronic Extended for the 600 and 700 series pumps.

In clinical studies of the Medtronic Extended infusion set, study participants observed a decrease in the number of times an infusion set needed to be changed by 50% and the number of infusion set failures associated with high glucose levels was lowered.3,4 Study participants using the Medtronic Extended infusion set commented on the new infusion set being more comfortable to wear compared to their previous infusion sets and were happy with the longer wear feature in helping reduce the overall burden of insulin pump therapy.3,4

Additionally, use of the Medtronic Extended infusion set is estimated to result in annual costs savings of insulin of up to 25% due to a reduced number of infusion set and reservoir changes that result in unrecoverable insulin, as well as plastic waste reduction of up to 50%.
https://www.prnewswire.com/news-releases/medtronic-launches-worlds-first-and-only-infusion-set-for-insulin-pumps-that-doubles-wear-time-up-to-7-days-in-us-301677790.html
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Recall for omnipod. This is an issue with the Omnipod 5 Controller charging port and cable. This does not impact the Omnipod 5 Pod, the Omnipod® DASH Insulin Management System, the Omnipod® Insulin Management System, or compatible Android smartphone devices that have the Omnipod 5 App installed. No serious injuries have been reported, but insulet has received reports tht the omnipod 5 controller chargting port or cable is discoloring or even melting due to excess heat. Customers are instructed to called insulet or login to an fda site. I’ll link up all of that info in the show notes.
at 1-800-6).
Additional informati41-2049, which is available 24 hours a day, 7 days a week. Alternatively, Omnipod 5 users can utilize the FDA’s MedWatch Adverse Event Reporting program either online (www.fda.gov/medwatch/report.htmExternal Link Disclaimer), by regular mail, or by fax (1-800-FDA-0178on, including instructions to customers to mitigate risk, can be found on the Company’s website at www.omnipod.com/insulet-alertsExternal Link Disclaimer.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-issues-nationwide-voluntary-medical-device-correction-omnipodr-5-controller
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Small study shows that using the Dexcom G7 is easier for older adults to insert and use. Results indicate that G7 CGM system required half as many steps to set up and deploy as the G6 system, with the system’s system usability scale survey scores indicating excellent usability.
The current study was launched to better understand ease of use and task burden of uptake of Dexcom’s G7 CGM system. To do so, investigators designed their study as a formal task analysis with the intent of identifying the number and complexity of tasks associated with deployment of the G7 CGM system compared to the fifth- and sixth-generation systems in adults aged 65 years or older. A cohort of 10 older adults with no prior CGM experience and 10 CDCESs were recruited for inclusion in the investigators’ formal task analysis. This analysis assessed ease of use among CDCESs through a survey after hands-on insertion and initiation of the system. For older adults in the study, ease of use was assessed using system usability scale (SUS) survey scores.

In the post-test survey and SUS survey given to older adults, no responses lower than neutral were recorded and the SUS score for setup and insertion of the G7 system was 92.8, which investigators noted was reflective of an excellent usability rating.
https://www.endocrinologynetwork.com/view/study-finds-dexcom-g7-set-up-is-easier-requires-fewer-tasks-for-older-adults-than-previous-generations
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Control IQ for people with type 2 works well and is safe. New study from Tandem Diabetes Care shows people with type 2 spent 3.6 hours a day long in target range after switching to the tslim x2 pump / Dexcom system from multiple daily injections or basal insulin only
https://www.medtechdive.com/news/tandem-pump-dexcom-CGM-Type-2-diabetes/636448/
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New program from Walgreens to help give more people access to information and diabetes services. Walgreens is teaming up with its Health Corners and third-party clinics to offer free A1C and blood glucose testing and diabetes education during November, Diabetes Awareness Month. For participating locations, visit Walgreens.com/FreeDiabetesScreening and I’ll link that up. Walgreen is the largest provider of continuous glucose monitors including the Dexcom G6 and FreeStyle Libre 2 which track glucose levels all day and night – fewer finger sticks required.

7. Affordable care options and tools including Walgreens Prescription Savings Club and Find Rx Coverage which offer insulin savings programs and affordable, predictable copayments on select insulins. Walgreens Find Care provides access to in-person and virtual healthcare expertise from the comfort of one’s home.
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Sleeping in a room exposed to outdoor artificial light at night may increase the risk of developing diabetes, according to a huge study of nearly 100,000 Chinese adults.
People who lived in areas of China with high light pollution at night were about 28% more likely to develop diabetes than people who lived in the least polluted areas.
We told you about a study published earlier this year that showed Sleeping for only one night with a dim light, such as a TV set with the sound off, raised the blood sugar and heart rate of the young people during the sleep lab experiment.
These researchers caution that any direct link between diabetes and nighttime light pollution is still unclear, however, because living in an urban area is itself a known contributor to the development of diabetes

https://www.cnn.com/2022/11/14/health/night-light-pollution-diabetes-sleep-wellness/index.html

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Researchers are recruiting 20,000 children for a trial to try to identify those at high risk of developing type 1 diabetes.

If left undiagnosed or untreated, the condition can lead to life-threatening complications.

The trial, led by the University of Birmingham, could mean access to new treatments for children at high risk.

The researchers say it may also offer insights that could make screening for type 1 diabetes a possibility.

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Type 1 diabetes is an autoimmune condition where the immune system attacks and destroys cells in the pancreas which produce insulin.

Insulin is crucial because it moves energy from food from the blood to the cells of the body - without it, the body cannot function properly.

Approximately 29,000 children in the UK currently have type 1 diabetes, out of a total of about 400,000 people. For them, managing the condition involves injecting insulin and testing blood glucose levels regularly.

The condition is very different to type 2 diabetes, which is often linked to poor diet or an unhealthy lifestyle.

The organisers want children aged three to 13 to sign up for the trial, which will analyse their blood - through finger prick and vein tests - for autoantibodies.

These are linked to the development of type 1 diabetes. Those with two or more autoantibodies have an 85% chance of having the condition within 15 years, and are almost certain to develop it in their lifetime.

'A simple test could have saved my son'
Parth Narendran, professor of diabetes medicine, and Dr Lauren Quinn, clinical research fellow at the University of Birmingham, said there was a need to explore if screening children for type 1 diabetes in the UK would be possible in the UK.

"Screening children can reduce their risk of DKA (diabetic ketoacidosis) at diagnosis around fivefold and can help them and their families settle into the type 1 diagnosis better," they said.

DKA is a life-threatening complication of type 1 which can occur when diagnosis does not happen quickly.

Rachel Connor, director of research partnerships at JDRF UK, which is co-funding the study, said new drugs that target the immune system were progressing through trials.

"We are demonstrating that it is possible to delay the need for intensive insulin treatment in those most at risk. When these drugs become available in the UK, we need to be ready to use them straight away," she said.

Dr Elizabeth Robertson, from Diabetes UK, which also funded the study, said: "Extra years without the condition means a childhood no longer lived on a knife-edge of blood sugar checks and insulin injections, free from the relentlessness and emotional burden of type 1 diabetes."
https://www.bbc.com/news/health-63622084
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New study on pancreas transplants. These researchers say Up to 90% of people who received a pancreas transplant enjoy freedom from insulin therapy and the need for close glucose monitoring. Biggest drawback is having to take immunosuppressants for the rest of their life. The number of pancreas transplants has declined in recent years. New paper this week in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism. Another downside is that this isn’t a long-term cure.. the paper says the median graft survival is around eight years and the transplanted pancreas does not always work well, so the patient might not be completely insulin-free. However, I do believe that the combined kidney/pancreas transplant should be considered for all patients with type 1 diabetes with an indication for a kidney transplant.”

https://www.healthline.com/health-news/type-1-diabetes-the-benefits-and-limitations-of-a-pancreas-transplant
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Medtrnoic sending emails out regarding the CareLink™ Software outages. .
For most of our customers, we were able to resolve the issue relatively quickly through an application fix that took effect when individuals logged out and then logged back into their CareLink™ accounts (reminder of these recommended actions available here). But we know this was not the experience for all, and for some of you the experience was extremely frustrating and lasted longer. Medtnoic is still working to resolve the issue for some customers. They stress this was not because of a security breach but don’t give further details.
https://app.medtronicdib.mdtpatient.com/e/es?s=357929245&e=822474&elqTrackId=b0ce7494b5bd47ad9b9c672c71086a1c&elq=3155b86a3ca045f0a2e27c182f392387&elqaid=7514&elqat=1&fbclid=IwAR1XYIdfEFpkUrdk-yTk6WKSvlsdncJBNrSy_OpdeuJhHXD2zi78WnxaSG8
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Women with polycystic ovary syndrome (PCOS) were found to be at higher risk for developing type 2 diabetes over a 30-year period, according to new research presented at the 2022 American Society for Reproductive Medicine (ASRM) Scientific Congress & Expo, and described in an article at Healio.

PCOS is a hormonal disorder that causes enlarged ovaries containing small fluid-filled sacs, and it can have painful symptoms. Hormonal changes related to PCOS can also have effects throughout the body — including effects related to diabetes. One study estimated that nearly one in five adolescent girls with type 2 diabetes also has PCOS, although the nature of the link between PCOS and diabetes is still not fully understood. Many scientists believe, though, that insulin resistance — when tissues in the body become less sensitive to insulin, which is a large part of the disease process in type 2 diabetes — also plays a role in the development of PCOS. There is also evidence that correcting the hormonal imbalances seen in PCOS may reduce the risk of developing type 2 diabetes. A recent study showed that taking oral birth control pills as a treatment for PCOS reduced the risk for type 2 diabetes.
https://www.diabetesselfmanagement.com/news-research/2022/11/16/polycystic-ovary-syndrome-linked-to-higher-risk-for-type-2-diabetes/
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Back to the news in a moment but first..
The T1D Exchange Registry is a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. The platform is open to both adults and children with T1D living in the U.S. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. The registry aims to improve knowledge of T1D, accelerate the discovery and development of new treatments and technologies, and generate evidence to support policy or insurance changes that help the T1D community. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy.
The registry is now available on the T1D Exchange website and is simple to navigate, mobile and user-friendly. For more information or to register, go to www.t1dregistry.org/stacey
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SAFE TRAVELS to all en route to San Francisco for the Fall 2022 #Diabetes Mine #Innovation Days. Can't wait to see u all in person! Nov 17 and 18
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On the podcast next week.. My daughter Lea talks about siblings and type 1. Last week was all about Eversense E3 and the future of long-term CGM sensors.
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That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

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