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In the News... New research in T1D prevention, fast-acting biosimilar insulin approved, Lilly lowers Zepbound price, and more!

Diabetes Connections | Type 1 Diabetes

Release Date: 02/28/2025

The Overlooked Challenges of Women with type 1 diabetes, with Courtney Pickett show art The Overlooked Challenges of Women with type 1 diabetes, with Courtney Pickett

Diabetes Connections | Type 1 Diabetes

Research is finally focusing on women with type 1 – hormones, periods, menopause. But there’s not a lot of guidance or conclusions yet. So what can you do to feel good now? I’m talking to Courtney Pickett this week – she lives with type 1, was a labor and delivery nurse, and is the founder of The CP Table, a holistic health coaching company. We’ll get her takes on everything from food, to frustration of cyclical blood sugar fluctuations, the pressure to be perfect and more. As Courtney says, women’s bodies are bad ass! This podcast is not intended as medical advice. If you have...

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G7 15-Day Approval: Dexcom’s Jake Leach Answers Your Questions show art G7 15-Day Approval: Dexcom’s Jake Leach Answers Your Questions

Diabetes Connections | Type 1 Diabetes

Dexcom G7 gets FDA approval for 15-day wear. It’s in adults-only and should hit the market in the second half of this year. I’m talking to Chief Operating Officer Jake Leach about this newest advance for Dexcom, why they didn’t go for pediatric approval, their partnership with sleep ring company Oura, what else is coming this year from Dexcom and I’m asking a lot of your questions. Read the This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Join us at Please visit our Sponsors & Partners -...

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In the News.. GLP-1 for T1D trials, Ozempic pill, Dexcom 15-day sensor, type 5 diabetes, and more! show art In the News.. GLP-1 for T1D trials, Ozempic pill, Dexcom 15-day sensor, type 5 diabetes, and more!

Diabetes Connections | Type 1 Diabetes

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Eli Lilly will start a lcinical trial for tirzepatide for people with type 1 diabetes, more details on Dexcom's 15 day G7 sensor, Ozepmic pill form tested, type 5 diabetes identified and more! Find out more about  Please visit our Sponsors & Partners - they help make the show possible! Learn more about   from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Here's where to find...

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The iLet, Two Years In: Real-World Insights & What’s Next for Beta Bionics with Chief Medical Officer Steven Russell show art The iLet, Two Years In: Real-World Insights & What’s Next for Beta Bionics with Chief Medical Officer Steven Russell

Diabetes Connections | Type 1 Diabetes

The iLet insulin pump system has been out in the real world for almost two years now. How’s it going? I’m talking to Beta Bionics chief medical officer Dr. Steven Russell about what they’ve learned from people using the system, what they’re changing in future iterations, and how the quest for a pump that uses insulin and glucagon is going. This is a deep dive episode – I had a lot of questions and so did you. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Our previous Earlier Join us at  Please...

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The DRI is The DRI is "Aggressively Working" on a T1D Cure. What does that mean?

Diabetes Connections | Type 1 Diabetes

The Diabetes Research Institute (DRI) is focused on curing and preventing diabetes. We’re checking in to see what’s on their radar. Safer islet cell Transplant Options Without Harsh Drugs, smarter devices to protect islets and what they call Quantum Leap projects. I’m talking with Dr. Matthias von Herrath, Scientific Director of DRI and Michael Burton, CEO of Diabetes Research Institute Foundation More More This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Join us at  Please visit our Sponsors...

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GlucoSense is on a Mission to  Simplify T1D Management show art GlucoSense is on a Mission to Simplify T1D Management

Diabetes Connections | Type 1 Diabetes

During his final exams at Georgia Tech, Jonathan Fitch had a seizure. He was fine, but it was a frightening wake up call – he says – that managing T1D reactively wasn’t enough. An industrial engineering student  he pivoted a creating an all in one app designed to help people stay ahead of diabetes. What does that mean? How does it work? We’re talking about .. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. More info Join us at  Please visit our Sponsors & Partners - they help make...

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In the News.. FDA warns Dexcom, Inreda dual-chambered pump, using insulin with GLP-1 meds studied, and more! show art In the News.. FDA warns Dexcom, Inreda dual-chambered pump, using insulin with GLP-1 meds studied, and more!

Diabetes Connections | Type 1 Diabetes

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Learning more about the FDA letter sent to Dexcom, news from ATTD including a bihormonal pump from a Dutch company, time in tight range update, more studies about using insulin and GLP-1 medications, eating chili to prevent gestational diabetes (really!) and more..  Find out more about  Please visit our Sponsors & Partners - they help make the show possible! Learn more about   from extreme temperatures The best way to keep up with Stacey and...

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504 Plans Under Fire: What Parents Need to Know Right Now show art 504 Plans Under Fire: What Parents Need to Know Right Now

Diabetes Connections | Type 1 Diabetes

Disability rights – particularly those spelled out in 504 plans – are being questioned right now, in a way we haven’t seen since the federal Americans with Disabilities Act was signed into law in 1990. There’s a lot of uncertainty, but there are some things you can do to protect your children. We’re going to talk about 504 plans – we’ll go over the basic, talk about the lawsuits, the dept of education situation, and much more. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. More issued after our...

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Tandem Releases Control IQ+ Software - What's new? (Bonus Episode) show art Tandem Releases Control IQ+ Software - What's new? (Bonus Episode)

Diabetes Connections | Type 1 Diabetes

Some changes coming to Tandem’s Control IQ software… which will now be called Control IQ Plus. What have they added? I’m talking with Dr. Laurel Messer, senior director of Medical Affairs at Tandem to answer your questions about this software update, type 2 indication, whatever happened to Tandem’s new infusion sets and reusable patch pump, and lots more. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Important Safety Information: RX ONLY. Indicated for patients with type 1 diabetes, 2 years and older...

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Teeing It Up with T1D:  Meet PGA Pro Morgan Reimler show art Teeing It Up with T1D: Meet PGA Pro Morgan Reimler

Diabetes Connections | Type 1 Diabetes

People with type 1 can be found in just about every professional, sport, hobby, you name it. But just because more and more people are living their dream with T1D, that doesn’t mean it’s easy to do that! I’m talking to this week – a PGA teaching professional who was playing golf in college when she was diagnosed. Morgan’s mom also lives with type 1- we’ll talk about how they’ve learned from each other, how Morgan manages during practice, tournament play and teaching, and of course as a recreational golfer myself, I had to get some advice Join us at  Please visit...

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More Episodes

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: New drug is looked at for T1D prevention, a new stem cell method is tested for beta cell transplanation without immunosuppresion drugs, the FDA okays the first fast-acting biosimilar insulin, Lilly lowers price of Zepbound, and more!

Find out more about Moms' Night Out 

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

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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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New research in type 1 diabetes prevention launches. Nektar Therapeutics and TrialNet will evaluate a drug currently used for exzema for patients with new onset stage 3 type 1 diabetes

The drug is RezPeg – that’s a shortened version of the name (rezpegaldesleukin)   This will be a study of about 70 adults and children and will launch this year.

The new study will use a mixed meal tolerance test (MMTT) to measure the efficacy of rezpegaldesleukin or placebo for preserving C-peptide area under the curve over a 12-month duration comprised of a 6-month treatment period and a 6-month follow-up. Secondary objectives include pharmacokinetics, pharmacodynamics, and additional disease assessments including HbA1c levels and patient insulin requirements.

Rezpegaldesleukin is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases.

https://www.prnewswire.com/news-releases/nektar-announces-clinical-trial-agreement-to-evaluate-rezpegaldesleukin-in-patients-with-new-onset-type-1-diabetes-mellitus-302383052.html

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NLS Pharmaceutics (NLSP) and Kadimastem announced successful completion of a pre-IND meeting with the FDA for iTOL-102, a potential diabetes treatment. iTOL-102 combines Kadimastem's IsletRx cells (stem cell-derived pancreatic islets) with iTolerance's immunomodulator iTOL-100, aiming to cure Type 1 Diabetes without requiring life-long immune suppression.

The treatment was evaluated at the Diabetes Research Institute at the University of Miami School of Medicine, where it demonstrated functional insulin release and disease reversal in animal models. Based on FDA feedback, the companies are updating plans for safety toxicology studies and First-in-Human clinical trials.

IsletRx is a clinical-grade product comprising human pancreatic islet-like cells capable of secreting insulin, offering a scalable source of insulin-producing cells to address donor islet shortages. The technology can detect glucose levels and produce required amounts of insulin and glucagon.

 

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FDA has signed off on a rapid-acting insulin biosimilar for the first time. The agency has given a thumbs up to Sanofi’s Merilog (insulin-aspart-szjj) as the first biosimilar to Novo Nordisk’s NovoLog for patients with diabetes.

Merilog will be provided by prefilled pen in a 3 mL dose or in a multiple-dose 10 mL vial. It is for adults and pediatric patients age 6 and older.

 

 

NovoLog and Novo Nordisk’s other rapid-acting insulin follow-on Fiasp are among the drugs subject to government price negotiations under the Inflation Reduction Act. The new prices will be enacted at the start of next year.

In July 2021, the FDA approved Biocon and Viatris’ Semglee (insulin glargine-yfgn) as the first biosimilar to Lantus. Five months later, the U.S. regulator endorsed Eli Lilly’s version of the drug, called Rezvoglar (insulin glargine-aglr).

https://www.fiercepharma.com/pharma/fda-signs-sanofis-biosimilar-first-novo-nordisks-rapid-acting-novolog

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Eli Lilly said Tuesday that it will offer more doses of its obesity drug Zepbound in vials and lower the prices of the doses it already sells, as the pharma giant seeks to draw patients away from cheap, compounded copies of weight loss medications.

The company launched 7.5 mg and 10 mg vials of tirzepatide, sold under the brand name Zepbound, which typically cost $599 and $699, respectively. However, they are now available for $499 per month for patients paying without insurance. This applies to the first fill and all refills that are delivered every 45 days.

Additionally, the company lowered the prices of the 2.5 mg and 5 mg vials to $349 and $499 per month, respectively.

The company, which has seen a significant boost in profits from Zepbound and Mounjaro – essentially the same drug with different FDA-approved uses – announced that the new vials and pricing are exclusively available through the company’s self-pay pharmacy, LillyDirect Self Pay Pharmacy Solutions.

https://www.bloomberg.com/news/articles/2025-02-25/zepbound-cost-for-vials-cut-to-battle-cheaper-copycats

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Medicare spending on 10 diabetes drugs, including popular GLP-1s, more than quadrupled over a five-year period and could reach $102 billion next year, an analysis by Health and Human Services' inspector general found.

The findings also come as the Trump administration weighs the fate of a Biden administration proposal that would require Medicare and Medicaid to cover GLP-1s for weight loss.

The biggest spikes in usage were for Rybelsus, Novo Nordisk's once-daily GLP-1 tablet, and for the company's weekly injectable Ozempic, whose spending about doubled every year under review.

https://www.axios.com/2025/02/25/medicare-spending-surge-diabetes-drugs

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Tandem Diabetes Care has secured a new FDA clearance for its insulin dose-calculating algorithm, opening up Control IQ for use in adults with Type 2 diabetes.

The expanded label was based on data from a pivotal, randomized trial of more than 300 people with Type 2 diabetes, comparing its use to manual multiple daily injections. Tandem said it plans to present the study’s results at the annual Advanced Technologies & Treatments for Diabetes meeting scheduled for next month in Amsterdam.

https://www.fiercebiotech.com/medtech/tandem-diabetes-care-insulin-dosing-algorithm-nets-fda-clearance-type-2-diabetes

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Drugs approved for diabetes and obesity might be useful for the treatment of cognitive and mental health disorders, according to a new paper published in Nature Mental Health.

 

The study reviewed and integrated data from both preclinical and clinical studies to gather evidence on the possible effects of these drugs GLP1s and semaglutide  in conditions such as dementia, substance use disorders, psychotic disorders, mood and anxiety disorders, and eating disorders.

 

 

The study found promising but still preliminary evidence that GLP-1RAs could be beneficial over a range of cognitive and mental health disorders. These drugs have shown potential in improving cognition, reducing addictive behavior, and alleviating depression and anxiety. More data from robustly designed studies (i.e., randomized controlled trials) are needed to better understand GLP-1RAs' prospective efficacy and safety profile, especially with long-term use.

https://medicalxpress.com/news/2025-02-diabetes-drugs-mental-health-treatment.html

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The FDA  issued draft guidance that includes recommendations to support the development and marketing of safe and effective AI-enabled

The guidance, if finalized, would be the first guidance to provide comprehensive recommendations for AI-enabled devices throughout the total product lifecycle, providing developers with an accessible set of considerations that tie together design, development, maintenance, and documentation recommendations to help ensure the safety and effectiveness of AI-enabled devices.

FDA is requesting public comment on this draft guidance by April 7.

The agency also released draft guidance for the use of AI to support regulatory decision-making for drug and biological products.

https://www.mddionline.com/artificial-intelligence/fda-issues-draft-guidance-for-ai-enabled-devices-seeks-public-feedback

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Congrats to Mila Clarke who some of you may know better as Hangry Woman on social. She has developed a great app called Glucose Guide and the Nutrition Assistant portion of that app went live this week.

Glucose Guide is a web and mobile app that offers diabetes meal tracking, coaching, resources, recipes and community to those looking for help managing diabetes. MEAL AND BLOOD SUGAR TRACKING FEATURES. 📢

🗓️Mark your calendars for our launch on February 26!

📰 Make sure you're signed up for my newsletter, so you know when these features go live: https://hangrywoman.myflodesk.com/subscribe

💥Plus, if you are one of the first 100 people to sign up on launch day, you'll get a VERY special deal.

📲I'll be sharing some sneak peeks of our new tools. I'm over the moon. FINALLY a tracker that keeps blood sugar tracking aligned with meal tracking, exercise, sleep, mood, and more. Oh, and did I mention it'll analyze your fridge? You can scan photos of your plate and it will give you recommendations on what to adjust for better blood sugar balance?

https://nutrition.glucoseguide.app/

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And finally, gold medal Olympian Jordan Chiles is speaking out about diabetes. The gymnast’s aunt lives with type 1. Chiles is teaming up with Sanofi to talk about auto antibody screening

https://beyondtype1.org/gymnast-jordan-chiles-personal-reason-for-type-1-diabetes-advocacy/