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In the News... BIG beta cell transplant news, a new pump team-up, FDA moves on GLP-1 compounds, and more!

Diabetes Connections | Type 1 Diabetes

Release Date: 01/10/2025

Dexcom at EASD 2025: Incoming CEO Jake Leach on Recalls, New Features, and User Experience show art Dexcom at EASD 2025: Incoming CEO Jake Leach on Recalls, New Features, and User Experience

Diabetes Connections | Type 1 Diabetes

This week on Diabetes Connections.. catching up with Dexcom’s Jake Leach.. our first interview with him since Leach was promoted to CEO. As always, a lot going on – we get the details on a recent recall for Dexcom software, studies presented at EASD, a look at what’s coming up for the rest of this year and into next and – of course – I ask your questions. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. More about the Join us at  Learn more about  Please visit our Sponsors &...

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Diabetes Connections | Type 1 Diabetes

Managing diabetes data can feel overwhelming, especially when every device speaks a different language. What if your care team could see it all in one place—and have a diabetes educator checking in between visits? This week, we’re talking about , a platform that hopes to make everything easier for the doctor and the person with diabetes. This is a big new trend in diabetes care – we’re talking about how it works, who pays for it and a lot more with Sweet Spot Director of Diabetes Education and Clinical Services Jodi Hughes, RD, LDN, CDCES This podcast is not intended as medical advice....

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In the News... top diabetes stories and headlines happening now! show art In the News... top diabetes stories and headlines happening now!

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It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: kids' A1C and tech access correlation, first generic GLP-1 for weight loss approved, Metformin cuts long covid risk, Tandem Diabetes & Eversense updates, 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 us: Learn more about...

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Lauren Cox and Gary Forbes both live with type 1 diabetes and both played at the very highest level of the sport: the WNBA and the NBA. Podcaster Rob Howe brought them together as part of the Diabetes Legends Basketball Clinic – an ongoing event for kids and teenagers with type 1 that takes place in different cities around the country. I sat down with all three of them to talk about what it takes to get to that level of pro sports with type 1, what setbacks they had along the way, what keeps them going, and advice they have for families today.  This episode was recorded live at the...

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In the News.. CRISPR transplant for type 1, T1D risk if dad has type 2, Metformin and the brain, oral GLP-1, and more! show art In the News.. CRISPR transplant for type 1, T1D risk if dad has type 2, Metformin and the brain, oral GLP-1, and more!

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It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: CRISPR modified cell transplant for type 1, risk of T1D if parent has a different type of diabetes, Metformin and the brain, oral GLP-1, 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 us: Learn more about everything at our...

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We've got an important update on a diabetes drug you may have never heard about. Sotagliflozin is known to have big benefits for people with type 2 but getting it approved for type 1 has been frustrating to say the least. The FDA has twice declined to approve it for people with T1D, but experts – including my guest – are pushing and hoping that will soon change. I’m talking to Dr. Steve Edleman, an endocrinologist who lives with type 1 and heads up the group We’ll talk about the risks that come with sotogliflozin, how continuous ketone monitoring could change the game, and what you...

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We've got a funny, informative, helpful and no holds barred “Ask Me Anything” panels. Recorded at Moms’ Night Out in Cleveland, you’ll hear from two incredible experts who’ve lived with type 1 diabetes for decades—Julia Blanchette, PhD, RN, CDCES, and Natalie Bellini, DNP, FNP-BC, CDCES. We tackle everything from helping grandparents understand modern T1D care, to balancing diabetes in a marriage, to managing ADHD alongside diabetes in teens. We’ll also dig into why screening for type 1 is so important—and how to find the community and resources that make life with diabetes...

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 It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: cancer reserach may lead to T1D treatment, GLP-1 oral pill moves forward, Tandem pharmacy moves, Medtronic-Abbott sensor unveield, parents of kids with T1D see income drop, Mannkind submits Afrezza for pediatrics, diabetes scholarships 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...

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We’re all supposed to know about ketones, but how much education did you actually get?   I’m talking to Dr. Jennifer Sherr, a pediatric endocrinologist who lives with type 1 about the basics of ketones and a lot more. She shares best practices to stay safe, what most people with diabetes really do and what she’s hopeful for in terms of making ketone monitoring easier. We’ve been managing T1D for 18 plus years and I was surprised, there was still a lot here I didn’t know.   This podcast is not intended as medical advice. If you have those kinds of questions, please...

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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: Sana announces beta cell transplantation without the need for immunosuppresion drugs, Modular Medical teams up with Nudge BG for a brand new completely closed-loop system, the FDA moves forward to crack down on compounded Ozempic and Mounjaro, Dexcom and Abbott bury the legal hatchett for a while, and more. 

Find out more about Moms' Night Out 

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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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Big news from Sana Biotechnology. Their first in human study of islet cells without any immunosuppression appears to be a success.

This is very early and hasn’t yet been peer reviewed and published.. but after four weeks, there were no safety issues and the transplanted beta cells were producing insulin.

Sana’s CEO says

 “As far as we are aware, this is the first study showing survival of an allogeneic transplant with no immunosuppression or immune-protective device in a fully immune competent individual. Safe cell transplantation without immunosuppression has the potential to transform the treatment of type 1 diabetes and a number of other diseases.”  

I’ve reached out to Sana to get more on this.. love to talk to them soon.

 

https://www.bakersfield.com/ap/news/sana-biotechnology-announces-positive-clinical-results-from-type-1-diabetes-study-of-islet-cell/article_d0390fd6-99cb-53bd-b04d-9337121e01bf.html

XX

FDA says no for sotagliflozin as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD).  Studies showed a meaningful reduction in A1C but a meaningful increase in DKA.

The FDA first rejected this in 2019 and was resubmitted last summer. But The advisory committee voted 11 to 3 against the approval of sotagliflozin stating that the benefits of sotagliflozin do not outweight the risks in adults with T1D and CKD.

Sotagliflozin is currently approved under the brand name Inpefa to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with 1) heart failure; or 2) type 2 diabetes mellitus, CKD, and other cardiovascular risk factors.  According to Lexicon, Inpefa will continue to be manufactured and made available to patients.

https://www.renalandurologynews.com/news/fda-denies-approval-of-zynquista-for-type-1-diabetes-and-ckd/

XX

Two companies we’ve been following are teaming up.. Modular Medical has an FDA clear patch pump and Nudge BG has an adaptive full closed loop. They’ve announced a new partnership agreement. From the release:

Modular Medical's easy-to-use and cost-effective MODD1 insulin pump technology. Our combined system is intended to nudge blood glucose by making small changes to insulin delivery based on estimated glucose inputs from a continuous glucose monitor."

Familiar name to some of you, Lane Desborough is the founder of Nudge BG. He says this will be a fully automated system, no mealtime bolusing needed.

 

https://www.accesswire.com/957703/modular-medical-announces-licensing-and-partnership-agreement-with-nudge-bg

XX

Beta Bionics filed for an initial public offering on Monday. The company did not disclose the number of shares it will offer or the price range. Beta Bionics plans for shares to be listed on the Nasdaq under the ticker symbol “BBNX.” The Irvine, California-based company makes an insulin pump called the iLet Bionic Pancreas, which was cleared by the Food and Drug Administration in 2023. Beta Bionics plans to use the proceeds to grow its sales and manufacturing infrastructure and develop new features for its device.

 

https://www.medtechdive.com/news/beta-bionics-insulin-pump-files-ipo/736805/

 

 

XX

Tandem Diabetes Care, Inc. signed a multi-year collaboration agreement with the University of Virginia Center for Diabetes Technology (UVA) to advance research and development efforts on fully automated closed-loop insulin delivery systems.

 

There’s a long history here – UVA is where the Control IQ algorithm was developed.  This agreement seems to keep the team together for another decade.

https://www.businesswire.com/news/home/20250107162995/en/Tandem-Diabetes-Care-Enters-Multi-Year-Research-Collaboration-with-UVA-Center-for-Diabetes-Technology-for-Development-of-Advanced-Insulin-Delivery-Systems

XX

New study says insulin is still the best treatment for gestational diabetes, compared to oral glucose-lowering medications. Metformin and gluburide are being closely looked at since they're easier to administer, less costly, and have better acceptance among patients. But this study says insulin was a bit better – slight more babies were born larger for the metformin group, and more moms had hypoglycemia.

https://www.medpagetoday.com/obgyn/pregnancy/113651

XX

In its Citizen Petition to the FDA, Novo Nordisk argued that there is no clinical need to allow compounding for liraglutide, the type 2 diabetes injection it sells as Victoza.

Novo Nordisk last month filed a Citizen Petition with the FDA asking the federal agency to exclude its type 2 diabetes injection Victoza (liraglutide) from a proposed list of drugs eligible for compounding.

https://www.biospace.com/fda/novo-launches-citizen-petition-to-block-compounded-victoza

XX

Bit of an update on compounded terzepatide and semaglutide. The FDA is allowing a grace period of 60 days before starting to enforce the end of allowing compounds of Mounjaro.

Meanwhile, semaglutide remains on the FDA’s shortage list for several dose strengths, though all doses have been reported as “available” since late October 2024.

Compounding pharmacies, especially larger 503B “outsourcing facilities,” maintain they provide an essential public service by offering lower-cost versions of medications that can cost over $1,000 per month. Many insurers still refuse to cover brand-name GLP-1 products for weight loss. Yet  the FDA has reported hundreds of adverse event reports allegedly linked to compounded versions of these drugs, which do not undergo the same rigorous manufacturing inspections and clinical testing as approved brands.

 

https://www.drugdiscoverytrends.com/compounders-and-drugmakers-clash-over-compounded-weight-loss-drugs-with-fda-in-the-middle/

XX

Interesting story here.. this study says a fecal transplant can help people with type 1 and severe gastroenteropathy. The researchers say diabetic gastroenteropathy commonly affects individuals with type 1 diabetes, causing debilitating symptoms like nausea, vomiting, bloating, and diarrhea; however, treatment options remain limited.

Researchers conducted a novel clinical trial to test the benefits of FMT in adult patients with type 1 diabetes and severe symptoms of gastroenteropathy, who were randomly assigned to receive either FMT or placebo capsules as the first intervention.

After four weeks, Compared with placebo, FMT led to significant changes in the diversity of the gut microbiome.

https://www.medscape.com/viewarticle/fmt-shows-early-success-type-1-diabetes-bowel-issues-2025a10000bg

XX

A couple of weeks ago, listeners told me that the Dexcom geofencing issue we reported on seems to be resolved. Dexcom is now confirming this. Previously, if you had an issue with Dexcom G7 outside of your home country, you couldn’t reinstall or use the app without customer support. As of last month, the geofencing issue has now been resolved with the latest Dexcom G7 2.6 app update.

Can I travel with my Dexcom G7? | Dexcom

XX

Abbott and Dexcom settled all patent lawsuits related to continuous glucose monitors (CGMs). The two competitors, who lead the U.S. market for CGMs, agreed on Dec. 20 to resolve all outstanding patent disputes and not sue each other over patents for 10 years.

 

Dexcom and Abbott previously reached a settlement in 2014 related to their diabetes devices, which included a cross-licensing deal and an agreement not to sue each other until 2021. After that agreement expired, the companies filed a volley of patent lawsuits.

https://www.medtechdive.com/news/abbott-dexcom-settle-cgm-patent-lawsuits/736300/