loader from loading.io

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

Diabetes Connections Type 2

Release Date: 01/10/2025

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

Diabetes Connections Type 2

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  Please visit our Sponsors & Partners - they help make the show possible! Learn more about   from extreme temperatures...

info_outline
In the News... Inhaled Insulin Studied for Kids, Dexcom Launches AI, App for Driving & T1D, and more! show art In the News... Inhaled Insulin Studied for Kids, Dexcom Launches AI, App for Driving & T1D, and more!

Diabetes Connections Type 2

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Mannkind releases info about it's Afrezza pediatric studies, Dexcom launches AI tech with Stelo, Health Canada approves Tandem/Dexcom G7, diabetes drug may help sleep apnea, an app in development to help drivers with T1D and more! Find out more about  Please visit our Sponsors & Partners - they help make the show possible! Learn more about   from extreme temperatures Learn more about  Drive  The best way to keep up with Stacey and...

info_outline
In the News.. Defining T1D stages, InsuJet approval, T2D dementia risk and more! show art In the News.. Defining T1D stages, InsuJet approval, T2D dementia risk and more!

Diabetes Connections Type 2

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: A push to change the defined stages of T1D, InsuJet is approved in Canada, new study linked T2D and dementia, new drug looked at to prevent hypoglycemia, big honors for a T1D author and more! Our Find out more about  Please visit our Sponsors & Partners - they help make the show possible! Learn more about   from extreme temperatures Learn more about  Drive  The best way to keep up with Stacey and the show is by signing up for our...

info_outline
Diabetes Digital: Bridging the gaps in type 2 care show art Diabetes Digital: Bridging the gaps in type 2 care

Diabetes Connections Type 2

Finding good diabetes info can be tough – there aren’t enough endos and even if you have a great GP, a lot of information can fall through the cracks. More and more digital services and telehealth options are trying to fill the void here – but of course you want to be careful about quality - and cost. I’m talking to two diabetes educators who want to change how we look at diabetes care, while working inside the complicated system of insurance. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Learn Please...

info_outline
In the News... World Diabetes Day, Free T1D Care(?!), More Mounjaro info, New pump system, and more! show art In the News... World Diabetes Day, Free T1D Care(?!), More Mounjaro info, New pump system, and more!

Diabetes Connections Type 2

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: World Diabetes Day roundup, existing drugs examined for T1D prevention, Blue Circle Health expands its novel T1D care model, Mounjaro studied further, Canada approves a new pumps system, and tragedy in the diabetes community.  Find out more about  Please visit our Sponsors & Partners - they help make the show possible! Learn more about   from extreme temperatures Learn more about  Drive  The best way to keep up with Stacey and...

info_outline
In the News... Omnipod 5 iPhone update, Libre & Dexcom news, overnight insulin pump and more! show art In the News... Omnipod 5 iPhone update, Libre & Dexcom news, overnight insulin pump and more!

Diabetes Connections Type 2

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: iPhone control for Omnipod 5 rolls out, Libre is approved for use in CT scans and MRIs, Dexcom files for 15 day wear, Luna nighttime pump goes to trial, iLet cell trials move forward and more! Find out more about  Please visit our Sponsors & Partners - they help make the show possible! Learn more about   from extreme temperatures Learn more about  Drive  The best way to keep up with Stacey and the show is by signing up for our weekly...

info_outline
In the News... Hurricane aid, Medtronic safety warning, Mounjaro supply update, stem cell T1D success... and more! show art In the News... Hurricane aid, Medtronic safety warning, Mounjaro supply update, stem cell T1D success... and more!

Diabetes Connections Type 2

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Hurricane aid for people with diabetes, Medtronic safety warning, stem cell updates for type 1, new study about teens and young adults with type 1, and Ryan Reed returns to racing. Find out more about  Please visit our Sponsors & Partners - they help make the show possible! Learn more about   from extreme temperatures Learn more about  Drive  The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:...

info_outline
In the News... Insulin price lawsuit, new CGM approved, diabetes camp scholarships... and more! show art In the News... Insulin price lawsuit, new CGM approved, diabetes camp scholarships... and more!

Diabetes Connections Type 2

It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: The FTC sues PBMs over insulin pricing, a new CGM is approved in Europe, more news about GLP-1s but some research says it may not work as well for one population, diabetes camps are invited to apply for grants, and more! Find out more about  Please visit our Sponsors & Partners - they help make the show possible! Learn more about   from extreme temperatures Learn more about  Drive  The best way to keep up with Stacey and the show is by...

info_outline
Omnipod 5 Brings Automated Insulin Delivery to Type 2 Diabetes show art Omnipod 5 Brings Automated Insulin Delivery to Type 2 Diabetes

Diabetes Connections Type 2

Automated insulin delivery has been an incredible advancement for insulin pumps. Now, for the first time, the FDA has approved a system for people with type 2. It’s called Omnipod 5. We’re going to talk about how it works, who it helps, and what the company found in their studies of people who use it. My guest this week is Dr. Trang Ly, truly one of the pioneers of studying and innovating around automated insulin delivery – or AID – systems. She is the Medical Director at Insulet, the company that makes Omnipod.  Prior to joining Insulet, Dr. Ly served as Clinical Assistant...

info_outline
CGM Without a Prescription: Stelo & the Future of Diabetes Care with Dexcom's Jake Leach show art CGM Without a Prescription: Stelo & the Future of Diabetes Care with Dexcom's Jake Leach

Diabetes Connections Type 2

For the first time, you can buy a continuous glucose monitor over the counter, no prescription needed. This summer we went from no CGMs available this way, to now having two. This week we’re talking about the Dexcom Stelo with the company’s COO Jake Leach. We’ll go through the features, the price, how to order and what you should know before you start a CGM. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. More Our Please visit our Sponsors & Partners - they help make the show possible! Check...

info_outline
 
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 

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: [email protected]

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.

XX

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/