In the News… $3 Semaglutide?, New Stem Cell Partnership, “Lyla’s Law” Debate, Patient-Led Insulin Dosing in Pregnancy, FDA GLP-1 Crackdown, and more!

It's In the News, a look at the top headlines and stories in the diabetes community.

This week's top stories: Stem Cell Islet Therapy Partnership, “Lyla’s Law” Type 1 Testing Debate, Patient-Led Insulin Dosing for Gestational Diabetes, $3 Semaglutide Manufacturing, FDA GLP-1 Compounding Crackdown

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transcript with links: 

Welcome! I’m your host Stacey Simms and this is an In The News episode.. where we bringing you the top diabetes stories and headlines happening now. A reminder that you can find the sources and links and a transcript and more info for every story mentioned here in the show notes.

I am definitely feeling better – that lingering cold is gone – but whew still recovering from non stop travel for the past five weeks. I have a great strech of time her at home, then going to Vegas for Brekathorugh T1D at the end of the month and we have two club 1921 events in April – Atlanta and Philly.

Before we jump into the news – I need your community commercials! These have been a lot of fun, I announced them late last year – your voice on the show. All the instructions it’s very easy in the show notes.

Okay.. our top story this week:

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A biotech company developing stem-cell treatments for type 1 diabetes has announced a new research partnership aimed at improving the survival of transplanted insulin-producing cells.

NewcelX, a clinical-stage company based in Switzerland, said it will work with Eledon Pharmaceuticals to study a combination approach.

The goal is to help transplanted cells survive longer in the body by reducing the immune response that often leads to transplant rejection. If successful, the strategy could support longer-lasting islet cell replacement and move the therapy closer to becoming a functional treatment for people with type 1 diabetes.

However, the companies have not yet released any safety or effectiveness data on the combination treatment, and financial details of the partnership were not disclosed.

The research agreement is focused on exploring whether combining stem-cell-derived islets with targeted immune therapy can lead to longer-lasting cell transplants and improved outcomes for people with type 1 diabetes.

https://www.stocktitan.net/news/ELDN/newcel-x-announces-strategic-collaboration-with-eledon-d10l1vqdofls.html

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Debate this week in the UK on whether testing for type 1 diabetes should become mandatory when children present with symptoms. The Westminster Hall debate, scheduled for 9 March, will consider calls for routine testing of babies, toddlers and young children who show signs associated with the condition.

It follows a petition backing the move, dubbed ‘Lyla’s Law’, which passed 121,000 signatures in December 2025. The campaign was launched by John Story after his two-year-old daughter, Lyla, died from diabetic ketoacidosis (DKA) on 3 May 2025, 16 hours after being diagnosed with tonsillitis.

https://www.nursinginpractice.com/clinical/diabetes-and-endocrinology/diabetes-community-urged-to-call-on-mps-to-attend-lylas-law-debate/

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A new study suggests that people with gestational diabetes who adjust their own insulin doses may reach healthy blood sugar levels faster than those whose doses are adjusted by clinicians.

Half of the participants were assigned to adjust their own insulin doses using a simple rule: increase the dose by two units if fasting blood glucose was above 95 mg/dL, decrease it by two units if it dropped below 70 mg/dL, and keep the same dose if levels fell in between. The other half had their insulin adjusted by clinicians through weekly reviews.

By the end of pregnancy, both groups had similar average fasting glucose levels before delivery: about 89 mg/dL in the patient-led group and 90 mg/dL in the clinician-led group.

However, those adjusting their own insulin reached their blood sugar targets more quickly, averaging 1.8 weeks compared with 2.5 weeks for those managed by clinicians.

The study also found lower risks of certain complications among the patient-led group.

https://www.medscape.com/viewarticle/self-insulin-dosing-leads-control-gestational-diabetes-2026a1000729

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A blockbuster anti-obesity and diabetes drug could cost as little as $3 per month to manufacture once it goes off patent later this month, researchers said Friday, providing a major opportunity to boost health in low and middle-income countries.

 

Semaglutide, the active molecule in Novo Nordisk's Ozempic and Wegovy will lose patent protection in countries such as Brazil, China, and India later this month, and researchers identified 150 countries where it was never patented.

These researchers estimated it will cost as little as $3 to produce a month's supply of semaglutide, which in its branded form sells for around $200 a month in the United States.

Another of the study's authors, Professor Francois Venter at the University of Witwatersrand in South Africa, said drugs to treat HIV, TB, malaria, and hepatitis are now available at prices close to production costs but still sufficient for generic manufacturers to operate.

https://www.sciencealert.com/weight-loss-drugs-could-cost-just-3-a-month-to-make-as-patents-end

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Here in the US the FDA is stepping up its efforts to combat widespread GLP-1 drug compounding. In its latest offensive, the agency has unleashed a fresh set of 30 warning letters targeting telehealth companies it says make “false or misleading” claims about compounded versions of popular obesity drugs.

The FDA says Compounded drugs can be important for overcoming shortages or meeting unique patient needs—but compounders should not try to compound drugs in a way that circumvents FDA’s approval process.”

https://www.fiercepharma.com/pharma/fda-ramps-crackdown-glp-1-drug-compounders-fresh-batch-30-warning-letters

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Check your infusion sets for an issue: Unomedical, a subsidiary of Convatec and a supplier of insulin infusion sets to diabetes tech firms, has received a warning letter from the FDA.

Inspectors raised concerns with leaking infusion sets, following a regulatory assessment of Unomedical’s facility in Reynosa, Mexico, last summer.

Unomedical supplies infusion sets to insulin pump makers including Medtronic, Tandem Diabetes Care and Beta Bionics. In a Feb. 3 statement, Convatec said the letter focuses on reporting procedures and quality protocols and does not place restrictions on producing, marketing or distributing any of Unomedical’s products. 

Unomedical told the FDA in its responses that it plans to conduct a retrospective review of complaints involving serious injury or death by January and conduct additional training on complaint handling by May.

 

https://www.medtechdive.com/news/fda-warns-insulin-infusion-set-maker-unomedical-over-leaks-mishandled-comp/813503/

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Nearly four in ten people with type 2 diabetes do not take their medications as prescribed, according to a new research review published in Diabetologia in November 2025.

 

Researchers examined existing studies on medication adherence, including how often patients miss doses, why it happens, and what strategies may help. They estimated that about 38% of patients with type 2 diabetes are not fully adherent to their medications.

 

Adherence rates vary depending on the type of medication. About 63% to 68% of patients take oral glucose-lowering drugs as directed, while adherence drops to 43% to 54% for injectable GLP-1 medications and 41% to 64% for insulin.

 

Poor adherence can lead to serious consequences. One retrospective study cited in the review found that patients who consistently took their glucose-lowering medications had a 31% lower risk of hospitalization or emergency department visits.

 

The review also highlighted ways to improve adherence. Simplifying medication routines can help, such as using fixed-dose combination pills, which combine multiple drugs into a single tablet. Studies show these combinations are linked to better adherence and improved blood sugar control.

 

Pharmacists can also play an important role by providing education, reviewing medications, setting up reminders, and helping patients organize their treatment plans. The researchers noted that support should be tailored to each patient. Older adults may benefit from simpler systems and caregiver support, while younger patients may respond better to digital tools like app-based reminders.

 

The authors also found that measuring adherence is challenging and recommend using multiple methods, such as pharmacy records, patient interviews, and objective tests when possible.

 

Overall, the review concludes that personalized, multi-step approaches lasting at least three months are most effective in helping people with type 2 diabetes stay on track with their medications.

https://www.pharmacytimes.com/view/type-2-diabetes-medication-adherence-rates-remain-low-and-pharmacists-can-help

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New clinical trial shows metformin does not directly reverse insulin resistance in people with type 1 diabetes. Instead, it lowers the total amount of insulin required to keep blood glucose levels within the recommended range.

The findings, published in Nature Communications, challenge long-held assumptions about how metformin works in type 1 diabetes. The results may help physicians refine treatment strategies and reduce the daily demands placed on people who rely solely on insulin therapy.

“Insulin resistance is a growing problem in type 1 diabetes. Not only does it make regulating blood sugar levels difficult, but it is an underappreciated risk factor for heart disease, which is one of the biggest causes of health complications and deaths in those with type 1 diabetes,” says Dr. Jennifer Snaith, endocrinologist and co-lead of the study.

 

https://scitechdaily.com/groundbreaking-trial-reveals-unexpected-benefit-of-metformin-in-type-1-diabetes/

 

Tech news ahead, including updates from Sensonics, Dexcom & Tandem.. right after this….

Back ot the wnews..

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Sensonics shares that it’s secured FDA investigational device exemption (IDE) for its self-powered, battery-enabled Gemini sensor. It enrolled the first patients in the IDE trial and expects to complete that in the second half of 2026.

Gemini builds on the implanted CGM to put the transmitter under the skin as well as the sensor.

https://www.drugdeliverybusiness.com/senseonics-q4-2025-ide-gemini-cgm/

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Medtronic Diabetes is now officially MiniMid, a stand alone public company. Medtronic  acquired MiniMed 25 years ago announed last May that it would spin its diabetes business off. In their statement the company points out that MiniMed is the only diabetes tech company to sell both insulin pumps and continuous glucose monitors.

 

https://www.investing.com/news/stock-market-news/medtronics-diabetes-unit-minimed-valued-at-53-billion-as-shares-fall-in-nasdaq-debut-4547518

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Kevin Sayer heads back to Dexcom.. The former CEO is back in his position as executive chair of the Board, he’d stepped away for a medical leave.

Dexcom (Nasdaq:DXCM) announced today in an SEC filing that former CEO Kevin Sayer has returned from his leave of absence. Sayer’s return to the board comes just days after Dexcom announced a new board member. Last week, the company announced that it added Google SVP, Platforms and Devices, Rick Osterloh, to its board as well.

 

 

https://www.drugdeliverybusiness.com/kevin-sayer-returns-dexcom-board-chair/

SAN DIEGO - DexCom, Inc. (NASDAQ:DXCM) announced the appointment of Rick Osterloh to its Board of Directors, effective today, according to a press release statement.

 

Osterloh serves as Senior Vice President, Platforms & Devices at Google, where he oversees Android, Google Play, Chrome, and Google’s hardware portfolio including Pixel phones, Google Nest devices, and Fitbit wearables. He has held this position since 2016.

 

https://www.investing.com/news/company-news/dexcom-appoints-google-executive-rick-osterloh-to-board-93CH-4529662

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Sequel Med Tech announced broad national availability of its twiist™ Automated Insulin Delivery (AID) System powered by Tidepool. After U.S. FDA clearance in 2024 and a controlled launch to optimize the twiist experience, the system is now fully available nationwide.

The release says: Built on Sequel’s proprietary iiSure™ Technology, the system enables earlier detection of delivery issues, alerting users to blockages up to nine times faster than other AID systems1, potentially reducing the risk of unexplained high glucose and giving you time to take action before experiencing severe high blood sugar or DKA2.

Designed to expand access to automated insulin delivery, twiist is available through pharmacy channels with a flexible access model,

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Tandem Diabetes Care’s Mobi automated insulin delivery system is now available with Android devices.

In November, Tandem announced that it received FDA approval for the Android version of its Mobi mobile app. The pump, which pairs with Tandem’s Control-IQ+ algorithm, previously worked with iOS software. At the time of the clearance, it said it would commence a limited rollout before the full launch — now underway — this year.

 

Tandem launched Mobi in the U.S. in February 2024. It initially received FDA clearance for people with diabetes ages six and up in July 2023. The system then received expanded clearance for pediatric indications in April 2024, then later won CE mark in May 2025.

 

Mobi features a 200-unit insulin cartridge and an on-pump button to provide an alternative to phone control for insulin boluses. It comes in at less than half the size of the flagship Tandem pump system, the t:slim X2 pump. Mobi can fit in a coin pocket, clip to clothing or go on the body with an adhesive sleeve.

https://www.drugdeliverybusiness.com/tandem-diabetes-care-launches-mobi-android/