In the News... Libre Freestyle recall, Dexcom 15 day launch, Omnipod & Tandem updates, Medicare price adjustments and more!

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: big FDA recall around Freestyle Libre (see more below to find out if you're affected), Dexcom launches their 15.5 day sensor, Omnipod announces enhancements, Tandem tests a fully closed loop (with high fat, high carb meals) and lots 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.

Our top story this week:

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Certain glucose monitors from Abbott Diabetes Care are providing users with incorrect glucose readings, an error that has been linked with the deaths of at least seven people and more than 700 serious injuries worldwide, according to an alert from the US Food and Drug Administration.

 

Incorrect glucose readings can lead to improper treatment. Abbott warned that about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors are affected, but no other Libre products. Patients can visit FreeStyleCheck.com to see if their sensors are affected and to get a replacement for free.

 

The FDA has also published specific information about the affected products in its alert. The agency considers this to be a “potentially high-risk issue” and will continue to update its website as information becomes available.

 

“Patients should verify if their sensors are impacted and immediately discontinue use and dispose of the affected sensor(s),” the FDA said.

 

https://www.cnn.com/2025/12/02/health/abbott-diabetes-glucose-monitors

https://www.freestylecheck.com/us-en/home.html

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Omnipod 5 is getting some enhancements.. and Omnipod 6 is announced. The FDA cleared updates including  a lower, 100 mg/dL target glucose option and what they call a more seamless automated experience.

“This is the most significant algorithm advancement to our Omnipod 5 System since its launch in 2022,” said Eric Benjamin, Insulet EVP and COO.

Insulet said the new 100 mg/dL target glucose expands Omnipod 5’s customization range. It now features six settings between 100 mg/dL and 150 mg/dL in 10 mg/dL increments. The company said this flexibility allows healthcare providers to tailor insulin delivery more precisely. It supports individuals seeking tighter glucose management or aiming to meet specific glucose goals.

Omnipod 5’s latest upgrades also help users stay in “Automated Mode” with fewer interruptions, even during prolonged high glucose events.

Insulet plans to launch the updates to the algorithm in the first half of 2026.

The company announced plans for an Omnipod 6 – without a lot of detail - at the company’s Investor Day event in November. They also talked about a new, fully closed-loop pump for the type 2 diabetes population.

https://www.drugdeliverybusiness.com/insulet-fda-clearance-omnipod-5-algorithm-enhancements/

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Dexcom, the global leader in glucose biosensing, announced today that the Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System will launch in the United States on Dec. 1, making it the longest-lasting CGM system with 15.5 days of wear.

 

Dexcom G7 15 Day will first be available through durable medical equipment (DME) providers on Dec. 1 with full retail launch in the coming weeks. Dexcom G7 15 Day will also be covered for Medicare beneficiaries.

 

Dexcom G7 15 Day’s industry-leading wear-time will provide fewer sensor changes, less disruption and more time for people with diabetes to benefit from life-changing CGM technology.

 

New with Dexcom G7 15 Day: 

Longest lasting CGM system with 15.5 days of wear.

Best-in-class accuracy1 with an overall MARD of 8.0%.

Easier glucose management with fewer monthly sensor changes and reduced monthly waste.

This follows yesterday’s announcement – the FDA has cleared Dexcom Smart Basal, the first and only CGM-integrated basal insulin dosing optimizer designed for adults 18 and older with Type 2 diabetes using long-acting insulin. Dexcom Smart Basal will use Dexcom G7 15 Day sensor data and logged doses to calculate personalized daily recommendations to guide users towards a more effective long-acting insulin dose, as directed by their healthcare provider.

At launch, Dexcom G7 15 Day will connect with the iLet Bionic Pancreas and Omnipod® 5§§. We are working closely with Tandem and look forward to extending the launch to their customers shortly as they finalize integration. For specific information on pump compatibility and availability with the Dexcom G7 15 Day system, visit Dexcom.com/connectedpumps

https://investors.dexcom.com/news/news-details/2025/Dexcom-G7-15-Day-Continuous-Glucose-Monitoring-System-to-Launch-on-Dec--1-in-the-United-States/default.aspx

 

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A small study of ten adults with type 1 diabetes tested Tandem’s new fully closed-loop “Freedom” insulin system — and the participants put it through a real-world stress test. For 72 hours in a hotel setting, they ate heavy carb-and-fat meals, skipped all meal announcements, and didn’t give any mealtime insulin boluses. The system handled almost everything automatically. Researchers said the device stayed in closed-loop mode 97% of the time and there were no incidents of diabetic ketoacidosis or severe hypoglycemia reported.

While using the Freedom system, participants spent a median 61% of the day in the glucose target range — slightly higher than the 56% achieved with their usual pump at home. But the biggest improvement came overnight: time in range jumped to 96% with the closed-loop system compared to just under 70% during their home-pump week. With almost zero time spent below 70 mg/dL, researchers concluded that the fully automated Tandem system was both safe and effective even with unannounced, high-impact meals — hinting at a future of diabetes management that demands less effort from users.

 

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Novo Nordisk reported promising mid-stage results for its experimental drug amycretin (AM-ee-creht-in) in diabetes patients on Tuesday.

Amycretin, targets both GLP-1 and amylin hormones. In this study, it helped patients with type 2 diabetes lose up to 14.5% of their body weight over 36 weeks with weekly injections, far outperforming a placebo. The oral version delivered weight loss of up to 10.1%.

Rival Eli Lilly  is surging ahead with its own amylin-based drug, eloralintide, which is advancing to late-stage testing after helping patients shed as much as 20% of their weight in a mid-stage trial.

https://www.cnbc.com/2025/11/25/novos-next-gen-obesity-drug-shows-positive-results-heads-to-late-stage-testing.html

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The U.S. Medicare health plan said on Tuesday that newly negotiated prices for 15 of its costliest drugs will save 36% on those medications compared with recent annual spending, or about $8.5 billion in net covered prescription costs.

The prices go into effect in 2027, including a monthly price of $274 for Novo Nordisk's popular GLP-1 drug semaglutide, sold as Wegovy for weight loss and Ozempic for diabetes.

medicare's recent net price for Ozempic, opens new tab was $428 a month, according to an analysis published in the Journal of Managed Care and Specialty Pharmacy. Medicare put the drug's list price, before confidential rebates and discounts, at $959 a month.

Based on such nondiscounted list prices, Medicare said savings on the 15 drugs ranged from 38% to 85%.

The annual price negotiations were established under President Joe Biden's signature Inflation Reduction Act (IRA) of 2022. Previously, Medicare was barred by law from negotiating with drugmakers.

https://www.reuters.com/business/healthcare-pharmaceuticals/us-negotiated-medicare-prices-15-more-drugs-test-cost-savings-promise-2025-11-25/

 

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LifeScan announced its Chapter 11 bankruptcy reorganization plan received U.S. Bankruptcy Court approval. LifeScan said it’s positioned to emerge from its financial restructuring process by the end of the year.

The CEO says, “This balance sheet restructuring provides a stronger foundation for LifeScan to support our base business, advance new growth strategies, and commence our journey to become one of the most comprehensive players in the glucose management space.”

https://www.drugdeliverybusiness.com/glucose-monitor-lifescan-emerge-from-bankruptcy/

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An artificial intelligence (AI)-led Diabetes Prevention Program (DPP) was as effective as a traditional human-led program in achieving recommended goals for weight loss, A1c reduction, and physical activity, according to a randomized trial of adults with prediabetes and overweight or obesity.

One example of a push notification: “Looks like you’re at the grocery store, Rita! Want a quick list of high-fiber snacks or smart swaps to stay on track this week?”

The app also provided location- and goal-based education, with gamification elements to promote engagement.

Approximately one third of participants in both the AI and human-led groups achieved the primary outcome (31.7% and 31.9%, respectively). Results were consistent across sensitivity analyses and individual components of the composite endpoint.

“As more AI-based programs emerge, head-to-head comparisons among different AI-DPPs will be informative. An AI-led approach will not suit everyone; some individuals benefit more from human interaction and accountability,” said Mathioudakis, adding that future research should focus on best matching patients to the modalities they prefer.

https://www.medscape.com/viewarticle/ai-directed-diabetes-prevention-program-effective-human-2025a1000xam

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A new study suggets metformin could help people with type 1, reducing the need for insulin.  The researchers were surprised to find that metformin did not improve insulin resistance or change blood sugar levels. This suggests that, unlike in type 2 diabetes, metformin doesn't combat insulin resistance in type 1 diabetes.

 

However, metformin did reduce the amount of insulin people needed to keep their blood sugar levels stable.

 

https://www.the-express.com/news/health/192157/diabetes-medicine-insulin-type-1

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Beyond Type 1 launches #TheBeyondType campaign in India to combat type 1 diabetes stigma. Nick Jonas is one of the founders of Beyond Type 1, his wife, Priyanka Chopra Jonas is his partner in this new non profit.

The initiative highlights inspiring individuals living with T1D and partners with local organisations to improve awareness, medical support, and community networks for affected families across the nation.

India has more young people living with T1D than any other nation, yet understanding of the condition remains limited.

Beyond Type 1 is partnering with grassroots organisations across high-need regions. These include HRIDAY in Delhi–NCR, Nityaasha Foundation in Pune, Gram Jyoti in Jharkhand, and SAMATVAM Trust in Bangalore—each group focusing on improving awareness, providing medical support and building stronger community networks for young people with T1D.