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

In the News... Libre Freestyle recall, Dexcom 15 day launch, Omnipod & Tandem updates, Medicare price adjustments 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: 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! Find out how to submit your Community Commercial 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 Check out VIVI Cap to protect your insulin from extreme temperatures 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: info@diabetes-connections.com 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: XX 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 XX 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/ XX 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 ...
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