• In the News.. FDA warns Dexcom, Inreda dual-chambered pump, using insulin with GLP-1 meds studied, and more!

  • Mar 28 2025
  • Duración: 8 m
  • Podcast

In the News.. FDA warns Dexcom, Inreda dual-chambered pump, using insulin with GLP-1 meds studied, 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: Learning more about the FDA letter sent to Dexcom, news from ATTD including a bihormonal pump from a Dutch company, time in tight range update, more studies about using insulin and GLP-1 medications, eating chili to prevent gestational diabetes (really!) 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 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. XX Our top story this week: Dexcom Dive Brief: A warning letter posted Tuesday by the Food and Drug Administration revealed quality control issues with Dexcom’s continuous glucose monitors. The FDA raised concerns with a design change to a component used in the resistance layer of Dexcom’s sensors. The sensors with the new component were less accurate than those with the original component, according to the warning letter. Dexcom has ceased distribution of G7 sensors with the component, but the company’s response did not address affected G6 sensors. J.P. Morgan analyst Robbie Marcus wrote in a research note Tuesday that the letter concerns a chemical compound that the sensor wire is dipped in. Dexcom began producing the compound internally to add redundancy to its supply chain. Dive Insight: Dexcom Chief Operating Officer Jake Leach said in an interview with MedTech Dive last week that the company does not expect the warning letter to affect future product approvals, including a 15-day version of its G7 CGM, and there’s no need yet to recall products. Dexcom has submitted the device to the FDA and anticipates a launch in the second half of the year. Marcus, after speaking to company leadership and a quality control expert, wrote that many of the issues outlined in the letter could be addressed quickly. He added that the warning letter could explain minor delays in approval to the 15-day sensor, but Dexcom is still within the 90-day window for a 510(k) submission. “While there’s always a risk this could impede future product approvals,” Marcus wrote, “we do not expect this to materially delay the 15 day G7 sensor approval.” The warning letter followed an FDA inspection last year of Dexcom’s facilities in San Diego and Mesa, Arizona. Marcus wrote that after the FDA requested additional information and a separate 510(k), Dexcom stopped in-sourcing the compound and reverted back to the external supplier. Dexcom’s devices were misbranded because the company did not submit a premarket notification to the FDA before making major changes to the sensors, according to the warning letter. The sensors with the changed coating “cause higher risks for users who rely on the sensors to dose insulin or make other diabetes treatment decisions,” the letter said. The FDA raised other concerns in the warning letter, including procedures to monitor the glucose and acetaminophen concentrations used in testing of the G6 and G7 CGMs. The FDA also cited problems with Dexcom’s handling last year of a deficiency in its G6 sensors with dissolved oxygen content values, a key input for measuring blood glucose levels. https://www.medtechdive.com/news/dexcom-warning-letter-cgm-coating-change/743597/ XX Lots of studies and info out of the recent ATTD conference. One highlight that has been sort of under the radar: a Dutch company has been using a Bihormonal fully closed-loop system for the treatment of type 1 diabetes in the real world. This is a company called Inreda (in-RAY-duh). The Inreda AP® is an automatic system (closed loop) and independently regulates the blood glucose level by administering insulin and glucagon. The AP5 is certified in Europe and is being used in multiple studies and projects. The AP®6 is currently under development. https://www.inredadiabetic.nl/en/discover-the-ap/ https://pubmed.ncbi.nlm.nih.gov/38443309/ XX Let’s talk about time in tight range. If you follow me and diabetes connections on social, you likely saw a video I made about this – it blew up last week. If not.. time in range has been a metric for a short...
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