Episode Details

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..

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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.

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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.

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