The U.S. FDA’s March 4, 2025, warning letter to Dexcom Inc. is a well-detailed but heavily redacted document explaining the agency’s misgivings about procedures such as monitoring of acetaminophen content in glucose test dishes.
For people with type 1 or type 2 diabetes and the companies developing technologies to help them, the International Conference on Advanced Technologies & Treatments for Diabetes delivered an abundance of good news. On the type 1 diabetes front, Insulet Corp.’s RADIANT study demonstrated massive improvement in time in range as well as lower glycemic levels for patients switching from multiple injections to the Omnipod 5 automated insulin delivery system.
Tandem Diabetes Care Inc.’s Control-IQ+ automated insulin delivery system improved multiple measures of glycemic control in individuals with type 2 diabetes who use insulin, a study presented March 19 at the 18th International Conference on Advanced Technologies & Treatments for Diabetes and published in The New England Journal of Medicine demonstrated.
Tandem Diabetes Care Inc. reported that its next-generation automated insulin delivery algorithm, Control-IQ+ technology (Control-IQ+), is cleared by the U.S. FDA for use by people with type 2 diabetes (T2D) ages 18 and older.
The U.S. FDA cleared Senseonic Holdings Inc.’s Eversense 365, the first continuous glucose monitor to last a full year with a single sensor rather than the 10 days to two weeks typical for wearable sensors such as those offered by Abbott Laboratories and Dexcom Inc.
The U.S. FDA cleared Senseonic Holdings Inc.’s Eversense 365, the first continuous glucose monitor to last a full year with a single sensor rather than the 10 days to two weeks typical for wearable sensors such as those offered by Abbott Laboratories and Dexcom Inc.
Dexcom Inc. revealed data from several studies showing significant benefits of its continuous glucose monitoring technology on adults with type 2 diabetes who are not treated with insulin. In one study, 100% of these users made dietary changes after starting to use Dexcom CGM, with 91% feeling empowered to manage their condition and 27% improving medication adherence after six months.
Abbott Laboratories’ diabetes unit opened the month with a two-cannon salvo – a partnership with Beta Bionics Inc. that will integrate Abbott’s Freestyle Libre 3 Plus continuous glucose monitor with the Ilet Bionic Pancreas system and the roll out of its over-the-counter Lingo CGM in the U.S.
As of this week, consumers can order Dexcom Inc.’s Stelo continuous glucose monitor (CGM) online without a prescription, making it the first to hit the market. Dexcom will have competition soon, however, with Abbott Laboratories planning to roll out its over-the-counter Lingo and Libre Rio CGMs in short order.
Insulet Corp.’s Omnipod 5 automated insulin delivery system has been cleared by the US FDA for the indication of type 2 diabetes, making it the first automated insulin delivery system cleared for both type 1 and type 2 diabetes management.