The FDA has cleared Dexcom's Stelo glucose biosensor system as the company’s first over-the-counter continuous glucose monitor (CGM) for children two years and older who do not use insulin. The sensor is for children and adults with prediabetes, individuals that use oral medication to manage their diabetes, and for people who don’t have diabetes who want to better understand their glucose levels.

This expands access to the device as prediabetes rates among U.S. children continue to rise, putting millions at greater risk for developing type 2 diabetes. The sensors last up to 15 days, much like the Dexcom G7 15-day. The Stelo system pairs the wearable sensor with a smartphone app to display real-time glucose readings every 15 minutes. Dexcom just unveiled an updated app at ADA that has an AI coach and a more consumer-friendly design.

At Dexcom’s 2026 Investor Day, executives emphasized the goal of expanding access to sensors for people with diabetes and beyond. The Dexcom Flex, a CGM designed for adults with type 2 diabetes who are not using intensive insulin therapy, is now available in specific European markets and the company is also developing a multi-analyte sensor that could provide glucose and potassium level readings. All of this news comes on the heels of the Dexcom G8 announcement, coming to the market in late 2027/early 2028, with a new algorithm and self-adapting technology.

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