FDA gives greenlight to Dexcom OTC CGM
By HME News Staff
Updated 10:58 AM CDT, Tue June 16, 2026
WASHINGTON – The U.S. Food and Drug Administration (FDA) has cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children: Dexcom’s Stelo Glucose Biosensor System, an integrated CGM (iCGM) indicated for people two years of age and older who do not use insulin. The FDA previously cleared the Stelo Glucose Biosensor System OTC for individuals 18 years and older in March 2024. “Children deserve access to the best tools available to manage their health," said Michelle Tarver, M.D., Ph.D., director of the Center for Devices and Radiological Health. "Today's clearance reflects the FDA's commitment to fostering innovation for pediatric patients and supporting the safe and effective use of medical devices where children live, learn, and play.” Stelo is indicated for children, including those with diabetes, who receive oral medication to manage their condition and people who want to understand how diet, exercise, and other lifestyle changes affect their glucose levels. The stystem uses a wearable sensor, paired with an application installed on a compatible smartphone, or other smart device, such as a parent’s or caregiver’s smartphone, to continuously measure, record, analyze and display glucose values. Each sensor lasts for up to 15 days before it must be replaced, although sensor wear time may be shorter in pediatric users than in adults due to several interconnected physiological and behavioral factors. The app displays glucose measurements and trends every 15 minutes.
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