Stelo OTC Glucose Monitor Cleared for Children

The FDA cleared Dexcom Inc.’s Stelo Glucose Biosensor System as the first over-the-counter continuous glucose monitor (CGM) for use in children, according to a June 12 FDA announcement.

The clearance expands Stelo from over-the-counter adult use to people aged 2 years and older who do not use insulin. The device may be used by children with diabetes managed with oral medication, as well as by people using glucose data to better understand how diet, exercise, and other lifestyle factors affect glucose levels.

Stelo is an integrated CGM that uses a wearable sensor and an application on a compatible smartphone or smart device. The app may be used on a parent’s or caregiver’s device. The system continuously measures, records, analyzes, and displays glucose values, with glucose readings and trends refreshed every 15 minutes. The FDA said users and caregivers should consult a health care provider before making medication changes based on device output.

Each Stelo sensor is designed to last up to 15 days, though the FDA noted that sensor wear time may be shorter in pediatric users because of physiologic and behavioral factors. The clearance was based on previous adult and pediatric clinical study data, along with real-world evidence from integrated CGM use in adults and children. In prior studies, participants reported mild adverse events, including local infection, skin irritation, and pain or discomfort.

The FDA said children should use Stelo under the supervision of an adult caregiver. The agency also noted that the device is not intended for people with problematic hypoglycemia because it is not designed to alert users to low glucose, and it is not intended for people on dialysis.

Source: FDA. FDA clears first over-the-counter continuous glucose monitor for children. News release. FDA; June 12, 2026. Accessed June 30, 2026.