The U.S. Food and Drug Administration cleared Dexcom Inc.'s (NASDAQ: DXCM) Stelo Glucose Biosensor System for over-the-counter use in children aged two years and older who do not use insulin. The agency previously approved the device for adults 18 and older in March 2024.

The continuous glucose monitor uses a wearable sensor paired with a smartphone application to measure, record and display glucose values every 15 minutes. Each sensor operates for up to 15 days before replacement, though pediatric users may experience shorter wear times due to physiological and behavioral factors.

The device targets children with diabetes who receive oral medication and individuals seeking to understand how diet, exercise and lifestyle changes affect glucose levels. The system cannot be used by people with problematic hypoglycemia, those on dialysis, or individuals with eating disorders without consulting healthcare providers.

The FDA used real-world evidence from previous clinical studies involving both pediatric and adult populations to evaluate device performance. Study participants reported mild adverse events including local infection, skin irritation and discomfort.

"Children deserve access to the best tools available to manage their health," said Michelle Tarver, director of the Center for Devices and Radiological Health.

The clearance addresses rising prediabetes rates among U.S. children, with the agency noting that millions face increased risk of developing Type 2 diabetes. For pediatric users, the device requires adult caregiver supervision.

The approval aligns with the FDA's Home as a Health Care Hub Initiative, which promotes patient-centered devices for home use. Users should consult healthcare providers before making medication adjustments based on device readings.