WASHINGTON, D.C. — The U.S. Food and Drug Administration has cleared the first over-the-counter continuous glucose monitor for children, expanding access to glucose-tracking technology as rates of prediabetes and Type 2 diabetes rise among younger Americans.
The agency authorized use of the Stelo Glucose Biosensor System, manufactured by Dexcom, for children ages 2 and older who do not use insulin. The device was previously cleared for over-the-counter use by adults 18 and older in March 2024.
The clearance broadens access to continuous glucose monitoring technology beyond traditional prescription-based diabetes management and reflects a growing emphasis on consumer health monitoring tools used outside clinical settings.
The wearable device continuously measures glucose levels through a sensor paired with a smartphone application and provides updated readings every 15 minutes. The system is intended for children, including those with diabetes managed through oral medications, as well as individuals seeking to better understand how diet, exercise and other lifestyle factors affect glucose levels.
Federal health officials pointed to increasing rates of pediatric prediabetes as a factor supporting broader access to glucose-monitoring technology. Real-time glucose data can help users and caregivers identify patterns and make informed decisions about lifestyle habits that affect blood sugar levels.
Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, stated that the clearance reflects the agency’s effort to expand access to medical technologies for pediatric patients while supporting safe use in everyday settings.
The Stelo system consists of a wearable sensor and companion application that can be connected to a child’s smartphone or a device used by a parent or caregiver. Each sensor is designed to operate for up to 15 days before replacement, although the FDA noted wear times may be shorter in children than in adults.
The decision relied in part on real-world evidence collected from existing users of integrated continuous glucose monitoring systems. According to the FDA, regulators combined data from previous pediatric and adult clinical studies with real-world performance information to evaluate the device’s effectiveness over its intended wear period.
Reported adverse events during prior studies were generally mild and included localized infection, skin irritation and discomfort at the application site.
The agency emphasized that the device should be used under adult supervision and is not intended for people with problematic hypoglycemia because it does not provide alerts for dangerously low blood sugar levels. The system is also not indicated for people undergoing dialysis.
The clearance aligns with the FDA’s Home as a Health Care Hub initiative, which promotes the development of medical devices designed for use in patients’ daily lives outside traditional healthcare settings.
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