In a landmark step for diabetes management, the U.S. Food and Drug Administration (FDA) has cleared the first over-the-counter (OTC) continuous glucose monitor (CGM) for use in children. The decision expands the indication of Dexcom’s Stelo Glucose Biosensor System, making it the first prescription-free CGM available for pediatric patients.
The expanded authorization allows children aged two years and older who do not use insulin to access continuous glucose monitoring without a prescription. Previously, Stelo was available only for adults. The device uses a wearable sensor paired with a smartphone application to provide glucose readings and trends throughout the day, helping users better understand how food, exercise, and daily activities affect blood sugar levels.
FDA officials noted that real-time glucose information can improve glycemic awareness for children and their caregivers, enabling them to recognize patterns and make informed lifestyle decisions that support long-term health. The agency emphasized that easier access to glucose-monitoring technology may help families manage diabetes more effectively and improve quality of life.
Continuous glucose monitoring has transformed diabetes care by reducing reliance on frequent finger-prick testing and providing a more complete picture of glucose fluctuations. By making this technology available over the counter for pediatric use, the FDA has taken a significant step toward improving accessibility and empowering families with additional tools for diabetes management.
The clearance is expected to broaden access to CGM technology among younger patients and reflects the growing role of digital health tools in chronic disease management.
