The U.S. Food and Drug Administration has expanded the clearance of Dexcom’s Stelo continuous glucose monitoring system, making it the first over-the-counter CGM authorized for children. Previously cleared for adults, the device can now be used by individuals aged two years and older who do not use insulin. The decision broadens access to glucose monitoring technology for pediatric users and reflects growing interest in making diabetes and metabolic health tools more accessible outside traditional prescription channels.
Stelo consists of a wearable sensor paired with a smartphone application that continuously tracks glucose levels and displays trends throughout the day. The system measures glucose values automatically and updates readings every 15 minutes, allowing users and caregivers to monitor patterns without routine fingerstick testing. The device can also be connected to a parent’s or caregiver’s smartphone, enabling remote monitoring of a child’s glucose information. Each sensor is designed to be worn for up to 15 days, although the FDA noted that wear time may vary in younger users due to physiological and behavioral factors.
The clearance was supported through a combination of clinical trial data and real-world evidence gathered from existing Dexcom users across both adult and pediatric populations. The FDA emphasized that the device should be used under adult supervision and noted that it is not intended for people with problematic hypoglycemia because it does not provide alerts for dangerous low glucose events. The expansion of Stelo’s indication highlights a broader trend toward consumer-accessible health monitoring technologies and the increasing use of real-world evidence to support regulatory decisions for digital health and medical devices.
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