Millions of children with prediabetes and Type 2 diabetes will soon be able to track their blood sugar without a prescription, after the Food and Drug Administration cleared the first over-the-counter continuous glucose monitor for pediatric use.
The agency on Friday authorized Dexcom’s Stelo Glucose Biosensor System for children as young as two who do not use insulin — expanding a device that was already available without a prescription for adults since March 2024. The move comes as prediabetes rates among American children continue to climb, with millions now at risk of progressing to full-blown Type 2 diabetes.
“Children deserve access to the best tools available to manage their health,” said Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health. She described the clearance as part of the agency’s push to foster innovation for pediatric patients and “supporting the safe and effective use of medical devices where children live, learn, and play.”
The Stelo system consists of a wearable sensor that sticks to the skin and transmits glucose readings to a smartphone app every 15 minutes. Each sensor lasts up to 15 days, though the FDA noted that wear time may be shorter in children due to physiological and behavioral factors. The data helps users and their caregivers spot patterns in how meals, exercise, and daily activities affect glucose levels — information that has traditionally required a doctor’s visit and a prescription.
The FDA backed its decision using real-world evidence drawn from how adults and children already using similar Dexcom devices performed outside of clinical trial settings. The approach, which the agency has been leaning on more heavily in recent years, allowed regulators to assess the device’s performance in pediatric users over the full 15-day wear period without requiring a dedicated pediatric study from scratch. Participants in earlier trials reported mild side effects including local infection, skin irritation, and pain or discomfort.
The device is intended for children with diabetes who manage their condition with oral medication, as well as those without diabetes who want to understand how their lifestyle choices affect their glucose. The agency stressed that children should use the system only under adult supervision.
The clearance comes with important caveats. The Stelo system does not alert users to dangerously low blood sugar — meaning it is not suitable for children with problematic hypoglycemia. It is also not intended for patients on dialysis, and the FDA recommends that people with a history of eating disorders consult their provider before using the device.
The decision aligns with the FDA’s broader “Home as a Health Care Hub” initiative, which aims to push more medical technology into everyday settings rather than keeping it confined to clinics and hospitals.
Source: FDA Press Release
