GoKawiilThe US Food and Drug Administration has approved Dexcom's Stelo Glucose Biosensor System, the first over-the-counter continuous glucose monitor for children, the agency said in a press release on Friday. Stelo can now be marketed for use by people 2 years of age and older who do not use insulin, including those with diabetes who take oral medication for their condition. It should be used under the supervision of an adult caregiver.
The FDA had already approved the system for people 18 years of age and older in 2024.
Over-the-counter continuous glucose monitors are designed to help people manage diabetes and other conditions that require monitoring blood sugar levels, also known as glucose levels. They're increasingly used by people without medical conditions who are curious about how their diet, exercise and other lifestyle factors affect their glucose levels.
Why children? Why now?
"Children deserve access to the best tools available to manage their health," Dr. Michelle Tarver, director of the FDA's Center for Devices and Radiological Health, said in the press release. "Today's clearance reflects the FDA's commitment to fostering innovation for pediatric patients and supporting the safe and effective use of medical devices where children live, learn and play."
According to the FDA, prediabetes is becoming more common among US children, putting millions of them at risk for Type 2 diabetes. The hope is that over-the-counter continuous glucose monitors can help address this concern by increasing children's and caregivers' awareness of the connections between blood sugar, diet and exercise, leading to healthier outcomes.
How Stelo works
Paired with an app on a smart device, the Stelo Glucose Biosensor System uses a wearable sensor to measure glucose levels and then displays them on the app every 15 minutes. Each sensor lasts up to 15 days before needing to be replaced, but its wear time may be shorter in children than in adults, "due to several interconnected physiological and behavioral factors," the FDA release said.
Before making medication adjustments based on Stelo's readings, children and their caregivers should consult their doctor.
Glucose measurements can be tracked in the Stelo app. Dexcom
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