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The US Food and Drug Administration has approved Dexcom’s Stelo Glucose Biosensor System, the first over-the-counter system Continuous glucose monitoring The agency said in press release Friday. Stelo can now be marketed for use by people 2 years of age and older who do not use insulin, including diabetics who take oral medications for their condition. It should be used under the supervision of an adult caregiver.
The Food and Drug Administration has already done this He agreed to the system For people ages 18 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 are 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 statement reflects FDA’s commitment to promoting innovation for pediatric patients and supporting the safe and effective use of medical devices where children live, learn, and play.”
According to the US Food and Drug Administration, prediabetes is becoming more common among children in the United States, putting millions of them at risk of developing type 2 diabetes. The hope is that over-the-counter continuous glucose monitors will 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 does Stelo work?
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 wear time may be shorter in children than in adults, “due to many interrelated physiological and behavioral factors,” the FDA statement said.
Before making medication adjustments based on STELO readings, children and their caregivers should consult a doctor.
Glucose measurements can be tracked in the Stelo app.
FDA and Dexcom research
According to the FDA, to understand how Stelo performed when used by children during the 15-day wear period, both the FDA and Dexcom used previous clinical study data from children and adults, along with Real-world evidence From pooled data on current iCGM use among both groups. iCGM is an FDA product classification. Which stands for Integrated Continuous Glucose Monitoring Systems.
“Participants in the previous study reported mild adverse events, including local infection, skin irritation, and pain or discomfort,” the FDA warned.
Who should not use Stilo?
Dexcom’s Stelo is not intended for people who use insulin, are on dialysis, or have low blood sugar, because it cannot alert people when glucose drops to unsafe levels. People with eating disorders or a history of eating disorders should consult a physician before using Stillo.
What does a Stelo sensor look like?
Why you should consult your doctor first
Before you buy an over-the-counter continuous glucose monitor for yourself or your child, consult your doctor. While these devices can be useful for some, they are not suitable for everyone.
Dr. David Ahn, Chief of Diabetes Services at Hoag Health Care System of California, He told the American Diabetes Association May 2025 There is not enough data for doctors to distinguish between healthy and unhealthy glucose elevations in people with and without prediabetes.
“In our enthusiasm to expand CGM and who uses it, it is important that we not overlook its drawbacks,” Ahn said.
