Everything you need to know about the fda just cleared the first.
[ad_1]The 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.
The FDA and Dexcom’s research
According to the FDA, to understand how Stelo performs when used by children during the 15-day wear period, both the administration and Dexcom used previous clinical study data from children and adults, along with real-world evidence from collected data on current iCGM use among both groups. iCGM is an FDA product classification that 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 shouldn’t use Stelo?
Dexcom’s Stelo is not 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 disordered eating should consult a doctor before using Stelo.
What the Stelo sensor looks 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 helpful for some, they aren’t right for everyone.
Dr. David Ahn, chief of diabetes services at Hoag, a health care system in California, told the American Diabetes Association in May 2025 that there isn’t enough data for doctors to distinguish healthy from unhealthy glucose spikes in people with prediabetes or no diabetes.
“In our enthusiasm to expand [the continuous glucose monitor] and who uses it, it is important that we are not blind to its shortcomings,” Ahn said.
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Frequently Asked Questions
Dexcom's Stelo Glucose Biosensor System — the first over-the-counter continuous glucose monitor for children, now marketable for people 2 years of age and older who do not use insulin.
People 2 years and older who do not use insulin, including those with diabetes who take oral medication. It should be used under the supervision of an adult caregiver. The FDA had already approved it for 18 and older in 2024.
Prediabetes is becoming more common among US children, putting millions at risk for Type 2 diabetes. FDA official Dr. Michelle Tarver said children deserve access to the best tools available to manage their health.
No. Over-the-counter CGMs are increasingly used by people without medical conditions who are curious about how diet, exercise and other lifestyle factors affect their glucose levels.
