The US Food and Drug Administration has approved Dexcom’s Stelo Glucose Biosensor System, the first over the counter. continuous glucose monitor in children, the agency said in a June 12 statement. Stelo can now be sold for use by people 2 years of age and older who do not use insulin. This includes diabetics who take oral medications for their condition. Adult supervision is required when a child uses Stelo.
The FDA had already approved the program for people 18 and older in 2024.
Over-the-counter continuous glucose monitors have gained popularity in recent years. These devices are designed to help people manage diabetes and other conditions that require monitoring of glucose (blood sugar) levels. However, people without medical conditions who want to know how their diet, exercise and other lifestyle factors affect glucose levels have also begun using CGMs.
Why children? Why now?
“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, in a statement. “Today’s approval demonstrates the 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 FDA, prediabetes is on the rise in US children, putting millions of them at risk for type 2 diabetes. The hope is that continuous over-the-counter glucose monitors can help address these concerns by increasing awareness among children and caregivers about the connection 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 display them on the app every 15 minutes. Each sensor lasts 15 days before needing to be replaced, but its wear time may be shorter in children than in adults, “due to several interrelated physical and behavioral factors,” the FDA release said.
Before making medication changes based on Stelo’s readings, children and their caregivers should consult their doctor.
Glucose measurements can be tracked in the Stelo app.
FDA and Dexcom research
According to the FDA, to understand how Stelo performs when used by children during the 15-day wear period, both management and Dexcom used previous clinical research data from children and adults, as well as real-world evidence from data collected from current iCGM use among both groups. iCGM is the FDA’s product system that stands for integrated continuous glucose monitoring systems.
“Participants in previous studies reported mild adverse events, including local infection, skin irritation and pain or discomfort,” the FDA warned.
Who should not use Stelo?
Dexcom’s Stelo is not for people on insulin, on dialysis or with low blood sugar, because it cannot warn people when glucose drops to unsafe levels. People with an eating disorder or a history of eating disorders 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, check with your doctor. While these tools may be helpful for some, they are not 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 is not enough data for doctors to distinguish healthy from unhealthy glucose increases in people with prediabetes or without diabetes.
“In our expansion game [the continuous glucose monitor] and who is using it, it is important that we do not see its mistakes,” said Ahn.
