The FDA has given the green light to Dexcom’s popular over-the-counter glucose monitor Stelo for children two years or older who don’t use insulin.
The regulatory agency previously cleared the glucose monitor platform in March 2024 as the first OTC of its kind. The device accounted for $130 million of Dexcom’s $4.7 billion overall revenue in 2025.
Stelo is indicated for children, including those with diabetes, who receive oral medication to manage their condition and for those who want to track how diet, exercise, and other lifestyle changes impact their glucose levels.
“Children deserve access to the best tools available to manage their health,” Michelle Tarver, M.D., the director of the Center for Devices and Radiological Health, said in a statement. “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.”
Stelo was originally designed for adults 18 years and older who are not taking any insulin therapies. That group represents about 25 million people living with Type 2 diabetes in the U.S.
The device also helps people with prediabetes reach their A1c goals and potentially slow the progression of diabetes, according to the company. People without diabetes can use the device to better understand the effects of diet and exercise.
It is worn on the back of the upper arm and can deliver 24/7 glucose readings to a smartphone app for up to 15 days. It's designed to provide personalized glucose insights revealing how food, exercise and sleep can affect glucose, and does not use fingersticks.