FDA clears Dexcom Stelo over-the-counter CGM for children

Dexcom (Nadsaq:DXCM) has received FDA clearance for its Stelo over-the-counter (OTC) continuous glucose monitor (CGM) for children.

The FDA said in a news release that it cleared Stelo for people two years of age and older who do not use insulin. It became the first OTC CGM system granted clearance in March 2024, initially getting the green light for people ages 18 and older. Stelo launched later that year.

Stelo is a small, wearable sensor, specifically for people with type 2 diabetes who do not use insulin. Worn on the back of the arm, the sensor provides insights directly to a user’s smartphone. Stelo features a 15-day wear based on the company’s G7 platform. It offers a software experience tailored specifically for non-insulin users. The company said it makes it easier for the target population to access CGM and offers an option for those who don’t have insurance coverage for CGM.

FDA clearance for children builds upon the Stelo system’s recently enhanced app platform, announced by Dexcom at the American Diabetes Association Scientific Sessions earlier this month.

The app now provides all people not on insulin seeking better health a smarter, more intuitive way to understand their metabolism. It features a suite of offerings, such as pattern recognition, proactive AI coaching and personalized summaries. These features add to the system’s enhanced AI meal logging, which the company announced earlier this year. Dexcom plans to fully launch the new app experience later this summer.

Read more on Stelo and other advances at Dexcom in a recent interview with President and CEO Jake Leach.

According to the FDA, OTC CGMs can play a critical role in addressing the rising impact of prediabetes in children. Delivering real-time glucose data to children can help caregivers build greater glycemic awareness and make informed adjustments to support healthier long-term outcomes and quality of life, the FDA said.

Dexcom can now bring Stelo to children, including those with diabetes, who receive oral medication to manage their condition. The system can also aid people who want to understand how diet, exercise and other lifestyle changes affect their glucose levels.

The FDA said its clearance highlights its use of real-world evidence to support regulatory decision-making. Dexcom and the FDA used previous clinical study data from both pediatrics and adults, plus real-world evidence from current CGM users in both groups, to understand expected device performance in pediatric users over the full 15-day wear period.

Children using Stelo should remain under the supervision of an adult caregiver.

“Children deserve access to the best tools available to manage their health,” said FDA Center for Devices and Radiological Health (CDRH) Director Dr. Michelle Tarver. “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.”