The Food and Drug Administration (FDA) on June 8, 2026, cleared Dexcom's Stelo, a continuous glucose monitor, for marketing in the United States. The clearance makes the device available without a prescription for children aged 2 and older.

The FDA stated that providing real-time glucose data can help pediatric patients and their caregivers build greater glycemic awareness, track patterns in response to meals and exercise, and make informed adjustments to support healthier long-term outcomes and quality of life. The Stelo device is approved for use in individuals with diabetes who do not take insulin, and it is also broadly approved for those who want to understand how lifestyle affects their blood glucose.

Pediatric endocrinologist Kristen Nadeau, from Children's Hospital Colorado, stated, "It may increase the access of an underserved population." Nadeau also said, "There's a little bit of 'the cart before the horse' happening," noting there is not enough data regarding normal blood sugar ranges for children without diabetes.

Pediatrician Wendy Schofer, who specializes in eating disorder prevention, stated, "So many of the wellness trends that are alive and well in our culture right now are being directed to our families." Schofer added, "Thinking about [CGMs] as a part of the clinical standard of care, let alone over the counter, is really premature right now." She stated, "It's something that we don't have enough information, let alone enough guidance for families to be able to really understand what this tool is providing and how to use it without harming the child."

The FDA's premarket notification for Dexcom Stelo referenced a clinical trial that included participants aged 2 years and older. This trial involved children and adolescents with type 1 diabetes using the Dexcom G7 prescription CGM, not the Dexcom Stelo device itself. Continuous glucose monitors are wearable devices that record blood sugar values every 15 minutes by placing a small sensor under the skin. Dexcom Stelo costs $99 per month for two 15-day sensors, and the package includes applicators and adhesive patches, with an accompanying free app.

Why It Matters

The FDA's clearance allows for over-the-counter access to continuous glucose monitoring for children. An estimated 1 in 3 adolescents in the U.S. have prediabetes or type 2 diabetes, and 1 in 5 children have obesity. Health Secretary Robert F. Kennedy Jr. advocates for the use of health tech wearables, including continuous glucose monitors, for personal health data collection.

The American Academy of Pediatrics has not yet established a position on the use of over-the-counter continuous glucose monitors in children and adolescents. Nadeau and other researchers are currently conducting the DISCOVERY trial, a study on blood glucose levels during puberty for children with a high BMI, family history, or other diabetes risk factors. This longitudinal study plans to enroll approximately 3,600 children aged 8 to 15.