On June 12, 2026, the FDA cleared Dexcom Inc.’s Stelo Glucose Biosensor System for people aged 2 years or older who don’t use insulin. The clearance broadens Stelo’s original indication, granted in March 2024, as the first over-the-counter (OTC) continuous glucose monitoring (CGM) system for adults aged 18 years or older.

The pediatric indication is “for children, including those with diabetes, who receive oral medication to manage their condition and people who want to understand how diet, exercise, and other lifestyle changes affect their glucose levels,” according to the FDA announcement.

Raul Arguello, MD, who is pediatric endocrinologist and chair of pediatrics at Stamford Health Medical Group, Stamford, Connecticut, is concerned that use of the OTC devices could fuel anxiety and potentially lead to unnecessary diet changes and/or disordered eating in children who don’t have diabetes, with little evidence or guidance on how to interpret the glucose data generated. Because the OTC devices are not covered by insurance, the cost may also be an issue.

“These are available to anybody who has the cash to purchase one…I fear we’re going to have a whole bunch of healthy kids who, for different reasons, are using CGMs, maybe out of curiosity, or maybe their parents’ anxiety,” Arguello said, adding that normal glucose fluctuations in a child without diabetes could be misinterpreted. “I’m afraid we’re going to see tons of kids coming in concerned that they have something terribly wrong. And that will lead to a lot of unnecessary testing.”

Moreover, he noted, “The data haven’t been validated to say this is how to use over-the-counter sensors to tell us if the child has prediabetes or diabetes and what values are normal or not normal.”

Arguello believes that clinicians should wait until the data from the OTC CGMs can be validated as to what glucose values or trends signal concern before recommending them for pediatric patients. “Once the data are validated to show that we can actually capture the kids we don’t know have prediabetes or diabetes and can impact treatment, then you’re talking about something that could be very useful. But I don’t think we have the data yet.”

Asked to comment, Maria J. Redondo, MD, PhD, pediatric endocrinologist and professor of pediatrics at Baylor College of Medicine in Houston, told Medscape Medical News, “I think the clinician has to inform each child or adolescent and their family about the potential benefits, limitations, and costs.”

She noted that OTC CGMs might be an option for children with type 2 diabetes who do not use insulin and could potentially benefit from CGM because insurance may not cover prescription CGM in the absence of insulin treatment. On the other hand, for most children with prediabetes and/or obesity, “we don’t want to go overboard and medicalize conditions that can often be addressed through lifestyle changes alone. And there are also cost considerations.”

Redondo added that more research is needed to understand when and how CGM may be useful beyond currently established indications.

In response to Medscape Medical News’s inquiry, a Dexcom representative sent a reply reading in part, “Stelo is now the first glucose biosensor without a prescription in the US cleared for pediatric use. This milestone expands access to glucose insights for millions of families at a time when youth-onset type 2 diabetes continues to rise. For more than 25 years, we have pioneered an industry, and we are proud to offer a portfolio of glucose biosensors that empower people of any age or any stage to take control of their health.”

Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X @MiriamETucker and BlueSky @miriametucker.bsky.social.