Two-year-old Maya Patel from suburban Chicago now wears a tiny sensor on her arm that her mom checks during snack time, not because Maya has diabetes, but because her pediatrician noticed early signs of insulin resistance last year. Thanks to the FDA’s recent clearance of the Stelo Glucose Biosensor System, Maya’s family can now track her glucose levels without a prescription—a first for children in the U.S. Manufactured by San Diego-based Dexcom Inc., Stelo is the first over-the-counter continuous glucose monitor (CGM) approved for children as young as 2, marking a pivotal shift in how families can proactively manage metabolic health from an early age.
This approval comes at a critical time. Rates of prediabetes and type 2 diabetes among American youth have climbed steadily over the past decade, with the CDC estimating that more than 1 in 5 adolescents now have prediabetes. The Stelo system, which pairs a wearable biosensor with a smartphone app, offers real-time insights into how food, activity, and sleep affect glucose levels—data that can empower families to make informed lifestyle changes before chronic conditions take root. It’s designed for children who don’t use insulin, including those on oral diabetes medications and those without a diagnosis but at risk due to family history or weight.
The device measures glucose every 15 minutes, with each sensor lasting up to 15 days. It’s waterproof—rated to function under eight feet of water for 24 hours—making it practical for active kids. In clinical evaluations, most side effects were minor, such as skin irritation or discomfort at the application site. Still, the FDA cautions that Stelo is not for children on insulin, those with frequent hypoglycemia, or patients undergoing dialysis. It also advises caution for children with a history of eating disorders, urging consultation with a healthcare provider before use.
While Stelo doesn’t replace medical care, it bridges a gap in preventive health technology. Parents can now access tools once reserved for diagnosed patients, fostering earlier intervention. "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, emphasizing the agency’s commitment to pediatric innovation.
As childhood metabolic disorders rise, Stelo represents more than a medical device—it’s a window into a child’s daily health rhythms, offering families a chance to act before a diagnosis becomes inevitable. With over 15 million children in the U.S. now at risk for type 2 diabetes, this small sensor could spark a big shift in how we raise healthier generations.