FDA Approves First Over-the-Counter Glucose Monitor for Children

Key TakeawaysThe U.S. Food and Drug Administration cleared the Stelo system as the first over-the-counter continuous glucose monitor for kidsThe device is designed for users age 2 and older who do not require insulin therapyReal-time data could help families track how specific foods and physical activities affect a child's glucose levels.MONDAY, June 15, 2026 (HealthDay News) — The U.S. Food and Drug Administration (FDA) has cleared the first over-the-counter wearable device to track blood sugar in young children.The continuous glucose monitor (CGM) — called the Stelo Glucose Biosensor System — is for use in children as young as 2 years old who do not use insulin.This marks the first time a CGM has been approved for over-the-counter sale to people under 18.It was approved for adults 18 and older in March 2024. This expansion dovetails with a rise in rates of prediabetes and type 2 diabetes among American youth, the FDA said.By offering a non-prescription CGM option, the FDA aims to help caregivers and children better understand the impact of lifestyle choices on their health.The FDA has cleared the device for children with diabetes who receive oral (non-insulin) medication to manage their condition and children without diabetes who could benefit from knowing how their diet, exercise and other lifestyle choices affect their glucose levels.Stelo consists of a small biosensor that sticks to the skin and pairs with a smartphone app. It automatically measures glucose levels every 15 minutes, allowing parents or older children to view trends and patterns throughout the day. Each sensor can be worn for up to 15 days, though the FDA notes that active children might require more frequent replacements due to daily wear and tear. The Stelo biosensor is waterproof and will function under eight feet of water for up to 24 hours without failure when properly installed, according to the manufacturer, Dexcom Inc.“Children deserve access to the best tools available to manage their health,” Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, said Friday in a news release. “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,” she added.In studies of the biosensor device, some users experienced mild adverse events, including local infection, skin irritation and pain or discomfort, according to the FDA.The FDA emphasized that this system is not designed for individuals who use insulin or those who experience problematic hypoglycemia (dangerously low blood sugar), as the device does not provide alerts for these critical events.Additionally, the system is not intended for patients on dialysis. Health officials also advise that individuals with a history of eating disorders should consult with their doctor before using the monitor to ensure it is a helpful, rather than harmful, tool for their specific needs.Because this is a non-prescription device, it acts as a supplement to professional medical care rather than a replacement. The FDA stresses that families should always consult with a healthcare provider before making any changes to a child’s medication regimen based on the data displayed in the app.Dexcom Inc., maker of Stelo and several glucose monitoring devices for adults, is headquartered in San Diego.More informationVisit the U.S. Centers for Disease Control and Prevention for more information on preventing type 2 diabetes in children.SOURCES: U.S. Food and Drug Administration, news release, June 12, 2026; Dexcom/Stelo, 2026 .What This Means For YouIf your child is at risk for diabetes or requires tracking due to oral (non-insulin) medication, this device offers a way to visualize glucose trends in real time. Discuss with your pediatrician whether this wearable monitor would be beneficial..Sign up for our weekly HealthDay newsletter

FDA Approves First Over-the-Counter Glucose Monitor for Children

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