FDA Clears First Over-the-Counter Glucose Monitor for Children
The Food and Drug Administration has approved the first over-the-counter continuous glucose monitor for children ages 2 to 18, expanding access to a technology commonly used in diabetes care.
The device, Dexcom’s Stelo Glucose Biosensor System, is designed to measure glucose levels through a wearable sensor connected to a smartphone app. It records and displays glucose trends every 15 minutes, and each sensor can be used for up to 15 days.
The FDA said the nonprescription device may be used by children with diabetes who manage their condition with oral medication, as well as by families seeking to better understand how diet, exercise, and other habits affect glucose levels. It is not intended for children who use insulin, people with problematic hypoglycemia, or those on dialysis. Regulators also advised that children use the monitor only under adult supervision.
Medical experts said continuous glucose monitors can provide families with more frequent information than traditional finger-prick tests. Pediatricians and endocrinologists noted that the data may help parents and teenagers make decisions about meals, physical activity, and other daily routines.
However, experts also cautioned that the devices should not replace medical care. Continuous glucose monitors measure glucose in tissue rather than directly in blood, and readings may differ from finger-stick results. Some clinicians expressed concern that families could misinterpret normal glucose changes, such as increases after meals, or attempt to manage diabetes without professional guidance.
The American Diabetes Association also emphasized that glucose monitors should be used as part of a broader care plan that includes clinical support, education, and individualized treatment decisions.
The approval comes as diabetes remains a significant pediatric health issue in the United States. About 364,000 people under age 20 have been diagnosed with diabetes, according to the ADA. Some projections suggest type 2 diabetes among young people could rise sharply in coming decades.
Experts continue to recommend balanced diets, regular exercise, and adequate sleep as key parts of diabetes prevention and management.