FDA Clears First Over-the-Counter Continuous Glucose…

FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children A New Chapter in Pediatric Diabetes Monitoring For the first time, families in the United States will be able to purchase a continuous glucose monitor (CGM) for children without a prescription, marking a significant shift in access to diabetes technology. The U.S. Food and Drug Administration (FDA) has authorized the over-the-counter use of Dexcom's Stelo Glucose Biosensor System for children aged 2 to 18 years. The approval expands access to real-time glucose monitoring beyond traditional prescription pathways and reflects growing recognition of the role technology can play in day-to-day metabolic health management. The device is intended for children with diabetes who are not using insulin therapy and for individuals interested in understanding how lifestyle factors influence glucose patterns. However, it is not designed for people who require alerts for dangerously low blood sugar levels or for those undergoing dialysis. Diabetes management has evolved dramatically over the past two decades. Traditional blood glucose monitoring relies on finger-prick testing, which provides only isolated measurements at specific moments. Continuous glucose monitoring offers a different approach by providing regular glucose readings throughout the day and night, allowing users to observe trends, fluctuations, and responses to daily activities. The Stelo system uses a small wearable sensor connected to a smartphone application. Glucose measurements are updated every 15 min