The U.S. Food and Drug Administration has approved the first over-the-counter continuous glucose monitor (CGM) for marketing. The Dexcom Stelo Glucose Biosensor System is designed for individuals 18 years and older who do not use insulin, such as those with diabetes managing their condition with oral medications or individuals without diabetes looking to track how diet and exercise impact blood sugar levels. It is important to note that this system is not suitable for individuals with problematic hypoglycemia, as it does not alert users to this potentially dangerous condition.
The Stelo Glucose Biosensor System utilizes a wearable sensor paired with a smartphone application to continuously measure, record, analyze, and display glucose values for users who are not on insulin and do not have problematic hypoglycemia. Each sensor can be worn for up to 15 days before needing replacement, and the device provides blood glucose measurements and trends every 15 minutes through the accompanying app. It is important for users not to make medical decisions solely based on the device’s output without consulting their healthcare provider.
Clinical study data submitted to the FDA demonstrated that the device performed comparably to other integrated CGMs. Reported adverse events included local infection, skin irritation, and pain or discomfort. As part of the Center for Devices and Radiological Health’s commitment to advancing health equity, the FDA will continue to support innovative technologies that promote care and wellness in the home setting.
The FDA, a division of the U.S. Department of Health and Human Services, is dedicated to safeguarding public health by ensuring the safety, effectiveness, and security of drugs, vaccines, medical devices, and other biological products for human and veterinary use. The agency also oversees the safety of the nation’s food supply, cosmetics, dietary supplements, products emitting electronic radiation, and regulates tobacco products.
