FDA Approves Marketing for First Over-the-Counter Continuous Glucose Monitor

The U.S. Food and Drug Administration has approved for marketing an over-the-counter (OTC) continuous glucose monitor (CGM) for the first time.

The Dexcom Stelo Glucose Biosensor System “is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. Importantly, this system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition.”

Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, lauds the decision as an important move to “expand access to [CGMs] by allowing individuals to purchase [one] without the involvement of a health care provider,” which will give “more individuals valuable information about their health, regardless of their access to a doctor or health insurance.”

The Stelo Glucose Biosensor System works by way of a wearable sensor that is paired with a smartphone application or other smart device in order to “continuously measure, record, analyze, and display glucose values in people 18 years and older that are not on insulin and who do not have problematic hypoglycemia.” Sensors last up to 15 days before they must be replaced, and the device gives measurements and trends in blood glucose levels every 15 minutes in the app.

The device “performed similarly to other iCGMs” in a clinical study presented to the FDA, with minor adverse events reported including “local infection, skin irritation and pain or discomfort.”

FDA’s website has the announcement.