The U.S. Food and Drug Administration cleared for marketing the first over-the-counter continuous glucose monitor, OR CGM.
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.
FDA made it clear that this system is not for individuals with problematic hypoglycemia as the system is not designed to alert the user to this potentially dangerous condition.
“CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for U.S. patients.”
The Stelo Glucose Biosensor System uses a wearable sensor, paired with an application installed on a user’s smartphone or other smart device, to continuously measure, record, analyze and display glucose values in people older than 18 years.
Users can wear each sensor up to 15 days before replacing with a new sensor. The device presents blood glucose measurements and trends every 15 minutes in the accompanying app.
FDA cautioned users not to make medical decisions based on the device’s output without talking to their healthcare provider.
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