FDA Clears First Over-the-Counter Continuous Glucose Monitor

The U.S. Food and Drug Administration cleared the first over-the-counter (OTC) continuous glucose monitor (CGM) for marketing. 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 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 healthcare provider,” said Jeff Shuren, MD, JD, 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 US patients.”

How does the Stelo continuous glucose monitor work?

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 18 years and older who are not on insulin and who do not have problematic hypoglycemia. Users can wear each sensor for up to 15 days before replacing it with a new sensor. The device presents blood glucose measurements and trends every 15 minutes in the accompanying app.

Data from a clinical study provided to the FDA showed that the device performed similarly to other iCGMs. Adverse events reported in the study included local infection, skin irritation, and pain or discomfort.

- This press release was originally published on the U.S. Food and Drug Administration website