Dexcom Stelo Biosensor Cleared as First OTC Continuous Glucose Monitor

The Food and Drug Administration (FDA) has cleared Dexcom Stelo Glucose Biosensor System, the first over-the-counter (OTC) continuous glucose monitor (CGM).

The Dexcom Stelo Glucose Biosensor System is an integrated CGM intended for individuals 18 years of age and older with or without diabetes who are not on insulin, and who want to better understand how diet and exercise influences blood glucose levels. The small sensor is worn on the back of the upper arm; each sensor can be worn for up to 15 days before requiring a replacement. 

The device is paired to an application using a smartphone or other smart device to continuously measure, record, analyze, and display glucose readings, providing blood glucose measurements and trends every 15 minutes. The user is not intended to take medical action based on these readings without consulting with a health care professional.

Read More: FDA Warns of Unauthorized Smartwatches, Smart Rings That Claim to Measure Blood Glucose

The FDA clearance was based on data from a clinical study that showed the performance of the Dexcom Stelo Glucose Biosensor System was similar to other iCGMs. Adverse events associated with use included local infection, skin irritation, and pain or discomfort.

“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, 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.”

Stelo is not intended for use in individuals with problematic hypoglycemia as the system is not designed to alert the user.

The device is expected to be available for purchase starting this summer.