FDA Greenlights First Over-the-Counter Continuous Glucose Monitor for Diabetes Management

FDA Greenlights First Over-the-Counter Continuous Glucose Monitor for Diabetes Management
09.03.2024

The U.S. Food and Drug Administration (FDA) has approved the first over-the-counter continuous glucose monitoring (CGM) system.

The Dexcom Stelo Glucose Biosensor System is meant for adults with or without diabetes who don’t use insulin. This would include people with diabetes who take oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels, There are about 25 million people in the U.S. with type 2 diabetes who do not take insulin, Dexcom said in a press release. 

The company did not say how much the device will cost, but said it will be available this summer. 

The system is not for people with low blood sugar, the FDA said in a statement. 

The Stelo system contains a wearable sensor paired with an smartphone app. It measures, records, analyzes, and displays blood sugar values every 15 minutes. Each sensor can be worn for up to 15 days before it must be replaced. It is not intended to be used to make medical decisions without first checking with a health care provider. 

“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, 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,” Shuren said. 

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