March 6, 2024 -- The FDA has approved the first over-the-counter continuous glucose monitoring 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 saidThe company did not say how much the device will cost, but said it will be available this summer.
"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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