FDA approves the first over-the-counter continuous glucose monitor

There is the US Food and Drug Administration Approved the first continuous glucose monitor (CGM) people can buy without a prescription. Dexcom’s Stelo Glucose Biosensor System It has a sensor similar to the company’s other CGMs that users need a doctor’s prescription to purchase. It pairs with a smartphone app that can display the user’s blood glucose readings and trends every 15 minutes.

The company specifically designed the device for people 18 and older who do not use insulin, such as non-diabetics who manage their diabetes with oral medications and make a conscious effort to control their sugar intake. This can be a great tool for people with insulin resistance, including those with PCOS and other metabolic problems that increase the likelihood of developing diabetes in the future. Overall, it can give users insight into how the foods they eat and the actions they take affect their overall health.

While CGMs are nothing new, they have become a thing health trend on social media Last year, even non-diabetic patients started using them. By clearing Stelo, the FDA is making monitors more accessible than ever. “CGMs can be a powerful tool for monitoring blood glucose,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “Today’s authorization expands access to these devices by allowing individuals to receive CGMs without health care involvement. Giving more people valuable information about their health, regardless of whether they have access to a doctor or health insurance, is an important step forward in advancing health equity for US patients.” “

Stelo will be available from this summer. Each patch is supposed to last for 15 days before users have to replace it. Dexcom has yet to say how much it will cost, but said Stelo will “provide an option for those without insurance coverage for CGM.”

Gray circular device.Gray circular device.


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