Gadget

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

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The US Food and Drug Administration has approved the first continuous glucose monitor (CGM) people can buy without a prescription. Dexcom’s Stelo Glucose Biosensor System has a sensor users are meant to insert into their upper arm, similar to the company’s other CGMs that need a doctor’s prescription for purchase. It pairs with a smartphone application that can show the user’s blood glucose measurements and trends every 15 minutes.

The company designed the device specifically for adults 18 and up who are not using insulin, such as those managing their diabetes with oral medications and non-diabetics making a conscious effort to control their sugar intake. It could be a great tool for people with insulin resistance, including individuals with PCOS and other metabolic issues that heighten their probability of developing diabetes in the future. In general, it could give users the insight to be able to better understand how the food they eat and the movements they make impact their overall health.

While CGMs aren’t anything new, they’ve become a wellness trend on social media last year, and even non-diabetics started using them. By clearing Stelo, the FDA is making the monitors more accessible than before. “CGMs can be a powerful tool to help monitor blood glucose,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provide. 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 U.S. patients.”

Stelo will be available starting this summer. Each patch is meant to last for 15 days before users will need to replace it. Dexcom has yet to reveal how much it would cost, but it said Stelo will “provide an option for those who do not have insurance coverage for CGM.”

A gray circular device.

Dexcom

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