FDA signs off on first over-the-counter continuous glucose monitor

By Chris Benson

March 5 (UPI) -- The U.S. Food and Drug Administration said Tuesday that the federal agency had approved an over-the-counter continuous glucose monitor for those who do not use insulin.

The new Dexcom Stelo Glucose Biosensor System -- a wearable sensor paired with an application installed on a user's smartphone or other smart device, to continuously measure, record, analyze and display glucose values -- is intended for anyone over the age of 18 and older who have diabetes but are not taking insulin


An FDA official said that the continuous glucose monitor "can be a powerful tool to help monitor blood glucose."

Tuesday's announcement by the FDA "expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider," Dr. Jeff Shuren, the FDA's Director of Center for Devices and Radiological Health, said in a statement.

"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," Shuren added.

But the FDA warned that the new system -- which can be work up to 15 days before needing a new sensor -- is not intended for those with problematic hypoglycemia, noting how it was "not designed to alert the user to this potentially dangerous condition."


This comes weeks after the FDA said that smartwatches and rings can be unreliable when it comes to reporting blood glucose levels.

But the Center for Devices and Radiological Healthlead by Shuren say as part of their "strategic priority" to "advance health equity," CDRH "will continue to support innovation that addresses health equity by moving care and wellness into the home setting."

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