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 5. FDA Clears First Over-the-Counter Continuous Glucose Monitor

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FDA News Release

FDA Clears First Over-the-Counter Continuous Glucose Monitor

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For Immediate Release:
    March 05, 2024

Espanol

Today, the U.S. Food and Drug Administration cleared for marketing
the first over-the-counter (OTC) continuous glucose monitor (CGM).
The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM)
intended for anyone 18 years and older who does not use insulin, such
as individuals with diabetes treating their condition with oral
medications, or those without diabetes who want to better understand
how diet and exercise may impact blood sugar levels. Importantly,
this system is not for individuals with problematic hypoglycemia (low
blood sugar) as the system is not designed to alert the user to this
potentially dangerous condition. 

"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 health care provider,"
said Jeff Shuren, M.D., J.D., 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 U.S. patients."

The Stelo Glucose Biosensor System uses 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 in people 18 years and older that are not on insulin and who
do not have problematic hypoglycemia. Users can wear each sensor up
to 15 days before replacing with a new sensor. The device presents
blood glucose measurements and trends every 15 minutes in the
accompanying app. Users should not make medical decisions based on
the device's output without talking to their healthcare provider. 

Data from a clinical study provided to the FDA showed that the device
performed similarly to other iCGMs. Adverse events reported in the
study included local infection, skin irritation and pain or
discomfort.

As part of the Center for Devices and Radiological Health's 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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