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FDA Clears First OTC Continuous Glucose Monitor

The U.S. Food and Drug Administration has approved the first over-the-counter continuous glucose monitor.

The Dexcom Stelo Glucose Biosensor System, an integrated continuous glucose monitor (iCGM), is approved for use in individuals 18 years and older who do not use insulin, such as individuals with diabetes using oral medications.

Additionally, the new iCGM can be used by people without diabetes who want to better understand how diet and exercise may impact blood sugar levels.

However, the system is not approved for individuals with problematic hypoglycemia (low blood sugar) as it is not designed to alert the user to this condition.

"Today's clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider," Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, said in a statement.

The system uses a wearable sensor worn on the back of the upper arm, which can be paired with an application installed on a user's smartphone or other smart device. The device presents blood glucose measurements and trends every 15 minutes in the app.

Adverse events reported in the study included local infection, skin irritation, and pain or discomfort.

The system will be available for purchase online without a prescription in the United States starting in the summer of 2024.

The manufacturer warns that the users should consult with a healthcare professional before taking medical action based on the device output.

In 2021, 38.4 million Americans, or 11.6% of the U.S. population, had diabetes. Of those, 8.7 million were undiagnosed.

Another 97.6 million adults had prediabetes, a condition where blood sugar levels are elevated but not high enough yet to be diagnosed as type 2 diabetes.

Glucose monitoring among people without diabetes has become more popular in recent years, thanks to influencers like Jessie Inchauspé, also known as "Glucose Goddess."

However, the evidence on the benefits of continuous glucose monitoring in healthy individuals is limited. For instance, a 2022 study involving 153 adults without diabetes found that most of the time, glucose levels were normal.

The HbA1c test, also known as the hemoglobin A1C test, is one of the most commonly used tests to diagnose prediabetes and diabetes.

Individuals over 45 and who are overweight and have one or more risk factors for diabetes should undergo the HbA1c test every three years.

People with prediabetes should repeat the test as often as recommended by their healthcare provider, usually one to two years.


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