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FDA Clears First OTC Continuous Glucose Monitor

— Dexcom's Stelo system available without a prescription by the summer

by Kristen Monaco, Senior Staff Writer, MedPage Today

MedpageToday
FDA APPROVED Dexcom Stelo Glucose Biosensor System over a photo of the device.

The first over-the-counter continuous glucose monitor (CGM) was cleared for use by adults with or without diabetes, the .

The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) that will be available without a prescription for adults with type 2 diabetes who don't use insulin, such as those who only manage their condition with oral agents.

And following a recent social media trend, the device is also cleared for adults without diabetes who want to better understand how diet and exercise may impact blood sugar levels.

"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 healthcare provider," Jeff Shuren, MD, JD, director of the FDA's 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."

That being said, the device is not indicated for patients with problematic hypoglycemia since it's not designed to alert for low blood sugar levels like other systems.

The Stelo iCGM system features a wearable sensor -- worn on the back of the upper arm for up to 15 days before replacement -- paired with a smartphone or smart device application to continuously measure, record, analyze, and display glucose values. It can provide blood glucose measurements every 15 minutes on the app.

"Users should not make medical decisions based on the device's output without talking to their healthcare provider," the FDA warned.

Underpinning the clearance were clinical study data that showed similar performance of the Stelo Glucose Biosensor System with other similar iCGMs. During the study, the most common adverse events were also similar to those of other iCGMs, including local infection, skin irritation, and pain or discomfort. About 78% of sensors lasted the full 15 days during the study.

Maker Stelo will be available for purchase online without a prescription this summer.

  • author['full_name']

    Kristen Monaco is a senior staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, she’s worked at the company since 2015.