First over-the-counter continuous glucose monitor FDA-cleared

First over-the-counter continuous glucose monitor FDA-cleared | Image Credit: © Minerva Studio - © Minerva Studio - stock.adobe.com.

The FDA has cleared the Dexcom Stelo Glucose Biosensor System, an integrated continuous glucose monitor (CGM), for marketing as the first over-the-counter (OTC) CGM for anyone aged 18 years and up, the federal agency stated in a press release.¹

According to the FDA, the device is intended for anybody who does not use insulin or those without diabetes who want to understand how diet could impact blood sugar levels.¹

The device, to be the first glucose biosensor cleared for use in the United States without a prescription, features a sensor to be worn on the back of the upper arm.²

The system is not intended for individuals with low blood sugar, or hypoglycemia, as the system is not designed to alert users to the condition.¹

The system uses a wearable sensor to go along with a smartphone application that continually measures, records, analyzes, and displays glucose levels. Blood glucose measurements and trends are presented in the app every 15 minutes.¹

Users can wear the sensor for up to 15 days before replacing.¹

“CGMs can be a powerful tool to help monitor blood glucose," said Jeff Shuren, MD, JD, director, Center for Devices and Radiological Health, FDA. "Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider."¹

The FDA received data from a clinical study demonstrating the device "performed similarly to other integrated CGMs, with adverse events reported such as local infection, skin irritation, and pain or discomfort.¹

“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,” added Shuren.¹

According to Dexcom, there are approximately 25 million people living in the United States who live with type 2 diabetes but do not use insulin.²

Starting in the summer of 2024, Stelo will be available for purchase online and without a prescription.²

References:

1. FDA clears first over-the-counter continuous glucose monitor. FDA. Press release. March 5, 2024. Accessed March 6, 2024. https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor

2. Stelo by Dexcom first glucose biosensor cleared by FDA as over-the-counter. Dexcom. Press release. March 5, 2024. Accessed March 6, 2024. https://investors.dexcom.com/news/news-details/2024/Stelo-by-Dexcom-First-Glucose-Biosensor-to-be-Cleared-by-FDA-as-Over-the-Counter/default.aspx