As more people look to get a grip on their diabetes, the United States Food and Drug Administration has approved an over-the-counter (OTC) continuous glucose monitor (CGM), a first in the country.

The Stelo Glucose Biosensor System, from Dexcom, is an integrated CGM for anyone 18 years and older, who does not use insulin. The device is not for those with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition, the US regulatory authority said. 

“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, Director of the FDA’s Center for Devices and Radiological Health.

The Stelo system uses a wearable sensor, paired with an application installed on a user’s smartphone or other smart device, to continuously measure, record, analyse and display glucose values, the note said. Users can wear each sensor up to 15 days before replacing with a new sensor. The device maps blood glucose measurements and trends every 15 minutes in the accompanying app, the note explained.

“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,” it added.

With the second largest number of people with diabetes, India has a CGM device in the market from multinational Abbott, that’s sold under the brand Libre.