First over-the-counter continuous glucose monitor for diabetes approved by FDA
The U.S. Food and Drug Administration has cleared the first over-the-counter monitor that continuously checks glucose levels.
The Stelo Glucose Biosensor System, a wearable sensor that pairs with a smartphone to track blood sugar levels, is meant for people 18 and older who don't use insulin and are treating diabetes with oral medications, and adults who don’t have diabetes but want to track glucose levels, the agency announced in a news release Tuesday. The product is made by the company Dexcom.
“Today’s clearance expands access to these devices" Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement. It's an "important step forward" because it allows people to assess their blood sugar "without the involvement of a health care provider,” advancing health equity for patients by providing valuable information regardless of access to a doctor or insurance.
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About 25 million people in the U.S. with type 2 diabetes don’t use insulin but can benefit from continuous glucose monitoring, according to a Dexcom news release. The company, based in San Diego, already has another monitor on the market, the Dexcom G7, for people with a prescription.
The new Stelo device pairs a sensor worn on the back of the upper arm with a smartphone app to monitor, record and analyze glucose values with updated measurements and trends. It takes these measurements every 15 minutes. The sensor can be used up to 15 days before the user needs to replace it.
The FDA noted that the monitor isn’t designed for people with concerns about low blood sugar, since it isn’t designed to alert people when levels are low or drop. Officials said users shouldn’t make medical decisions based on the device’s output without consulting their health providers.
The FDA based its decision this week on an outside clinical study that showed the device performed similarly to other integrated continuous glucose monitors, officials said. Dexcom said it would release details of this study in the coming days, a company spokesperson said in an email.
Dexcom plans to make Stelo available this summer. A company spokesperson declined to provide pricing estimates, but said the device would be competitive. Dexcom’s current prescription-required device, the Dexcom G7, costs $377.73 for a 30-day supply without insurance on Amazon, though Amazon estimates the monthly supply drops to $51 with insurance.
Eduardo Cuevas covers health and breaking news for Paste BN. He can be reached at EMCuevas1@usatoday.com.