March 6, 2024 – The FDA has approved the primary over-the-counter continuous glucose monitoring (CGM) system.
The Dexcom Stelo Glucose Biosensor System is meant for adults with or without diabetes who don’t use insulin. This includes individuals with diabetes who’re taking oral medications or people without diabetes who want to raised understand how weight-reduction plan and exercise can affect blood sugar levels. There are about 25 million people within the U.S. with type 2 diabetes who don't take insulin, Dexcom said in a press release.
The company didn’t disclose how much the device will cost, but said it’ll be available this summer.
The system will not be suitable for individuals with low blood sugar, the FDA said in a statement.
The Stelo system features a wearable sensor paired with a smartphone app. It measures, records, analyzes and displays blood sugar levels every quarter-hour. Each sensor may be worn for as much as 15 days before needing to get replaced. It will not be intended for use to make medical decisions without first consulting a healthcare provider.
“CGMs can be a powerful tool for monitoring blood sugar. “Today’s approval expands access to these devices by allowing individuals to purchase a CGM without the involvement of a healthcare provider,” said Dr. Jeff Shuren, director of the FDA's Center for Devices and Devices Radiological Health.
“Providing more people with valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in promoting health equity for U.S. patients,” Shuren said.