FDA Clears Freestyle Libre 3 Reader
By Andrew Briskin
The FDA has cleared a reader device for the Freestyle Libre 3 continuous glucose monitoring system. Users can now choose between the reader or mobile app to track glucose levels.
Abbott’s Freestyle Libre 3 reader, a handheld device that displays glucose readings from the wearable sensor in real-time, has received clearance by the Federal Drug Administration.
Similar to the mobile app, the continuous glucose monitor (CGM) reader allows people to view their glucose trends and time in range, without having to manually scan the sensor.
Though many users use their smartphone as opposed to the reader, those using Libre 3 now have a choice about which display they would prefer. In a statement, Abbott highlighted that the clearance of the reader will not affect the mobile app – the app will still be available.
Users can also switch between the reader and mobile app, but they must change sensors to do so. In other words, if someone chooses to use a reader, they must stick to it for the full wear period of the sensor (up to 15 days) before switching to the mobile app.
The FDA clearance of the Libre 3 reader follows several wins for Abbott’s CGM system, including its 2022 approval of the system, followed by expanded insurance coverage for more people with type 2 diabetes, and integration with automated insulin delivery systems.
Abbott also announced on April 17 that the previous generation Libre 2 will now be covered for all people with diabetes on medicare who take insulin, or those who have a history of problematic hypoglycemia when taking other medications. Going forward, the company is working to expand medicare coverage for the Libre 3 system to this same group.