Standalone reader for FreeStyle Libre 3 CGM receives FDA clearance
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Key takeaways:
- The FDA granted clearance for a standalone reader to be used for glucose management with the FreeStyle Libre 3 CGM.
- Users will have the option to use either the reader or the device’s smartphone app.
The FDA granted clearance for use of a standalone reader to display real-time glucose levels with an integrated continuous glucose monitoring system, according to a press release.
The reader is designed for use with the FreeStyle Libre 3 system (Abbott Diabetes Care). The reader is a small handheld device that displays glucose readings directly from a small sensor worn on the back of the user’s upper arm. This allows the user to manage their glucose on the reader’s screen.
The reader uses a rechargeable lithium-ion battery similar to what is used in other electronic devices, such as mobile phones. The reader comes with a provided USB cable and power adapter to charge the device. More details on how to store, charge and use the device are provided in the user manual.
As Healio previously reported, the FreeStyle Libre 3 was initially cleared by the FDA in May of 2022. In March of 2023, the FreeStyle Libre 3 along with the FreeStyle Libre 2 received clearance for use with automated insulin delivery systems.
“The FreeStyle Libre 3 reader provides more choice to people living with diabetes to have access to lifesaving technology that is smaller and easier to use and comes without the high-cost burdens of other systems,” Jared Watkin, senior vice president for Abbott's diabetes care business, said in a press release.
Users will have the option to use either the reader or the current FreeStyle Libre 3 smartphone app. People who start a new sensor with the reader will not be able to use their smartphone app to check their glucose for the entire sensor wear period. If a user wants to switch back to the smartphone app, they must start a new sensor, according to the release.
With the FDA’s clearance of the FreeStyle Libre 3 reader, Abbott plans to pursue adding the system to the Medicare list of covered systems as soon as possible, according to the release.
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