FDA clears Abbott's hand-held diabetes reader for FreeStyle Libre 3 CGM

As it embarks on a widespread effort to remind users of the proper care and keeping of the hand-held readers used with its FreeStyle Libre continuous glucose monitors, Abbott is further expanding the devices’ user pool.

A version of the standalone digital reader that’s specific to the FreeStyle Libre 3 CGM has now been cleared by the FDA, Abbott announced Friday.

That clearance gives users of the FreeStyle Libre 3—Abbott’s newest CGM, which itself was cleared by the FDA last May—the option to decide whether they’d prefer to use either the Abbott-branded reader or their own smartphone to display real-time readings from their glucose sensors. Both devices pick up on those blood sugar readings via Bluetooth when they’re near a linked FreeStyle Libre sensor that’s been placed on the back of a user’s arm.

Once that decision has been made, users will have to stick with their chosen device for the full sensor wear period, which can last up to 15 days. For example, as Abbott noted in the announcement, if a FreeStyle Libre 3 wearer first uses the reader to check their glucose levels after applying a new sensor, they won’t be able to switch to the smartphone app until their next sensor application.

FreeStyle Libre 3 reader

The FDA OK comes just a few weeks after the agency expanded its clearance for both the FreeStyle Libre 2 and 3 glucose sensors. The CGMs can now be integrated into automated insulin delivery systems, and they can also be used by people with diabetes who are as young as 2 years old and by pregnant women with Type 1, Type 2 and gestational diabetes.  

With regulatory nods now secured for all FreeStyle Libre 3 components, Abbott said it’s working to secure Medicare coverage for the entire CGM system.

“The FreeStyle 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 VP of Abbott’s diabetes care business, said in Friday’s announcement.

The reader’s clearance also comes as Abbott and the FDA have issued warnings about safety risks associated with improper use of previous iterations of the reader. The warnings state that if a device isn’t “properly stored, charged, or used with its Abbott-provided USB cable and power adapter,” it could potentially heat up, spark or even catch on fire.

Though not a true recall in the standard definition of the word—since Abbott isn’t asking users to return all readers, and since the devices are safe to continue using as long as they’re charged only with the company’s hardware—the safety event has nonetheless been categorized by the FDA as a Class I recall, denoting a heightened risk of injury or death associated with the issue.

The warning covers more than 4.2 million devices distributed in the U.S. since late 2017, per the FDA, spanning those used with the FreeStyle Libre, Libre 14-Day, and Libre 2 Flash CGM systems. The agency said there have been 88 incidents so far linked to the issue, including at least seven fires and one injury, with no deaths reported.

The newly cleared FreeStyle Libre 3 reader uses the same rechargeable lithium-ion battery as the recalled devices—as do a wide range of smartphones and other mobile devices—and Abbott noted that the accompanying user manual “provides details on how to safely store, charge and use the device, including always using the Abbott-provided USB cable and power adapter.”