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FDA Clears Freestyle Libre 2 and 3 for Use With Automated Insulin Delivery

The FDA has cleared Abbott's Freestyle Libre 2 and Libre 3 continuous glucose monitors (CGM) for integration with automated insulin delivery (AID) systems. These devices have also been cleared for younger children, extended wear time, and for use during pregnancy.

The FDA on March 6 cleared Abbott’s Freestyle Libre 2 and Freestyle Libre 3 CGM for use with automated insulin delivery (AID) systems.

AID systems connect a CGM, insulin pump, and smartphone to automatically adjust insulin dosing in real-time in response to changing glucose levels. These systems have been demonstrated to help many people with diabetes improve their time in range and reduce the time spent thinking about managing glucose each day. 

With this new clearance from the FDA, Libre 2 and 3 CGMs and the connected smartphone app will soon integrate with insulin pumps to adjust insulin dosing.

Freestyle Libre 2 and Libre 3 CGMs were previously cleared for use by people with diabetes ages 4 and older. Freestyle Libre 3, cleared in the United States in May 2022, is compatible with both iOS and Android smartphones. Among several upgrades made from Libre 2, Libre 3 no longer requires users to manually scan their device with their smartphone to see glucose levels – data is sent to the mobile app automatically.

In the announcement, Abbott said the device has also been cleared for an extended wear time of 15 days, for use by children as young as age 2, and for use during pregnancy by women with type 1, type 2, or gestational diabetes. 

Current users of Libre CGMs should note that the devices available now cover people with diabetes ages 4 and older and can be worn for 14 days. According to Abbott, the modified Libre 2 and 3 sensors will be available in the U.S. later this year. This means that current users should continue changing sensors every 14 days until that time. Current devices can, however, be used during pregnancy following the recent clearances.

Which AID systems will integrate with Freestyle Libre CGMs? 

AID compatibility with Libre CGMs had been authorized in Europe in 2022, with Abbott announcing in December the device’s compatibility with the mylife Loop AID system from Ypsomed and CamDiab. The integrated system was launched in Germany in December 2022, with plans for additional launches in the UK, Switzerland, and the Netherlands in the first half of 2023.

Abbott has partnerships with insulin pump manufacturers Tandem and Insulet, and plans to integrate Libre 2 and Libre 3 sensors with these systems in multiple countries, including the United States.

When Will AID Systems Integrate with Freestyle Libre CGMs? 

People who currently use a Libre CGM will not be able to integrate it with an AID system immediately, as Abbott is working to finalize partnerships with insulin pump manufacturers and roll out the modified sensors later in 2023. The modified devices with the extended wear time and AID compatibility will gradually replace the sensors that are available today.

Along with AID integration, the approvals for use during pregnancy and a wear time of 15 days could increase the number of users who can access and benefit from a CGM, and improve the overall user experience with the device. Also, people who already use an AID system will have more flexibility when choosing different components (pump and CGM) that they most enjoy using.

“Our goal is to help as many people living with diabetes as possible,” said Lindsy Delco, a spokesperson from Abbott. “By modifying our FreeStyle Libre 2 and FreeStyle Libre 3 sensors to enable integration with AID systems, people in the U.S. will soon have an affordable integrated CGM system to pair with their automated insulin pump.”