FDA Clears Integration of FreeStyle Sensors and Automated Insulin Delivery Systems

The FDA has cleared the Abbott FreeStyle Libre 2 and FreeStyle Libre3 continuous glucose monitoring (CGM) sensors to be integrated with automated insulin delivery systems (AID) which automatically adjusts and administers insulin based on real-time blood glucose data.

Abbott modified the sensors to enable the integration with AID systems and is now collaborating with other insulin pump manufacturers such as Insulet and Tandem to integrate their systems with the FreeStyle Libre 2 and FreeStyle Libre 3 sensors as soon as possible.

The modified sensors are cleared for pregnant women with all types of diabetes and for children starting at two years of age.

Abbot says the modified FreeStyle Libre 2 and FreeStyle Libre 3 sensors will be available in the U.S. later this year.