The Food and Drug Administration (FDA) has cleared Abbott’s FreeStyle Libre 2® and FreeStyle Libre 3® continuous glucose monitoring (CGM) system sensors for integration with automated insulin delivery (AID) systems.
The Company is now working with insulin pump manufacturers to integrate their AID systems with the FreeStyle Libre 2 and FreeStyle Libre 3 sensors as soon as possible. The sensors were modified to allow for integration with AID systems.
The modified sensors were also cleared for use by pediatric patients as young as 2 years old and for wear time up to 15 days; the current version is approved for patients 4 years of age and older with a wear time of up to 14 days. Both the current and modified sensors have been cleared for use in pregnant women with all types of diabetes.
“Our goal is to make diabetes care as easy as possible,” said Jared Watkin, senior vice president for Abbott’s diabetes care business. “The FreeStyle Libre portfolio is already the most prescribed CGM in the United States and, with the integration of automated insulin delivery systems, people in the US will soon have an affordable option to pair with insulin pumps.”
The modified FreeStyle Libre 2 and FreeStyle Libre 3 sensors will be available in the US later this year and will eventually replace the current versions.
US FDA clears Abbott’s FreeStyle Libre® 2 and FreeStyle Libre® 3 sensors for integration with automated insulin delivery systems. News release. Abbott. Accessed March 6, 2023. https://www.prnewswire.com/news-releases/us-fda-clears-abbotts-freestyle-libre-2-and-freestyle-libre-3-sensors-for-integration-with-automated-insulin-delivery-systems-301763020.html.