Freestyle Libre 2 and 3 Receive FDA Clearance for Integration with Automated Insulin Delivery Systems
On Monday, March 6, 2023, Abbott announced that its Freestyle Libre 2 and 3 products received U.S. Food and Drug Administration (FDA) clearance for integration with automated insulin delivery systems (AIDs).
According to Jared Watkin, senior vice president for Abbott’s diabetes care business, this effort contributes to the company’s goal of making diabetes care “as easy as possible.”
Automated insulin delivery, also referred to as hybrid closed loop (HCL) systems or artificial pancreas device systems within the diabetes community, is a way of delivering insulin through an insulin pump that communicates with a continuous glucose monitor (CGM). This means Freestyle Libre 2 or 3 users will soon be able to pair their sensors with insulin pumps.
Using automated insulin delivery systems can make it easier for people with diabetes to be more hands-off with their management, improving the quality and enjoyability of life.
The clearance allows for all FreeStyle Libre 2 and FreeStyle Libre 3 sensors—both those available today and the modified sensors available in the future—to be used by women with any type of diabetes who are pregnant. Modified Freestyle Libre 2 and 3 sensors will be available in the U.S. later in 2023, can be worn for up to 15 days, and are also approved for use in children as young as 2 years old. Current Freestyle Libre 2 and 3 devices are approved for use in people 4 years old and older in the U.S., with a wear time of up to 14 days.
Abbott is working with leading insulin pump device manufacturers to make integrations possible across device types, which should help improve access to the functionality. Abbott announced it would partner with Insulet and Tandem in the U.S., and its integration is already authorized with several other companies outside the U.S.
Abbott currently has the most prescribed suite of CGM products.
Freestyle Libre devices are well-known for their affordability in the space. Freestyle Libre 2 users have reported paying around $130-140 for a month’s supply at the pharmacy counter without even having to run insurance. Abbott also offers a savings program called MyFreestyle, which allows people with diabetes to try Freestyle Libre 2 or 3 sensors for free.
Modified versions of the company’s sensors will slowly replace current Freestyle Libre 2 and 3 sensors. This significant change for users of Freestyle Libre 2 or 3 sensors with an insulin pump is poised to be a diabetes management game-changer for millions of people.