Abbott’s FreeStyle 2 & 3 iCGM Sensors OK’ed for Automated Insulin Delivery Systems

Abbott Labs has earned U.S. Food and Drug Administration (FDA) clearance for its FreeStyle Libre 2 and Freestyle Libre 3 integrated continuous glucose monitoring (iCGM) system sensors to integrate with automated insulin delivery (AID) systems.
 
Abbott modified its sensors to allow integration with AID systems.
 
“Our goal is to make diabetes care as easy as possible,” Jared Watkin, senior VP for Abbott’s diabetes care business told the press. “The FreeStyle Libre portfolio is already the most prescribed CGM in the United States³ and, with the integration of automated insulin delivery systems, people in the U.S. will soon have an affordable2 option to pair with insulin pumps. This means less time thinking about diabetes and more time living.”
 
AID systems automatically adjust and administer insulin delivered by an insulin pump based on real-time glucose data.
 
Abbott is collaborating with leading insulin pump makers to integrate their systems—the company is partnering with Insulet and Tandem Diabetes for future integrations in multiple countries, U.S. included. Outside the U.S., the FreeStyle Libre 3 sensor is authorized for the mylife Loop solution from Ypsomed and CamDiab in Germany, with additional European launches planned soon.
 
The modified sensors were also cleared for users two years and up and for wear time up to 15 days. The clearance allows for the sensors available today and modified sensors available in the future to be used by pregnant women with all types of diabetes.
 
The modified sensors will be available in U.S. later this year, and over time Abbott aims to replace the current FreeStyle Libre 2 and FreeStyle 3 sensors available in the U.S. today.