Abbott: FDA Clears FreeStyle Libre 2, 3 Sensors For Integration With AID Systems

(RTTNews) - Abbott (ABT) announced Monday that the U.S. Food and Drug Administration has cleared its FreeStyle Libre 2 and FreeStyle Libre 3 integrated continuous glucose monitoring or iCGM system sensors for integration with automated insulin delivery or AID systems in the U.S.

The company said it modified the sensors to enable integration with AID systems. These systems help people manage daily diabetes care by automatically adjusting and administering the insulin delivered by an insulin pump based on real-time glucose data from their FreeStyle Libre 2 or FreeStyle Libre 3 sensors.

The modified FreeStyle Libre 2 and FreeStyle Libre 3 sensors will be available in the U.S. later this year. Over time, the modified sensors will replace the current FreeStyle Libre 2 and FreeStyle Libre 3 sensors available at present in the country.

The modified sensors were also cleared for use by children as young as two years old and for wear time up to 15 days. Current FreeStyle Libre 2 and FreeStyle Libre 3 sensors available in the U.S. are approved for people four years and older and have a wear time of up to 14 days.

The clearance also allows for FreeStyle Libre 2 and FreeStyle Libre 3 sensors to be used by women with all types of diabetes (Type 1, Type 2 and gestational) who are pregnant.

Abbott said it is working with insulin pump manufacturers to integrate their systems with the FreeStyle Libre 2 and FreeStyle Libre 3 sensors as soon as possible.

The company is partnering with Insulet and Tandem for future integrations in multiple countries, including the U.S.

Outside the U.S., Abbott's FreeStyle Libre 3 sensor is already authorized to work with the mylife Loop solution from Ypsomed and CamDiab in Germany, with additional launches in the UK, Switzerland and the Netherlands planned for the first half of this year.

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