FDA Approves Integration of Abbott’s Updated Glucose Sensor With Automated Insulin Delivery System for Patients With Diabetes

The FDA has approved Abbott’s FreeStyle Libre 2 and FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system sensors to be integrated with automated insulin delivery (AID) systems. Abbott is currently partnering with insulin pump manufacturers Insulet and Tandem to integrate the FreeStyle iCGM sensors in an artificial pancreas system that will be made available in the United States and other countries.^1,2

"Our goal is to make diabetes care as easy as possible," said Jared Watkin, senior vice president of Abbott's diabetes care business, in a press release.¹

The newly modified FreeStyle Libre 2 and FreeStyle Libre 3 sensors can be worn by children aged 2 years and older and can be worn for 15 days. Existing FreeStyle Libro sensors are only approved for 14 days of wear, and are only approved for children aged 4 years and older.¹ What is also unique about the modified sensors is that they can be used by women who are pregnant and have type 1, type 2, or gestational diabetes.¹

AID systems seek to completely manage insulin adjustments and delivery without the need for a patient to manually dose themselves.² The FreeStyle Libre sensors add another element to AID delivery.² Ideally, the FreeStyle Libro sends blood sugar readings to an insulin pump (smartphone or other middleman), which then makes dose adjustments without the need for patient intervention.²

The FreeStyle sensor systems could result in injury by missing a severe low or high glucose event, and/or not making a treatment decision. Experts recommend that patients use a fingerstick blood glucose meter to get accurate readings if their CGM readings do not match symptoms.¹

Abbott announced that FreeStyle Libre 2 and FreeStyle Libre 3 will be made available in the latter part of 2023.² The company hopes that, in time, the modified sensors will replace existing devices in the FreeStyle portfolio.1 The FreeStyle Libre system is the number 1 sensor-based glucose monitoring system on the market, according to Abbott.^1,2

In Germany, the CGM sensors are already approved for use with the MyLife Loop—an AID developed with pump-maker Ypsomed and CamDiab.² Abbott anticipates their CGM will be integrated with MyLife Loop in the UK, Switzerland, and the Netherlands during the first half of 2023.¹

“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,” Watkin said in the press release. “This means less time thinking about diabetes and more time living."¹

References

1. Abbott. U.S. FDA CLEARS ABBOTT'S FREESTYLE LIBRE® 2 AND FREESTYLE LIBRE® 3 SENSORS FOR INTEGRATION WITH AUTOMATED INSULIN DELIVERY SYSTEMS. News Release. March 6, 2023. Accessed March 7, 2023. https://abbott.mediaroom.com/2023-03-06-U-S-FDA-Clears-Abbotts-FreeStyle-Libre-R-2-and-FreeStyle-Libre-R-3-Sensors-for-Integration-with-Automated-Insulin-Delivery-Systems
2. Park A. Modified Abbott CGM sensors score FDA nod for use in automated insulin delivery systems. News Release. March 6, 2023. Accessed March 7, 2023. fiercebiotech.com/medtech/modified-abbott-cgm-sensors-score-fda-nod-use-automated-insulin-delivery-systems