Modified Abbott CGM sensors score FDA nod for use in automated insulin delivery systems

As diabetes device makers race to build completely hands-off artificial pancreas systems, Abbott’s continuous glucose monitors are getting a significant upgrade.

New regulatory clearance passed down by the FDA not only expands the FreeStyle Libre 2 and 3 devices’ patient pool, but also allows both CGMs to be integrated into automated insulin delivery systems. The clearance was bestowed specifically upon updates to the devices’ sensors, Abbott announced Monday.

The updates come just a few months after the FreeStyle Libre 3 received its initial clearance in the U.S. and began its stateside rollout. Its predecessor, meanwhile, has been available in the U.S. since 2020.

Automated insulin delivery systems combine continuous glucose monitors and insulin pumps into closed-loop systems that aim to completely manage the process of adjusting and delivering insulin doses throughout the day without requiring any manual input from a user.

The new FDA clearance allows the FreeStyle Libre sensors to be the CGM in that equation. When all is running smoothly, the devices will send their blood sugar readings to an insulin pump—or to a smartphone or other controller acting as a middleman—where an algorithm will automatically translate the data into hands-free insulin dose adjustments.

“Our goal is to make diabetes care as easy as possible,” said Jared Watkin, senior VP 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 U.S. will soon have an affordable option to pair with insulin pumps. This means less time thinking about diabetes and more time living.”

Abbott is already in the process of folding the FreeStyle Libre devices into so-called artificial pancreas systems with Insulet’s Omnipod 5 insulin pump and Tandem Diabetes Care’s t:slim X2 pump, both of which are equipped with automated dosing software.

As Abbott noted in this week’s announcement, its sensors have already been embedded into another automated insulin delivery system outside the U.S.: MyLife Loop, which Abbott developed in partnership with pump maker Ypsomed and University of Cambridge spinout CamDiab. MyLife Loop launched in Germany last year and is on track to expand into the U.K., Switzerland and the Netherlands in the coming months, per Abbott.

In addition to allowing the FreeStyle Libre 2 and 3 CGMs to fit into closed-loop diabetes management systems, the FDA’s latest clearance further expands the devices’ footprints. For one, they can now be used by people with diabetes as young as 2 years old, compared to the initial age group that started at 4 years old. Additionally, while the sensors previously couldn’t be used during pregnancy, the FDA has now given Abbott the green light to offer its CGMs to pregnant women with Type 1, Type 2 and gestational diabetes.

On top of expanding the patient pool, the updates to the sensors also extended their lifespan by one day—so each sensor can now be worn for up to 15 days, rather than the original two-week cutoff.

The modified sensors will be available in the U.S. beginning “later this year,” Abbott said in Monday’s announcement, with a goal of completely replacing the original FreeStyle Libre 2 and 3 sensors over time.