Insulet (Nasdaq:PODD) announced today that it received CE mark approval for the integration of the Abbott (NYSE:ABT) FreeStyle Libre 2 Plus with Omnipod 5.
European approval covers the compatibility of Abbott’s glucose sensor with the Insulet automated insulin delivery system for individuals aged two years and older with type 1 diabetes.
Currently, Omnipod 5 works with Dexcom CGM. Right now, it has compatibility with the previous-generation G6 as the companies work on integrating the G7. However, Insulet hinted at the future integration with Abbott’s popular FreeStyle Libre system midway through last year.
This also marks the second major insulin pump integration for Abbott in 2024. Last month, the company announced FreeStyle Libre 2 Plus compatibility with the Tandem Diabetes Care t:slim X2 system.
“The addition of the Abbott FreeStyle Libre 2 Plus sensor to our CGM compatibility expands accessibility of Omnipod 5, which has been a priority for Insulet since the system launched in 2022,” said Patrick Crannell, SVP and international GM of Insulet. “We are excited to have achieved this key milestone, which allows us to bring Omnipod 5 and choice of CGM to more people with diabetes.”
More about the Insulet Omnipod 5
The latest-generation Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January 2022. Insulet commenced its U.S. full-market launch in August 2022. The Omnipod 5 picked up CE mark approval for ages two and up in September 2022.
Omnipod 5, a tubeless pod, features SmartAdjust technology. It integrates with the Dexcom 6 continuous glucose monitor (CGM). With CGM data, SmartAdjust predicts where glucose will be 60 minutes into the future every five minutes. Omnipod 5 then increases, decreases, or pauses insulin delivery based on the user’s desired and customized glucose target.
The device also features the Omnipod 5 mobile app with an integrated SmartBolus calculator, too. Users can download the app onto a compatible smartphone or use the Omnipod 5 controller.
It’s the only tubeless, hybrid closed-loop system approved in Europe with integration with two CGM sensor brands in Abbott and Dexcom.
Insulet expects availability for the system with Abbott’s CGM to come first in the UK and the Netherlands through a phased launch in the first half of 2024. It then projects other markets in Europe to follow. Dexcom’s technology remains the only approved CGM for use with Insulet pumps in the U.S.