Insulet locks down EU approval for Omnipod 5 automated insulin pump

Nearly a year into its U.S. rollout, the latest version of Insulet’s diabetes management system is heading across the pond.

The Omnipod 5 system has landed CE mark clearance, Insulet announced Tuesday, making it available throughout the European Union. It’s cleared on the continent for use by adults and children aged two and older with Type 1 diabetes, matching the device’s newly expanded user pool in the U.S.

The insulin delivery system includes a tubeless pod that’s worn on the back of the arm and that links to a wearer’s Dexcom G6 continuous glucose monitor. Every five minutes, the CGM wirelessly sends glucose readings to the Omnipod system, which predicts how those blood sugar levels may change over the next hour and adjusts insulin dosages accordingly.

The disposable pod can hold enough insulin to manage dosages for up to three days, and the entire automated system is meant to eliminate the need for people with Type 1 diabetes to perform multiple daily injections and calibration fingersticks.

The Omnipod 5’s European rollout is slated to begin in select countries in mid-2023.

Meanwhile, the insulin pump’s U.S. launch is already well underway. The system landed its first FDA clearance in January—allowing it to be used by Type 1 diabetes patients aged six and older—and Insulet began a limited rollout soon after.

By the beginning of August, the diabetes devicemaker had opened up availability of the system to all eligible users. It can now be accessed via retail, specialty and mail-order pharmacy channels, covered by standard insurance benefits and available on a more affordable pay-as-you-go basis—as opposed to the durable medical equipment suppliers that typically sell insulin pumps at high upfront costs.

Just a few weeks later, Insulet saw its U.S. user pool open up, as the FDA granted another clearance for the system, this one allowing it to be used by toddlers as young as two years old with Type 1 diabetes.

With both U.S. and European clearance of its entire intended Type 1 diabetes patient population in the rearview mirror, Insulet is now looking ahead to further expansions of the Omnipod 5’s reach.

That could include future regulatory clearances allowing people with Type 2 diabetes—a group that hasn’t traditionally used automated insulin pumps to manage their diabetes—to access the system.

At the American Diabetes Association’s annual meeting earlier this year, Insulet shared study results showing that when adults with Type 2 diabetes used the Omnipod 5 for about two months, their average blood sugar levels dropped from a baseline A1C of 9.4% to about 8%. With another 13 weeks of use, that number continued to drop, reaching an average of 7.7%.