Insulet can now market Omnipod 5 in Europe for individuals 2 years and older with type 1 diabetes. Acton, Massachusetts-based Insulet said it represents the first CE-marked tubeless hybrid closed loop system.
The latest-generation Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January. That clearance covered individuals 6 years of age and older. Last month, the FDA cleared Omnipod 5 for individuals aged 2 and older.
In June, Insulet presented data supporting the use of Omnipod 5 in young children. The platform significantly improved time in range. It reduced HbA1c in children aged 2 through 5.9 years old with type 1 diabetes over 12 months.
“There is tremendous enthusiasm for Omnipod 5 from the global diabetes community, and we are thrilled to have achieved this latest milestone,” said Jim Hollingshead, president and CEO of Insulet. “With Omnipod 5, customers can enjoy the lifestyle benefits of a tubeless, wearable innovation and achieve positive clinical outcomes while managing their diabetes.”
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. 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.
‘A significant step forward’
“Today’s announcement is a significant step forward for people in Europe living with diabetes,” said Kevin Sayer, chair, president and CEO of Dexcom. “We’re proud to partner with Insulet, combining our industry-leading Dexcom G6 CGM technology with their tubeless, wearable insulin delivery system, to improve clinical outcomes and reduce the burden of glucose management for people with diabetes.”
Insulet plans to make Omnipod 5 available in select countries beginning in mid-2023. The company plans to present new data on Omnipod 5’s safety and effectiveness later this month. Data will be presented at the European Association for the Study of Diabetes (EASD) meeting in Stockholm, Sweden on Thursday, September 22.
Insulet expects Omnipod 5 to be available in select countries starting mid-2023. To learn more about Omnipod 5, visit the Omnipod website.
