On the heels of launching Omnipod 5 in the United States, Insulet now has permission to sell the latest version of its popular tubeless insulin pump in the European Union.

Amanda Pedersen

September 21, 2022

2 Min Read
Woman with diabetes shown walking through a park wearing Insulet Omnipod 5 advanced insulin delivery system and Dexcom G6
Image courtesy of Insulet

On the heels of launching Omnipod 5 in the United States, Insulet has received CE marking to sell the device in Europe. The Omnipod 5 is the first CE marked tubeless hybrid closed loop system (also known as automated insulin delivery) that integrates with the Dexcom G6 continuous glucose monitoring (CGM) system to help with diabetes management.

In Europe, the Omnipod 5 can be marketed for people aged two years and older with type 1 diabetes. The system consists of the tubeless Pod enhanced with SmartAdjust technology, the Omnipod 5 controller with its integrated SmartBolus Calculator, and the Dexcom G6 CGM.

"There is tremendous enthusiasm for Omniopod 5 from the global diabetes community, and we are thrilled to have achieved this latest milestone," said Jim Hollingshead, president and CEO of Acton, MA-based Insulet.

Every five minutes, SmartAdjust technology receives a CGM value and trend, and predicts where glucose will be 60 minutes into the future. The system then increases, decreases, or pauses insulin delivery based on the user’s desired and customized glucose target.

Image of an Omnipod 5 pod beside a smartphone showing the Insulet Omnipod 5 app for diabetes management

"Today’s announcement is a significant step forward for people in Europe living with diabetes,” said Dexcom CEO Kevin Sayer. “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.”

New clinical data demonstrating the safety and effectiveness of Omnipod 5 on recently diagnosed people with type 1 diabetes is expected to be presented at the upcoming European Association for the Study of Diabetes (EASD) meeting in Stockholm, Sweden on September 22.

Insulet expects Omnipod 5 to be available in select countries starting mid-2023.

FDA cleared Omnipod 5 for type 1 diabetes patients ages six years and older in late January, but the company just announced the U.S. launch in August. The technology had been among the most anticipated medical devices of 2021, although it didn't quite make it to market by the end of last year as previously anticipated.

Insulet also went through a major leadership change earlier this year after Hollingshead's predecessor, Shacey Petrovic, stepped down for personal family reasons on June 1.

About the Author(s)

Amanda Pedersen

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.

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