FDA Approves Omnipod 5 Automated Insulin Delivery System for Type 1 Diabetes in Ages 6 and Older

The US Food and Drug Administration has approved the Omnipod 5 Automated Insulin Delivery System for use in individuals aged 6 years and older with type 1 diabetes, according to a statement from Insulet Corporation.

Announced on January 28, Insulet suggests the approval Omnipod 5 the first tubeless automated insulin delivery system with the ability to integrate with the Dexcom G6 continuous glucose Monitoring System and a compatible smartphone to automatically adjust insulin and protect against glycemic events.

“As the pioneer of integrated CGM, we are excited to see our years of collaborative work with Insulet culminate into the first and only FDA-cleared tubeless automated insulin delivery system,” said Kevin Sayer, Chairman, President and CEO of Dexcom, in the aforementioned statement. “Omnipod 5 combines the accuracy and unmatched user experience of the Dexcom G6 CGM with the simplicity of tubeless insulin delivery to offer people with diabetes a revolutionary new way to optimize time in range.”

The Omnipod 5 system includes a tubeless pod enhanced with SmartAdjust technology, the Dexcom G6 CGM, and the Omnipod 5 mobile app, which includes a SmartBolus calculator. When in use, the Pod with SmartAdjust technology receives a CGM value and trend every 5 minutes which is used to predict glucose levels an hour in the future.

In their statement, Insulet noted the Omnipod 5 will launch in a limited market release initially to allow them to incorporate learnings and improve user experience, but the Omnipod 5 will become broadly available shortly after the limited market release.

“Omnipod 5 is a life-changing technology that we believe will revolutionize the market and the lives of people with diabetes,” said Shacey Petrovic, President and Chief Executive Officer of Insulet. “We are incredibly proud of this simple-to-use, elegant system, designed to deliver unmatched freedom and to greatly simplify insulin management and improve glucose control for our users.”