Insulet—a tubeless insulin pump tech—has received clearance from the U.S. Food and Drug Administration (FDA) for its Omnipod 5 Automated Insulin Delivery System for individuals with type 1 diabetes.

Omnipod 5 is a tubeless automated insulin delivery (AID) system that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System and a compatible smartphone to automatically adjust insulin and help protect against highs and lows.

Omnipod 5 is designed to make it easier to manage glucose with no multiple daily injections, no tubes, and no fingersticks.

“Omnipod 5 is a life-changing technology that we believe will revolutionize the market and the lives of people with diabetes,” says Shacey Petrovic, president and CEO 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.”

The Omnipod 5 System consists of the tubeless Pod enhanced with SmartAdjust technology, the Dexcom G6 CGM, and the Omnipod 5 mobile app with its integrated SmartBolus Calculator. The user has the option to download this app onto a compatible personal smartphone or to use the Omnipod 5 Controller, which is provided free with the first prescription.

Every five minutes, SmartAdjust receives a Dexcom CGM value and trend, and predicts where glucose will be 60 minutes into the future. The system then increases, decreases, or pauses insulin delivery using the user’s desired and customized glucose target, helping to protect against highs and lows.

“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,” says Kevin Sayer, chairman, president, and CEO of Dexcom. “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.”

Insulet will also offer Omnipod 5 in a limited market release so that the Company can incorporate learnings to deliver a best-in-class product experience. Omnipod 5 is expected to be broadly available shortly after the limited market release.

Omnipod 5 was recently selected as a CES 2022 Innovation Award honoree in two categories: Health and Wellness and Wearable Technologies.

People with diabetes can enjoy the benefits of Pod Therapy today through OmnipodPromise, which allows new and existing users to start on Omnipod DASH and upgrade to Omnipod 5 at no additional cost when coverage is available.

To learn more, visit the Omnipod website.