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

The Omnipod 5 Automated Insulin Delivery System (Omnipod 5) has received FDA clearance for patients 6 years of age and older with type 1 diabetes, according to a press release from Insulet Corporation.

Omnipod 5 is the first tubeless automated insulin delivery system that integrates with the Dexcom G6 Continuous Glucose Monitoring System and a compatible smartphone in order to automatically adjust insulin and help protect against highs and lows, according to the press release. The system is designed to make it easier to manage glucose with no multiple daily injections, tubes, or finger sticks.

“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 CEO of Insulet, in the press release. “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 system includes the tubeless Pod enhanced with SmartAdjust technology, the Dexcom G6 continuous glucose monitor (CGM), and the Omnipod 5 mobile app with an integrated SmartBolus calculator. Users can download the app onto a compatible smartphone or can use the controller provided with the first prescription.

According to the press release, SmartAdjust receives a Dexcom CGM value and trend every 5 minutes and predicts where glucose levels will be in 60 minutes. The system then increases, decreases, or pauses insulin delivery using a customized glucose target, which helps avoid highs and lows in insulin levels.

“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,” said Kevin Sayer, chairman, president, and CEO of Dexcom, in the press release.

The system will launch through the pharmacy channel and will be offered in a limited market release soon so that the company can incorporate the findings prior to the full launch. It is expected to be broadly available shortly after the limited market release.

Omnipod 5 was also recently selected as a CES 2022 Innovation Award honoree in both the Health and Wellness and Wearable Technologies categories. The awards are an annual competition for design and engineering in consumer technology products, according to the press release.

REFERENCE

Insulet Announces FDA Clearance of its Omnipod 5 Automated Insulin Delivery System, First Tubeless System with Smartphone Control. News release. Insulet; January 28, 2022. Accessed January 28, 2022. https://investor.insulet.com/news-releases/news-release-details/insulet-announces-fda-clearance-its-omnipodr-5-automated-insulin