FDA Clears Omnipod 5 Tubeless Insulin System for Diabetes Management

The Food and Drug Administration (FDA) has cleared the Omnipod^® 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged 6 years and older with type 1 diabetes.

The Omnipod 5 System consists of a tubeless, waterproof, wearable Pod, the Dexcom G6 Continuous Glucose Monitoring (CGM) system (sold separately), and the Omnipod 5 mobile app.

The Pod delivers insulin using built-in SmartAdjust™ technology, which receives a Dexcom CGM value and trend every 5 minutes and predicts where glucose will be in the next 60 minutes. The system then automatically adjusts or pauses insulin delivery using the user’s customized glucose target. Individuals can place the Pod on the arm, leg, back, abdomen, or buttocks. 

The approval was based on data from a clinical trial that evaluated the Omnipod 5 System in 128 adult and adolescents (aged 14 to 70 years) and 112 children (aged 6 to 13.9 years) with type 1 diabetes. Participants used Omnipod 5 for a period of 3 months after a 14 day period using their standard therapy.

Results showed a significant increase in time in range (an additional 2.2 hours/day) in adults and adolescents, as well as an overall reduction in HbA1c from 7.16% to 6.78%. Mean glucose levels also decreased from 161mg/dL to 154mg/dL.

Among pediatric patients, time in range increased from 53% to 68%, which corresponded to an additional 3.7 hours per day. Findings also showed an improvement in HbA1c (from 7.67% to 6.99%) and mean glucose levels (from 183mg/dL to 160mg/dL).

Following completion of the 3-month study, 95% of the study participants continued on to the extension phase, where they used the Omnipod 5 at home for a period of 12 months. Results showed the Omnipod 5 System continued to significantly improve time in range and reduce HbA1c in children, adolescents, and adults.

“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. “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 mobile app is currently compatible with the Samsung Galaxy S10 (4G); the Company is working on iOS compatibility. The system can also be controlled with the wireless Omnipod 5 Controller, which is provided at no additional cost with the first prescription.

Omnipod 5 is expected to be broadly available shortly after a limited market release.

References

1. Insulet announces FDA clearance of its Omnipod^® 5 Automated Insulin Delivery System, first tubeless system with smartphone control. News release. Insulet Corporation. January 28, 2022. https://www.businesswire.com/news/home/20220127006047/en/Insulet-Announces-FDA-Clearance-of-its-Omnipod%C2%AE-5-Automated-Insulin-Delivery-System-First-Tubeless-System-with-Smartphone-Control.
2. Insulet’s Omnipod^® 5 Automated Insulin Delivery System improves clinical outcomes in type 1 diabetes. News release. Insulet Corporation. March 20, 2021. https://investor.insulet.com/news-releases/news-release-details/insulets-omnipodr-5-automated-insulin-delivery-system-improves.
3. Insulet’s Omnipod^® 5 pivotal study extension data shows significant improvements in glycemic control with one year of use. News release. Insulet Corporation. September 30, 2021. https://investor.insulet.com/news-releases/news-release-details/insulets-omnipodr-5-pivotal-study-extension-data-shows.