Acton, Massachusetts-based Insulet plans to discuss a range of developments related to its product line in the coming days at the American Diabetes Association (ADA) 83rd Scientific Sessions in San Diego. Presentations include real-world evidence of improved outcomes and optimization using the Omnipod 5 automated insulin delivery system.
“Insulet’s flagship product, Omnipod 5, is having an incredible impact on people with diabetes, including improved glycemic outcomes and better quality of life,” said Jim Hollingshead, Insulet president and CEO. “We are thrilled with the opportunity to present real-world evidence from the first year on Omnipod 5 in the U.S., and further educate diabetes clinicians on how they can improve care for their patients using our tubeless automated insulin delivery technology.”
The company said that it submitted its Omnipod 5 App for iPhone to the FDA for 510(k) clearance. The company aims to provide smartphone control for iOS mobile technology users.
Insulet said it enhanced its app’s user interface to align with the iOS operating system. It also added a new custom food feature for the iPhone app.
The company also reported progress toward its goal of giving Omnipod 5 users a choice over the sensor that accompanies their pump. Currently, Omnipod 5 works in conjunction with the Dexcom G6 continuous glucose monitor (CGM). Insulet said it expects to soon begin enrollment for a clinical study integrating Omnipod 5 with the Abbott FreeStyle Libre 2 sensor.
This study aims to recruit up to 200 participants with type 1 diabetes, both in the adult and pediatric age groups. It spans the UK, France and Belgium. Insulet said it hopes to demonstrate superior efficacy with Omnipod 5 compared to multiple daily injections.
News of these developments follows the UK launch of Omnipod 5 earlier this week.
About the Insulet Omnipod 5
The latest-generation Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January 2022. Insulet commenced its U.S. full-market launch in August 2022. The Omnipod 5 picked up CE mark approval for ages two and up in September of last year.
Omnipod 5, a tubeless pod, features SmartAdjust technology. It integrates with the Dexcom 6 continuous glucose monitor (CGM). With CGM data, SmartAdjust predicts where glucose will be 60 minutes into the future every five minutes. Omnipod 5 then increases, decreases, or pauses insulin delivery based on the user’s desired and customized glucose target.
The device also features the Omnipod 5 mobile app with an integrated SmartBolus calculator, too. Users can download the app onto a compatible smartphone or use the Omnipod 5 controller.
New developments for Omnipod 5 accompany separate product news for Insulet as well. In April, the company announced FDA clearance for its basal-only insulin delivery system, the Omnipod GO.
The first-of-its-kind, standalone, wearable insulin delivery system provides a fixed rate of continuous, rapid-acting insulin for 72 hours. It features a tubeless and waterproof pod offered in seven different pre-programmed daily rates. These rates range from 10 to 40 units per day.
