Omnipod 5, the company’s latest-generation automated insulin delivery (AID) system, became the first and only such system cleared for type 1 and type 2 diabetes last August. Insulet said at the time of its June submission to the FDA that it aimed for a launch in the U.S. in early 2025.
The small, discreet, tubeless, wearable patch pump features SmartAdjust technology that uses CGM readings to predict where glucose will be 60 minutes into the future. Omnipod 5 then increases, decreases, or pauses insulin delivery based on the user’s desired and customized glucose target.
According to the JAMA abstract, the study was constructed because of a need for additional treatment options for people with type 2 diabetes on insulin.
In the nonrandomized clinical trial, investigators evaluated 305 adults with type 2 diabetes. Patient ages ranged between 18 to 75 years old. Those subjects are being treated with insulin with or without other glucose-lowering medications. Subjects used insulin for at least three months prior to screening.
Investigators sought to determine if AID is safe and effective for use in this patient population. The study started with a 14-day standard therapy phase, followed by 13 weeks of treatment with Omnipod 5. In the study, patients paired Omnipod 5 with the Dexcom G6 CGM. Investigators enrolled the first patient in April 2023. The last follow-up visit took place on Feb. 29, 2024.
Outcomes included a significant decrease in HbA1c levels (from 8.2% to 7.4%) after 13 weeks of AID use. That marked a 0.8% point reduction. The study also evaluated HbA1c in a socioeconomically, racially and ethnically diverse cohort of adults with type 2 diabetes.
The study concluded that the lower HbA1c levels suggest AID could prove a beneficial and safe option for this patient population.
Other developments at Insulet
Insulet also made two separate announcements on LinkedIn, highlighting new milestones at the company.
First, the company announced the availability of Omnipod 5 on the U.S. Federal Supply Schedule. It joins the previous-generation Omnipod Dash, which got on the schedule in fall 2023.
Insulet said this addition proves important for those served by federal healthcare program agencies. Those include the Veterans Administration (VA), Defense Dept. (DOD) and Indian Health Services.
Additionally, Insulet said its R&D labs recently expanded at its corporate headquarters at Acton, Massachusetts. This included the creation of a new integrated systems area. The company said this ensures its labs are among the most vital spaces in the company, serving as collaborative environments for hundreds of employees.
“By recognizing and responding to changing engineering needs we ensure that our talented employees have the tools and support they need to bring bold new ideas to life,” said Maciej (Matt) Zawadzki, manager, lab operations, R&D.
