Insulet (Nasdaq:PODD) today unveiled study results for the new Omnipod 5 automated insulin delivery system in type 1 and type 2 diabetes.
Acton, Massachusetts-based Insulet presented results from studies as well as user experience data for both type 1 and type 2 diabetes at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Barcelona, Spain.
Paired with Dexcom’s G6 continuous glucose monitoring (CGM) system, Omnipod 5 — which received FDA clearance for individuals aged six years old and up with type 1 diabetes in January — is the first tubeless, wearable, automated insulin delivery system, Insulet President and CEO Shacey Petrovic told Drug Delivery Business News in an interview last year.
The company’s feasibility study evaluated use of the Omnipod 5 in adults with type 2 diabetes, while user experience data came from the same population and built upon the existing body of evidence for treating type 1 diabetes thanks to new insights from the Omnipod 5 pivotal study data, according to a news release.
In the type 2 study, 24 adults aged between 18 and 75 years old with type 2 diabetes and an HbA1c from 8% to 12% were evaluated. The population were using insulin injection therapy prior to the study, either through multiple daily injections or basal-only injections
Study participants used the Omnipod 5 in automated mode for eight weeks, then had the option to continue in a six-month extension phase. The group of 12 participants previously using multiple daily injections averaged 62 years old with a mean diabetes duration of 20 years and a baseline HbA1c of 9.4%, while the basal-only users had an average of 59 years, 18-year diabetes duration and HbA1c baseline of 9.5%.
The study demonstrated significant HbA1c improvements (1.3%) and time in range improvements (4.6 hours per day) over the eight-week study. Hypoglycemia was also reduced by four minutes per day in the multiple daily injection group, while it did not change in the basal-only group, which had already shown very low rates of hypoglycemia.
Insulet’s type 1 data, which adds to existing data for the FDA-cleared Omnipod 5, covers clinical outcomes for both children and adults with type 1 diabetes. It will also cover the performance of Omnipod 5 with missed boluses and will later be presented at ATTD.
“This is the first AID system study of people with type 2 diabetes conducted in the United States and the results are very impressive,” Insulet SVP and Medical Director Dr. Trang Ly said in the release. “It’s an exciting milestone for Insulet, as we look ahead to a pivotal study for this population. We are driven in our pursuit to provide Omnipod 5 to as many people with diabetes as possible, and this data demonstrates the potential benefits Omnipod 5 can provide for the type 2 diabetes community.”