ACTON, Mass.– Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today presented new Omnipod® 5 Automated Insulin Delivery (AID) System study results in type 2 diabetes and other clinical data in type 1 diabetes at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Barcelona, Spain, and online.
Insulet presented the results of its feasibility study to evaluate use of the Omnipod 5 in adults with type 2 diabetes. The Company also shared Omnipod 5 user experience data in the same population and built upon the existing body of evidence for the treatment of type 1 diabetes with new insights from the Omnipod 5 pivotal study data.
The Omnipod 5 System was used by 24 adults aged 18 to 75 years with type 2 diabetes and an HbA1c from 8% to 12%. These adults were using insulin injection therapy prior to the study, either through multiple daily injections or basal-only injections. Participants used the Omnipod 5 System in Automated Mode for eight weeks, and then had the option to continue in a six-month extension phase. The group of 12 participants previously using multiple daily injections had an average age of 62 years, diabetes duration of 20 years, and baseline HbA1c of 9.4% (79 mmol/mol), while the group of 12 participants previously using basal-only injections had an average age of 59 years, diabetes duration of 18 years, and baseline HbA1c of 9.5% (80 mmol/mol).
Overall, the study showed significant improvements in HbA1c by 1.3% (14.2 mmol/mol) and improved Time in Range (TIR) by 4.6 hours per day during the eight-week study compared with baseline. Additionally, hypoglycemia (as measured by percent time glucose levels were under 70mg/dL) was reduced by 4 minutes per day in the group previously using multiple daily injections and did not change for the group previously using basal-only injections. This latter group already showed very low rates of hypoglycemia and resulted in a median of just 0.04% of time under 70mg/dL using Omnipod 5.
The improvements in glycemic results were achieved alongside a reduction in insulin use (-29 units per day, or 31.4%) for the prior multiple daily injections group (no change for prior basal-only injection group), and with no change in Body Mass Index (BMI) in either group. Fourteen participants who volunteered for a post-study human factors interview reported a System Usability Scale of 90.5 after the conclusion of the study. Twenty-two of the 24 participants chose to continue system use in an optional six-month extension, the results of which will be shared at ADA 2022.
“This is the first AID system study of people with type 2 diabetes conducted in the United States and the results are very impressive,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director. “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.”
Omnipod 5 is currently cleared for use in the U.S. for individuals with type 1 diabetes aged 6 years and older. Omnipod 5 is the first tubeless automated insulin delivery system in the U.S. that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System and a compatible smartphone to automatically adjust insulin and help protect against highs and lows.
