Results of Omnipod 5 Type 2 Feasbility Study Presented at ATTD

Insulet Corporation presented results for its Omnipod 5 tubeless insulin pump technology at last week’s Advanced Technologies & Treatments for Diabetes (ATTD) conference in Barcelona, Spain, according to a statement from the company. Data presented included results of a feasibility study that examined the use of the Omnipod 5 in adults with type 2 diabetes (T2D).

Omnipod 5 is cleared for use in the United States for individuals with type 1 diabetes (T1D) aged 6 years and older. Omnipod 5 is the first tubeless AID system in the United States that combines the Dexcom G6 continuous glucose monitoring (CGM) system with a compatible smartphone to automatically adjust insulin and help protect against high and low glycemic levels, which can cause both short-term and long-term health complications in patients with T1D and T2D.

Use of CGM, with or without insulin pump technology, has been considered standard of care for T1D for several years. However, it’s only been in the past year that Medicare has fully covered this technology without requiring “finger sticks,” even though Dexcom had achieved this milestone several years prior. Making CGM and pump technology less burdensome is considered essential to bringing this technology to the much larger T2D population—a group that many believe would benefit from closer monitoring of their glucose levels. According to the CDC, about 37 million Americans have diabetes, and 90% to 95% of them have T2D.

In this T2D feasibility study, the automated insulin delivery (AID) system was used by 24 adults who were 18 to 75 years of age with glycated hemoglobin (A1C) that ranged from 8% to 12%. Prior to the study, half the adults were using insulin through multiple daily injections (MDI); the other half used basal injections (BI).

Participants used the Omnipod 5 in automated mode for 8 weeks, with the option to continue for 6 more months. Among those that had been using MDI, the average age was 62 years and the average T2D duration was 20 years, with baseline A1C of 9.4%. The BI group had an average age of 59 years and diabetes duration of 18 years, with baseline A1C of 9.5%.

In the first 8 weeks, participants improved A1C by 1.3% and improved their time in range (TIR) by 4.6 hours per day compared with baseline.

Hypoglycemia, measured as the percent of time glucose levels were under 70 mg/dL, was reduced by 4 minutes per day among those that had been using MDI and did not change for those using BI; the BI group already had low hypoglycemia rates and had a median of 0.04% of time under 70 mg/dL with Omnipod 5.

At the same time, the MDI patients in the study used less insulin—an average reduction of 29 units per day (31.4%). Those previously using BI had no change. There was no change in body mass index in either group. Fourteen participants volunteered for a post-study interview and reported a System Usability Scale of 90.5.

Finally, 22 of the 24 participants elected to continue with system for an additional 6 months. Results will be reported in June during the American Diabetes Association 82nd Scientific Sessions.

“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 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.”

Reference

Peters A. Improvement in HbA1C after 8 weeks of Omnipod 5® Automated Insulin Delivery System use in adults with Type 2 diabetes: From injections to hybrid closed-loop therapy. Presented at: Advanced Technologies & Treatments for Diabetes 2022; Barcelona, Spain; April 27-30, 2022. Poster 002.