Insulet Releases Results of Omnipod 5 System Study for Diabetes

Insulet Corporation presented results of a study of Omnipod 5 Automated Insulin Delivery System, a tubeless insulin pump, for type 2 diabetes (T2D) as well as clinical data in type 1 diabetes (T1D) at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Barcelona, Spain.

The company presented the results of its feasibility study to evaluate the use of Omnipod 5 in individuals with T2D. Additionally, the company shared Omnipod 5 user data in the same population and built upon existing evidence for the treatment of T1D with new insights.

In the study of T2D, investigators included 24 individuals, aged 18 to 75 years, with T2D and an HbA2c from 8% to 12%. These individuals were using insulin injection therapy prior to the study, either through basal-only or multiple daily injections.

The individuals used the Omnipod 5 System in Automated Mode for 8 weeks and had the option to continue in a 6-month extension phase.

In the group of 12 individuals who previously used multiple daily injections, the average age was 62 years, the baseline HbA1c of 9.4%, and the diabetes duration was 20 years. The other 12 participants previously used basal-only injections and had an average age of 59 years, baseline HbA1c of 9.5%, and diabetes duration of 18 years.

Overall, the results showed a significant improvement in HbA1c by 1.3% and improved time in range by 4.6 hours per day during the 8-week study compared with the baseline. Additionally, hypoglycemia was reduced by 4 minutes per day in the group that previously used multiple injections per day but did not change for the group that previously used basal-only injections.

The group that previously used basal-only injections already showed very low rates of hypoglycemia and resulted in a median of 0.04% of time under 70mg/dL when using Omnipod 5.

Additionally, the improvements in glycemic results were achieved alongside a reduction in insulin use by 31.4% for the prior multiple daily injection group with no change for the prior basal-only injection group. There was no change in body mass index for either group.

Furthermore, 14 individuals who volunteered for the post-study human factors interview reported a system usability scale of 90.5 after the conclusion of the study. Twenty-two of the 24 individuals participated in the optional 6-month extension.

Results or the extension will be shared at the American Diabetes Association 82nd Scientific Sessions 2022.

Additionally, Insulet will present data and clinical outcomes for adults and children with T1D, including data on the performance of Omnipod 5 with missed boluses, for a total of 5 oral and poster presentations at the ATTD conference.

Omnipod 5 is cleared for use in the United States for individuals with T2D aged 6 years and older. It is the first tubeless automated insulin delivery system in the United States and integrates with the Dexcom G6 Continuous Glucose Monitoring System.

Reference

Insulet presents new Omnipod 5 system data for type 1 and type 2 Diabetes. Insulet Corporation. News release. April 27, 2022. Accessed April 27, 2022. https://investor.insulet.com/news-releases/news-release-details/insulet-presents-new-omnipodr-5-system-data-type-1-and-type-2