Omnipod 5 AID System Proves Benefit for Adults with Type 2 Diabetes

Use of the Omnipod 5 automated insulin delivery (AID) system decreased median HbA1c from 8.2% to 7.4% in 13 weeks among users with type 2 diabetes, according to results of the SECURE-T2D trial.

Billed as the largest, longest, and most racially diverse study of AID in people with type 2 diabetes to date, results of the SECURE-T2D trial demonstrate provided substantial benefit, including a nearly 5-hour increase in time in range per day, with results of AID use similar across subgroups defined by race/ethnicity, GLP-1 RA use, prior insulin regimen, and pre-study insulin meal dosing method.^1,2

“Our findings demonstrate substantial improvements in blood glucose outcomes and overall quality of life, highlighting the potential for this innovative technology to transform type 2 diabetes management with automated insulin delivery,” said chair of the study Francisco Pasquel, MD, MPH, associate professor of Medicine of Emory University.² “As the largest study of AID therapy in people with type 2 diabetes, we look forward to these results supporting the FDA clearance of Omnipod 5 as a safe and effective therapy for this patient population.”

With the receipt of FDA clearance for type 1 diabetes in January 2022, the Omnipod 5 became the first tubeless AID system with smartphone control. As the benefits of diabetes technology has continued to emerge in recent years, an interest in their utility among people with type 2 diabetes has become evident. At the 2024 International Conference on Advanced Technologies & Treatments for Diabetes, Insulet presented data from an 8-week feasibility study among adults with type 2 diabetes confirming the potential of the Omnipod 5 among this patient population.^3,4

In SECURE-T2D, which was presented at the 84th American Diabetes Association Scientific Sessions, investigators enrolled 305 individuals from 21 sites across the US. For inclusion, patients were required to be 18 to 75 years of age, have type 2 diabetes, have been on their current insulin regimen for 3 or more months, and have no previous AID use. Investigators pointed out HbA1c requirements required patients to have an HbA1c less than 12% among basal/bolus or pre-mix insulin users and 7% or more and less than 12% among basal-only users.¹

The study cohort had a mean age of 57 (SD, 11) years and 57% were female. The median duration of diabetes was 17 years, the mean HbA1c at screening was 8.2% (SD, 1.4), 62% were currently using CGM, and 25% had never used CGM. Regarding race and ethnicity, 50% of patients were non-Hispanic White, 24% were non-Hispanic Black, 22% were Hispanic or Latino, and 2% were Asian or Pacific Islander.¹

Per trial design, participants underwent a 14-day period of standard therapy to collect baseline data, which was followed by a 13-week period where all patients received the Omnipod 5 AID system with the Dexcom G6 continuous glucose monitoring system.¹

At the end of the 13 weeks, the mean HbA1c among the cohort decreased from 8.2% (SD, 1.3) at baseline to 7.4% (SD, 0.9) (treatment effect= -0.8%; 95% CI, -1.0 to -0.7; P <.001). When assessing secondary glycemic metrics, results indicated use was associated with a 20% increase in time in range of 70 to 180 mg/dL (4.8 hours per day) and a 20% decrease in time above 180 mg/dL (4.8 hours per day) (P <.001). Investigators pointed out these improvements in time in range were primarily driven by a significant reduction in hyperglycemia with no increase in hypoglycemia.¹

When assessing secondary endpoints in a pre-specified hierarchical order, significance was achieved for the first 11 endpoints, including mean glucose, time in range of 70 to 180 mg/dL, time in range of 70 to 140 mg/dL, time at or above 300 mg/dL, time above 250 mg/dL, time above 180 mg/dL, time below 70 mg/dL, time below 54 mg/dL, diabetes distress, percentage with high distress scores, and sleep quality. After the 13-week period with Omnipod 5, 90% of participants indicated they would recommend Omnipod 5 to a friend and 78% of participants expressed interest in continuing use of Omnipod 5 following study conclusion.¹

“These data demonstrate that simple, easy-to-use AID technology, such as Omnipod 5, can be adopted by a broad population of people with type 2 diabetes and improve their lives,” said Trang Ly, MBBS, PhD, senior vice president and medical director at Insulet Corporation.² “A major strength of this study is the diversity of the enrolled population in terms of varying education level, income, ethnicity, and race. These results could have a particularly striking impact among Black and Hispanic people, who experience a higher prevalence of type 2 diabetes and increased mortality rates.”

References:

1. ^{Pasquel FJ, DAvis GM, Huffman DM, et al. Glycemic Improvement with Use of the Omnipod 5 Automated Insulin Delivery System in Adults with Type 2 Diabetes—Results of the SECURE-T2D Pivotal Trial. Presented at: American Diabetes Association (ADA) 84th Scientific Sessions. June 21 - 24, 2024. Orlando, FL.}
2. ^{Insulet Corporation. Insulet’s SECURE-T2D Pivotal Trial Results Demonstrate Omnipod® 5 Improves Clinical Outcomes and Quality of Life in Type 2 Diabetes. Insulet Corporation. June 21, 2024. Accessed June 22, 2024. https://investors.insulet.com/news/news-details/2024/Insulets-SECURE-T2D-Pivotal-Trial-Results-Demonstrate-Omnipod-5-Improves-Clinical-Outcomes-and-Quality-of-Life-in-Type-2-Diabetes/default.aspx.}
3. ^{Insulet Corporation . Insulet announces FDA clearance of its Omnipod® 5 automated insulin delivery system, first tubeless system with smartphone control. Insulet Corporation . January 28, 2022. Accessed June 22, 2024. https://investor.insulet.com/news/news-details/2022/Insulet-Announces-FDA-Clearance-of-its-Omnipod-5-Automated-Insulin-Delivery-System-First-Tubeless-System-with-Smartphone-Control/default.aspx.}
4. ^{Davis GM, Peters AL, Bode BW, et al. Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes: From Injections to Hybrid Closed-Loop Therapy. Diabetes Care. 2023;46(4):742-750. doi:10.2337/dc22-191}