SECURE-T2D Trial Results Show Efficacy of Automated Insulin Delivery System in Treatment of Type 2 Diabetes

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Results from the pivotal SECURE-T2D trial (NCT05815342) demonstrated that use of Insulet’s Omnipod 5 Automated Insulin Delivery System produced glycemic improvements in adult patients with type 2 diabetes compared to previous treatment with insulin injections or pump therapy. These findings, presented at the American Diabetes Association 84th Scientific Sessions, represented the largest, longest, and most racially diverse study population to evaluate automated insulin delivery (AID) in patients with type 2 diabetes, according to Insulet.¹

“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,” study chair Francisco Pasquel, MD, MPH, of Emory University, said in a press release. “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.”¹

Omnipod 5 was granted FDA clearance for patients aged 6 years and older with type 1 diabetes in January 2022. A few months later, the agency cleared Omnipod 5 for patients aged 2 years and older with type 1 diabetes.^2,3

Omnipod 5 can be integrated with the Dexcom G6 Continuous Glucose Monitoring (CGM) System and a compatible smartphone, which allows for insulin to be automatically adjusted to help protect against highs and lows. The system was developed to enable easier glucose management without requiring multiple daily injections, tubes, or finger sticks.

The system includes a tubeless pod enhanced with SmartAdjust technology, the Dexcom G6 CGM, and the Omnipod 5 mobile app with integrated SmartBolus calculator. SmartAdjust is sent a Dexcom CGM value and trend every five minutes, which helps it to predict glucose levels over the following 60 minutes. The system is then able to adjust or pause insulin delivery to within a customized glucose target.²

The single arm, multi-center, prospective SECURE-T2D study enrolled 343 participants.⁴ The trial’s first phase was comprised of a 14-day period in which investigators gathered baseline glucose and insulin data.

Participants managed their disease in an outpatient setting following their typical routine while wearing a blinded CGM to collect baseline glycemic data. The second phase was comprised of a 13-week treatment period, in which participants used the Omnipod 5 System, had in-clinic or virtual visits at least monthly across a total of eight visits, and had supervised exercise and meal challenges.⁴

The trial’s primary objective was an analysis of change in HbA1c levels with Omnipod 5 in patients 18 to 75 years of age with type 2 diabetes who were on their current insulin regimen for at least three months. Other objectives included a baseline HbA1c between 7% and 12% for patients using basal insulin only and 12% or less for patients using basal and bolus or pre-mixed insulin; improved time in range (TIR); improved time in hyperglycemia and non-inferiority for hypoglycemia; and the patient-reported outcome of diabetes distress.

The investigators highlighted that the study population included 24% Black and 22% Hispanic participants. Of the trial population, 55% were on a stable dose of GLP-1 receptor agonists, while 73% received multiple daily injections of insulin, 21% used basal-only insulin at baseline, and 5.6% used an insulin pump at baseline.

During the trial, investigators observed significant decreases in HbA1c, time in hyperglycemia, and total daily insulin dose, as well as a significant improvement in TIR without an increase in time in hypoglycemia. Patients also reported a clinically meaningful improvement in diabetes distress.

Mean HbA1c dropped 0.8% from 8.2% to 7.4% among the total population. Patients with a baseline HbA1c ≥9.0% experienced a drop in HbA1c of 2.1%.

TIR increased by 4.8 hours/day from 45% to 66% driven by decreased hyperglycemia levels, including time above 180, 250, and 300 mg/dL. The total amount of insulin used per day dropped from an average of 0.80 U/kg/day with standard therapy to 0.57 U/kg/day with AID, which translates to an average reduction of 23 U/day.

“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,” Trang Ly MBBS, FRACP, PhD, Insulet senior vice president and medical director, said in a press release. “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.”¹

References

1. Insulet’s SECURE-T2D Pivotal Trial Results Demonstrate Omnipod® 5 Improves Clinical Outcomes and Quality of Life in Type 2 Diabetes. News release. Insulet. June 21, 2024. Accessed June 24, 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

2. Insulet Announces FDA Clearance of its Omnipod 5 Automated Insulin Delivery System, First Tubeless System with Smartphone Control. News release. Insulet; January 28, 2022. Accessed June 24, 2024. https://investor.insulet.com/news-releases/news-release-details/insulet-announces-fda-clearance-its-omnipodr-5-automated-insulin

3. Insulet Announces FDA Clearance of Omnipod® 5 for Children Aged Two Years and Older with Type 1 Diabetes. Insulet Corporation. News release. August 22, 2022. Accessed June 24, 2024. https://investor.insulet.com/news-releases/news-release-details/insulet-announces-fda-clearance-omnipodr-5-children-aged-two

4. OP5-005 Using Omnipod 5 in Adults With Type 2 (SECURE-T2D). Clinicaltrials.gov. Updated May 31, 2024. Accessed June 24, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT05815342