SECURE-T2D: Automated Insulin Delivery System Reduced A1c in Adults with Type 2 Diabetes

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A tubeless automated insulin delivery (AID) system improved glycemic outcomes among a large diverse group of adults with type 2 diabetes (T2D), according to data presented at the American Diabetes Association’s (ADA) 84th Scientific Sessions, June 21-24, in Orlando, Florida.¹

Researchers presented findings from the SECURE-T2D pivotal clinical trial, which showed that participants with T2D on a stable insulin regimen who were started on the Omnipod 5 AID system had an A_1c reduction from 8.2% at baseline to 7.4% at 13 weeks (treatment effect -0.8%, 95% CI -1.0 to -0.7; P < .001).¹

The multicenter clinical trial included 305 adults aged 18 to 75 years with T2D using insulin (basal-bolus, premix, or basal-only) who had an A_1c of less than 12%. The mean age of the cohort was 57 years and 24% were Black and 22% were Hispanic/Latino, according to the study abstract simultaneously published in the journal Diabetes.¹

Baseline data were collected during 14 days of standard therapy, after which participants were started on the Omnipod 5 system for 13 weeks. The primary endpoint was change in A_1c from baseline to 13 weeks.¹

The majority of participants used basal-bolus insulin delivery (79%), 21% used basal-only injections, 55% used glucagon-like peptide 1 receptor agonists, and 44% used sodium-glucose cotransporter-1 or 2 inhibitors.¹

In addition to finding that the Omnipod 5 system was associated with statistically significant improved glycemic outcomes, researchers reported that the benefit was greatest in those with the highest baseline A_1c. They observed a 2.1 percentage point decrease for participants with A_1c of 9% or greater at baseline (10.1% at baseline vs 8.1% at 13 weeks).¹

"The results from the SECURE-T2D trial underscore the potential of the Omnipod 5 AID System to transform diabetes management for adults with type 2 diabetes,” lead SECURE-T2D author Francisco J. Pasquel, MD, MPH, associate professor of medicine and global health, Emory University, said in an ADA press release. “The substantial improvements in glycemic control and quality of life, particularly among minority populations, are promising steps toward more equitable diabetes care."²

Omnipod 5 was cleared by the FDA in 2022 for use by people with type 1 diabetes aged 2 years and older. Omnipod GO received FDA clearance in 2023 for individuals with type 2 diabetes aged 18 and older who use basal-only insulin.

References:

1. Pasquel FJ, Davis GM, Huffman DM, et al. 1904-LB: 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. Diabetes. Published online June 21, 2024. doi:10.2337/db24-1904-LB
2. Breakthrough studies on automated insulin delivery and CGM for type 2 diabetes unveiled at ADA Scientific Sessions. News item. American Diabetes Association. June 24, 2024. Accessed June 27, 2024. https://diabetes.org/newsroom/press-releases/breakthrough-studies-automated-insulin-delivery-and-cgm-type-2-diabetes