Understanding Omnipod 5 AID and SECURE-T2D

A recent nonrandomized clinical trial found the initiation of automated insulin delivery (AID) safe and effective for a population of insulin-requiring adults with type 2 diabetes (T2D), particularly for lowering hemoglobin A1c (HbA1c) levels.1

The SECURE-T2D trial evaluated the impact of the Omnipod 5 AID system on glycemic control among 305 participants with diverse representation, including 24% Black and 22% Hispanic or Latino. After a 14-day standard therapy phase, the population used the Ompiod 5 AID system for 13 weeks.

In a recent episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, examined the benefit of the diverse trial population on applying these notable data to wider populations

“One of the criticisms of insulin pumps or technology trials is that they include a highly educated population that is tech savvy and it becomes difficult to apply that to the general population, because the average person may not have that education,” Isaacs said. “They were much more diverse in terms of education level, income level, and even when you look at race and ethnicity, 50% were White and the other half came from different ethnicities.”

The US Food and Drug Administration cleared Omnipod 5 Automated Insulin Delivery (AID) System in August 2024, becoming the first AID system to be FDA-cleared for both type 1 (T1D) and T2D management.2

Analyses from SECURE-T2D showed the Omnipod 5 AID system led to a decrease in HbA1c from 8.2% at baseline to 7.4% (mean difference, -0.8 percentage points; 95% CI, -1.0 to -0.7; P <.001), while time in range (70-180 mg/dL) increased from 45% to 66% (mean difference, 20 percentage points; 95% CI, 18 to 22; P <.001).3

“For them to get that FDA approval, we needed more data and this HbA1c reduction is huge,” Bellini said. “For the time in range, which [we] have been believers in since we first started using CGM, every 5% increase reduces complications and we’re at a 20% increase. That’s incredible and they’re not having to add different medication or taking insulin at every meal.”

Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

References

1. Diana Isaacs P, Natalie Bellini D. Diabetes dialogue: Omnipod 5 and Medtronic 780G for Type 2 diabetes. HCP Live. February 15, 2025. Accessed February 25, 2025. https://www.hcplive.com/view/diabetes-dialogue-omnipod-5-and-medtronic-780g-for-type-2-diabetes.

2. Campbell P. FDA clears omnipod 5 aid system for type 2 diabetes. HCP Live. August 26, 2024. Accessed February 25, 2025. https://www.hcplive.com/view/fda-clears-omnipod-5-aid-system-for-type-2-diabetes.

3. Pasquel FJ, Davis GM, Huffman DM, et al. Automated Insulin Delivery in Adults With Type 2 Diabetes: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025;8(2):e2459348. doi:10.1001/jamanetworkopen.2024.59348