Insulet (PODD) Omnipod® 5 competitive clinical performance presentation summary

Executive summary and clinical context

• Automated Insulin Delivery (AID) is now the preferred method for insulin delivery in both type 1 and type 2 diabetes, as per 2026 ADA guidelines, but adoption remains low, especially among adults.

• Omnipod 5 has contributed robust evidence shaping these guidelines and demonstrates competitive clinical results across diverse populations.

• Diabetes management requires stabilizing blood glucose, with AID systems offering improved glycemic control and reduced hypoglycemia risk.

Performance metrics and comparative assessment

• No head-to-head randomized trials exist between AID systems; indirect comparisons are limited by differences in study populations and CGM accuracy.

• Both HbA1c and Time in Range (TIR) are essential for assessing glycemic control; TIR alone is insufficient and can be affected by CGM device accuracy.

• Baseline glycemic status significantly influences final outcomes; higher baseline TIR predicts higher end-of-study TIR regardless of system.

Clinical evidence and real-world outcomes

• Independent real-world studies show Omnipod 5 achieves similar HbA1c and TIR as other leading AID systems, with lower hypoglycemia rates and strong performance across age groups.

• In T2D, Omnipod 5 trials enrolled more racially diverse cohorts and demonstrated the largest TIR improvement and significant insulin reduction.

• Meta-analyses confirm that change in TIR, not just final TIR, is the best measure of therapy benefit, with Omnipod 5 showing consistent improvements.