Real-World HbA1c Following Initiation of the Omnipod 5 Automated Insulin Delivery System

<b><i>Introduction:</i></b> The Omnipod® 5 Automated Insulin Delivery (AID) System is the first wearable, on-body, tubeless AID system in the United States. Clinical trials have demonstrated hemoglobin A1C (HbA1c) improvements with Omnipod 5 use. The aim of the study was to evaluate HbA1c changes after initiating Omnipod 5 in a real-world setting. <b><i>Methods:</i></b> This retrospective study utilized commercial and Medicare Advantage with Part D enrollees' claims data from the Optum Research Database between August 1, 2021, and December 31, 2023. The study included individuals diagnosed with type 1 diabetes (T1D) or type 2 diabetes (T2D) who initiated Omnipod 5. Participants were required to have continuous enrollment for 12 months pre- and post-initiation and at least two medical claims for diabetes during these periods. Demographic and clinical characteristics were measured at the index date, and HbA1c levels were compared pre- and post-initiation of Omnipod 5. <b><i>Results:</i></b> The final sample included 2,504 users, with 792 having pre- and post-initiation HbA1c results. The mean age was 54 years; 48% were enrolled in Medicare Advantage, 90% had prior continuous glucose monitoring, and 64% had prior pump therapy. A mean reduction in HbA1c of 0.4% was observed (<i>P</i> < 0.001); mean reductions were 0.4% and 0.5% among those with type 1 and type 2 diabetes, respectively. Among 135 users with pre-initiation HbA1c levels ≥9%, a reduction of 1.4% was noted (<i>P</i> < 0.001). Pre-initiation, 31% achieved the American Diabetes Association (ADA) target of <7% compared to 44% post-initiation (increase of 13%; <i>P</i> < 0.001). For the Healthcare Effectiveness Data and Information Set (HEDIS) target of <8%, 62% of individuals achieved the target pre-initiation compared to 78% post-initiation (increase of 16%; <i>P</i> < 0.001). <b><i>Conclusions:</i></b> In a real-world setting, Omnipod 5 was associated with reduced HbA1c and an increased proportion of individuals achieving ADA and HEDIS glycemic targets.