Efficacy and Safety of a Tubeless AID System Compared With Pump Therapy With CGM in the Treatment of Type 1 Diabetes in Adults with Suboptimal Glycemia: A Randomized, Parallel-Group Clinical Trial
Objective: To examine the efficacy and safety of the tubeless Omnipod® 5 Automated Insulin Delivery (AID) System compared with pump therapy with a continuous glucose monitor (CGM) in adults with type 1 diabetes with suboptimal glycemic outcomes. Research Design and Methods: In this 13-week multicenter, parallel-group, randomized controlled trial in the United States and France, adults aged 18-70 years with type 1 diabetes and HbA1c 7-11% (53-97mmol/mol) were randomly assigned (2:1) to intervention (tubeless AID) or control (pump therapy with CGM) following a two-week standard therapy period. The primary outcome was a treatment group comparison of time in range (TIR; 70-180mg/dL) during the trial period. Results: A total of 194 participants were randomized; 132 to intervention and 62 to control. TIR during the trial was (mean difference (95% CI)) 17.5% (14.0%, 21.1%) (4.2 hours per day) higher in the intervention compared with the control arm (P<0.0001). The intervention arm had a greater reduction in HbA1c from baseline compared with control (mean±SD) (-1.24±0.75% [-13.6±8.2mmol/mol] vs. -0.68±0.93% [-7.4±10.2mmol/mol], respectively) (P<0.0001), accompanied by significantly lower time <70mg/dL (1.18±0.86% vs. 1.75±1.68%, P=0·005) and >180mg/dL (37.6±11.4% vs. 54.5±15.4%, P<0.0001). All primary and secondary outcomes were met. No instances of diabetes-related ketoacidosis or severe hypoglycemia occurred in the intervention arm. Conclusions: Use of the tubeless AID system led to improved glycemic outcomes compared with pump therapy with CGM among adults with type 1 diabetes, underscoring the clinical benefit of AID and bolstering recommendations to establish AID systems as preferred therapy for this population.