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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

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posted on 2024-10-18, 16:23 authored by Eric Renard, Ruth S. Weinstock, Grazia Aleppo, Bruce W. Bode, Sue A. Brown, Kristin Castorino, Irl B. Hirsch, Mark S. Kipnes, Lori M. Laffel, Rayhan A. Lal, Alfred Penfornis, Jean-Pierre Riveline, Viral N. Shah, Charles Thivolet, Trang T. Ly

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.

Funding

This study was funded by Insulet Corporation.

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