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
Authors: Renard Eric , Weinstock Ruth S. , Aleppo Grazia , Bode Bruce W. , Brown Sue A. , Castorino Kristin , Hirsch Irl B. , Kipnes Mark S. , Laffel Lori M. , Lal Rayhan A. , Penfornis Alfred , Riveline Jean-Pierre , Shah Viral N. , Thivolet Charles , Ly Trang T. ,   OP5-003 Research Group, Renard Eric , Farret Anne , Villard Orianne , Masri Manal Al , Weinstock Ruth S. , Stone Sheri L. , Bzdick Suzan , Aleppo Grazia , Kravarusic Jelena , Guevara Evelyn , Herrmann Stefanie , Penn Samsam , Bode Bruce W. , Ownby Jonathan , Johnson Joseph , Tabb Courtney , Maxson Amanda , Dunn Ethan , Lewis Monica , Reed Dajah , Wilby Cate , Brown Sue A. , Stumpf Meaghan , Fuller Morgan , Alix Carlene , Castorino Kristin , Church Mei Mei , Thorsell Ashley , Shelton Nina , Blanscet Hannah , Hirsch Irl B. , Malik Faisal , Averkiou Xenia , Dong Xiaofu , Mandava Patali , Kipnes Mark S. , Salhin Amna , Christie Kalicia , Beltran Stephanie , Ramon Vanessa , Oliver Danielle , Rosas Krizia , Mulvey Suzanne , Ryan Terri , Hernandez Joann , Pour Fatemeh Movaghari , Hirchak Chad , Laffel Lori M. , Isganaitis Elvira , Ambler-Osborn Louise , Goroza Evelyn , Doolan Jade , Turcotte Christine , Herndon Christopher , Volkening Lisa , Oliveri Mary , Kollar Laura , Lal Rayhan A. , Buckingham Bruce A. , Hughes Michael , Norlander Lisa , Kingman Ryan , Suh Bailey , Hsu Liana , Penfornis Alfred , Petit Catherine , Siadoua Marcelle , Riveline Jean-Pierre , Gautier Jean-François , Vidal-Trecan Tiphaine , Julia Jean Baptiste , Potier Charline , Bellili Djamila , Shah Viral N. , Akturk Halis Kaan , Joseph Hal , Moore Alexis , Downs Ashleigh , Beatson Christie , Walker Sonya , Bloks Tanner , Qamar Lubna , Wodetzki Darya , Shoemaker Ryan , Thivolet Charles , Fimbel Sylvie Villar , Hami Redhouane , Kivilaid Kaisa , Ly Trang T. , Dumais Bonnie , Vienneau Todd , Huyett Lauren M , Conroy Lindsey R. 
Published: October 2024

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 performed in the U.S. and France, adults aged 18–70 years with type 1 diabetes and HbA1c 7–11% (53–97 mmol/mol) were randomly assigned (2:1) to intervention (tubeless AID) or control (pump therapy with CGM) following a 2-week standard therapy period. The primary outcome was a treatment group comparison of time in range (TIR) (70–180 mg/dL) during the trial period.

RESULTS

A total of 194 participants were randomized, with 132 assigned to the intervention and 62 to the control. TIR during the trial was 4.2h/day higher in the intervention compared with the control group (mean difference 17.5% [95% CI 14.0%, 21.1%]; P &lt; 0.0001). The intervention group had a greater reduction in HbA1c from baseline compared with the control group (mean ± SD −1.24 ± 0.75% [−13.6 ± 8.2 mmol/mol] vs. −0.68 ± 0.93% [−7.4 ± 10.2 mmol/mol], respectively; P &lt; 0.0001), accompanied by a significantly lower time &lt;70 mg/dL (1.18 ± 0.86% vs. 1.75 ± 1.68%; P = 0.005) and &gt;180 mg/dL (37.6 ± 11.4% vs. 54.5 ± 15.4%; P &lt; 0.0001). All primary and secondary outcomes were met. No instances of diabetes-related ketoacidosis or severe hypoglycemia occurred in the intervention group.

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.