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: 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, Eric Renard, Anne Farret, Orianne Villard, Manal Al Masri, Ruth S. Weinstock, Sheri L. Stone, Suzan Bzdick, Grazia Aleppo, Jelena Kravarusic, Evelyn Guevara, Stefanie Herrmann, Samsam Penn, Bruce W. Bode, Jonathan Ownby, Joseph Johnson, Courtney Tabb, Amanda Maxson, Ethan Dunn, Monica Lewis, Dajah Reed, Cate Wilby, Sue A. Brown, Meaghan Stumpf, Morgan Fuller, Carlene Alix, Kristin Castorino, Mei Mei Church, Ashley Thorsell, Nina Shelton, Hannah Blanscet, Irl B. Hirsch, Faisal Malik, Xenia Averkiou, Xiaofu Dong, Patali Mandava, Mark S. Kipnes, Amna Salhin, Kalicia Christie, Stephanie Beltran, Vanessa Ramon, Danielle Oliver, Krizia Rosas, Suzanne Mulvey, Terri Ryan, Joann Hernandez, Fatemeh Movaghari Pour, Chad Hirchak, Lori M. Laffel, Elvira Isganaitis, Louise Ambler-Osborn, Evelyn Goroza, Jade Doolan, Christine Turcotte, Christopher Herndon, Lisa Volkening, Mary Oliveri, Laura Kollar, Rayhan A. Lal, Bruce A. Buckingham, Michael Hughes, Lisa Norlander, Ryan Kingman, Bailey Suh, Liana Hsu, Alfred Penfornis, Catherine Petit, Marcelle Siadoua, Jean-Pierre Riveline, Jean-François Gautier, Tiphaine Vidal-Trecan, Jean Baptiste Julia, Charline Potier, Djamila Bellili, Viral N. Shah, Halis Kaan Akturk, Hal Joseph, Alexis Moore, Ashleigh Downs, Christie Beatson, Sonya Walker, Tanner Bloks, Lubna Qamar, Darya Wodetzki, Ryan Shoemaker, Charles Thivolet, Sylvie Villar Fimbel, Redhouane Hami, Kaisa Kivilaid, Trang T. Ly, Bonnie Dumais, Todd Vienneau, Lauren M Huyett, Lindsey R. Conroy
Journal: Diabetes Care (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 &amp;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 &amp;lt; 0.0001), accompanied by a significantly lower time &amp;lt;70 mg/dL (1.18 ± 0.86% vs. 1.75 ± 1.68%; P = 0.005) and &amp;gt;180 mg/dL (37.6 ± 11.4% vs. 54.5 ± 15.4%; P &amp;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.