Automated Insulin Delivery in Adults With Type 2 Diabetes

作者：Francisco J. Pasquel, Georgia M. Davis, David M. Huffman, Anne L. Peters, John C. Parker, Lori M. Laffel, Giulio R. Romeo, Justin T. Mathew, KRISTIN N. CASTORINO, Davida F. Kruger, Kathleen Marie Dungan, Mark S. Kipnes, Edward C. Jauch, Tamara K. Oser, Viral N. Shah, Barry S. Horowitz, Anders L. Carlson, Mark Warren, Wasim Deeb, John B. Buse, John H. Chip Reed, Jason Berner, Thomas Blevins, CHRIS BAJAJ, Craig Kollman, Dan Raghinaru, Trang T. Ly, Roy W. Beck, Lizda Guerrero-Arroyo, Jason Hughes-Palmer, Martha Lentz Walker, Kevin S. Cannon, Ashlee Wagner, ELVIRA M. ISGANAITIS, Jade Doolan, Shivani Agarwal, David Zybert, Nathalie Zavala, Mei Mei Church, Karla Gonzales, Maggie Shuirman, Kathleen Estrada, J. Kimberly Jones, Terra Cushman, Shereen Muhkahsen, Eileen R. Faulds, Lindsey Aldrich, Stephanie Beltran, Wendy S. Lane, Casey B. Wells, D Kaan, Rachel C Duncan, Sarah A. Friedman, Sean M. Oser, Erik Seth Kramer, Kelsey Huss, William E. Kaye, Morolake Amole, Sandy Diazgranados, Richard M. Bergenstal, Thomas W. Martens, Molly J. Carlson, Samar Malaeb, Heather Lage, Lindsey Smith, Regina Dodis, Matthew Hager, Elizabeth A. Kirk, Lindsay Choate, Chelsea Brouillet, Rebecca F. Goldfaden, Hannah Schaffner, Stephanie Niman, Debbie Domingo, Klara Rachel Klein, Laura Young, Tahereh Ghorbani Rodriguez, Jean M. Dostou, Jamie Diner, Andrea D. Coviello, Emily Curlin, Eileen C. Borkovich, Jessica Tapia, Lauralie Korey, Kirby Reinecke, Shannon Caldwell, Valerie Espinosa, Luis Casaubon, Keta Pandit, Jennifer Perez, Anjanette S. Tan, Chelsea Padilla, Katrina J. Ruedy, Bonnie Dumais, Jacqueline Namati, Todd E. Vienneau, Kellee M. Miller, Lauren M. Huyett, Lindsey R. Conroy · 发表于：JAMA Network Open · 年份：2025 · DOI：10.1001/jamanetworkopen.2024.59348 · 被引用次数：41 · 研究领域：Diabetes Management and Research、Hyperglycemia and glycemic control in critically ill and hospitalized patients、Diabetes Treatment and Management

Importance: There is a need for additional treatment options for people with type 2 diabetes treated with insulin. Given the limited data on the use of automated insulin delivery (AID) systems in type 2 diabetes, studies evaluating their safety and efficacy are important. Objective: To evaluate the association of AID with hemoglobin A1c (HbA1c) levels in a diverse cohort of adults with type 2 diabetes. Design, Setting, and Participants: This single-arm prospective trial was conducted at 21 clinical centers in the United States among individuals aged 18 to 75 years with type 2 diabetes who had been using insulin for at least 3 months prior to screening. Participants with AID system use were excluded. The study started with a 14-day standard therapy phase, followed by 13 weeks of treatment with the investigational device. The first participant was enrolled April 11, 2023, and the last participant follow-up visit was February 29, 2024. Intervention: Participants used the Omnipod 5 AID System for 13 weeks following the 14-day standard therapy phase. Main Outcomes and Measures: Primary outcome was change in HbA1c level at 13 weeks, tested sequentially for noninferiority (0.3% margin) and superiority, compared with baseline. Results: Among 305 participants (mean [SD] age, 57 [11] years; 175 [57%] female; 72 [24%] Black, 66 [22%] Hispanic or Latino, and 153 [50%] White), 289 (95%) completed the trial. At baseline, 223 (73%) were using multiple daily injections, 63 (21%) were using b...