Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes
Sue A. Brown, Gregory P. Forlenza, Bruce W. Bode, Jordan E. Pinsker, Carol J. Levy, Amy Criego, David W. Hansen, Irl B. Hirsch, Anders L. Carlson, Richard M. Bergenstal, Jennifer L. Sherr, Sanjeev N. Mehta, Lori M. Laffel, Viral N. Shah, Anuj Bhargava, Ruth S. Weinstock, Sarah A. MacLeish, Daniel J. DeSalvo, Thomas C. Jones, Grazia Aleppo, Bruce A. Buckingham, Trang T. Ly, Sue A. Brown, Mary Voelmle, Emma Emory, Gregory P. Forlenza, R. Paul Wadwa, Robert H. Slover, Erin Cobry, Laurel H. Messer, Cari Berget, Susan McCoy, Viral N. Shah, Halis Kaan Aktürk, Nicole Schneider, Hal Joseph, Prakriti Joshee, Christie Beatson, Bruce W. Bode, Brooke Narron, Tricia Lopez, Jordan E. Pinsker, Mei Mei Church, Kristin Castorino, Molly Piper, Jimena Pérez, Carol J. Levy, David W. Lam, Camilla Levister, Grenye O’Malley, Selassie Ogyaadu, Dushyanthy Arasaratnam, Mitchell Plesser, Emily Nosova, Suzan Bzdick, David W. Hansen, Sheri Stone, Ruth S. Weinstock, Irl B. Hirsch, Subbulaxmi Trikudanathan, Nancy Sanborn, Dori Khakpour, Anders L. Carlson, Amy Criego, Richard M. Bergenstal, Thomas Martens, Aimee Grieme, Jamie Hyatt, Alina Punel, Diane Whipple, Jennifer L. Sherr, Michelle Van Name, Michelle Brei, Melinda Zgorski, Amy Steffen, Lori Carria, Sanjeev N. Mehta, Lori M. Laffel, Lindsay Roethke, Margaret C. Fisher, Rebecca Ortiz La Banca, Lisa K. Volkening, Louise Ambler-Osborn, Christine Turcotte, Emily Freiner, Anuj Bhargava, Lisa Borg, Sarah A. MacLeish, Jamie Wood, Beth A. Kaminski, Terri Casey, Wendy Campbell, Daniel J. DeSalvo, Siripoom McKay, Mary Kylie DeLaO, Carolina Villegas, Thomas C. Jones, Barry Johns, Ashwini Gore, L Harvill
Abstract
OBJECTIVE Advances in diabetes technology have transformed the treatment paradigm for type 1 diabetes, yet the burden of disease is significant. We report on a pivotal safety study of the first tubeless, on-body automated insulin delivery system with customizable glycemic targets. RESEARCH DESIGN AND METHODS This single-arm, multicenter, prospective study enrolled 112 children (age 6–13.9 years) and 129 adults (age 14–70 years). A 2-week standard therapy phase (usual insulin regimen) was followed by 3 months of automated insulin delivery. Primary safety outcomes were incidence of severe hypoglycemia and diabetic ketoacidosis. Primary effectiveness outcomes were change in HbA1c and percent time in sensor glucose range 70–180 mg/dL (“time in range”). RESULTS A total of 235 participants (98% of enrolled, including 111 children and 124 adults) completed the study. HbA1c was significantly reduced in children by 0.71% (7.8 mmol/mol) (mean ± SD: 7.67 ± 0.95% to 6.99 ± 0.63% [60 ± 10.4 mmol/mol to 53 ± 6.9 mmol/mol], P < 0.0001) and in adults by 0.38% (4.2 mmol/mol) (7.16 ± 0.86% to 6.78 ± 0.68% [55 ± 9.4 mmol/mol to 51 ± 7.4 mmol/mol], P < 0.0001). Time in range was improved from standard therapy by 15.6 ± 11.5% or 3.7 h/day in children and 9.3 ± 11.8% or 2.2 h/day in adults (both P < 0.0001). This was accomplished with a reduction in time in hypoglycemia <70 mg/dL among adults (median [interquartile range]: 2.00% [0.63, 4.06] to 1.09% [0.46, 1.75], P < 0.0001), while this parameter remained the same in children. There were three severe hypoglycemia events not attributable to automated insulin delivery malfunction and one diabetic ketoacidosis event from an infusion site failure. CONCLUSIONS This tubeless automated insulin delivery system was safe and allowed participants to significantly improve HbA1c levels and time in target glucose range with a very low occurrence of hypoglycemia.