Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes
Authors: Brown Sue A. , Forlenza Gregory P. , Bode Bruce W. , Pinsker Jordan E. , Levy Carol J. , Criego Amy B. , Hansen David W. , Hirsch Irl B. , Carlson Anders L. , Bergenstal Richard M. , Sherr Jennifer L. , Mehta Sanjeev N. , Laffel Lori M. , Shah Viral N. , Bhargava Anuj , Weinstock Ruth S. , MacLeish Sarah A. , DeSalvo Daniel J. , Jones Thomas C. , Aleppo Grazia , Buckingham Bruce A. , Ly Trang T. ,   Omnipod 5 Research Group, Brown Sue A. , Voelmle Mary , Emory Emma , Forlenza Gregory P. , Wadwa R. Paul , Slover Robert , Cobry Erin , Messer Laurel H. , Berget Cari , McCoy Susan , Shah Viral N. , Akturk Halis K. , Schneider Nicole , Joseph Hal , Joshee Prakriti , Beatson Christie , Bode Bruce W. , Narron Brooke , Lopez Tricia , Pinsker Jordan E. , Church Mei Mei , Castorino Kristin , Piper Molly , Perez Jimena , Levy Carol J. , Lam David W. , Levister Camilla , O’Malley Grenye , Ogyaadu Selassie , Arasaratnam Dushyanthy , Plesser Mitchell , Nosova Emily , Bzdick Suzan , Hansen David W. , Stone Sheri L. , Weinstock Ruth S. , Hirsch Irl B. , Trikudanathan Subbulaxmi , Sanborn Nancy , Khakpour Dori , Carlson Anders L. , Criego Amy B. , Bergenstal Richard M. , Martens Thomas , Grieme Aimee , Hyatt Jamie , Punel Alina , Whipple Diane , Sherr Jennifer L. , Van Name Michelle , Brei Michelle , Zgorski Melinda , Steffen Amy , Carria Lori , Mehta Sanjeev N. , Laffel Lori M. , Roethke Lindsay , Fisher Margaret , Ortiz La Banca Rebecca , Volkening Lisa , Ambler-Osborn Louise , Turcotte Christine , Freiner Emily F. , Bhargava Anuj , Borg Lisa , MacLeish Sarah A. , Wood Jamie R. , Kaminski Beth A. , Casey Terri L. , Campbell Wendy , DeSalvo Daniel J. , McKay Siripoom , DeLaO Mary Kylie , Villegas Carolina , Jones Thomas C. , Russel Johns Barry , Gore Ashwini , Harvill Leslie , Merritt Kayla , Stanfield Jennifer , Sheldon Jennifer , Hichkad Lisa , Burnett Erica , Castelot Alicia , Bounds Lindsay , Preston Kaitlyn , Goldfaden Rebecca , Aleppo Grazia , Kravarusic Jelena , Bansal Anupam , Buckingham Bruce A. , Ekhlaspour Laya , Kingman Ryan , Kivilaid Kaisa , Kleve Krista , Ly Trang T. , Dumais Bonnie , Vienneau Todd , Huyett Lauren M. , Lee Joon Bok , O’Connor Jason , Benjamin Eric 
Published: June 2021

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 &lt; 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 &lt; 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 &lt; 0.0001). This was accomplished with a reduction in time in hypoglycemia &lt;70 mg/dL among adults (median [interquartile range]: 2.00% [0.63, 4.06] to 1.09% [0.46, 1.75], P &lt; 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.