Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes

<b>Objective:</b> 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. <p><b>Research Design and Methods: </b>This single-arm, multicenter, prospective study enrolled 112 children (6-13.9 years) and 129 adults (14-70 years). A two-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 70-180mg/dL. </p> <p><b>Results: </b>235 participants (98% of enrolled: 111 children, 124 adults) completed the study. HbA1c was significantly reduced in children by 0.71% (7.8mmol/mol) (mean±standard deviation: 7.67±0.95% to 6.99±0.63%, 60±10.4mmol/mol to 53±6.9mmol/mol, <i>p</i><0.0001) and in adults by 0.38% (4.2mmol/mol) (7.16±0.86% to 6.78±0.68%, 55±9.4mmol/mol to 51±7.4mmol/mol, <i>p</i><0.0001). Time in range was improved from standard therapy by 15.6±11.5% or 3.7 hours/day in children and 9.3±11.8% or 2.2 hours/day in adults (both <i>p</i><0.0001). This was accomplished with a reduction in time in hypoglycemia <70mg/dL among adults (median (interquartile range): 2.00% (0.63, 4.06) to 1.09% (0.46, 1.75), <i>p</i><0.0001), while this parameter remained the same in children. There were 3 severe hypoglycemia events not attributable to automated insulin delivery malfunction and 1 diabetic ketoacidosis event from an infusion site failure.<a></a><a></a></p> <p><b>Conclusions: </b>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.<br> </p>