New tubeless, automated insulin pump improves HgA1c and time in pre-defined glucose range

Brown SA, Forlenza GP, Bode BW, Pinsker JE, Levy CJ, Criego AB, et al. Omnipod 5 Research Group. Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System with Customizable Glycemic Targets in Pediatric and Adult Participants with Type 1 Diabetes. Diabetes Care 2021;44:1630–40. https://doi.org/10.2337/dc21-0172 Among children and adults with type 1 diabetes, what are the safety and effectiveness benefits of a tubeless, automated insulin delivery system? Prospective, single cohort, multicenter. Seventeen sites across the U.S. Six to 70 years old, diagnosed with type 1 diabetes for at least 6 months. Two cohorts: 111 children (ages 6-13.9 years) and 129 adolescents/adults (ages 14-70 years). A tubeless insulin pump (Pod) with an embedded automated insulin delivery algorithm (Omnipod 5), an interoperable glucose sensor, and a mobile app (Omnipod 5 app) on a locked-down Android phone. Two weeks of usual insulin regimen preceded 3 months of automated insulin delivery. Primary safety outcomes: incidence of severe hypoglycemia and diabetic ketoacidosis. Primary effectiveness outcomes: change in HbA1c and percent time in sensor glucose range 70-180 mg/dL (time in range). HbA1c was significantly reduced in children by 0.68% (mean ± SD: 7.67 ± 0.95% to 6.99 ± 0.63%, P < .0001) and in adults by 0.38% (7.16 ± 0.86% to 6.78 ± 0.68%), P < .0001). Time in range improved by 3.7 h/day in children and 2.2 h/day in adults (both P < .0001). Time in hypoglycemia <70 mg/dL among adults (median [interquartile range] decreased from 2.00% [0.63-4.06] to 1.09% [0.46-1.75], P < .0001). There was no change in children. The Omnipod 5 appears safe and demonstrated modest improvement in HgB A1c and time in a pre-defined glucose range. Adults experienced less time in hypoglycemia.