Background and Aims

Insulin therapy should be individualized to reflect patients’ unique treatment goals. The Omnipod 5 System provides novel full on-body hybrid closed-loop (HCL) control with customizable glucose targets from 110-150mg/dL (6.1-8.3mmol/L). This analysis aimed to assess system performance at varying glucose targets during the 3-month pivotal study in adults and adolescents.

Methods

Participants aged 14-70y with T1D≥6 months and A1C<10% used the HCL system for 3 months at home after a 14-day run-in phase of their standard therapy (ST). Participants selected glucose targets from 110-150mg/dL (6.1-8.3mmol/L) in 10mg/dL (0.6mmol/L) increments in a daily profile with up to 8 segments. Primary safety and efficacy endpoints, respectively, were occurrence of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA), and sensor glucose percent time in target range (TIR) (70-180mg/dL, 3.9-10.0mmol/L) during HCL at each glucose target compared with ST.

Results

Participants (N=128) were aged (mean±SD) 37±14y with T1D duration 18±12y and baseline A1C 7.2±0.9% (range 5.2-9.8%). TIR improved during the HCL phase for most targets, with reductions in time below range (TBR <70 and <54mg/dL [<3.9 and <3.0mmol/L]) (Table). There were 2 episodes of SH (both following user-initiated boluses), and no episodes of DKA reported.

Conclusions

The Omnipod 5 System was safely used by a large cohort of adults and adolescents with T1D at glucose targets from 110-150mg/dL (6.1-8.3mmol/L). Optimal results were seen using 110mg/dL (6.1mmol/L) as target, with 75.6% TIR and minimal TBR. Most (92%) participants completing the pivotal study opted to continue using the system in an extension phase.

Omnipod 5 Study Group as an author.