Background and Aims

Insulin therapy should be individualized for 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 children.

Methods

Participants aged 6-13.9y 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 (or caregivers) selected glucose targets from 110-150mg/dL (6.1-8.3mmol/L) in 10mg/dL (0.6mmol/L) increments which could vary by time of day. 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=112) were aged (mean±SD) 10.3±2.2y with T1D duration 4.7±2.6y and baseline A1C 7.7±0.9% (range 5.8-10.3%). TIR improved during the HCL phase for most targets, while time below range (TBR <70 and <54mg/dL [<3.9 and <3.0mmol/L]) remained low (Table). There was 1 SH episode (delayed eating after pre-meal bolus) and 1 DKA episode (suspected failed pump site) reported.

Conclusions

The Omnipod 5 System was safely used by a large cohort of children 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 68.4% TIR and minimal TBR. Most (99%) participants completing the pivotal study opted to continue using the system in an extension phase.

Omnipod 5 Study Group as an author.