Safety Evaluation of the Omnipod® 5 Automated Insulin Delivery System Over Three Months of Use in Children With Type 1 Diabetes (T1D)

Advances in diabetes technology have transformed the treatment paradigm for T1D, yet the burden of the disease remains significant. The pediatric population poses unique challenges to glucose management with unpredictable exercise and food consumption. The Omnipod 5 System is a novel hybrid closed-loop (HCL) system with fully on-body operation. A tubeless insulin pump (pod) containing a personalized Model Predictive Control algorithm communicates directly with a Dexcom G6 continuous glucose monitor (CGM, or sensor) to automate insulin delivery. Therapy customization is enabled through glucose targets from 110–150 mg/dL, adjustable by time of day, which is a critical component to individualize glucose management in children. We report on the first, pivotal outpatient safety evaluation of the Omnipod 5 System in a large cohort of children with T1D. 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, included both pump therapy and multiple daily injections). The primary safety and effectiveness endpoints, respectively, were occurrence of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA), and change in A1C and sensor glucose percent time in target range (TIR) (70–180 mg/dL) during HCL compared with ST. 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 increased significantly from ST to HCL, from 52.5±15.6% to 68.0±8.1% (p<0.0001), corresponding to an additional 3.7 hours/day in target range. A1C at end of study was reduced by 0.7% to 7.0±0.6% (p<0.0001). Percentages of time in hyperglycemia were reduced: >180 mg/dL from 45.3±16.7% to 30.2±8.7% and ≥250 mg/dL from 19.1±13.1% to 9.6±5.4% (both p<0.0001). Percentages of time in hypoglycemia remained low from ST to HCL: <54 mg/dL from 0.4±0.8% to 0.3±0.3% and <70 mg/dL from 2.2±2.7% to 1.8±1.4% (both p>0.05). Mean glucose decreased from 183±32 to 160±15 mg/dL (p<0.0001). During the HCL phase there was 1 episode of SH (delayed eating after pre-meal bolus) and 1 episode of DKA (suspected infusion site failure) reported. Virtually all participants completing the pivotal study (99%) continued system use during an extension phase. In this multi-center pivotal study in a large cohort of children with T1D, the Omnipod 5 System was safe and effective when used for 3 months at home. There were significant improvements in both TIR and A1C, while time below range (<70 mg/dL) remained low. The beneficial glycemic outcomes are critical for children, given that neurologic outcomes can be negatively impacted by hyperglycemia. The current results and commitment to the extension phase emphasize the safe and effective use of the HCL system, as well as the preference for the Omnipod 5 System over participants’ previous therapy.