Study: Efficacy and Safety of Omnipod 5 Automated Insulin Delivery System in Young Children With Type 1 Diabetes

From our sister publication, Contemporary Pediatrics.

Jennifer Sherr, MD, an associate professor in pediatrics at the Yale School of Medicine, led a discussion at the virtual Scientific Sessions for the American Diabetes Association on a study examining the benefits of the Omnipod 5 delivery system for very young children with type 1 diabetes. The study's objective was to evaluate the safety and efficacy of the Omnipod 5 system in children aged 2 to 5.9 years. The multicenter, single-arm outpatient study included 80 participants at 10 institutions across the United States. Participants had been diagnosed with type 1 diabetes, had an HbAc of less than 10% at the screening visit and had prior insulin therapy, such as continuous subcutaneous insulin infusion or multiple daily injection.

Sherr began her presentation by explaining how the Omnipod 5 System works. The delivery system communicates directly with Dexcom G6 sensor for a continuous glucose monitor. An algorithm is built into the pod, so that the insulin delivery can continue without the handheld controller nearby. The Omnipod 5 app is used to start and stop atuomated mode, deliver boluses, view data, and change settings. It includes customizable glucose targets, with a HypoProtect feature for times of elevated hypoglycemic risk (such as exercise).

After 3 months of use of the automatic insulin delivery (AID) system, 54% of the participants had an HbA1c of less than 7%, compared with 31% at baseline.

Additionally, there was improved sleep quality for parents and caregivers, with the percentage reporting overall sleep quality as "very good" or "fairly good" increasing fro 65% at baseline to 90% with the tubeless AID system. "Very bad" sleep quality, which was reported by 8.8% of the cohort at baseline, fell to 0% with the tubeless AID. Finally, there was no reported severe hypoglycemia or diabetic ketoacidosis during the 3-month AID phase of the study.

Sherr concluded that the Omnipodi 5 AID system was safe and performed well in very young children with T1D for 3 months at home.

Reference
1. Sherr, J. Evaluation of the Omnipod 5 automated insulin delivery system in very young children with type 1 diabetes (T1D). American Diabetes Association Scientific Sessions 2021; June 26, 2021; virtual. Accessed June 26, 2021.