Evaluation of the Omnipod 5 automated insulin delivery system in very young children with type 1 diabetes

dr. Jennifer Sherr, MD, an associate professor of pediatrics at Yale School of Medicine, led a discussion during the virtual science sessions for the American Diabetes Association about a study on the benefits of the Omnipod 5 delivery system for very young children with type 1 diabetes. The purpose of the study 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 involved 80 participants in 10 institutions in the United States. The participants had been diagnosed with type 1 diabetes, had an HbAc of less than 10% at the screening visit, and had received prior insulin therapy such as continuous subcutaneous insulin infusion or multiple daily injection.

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

After 3 months of use of the Automatic Insulin Delivery System (AID), 54% of participants had an HbA1c of less than 7%, compared to 31% at baseline.

In addition, there was improved sleep quality for parents and caregivers, with the percentage reporting overall sleep quality as “very good” or “fairly good” increasing from 65% at baseline to 90% with the tubeless AID system. “Very poor” sleep quality, which was reported by 8.8% of the cohort at baseline, decreased 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.

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