Omnipod 5 Implementation in Belgian Paediatric Diabetes Care

Overview

This study will evaluate the introduction and use of the Omnipod® 5 hybrid closed-loop insulin delivery system in children and adolescents with type 1 diabetes following its reimbursement in Belgium. The study will describe how quickly the system is adopted in routine paediatric diabetes care, which patients are offered this technology, and the reasons for choosing Omnipod® 5. It will also evaluate changes in the use of different insulin pump systems and assess diabetes control, safety, and continued use of Omnipod® 5 during follow-up. The study is observational, meaning that participants will receive their usual diabetes care and their treatment will not be changed for research purposes. Information collected during routine diabetes follow-up, including glucose sensor, insulin pump, and medical record data, will be analysed. No additional examinations, blood tests, or hospital visits will be required for participation.

Hybrid closed-loop (HCL) systems have become an increasingly important component of paediatric type 1 diabetes management by combining continuous glucose monitoring with automated insulin delivery. The Omnipod® 5 system is a tubeless HCL system that offers an alternative to conventional tubed insulin pumps. Following national reimbursement of Omnipod® 5 in Belgium in May 2025, the system became available as part of routine diabetes care. Its introduction provides an opportunity to evaluate how a newly reimbursed diabetes technology is adopted in real-world paediatric clinical practice. This prospective observational study will follow children and adolescents with type 1 diabetes who initiate Omnipod® 5 as part of their routine diabetes care. Data generated during usual clinical follow-up will be collected prospectively from medical records, insulin pump platforms, and continuous glucose monitoring systems. No study-specific intervention will be performed. The choice of Omnipod® 5 and all aspects of clinical management will remain under the responsibility of the treating diabetes team and will not be influenced by participation in the study. No additional examinations, blood tests, or study visits are required. The study will provide real-world information on the implementation of a newly reimbursed HCL technology within a structured multidisciplinary paediatric diabetes programme.