Omnipod 5 Implementation in Belgian Paediatric Diabetes Care

Sponsor
Queen Fabiola Children's University Hospital
Study ID
NCT07785037
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 16 Years
Healthy Volunteers
Not accepted

Interventions

  • Tubeless Hybrid Closed-Loop Insulin Delivery System — DEVICE
    A tubeless hybrid closed-loop insulin delivery system that combines a wearable insulin pump (Pod) with continuous glucose monitoring to automatically adjust insulin delivery. The system is used as part of routine clinical care in children and adolescents with type 1 diabetes.

Study Details

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.

Key Dates

First listed
Aug 25, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Jun 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
200 participants (estimated)

Primary Outcome Measure

Omnipod 5 uptake [ Time Frame: From May 2025 to May 2026 (12 months following national reimbursement). ]

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