NCT Number: NCT07785037
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.
Trial opening soon.
Get Notified1 year–16 year
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Children and adolescents (<16 years) diagnosed with type 1 diabetes. Followed at the Paediatric Diabetes Centre of HUDERF. Initiation of the Omnipod® 5 hybrid closed-loop system during the study period as part of routine clinical care (1/05/2025 au 30/04/2026) Written informed consent provided by the parent(s) or legal guardian(s), and assent from the child or adolescent when applicable, in accordance with Belgian regulations.
Exclusion criteria
Decline participation or withdraw informed consent (or assent, when applicable).
Have insufficient clinical or device data available for the planned analyses.
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.
Time frame: From May 2025 to May 2026 (12 months following national reimbursement).
Number and proportion of children and adolescents with type 1 diabetes initiating the Omnipod® 5 system during the first year following national reimbursement in Belgium, including the evolution of uptake over time.
Queen Fabiola Children's University Hospital
Other
One-year Implementation of the Omnipod® 5 Hybrid Closed-loop System Following Reimbursement in Belgium: Real-world Experience From a Paediatric Diabetes Centre
Acronym: O5-IMPACT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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