An observational study in Type 1 Diabetes Mellitus, sponsored by Queen Fabiola Children's University Hospital. Not yet recruiting. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Queen Fabiola Children's University Hospital · Observational
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 200 is above the median of 125 across 792 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Queen Fabiola Children's University Hospital is the lead sponsor of 28 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children and adolescents under 18 years of age with type 1 diabetes who are followed at the Paediatric Diabetes Centre of Queen Fabiola University Children's Hospital (HUDERF), Brussels, Belgium, and who initiate the Omnipod® 5 hybrid closed-loop system as part of routine clinical care during the study period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 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 (or assent, when applicable).
Have insufficient clinical or device data available for the planned analyses.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Omnipod 5 uptake
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.
Time frame: From May 2025 to May 2026 (12 months following national reimbursement).
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Queen Fabiola Children's University Hospital