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Omnipod 5 Implementation in Belgian Paediatric Diabetes Care

NCT07785037 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-08-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Tubeless Hybrid Closed-Loop Insulin Delivery System

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.

Sponsors & Collaborators

  • Queen Fabiola Children's University Hospital

    lead OTHER

Eligibility

Min Age
1 Year
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-06-01
Completion
2027-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07785037 on ClinicalTrials.gov