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Semi-closed Loop Automated Insulin Therapy in the Pediatric Population Aged 2-6 Years With Type 1 Diabetes: Impact on Quality of Life and Glycemic Control

Recruitingn/aAges 2 Years - 6 YearsAllFondation Lenval
NCT06875167 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The incidence of type 1 diabetes is increasing, with an incidence of +4% per year in France today. The treatment for type 1 diabetes is insulin therapy. In recent years, new systems have emerged, so-called "semi-closed loop" systems, also called automated insulin therapy, which have proven their superiority in terms of quality of life and glycemic balance in adults and children over 6 years old. Since January 24, 2024, the HAS now recognizes the indication of the semi-closed loop for the YPSOPUMP model in children aged 2 to 6 years. This is the first reimbursement in France of a closed loop system for the 2-6 year old age group. There are currently few studies comparing the quality of life of children in semi-closed loop versus other treatments (open loop or injections). Regarding quality of life, the studies found mainly concern the contribution for parents and the improvement of adol

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📋 Eligibility rules (as published)
Inclusion Criteria: * -Patients aged 2 to 6 years inclusive * Presenting type 1 diabetes on insulin therapy * Social security affiliates * Patient initiating semi-closed loop treatment * Family (at least one parent or representative of parental authority) agreeing to follow the training necessary for continuous measurement of glucose in real time. * collection of non-opposition from one of the two parents or the representative of parental authority agreement Exclusion Criteria: * Opposition to participation in research involving humans or opposition to the use of data or samples and associated data (withdrawal of non-opposition).
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What it tests

  • Not listed
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Where

1 site
Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval
Nice, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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