RecruitingNCT06875167

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


Sponsor

Fondation Lenval

Enrollment

20 participants

Start Date

Mar 17, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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 adolescents' sleep as in the study by Erin C Cobry et al from 2020 (6). Our study therefore aims to demonstrate an improvement in quality of life but also in diabetes balance in type 1 diabetic patients on a closed loop insulin pump versus open loop or injections in the pediatric population aged 2-6 years.


Eligibility

Min Age: 2 YearsMax Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how a semi-automated insulin delivery system — a device that monitors blood sugar continuously and adjusts insulin automatically — affects quality of life and blood sugar control in very young children with type 1 diabetes. **You may be eligible if...** - Your child is between 2 and 6 years old - Your child has type 1 diabetes and is on insulin therapy - Your family is starting or has started using a semi-closed loop insulin delivery system - At least one parent or guardian agrees to complete training on the continuous glucose monitoring system **You may NOT be eligible if...** - A parent or guardian objects to participation in research - Your child has conditions that would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval

Nice, France, France

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NCT06875167


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