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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-17

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 1 Diabetes Closed Loop Insulin Quality of Life Pediatric

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study of the quality of life of diabetic children closed loop treatment versus other insulin therapy

Study of the quality of life of T1D children aged 2 to 6 years inclusive treated with a semi-closed loop insulin pump versus other types of insulin therapy. Each patient will be it's one controle.

No interventions assigned to this group

Eligibility Criteria

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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).

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No