Actively Recruiting
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
Led by Fondation Lenval · Updated on 2025-04-20
20
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 2 to 6 years inclusive
- Diagnosed with type 1 diabetes and on insulin therapy
- Covered by social security
- Starting semi-closed loop insulin pump treatment
- At least one parent or guardian agrees to participate in training for continuous real-time glucose monitoring
- Consent obtained from one parent or legal guardian
You will not qualify if you...
- Refusal to participate in human research or refusal to allow use of data or samples (withdrawal of consent)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval
Nice, France, France, 06000
Actively Recruiting
Research Team
A
Aline JOULIE, PHD
CONTACT
V
Valentine FOURNY-SARGHAT, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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