NCT06875167 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
| NCT ID | NCT06875167 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Lenval |
| Condition | Type 1 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-03-17 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-03-17 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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).
Contact & Investigator
Céline Gouillard-Darnaud, MD
PRINCIPAL INVESTIGATOR
Fondation Lenval
Frequently Asked Questions
Who can join the NCT06875167 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 6 Years, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06875167 currently recruiting?
Yes, NCT06875167 is actively recruiting participants. Contact the research team at joulie.a@chu-nice.fr for enrollment information.
Where is the NCT06875167 trial being conducted?
This trial is being conducted at Nice, France.
Who is sponsoring the NCT06875167 clinical trial?
NCT06875167 is sponsored by Fondation Lenval. The principal investigator is Céline Gouillard-Darnaud, MD at Fondation Lenval. The trial plans to enroll 20 participants.
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