NCT06875167Recruiting
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
Source: ClinicalTrials.gov · Last updated 20 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 4 Mar 2025
- Start date
- 17 Mar 2025
- Primary completion date
- Jun 2026
- Lead sponsor
- Fondation Lenval
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT06875167
What you commit to
- Study type: Observational
- Planned participants: 20
- From 17 Mar 2025 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Opposition to participation in research involving humans or opposition to the use of data or samples and associated data (withdrawal of non-opposition).
Who the study is looking for
- -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
Age in the registry: 2 years to 6 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval Coordinator of this site? Confirm its status | Nice | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.