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
Key facts
- Where
- Nice, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 6 years old?
Source: NCT06875167, who can take part
Where in France
- Fondation Lenval Hôpitaux pédiatrique Nice CHU LenvalNice, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondation Lenval
- Trial code
- NCT06875167
- Record updated
- 20 April 2025
- Original description
The incidence of type 1 diabetes is increasing, with an incidence of +4% per year in France today.Read full original descriptionShow less
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.
Inclusion: -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: Opposition to participation in research involving humans or opposition to the use of data or samples and associated data (withdrawal of non-opposition).