An observational study in Type 1 Diabetes, Closed Loop and Insulin, sponsored by Fondation Lenval. Recruiting at 1 site in France. Open to participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2025-04-20.
Sponsored by Fondation Lenval · Observational
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 20 is below the median of 125 across 792 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Fondation Lenval is the lead sponsor of 61 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Type 1 Diabetic children aged 2 to 6 years treated with a semi-closed loop insulin pump at the Nice pediatric hospital
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Exclusion Criteria:
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.
An improvement in the score on the general quality of life questionnaire in pediatrics PedsQL 4.0 which will be evaluated before the implementation of the semi-closed loop, at 1 month and 6 months after the implementation of the semi-closed loop.
The quality of life questionnaire includes 4 categories of questions regarding the last month: 1 category on physical capacity problems, 1 category on emotional state problems, 1 category on problems relating to others, and 1 category on problems with the community. Each category is rated from 0 (never) to 4 (almost always). The quality of life questionnaire intended for children aged 5 to 6 years concerns the last 7 days. The response is rated using a face scale (3 different faces) corresponding to the rating 0 (never), 2 (sometimes) and 4 (almost always). The overall quality of life of the diabetic child corresponds to the combined score of all the questions. The score range is 0 to 92, with lower scores indicating better quality of life.
Time frame: the assessment of quality of life via the PedsQL 4.0 questionnaire will be evaluated before the implementation of the semi-closed loop, at 1 month and 6 months after the implementation of the semi-closed loop.
Compare the glycemic balance of patients on automated insulin therapy versus other treatments (open loop or injections) via TIR (time in range or time within the target).
Evolution of TIR (time in range or time in the target) when switching to semi-closed loop versus open loop.
Time frame: The evaluation of the secondary criteria is carried out before the implementation of the semi-closed loop, then at 1 month and 6 months after implementation.
Compare the glycemic balance of patients on automated insulin therapy versus other treatments (open loop or injections) via HbA1c.
Evolution of HbA1c during the transition to semi-closed loop versus open loop.
Time frame: The evaluation of the secondary criteria is carried out before the implementation of the semi-closed loop, then at 1 month and 6 months after implementation.
Compare the number of hypoglycemic episodes
Evolution of TUR (time spent in hypoglycemia) when switching to semi-closed loop versus open loop.
Time frame: The evaluation of the secondary criteria is carried out before the implementation of the semi-closed loop, then at 1 month and 6 months after implementation.
Compare time in hyperglycemia
Evolution of TAR (time spent in hyperglycemia) when switching to semi-closed loop versus open loop
Time frame: The evaluation of the secondary criteria is carried out before the implementation of the semi-closed loop, then at 1 month and 6 months after implementation.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Jun 2026, 15 months after the start.
Of 249 non-industry observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 78. This study's planned 15 months is below that.
Counting every sponsor, half of 299 studies reached it within 30 months; a quarter within 12 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
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Fondation Lenval