Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Closed Loop
Insulin
Quality of Life
Pediatric
Keywords: Closed-loop insulin therapy
type 1 Diabetic
Quality of life
pediatric patient
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 Diabetic children aged 2 to 6 years treated with a semi-closed loop insulin pump at the Nice pediatric hospital

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).

Primary outcomes:
measure: 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.
timeFrame: 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.
Secondary outcomes:
measure: 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).
timeFrame: 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.
measure: Compare the glycemic balance of patients on automated insulin therapy versus other treatments (open loop or injections) via HbA1c.
timeFrame: 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.
measure: Compare the number of hypoglycemic episodes
timeFrame: 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.
measure: Compare time in hyperglycemia
timeFrame: 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.
Other outcomes:
Locations:
city: Nice
country: France
facility: Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval
Study officials:
affiliation: Fondation Lenval
name: Céline Gouillard-Darnaud, MD
role: PRINCIPAL_INVESTIGATOR
References: