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 (Diablife)

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Type 1 Diabetes; Insulin; Pediatric; Closed Loop

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: ALINE JOULIE, PHD; Phone Number: +33492030520; Email: joulie.a@chu-nice.fr
• Study Contact Backup: Name: Valentine FOURNY-SARGHAT, MD; Phone Number: +33602273069; Email: valentine.fourny@free.fr

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study of the quality of life of diabetic children closed loop treatment versus other insulin therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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.

Collaborators and Investigators

• Sponsor: Fondation Lenval
• Investigators: Principal Investigator: Céline Gouillard-Darnaud, MD, Fondation Lenval

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; pediatric patient; Closed-loop insulin therapy; type 1 Diabetic
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 24-HPNCL-07 Diablife

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No