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

NCT06875167 | Recruiting

• 1 other identifier: 24-HPNCL-07 Diablife
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Closed Loop; Insulin; Quality of Life; Pediatric

Keywords

Closed-loop insulin therapy; type 1 Diabetic; Quality of life; pediatric patient

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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).

  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.

  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

  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

  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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• Opposition to participation in research involving humans or opposition to the use of data or samples and associated data (withdrawal of non-opposition).

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval

Nice, France, 06000, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Study Officials

• Céline Gouillard-Darnaud, MD

  Fondation Lenval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aline JOULIE, PHD

CONTACT

+33492030520; joulie.a@chu-nice.fr

Valentine FOURNY-SARGHAT, MD

CONTACT

+33602273069; valentine.fourny@free.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 13, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

FR (1)