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NCT Number: 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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Closed Loop Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pediatric Quality of Life

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval

Nice, France, 06000

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

    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.

    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.

Secondary outcomes

  1. 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).

    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.

    Evolution of TIR (time in range or time in the target) when switching to semi-closed loop versus open loop.

  2. Compare the glycemic balance of patients on automated insulin therapy versus other treatments (open loop or injections) via HbA1c.

    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.

    Evolution of HbA1c during the transition to semi-closed loop versus open loop.

  3. Compare the number of hypoglycemic episodes

    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.

    Evolution of TUR (time spent in hypoglycemia) when switching to semi-closed loop versus open loop.

  4. Compare time in hyperglycemia

    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.

    Evolution of TAR (time spent in hyperglycemia) when switching to semi-closed loop versus open loop

Study contacts

Contact information is provided by the study sponsor or research team.

Aline JOULIE, PHD

CONTACT

[email protected]

+33492030520

Valentine FOURNY-SARGHAT, MD

CONTACT

[email protected]

+33602273069

Sponsors and collaborators

Lead sponsor

Fondation Lenval

Other

Registry information

Acronym: Diablife

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2025
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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