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

Launched by FONDATION LENVAL · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a new type of insulin pump, called a semi-closed loop system, on young children aged 2 to 6 years with type 1 diabetes. The goal is to see how this automated insulin therapy can improve both blood sugar control and the overall quality of life for these children and their families. Type 1 diabetes is a condition where the body cannot produce insulin, which is necessary to manage blood sugar levels, and this innovative treatment could offer significant benefits compared to traditional methods like insulin injections.

To participate in the trial, children must be between 2 and 6 years old, have type 1 diabetes, and currently be on insulin therapy. Families need to agree to learn how to use the new system, which includes continuous monitoring of glucose levels. By joining the study, families can help researchers understand how this new therapy works for young children and contribute to future improvements in diabetes care. Participants will receive support and training to help manage the new insulin pump effectively.

Gender

ALL

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).