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Search / 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

Launched by FONDATION LENVAL · Mar 10, 2025

Trial Information

Current as of April 29, 2025

Recruiting

Keywords

Closed Loop Insulin Therapy Type 1 Diabetic Quality Of Life Pediatric Patient

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).

About Fondation Lenval

Fondation Lenval is a prominent clinical trial sponsor dedicated to advancing pediatric healthcare through innovative research and development. Based in Nice, France, the foundation focuses on improving treatments and outcomes for children with various medical conditions, particularly in the fields of neonatology and pediatrics. By collaborating with leading healthcare professionals and institutions, Fondation Lenval aims to bridge the gap between clinical practice and research, ensuring that its studies adhere to the highest ethical standards and regulatory requirements. Through its commitment to enhancing child health and well-being, the foundation plays a crucial role in shaping the future of pediatric medicine.

Locations

Nice, , France

Patients applied

0 patients applied

Trial Officials

Céline Gouillard-Darnaud, MD

Principal Investigator

Fondation Lenval

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported