Clinical trial Recruiting at 1 site Observational Ages 2 to 6

Automated insulin therapy for young children with type 1 diabetes

Official title: 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

Run by Fondation Lenval · NCT06875167 · Data updated 2026-11-12

This study tests if a new automated insulin delivery system can improve the quality of life and blood sugar control for young children with type 1 diabetes compared to traditional methods.

More Type 1 Diabetes trials

Quick facts

Study typeObservational
Ages2 Years to 6 Years
SexAll
Enrollment20 (estimated)
SponsorFondation Lenval
Academic / other
Locations1 site (Nice, France)
StatusRecruiting
StartedMarch 17, 2025
Main results expectedJune 2026
Study endsDecember 2026
Registry record updatedApril 20, 2025
Trial IDNCT06875167 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 2 to 6 years who have been diagnosed with type 1 diabetes and are starting semi-closed loop insulin therapy.

Probably not a fit

Patients who are older than 6 years or those not initiating semi-closed loop treatment may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the impact of semi-closed loop automated insulin therapy on the quality of life and glycemic control in children aged 2 to 6 years with type 1 diabetes. It aims to compare the experiences of children using this new insulin delivery system against traditional methods such as open-loop systems or injections. The study is particularly significant as it is the first to evaluate the quality of life benefits for this younger age group following the recent approval of the YPSOPUMP model in France. Participants will be required to have parental consent and undergo training for continuous glucose monitoring.

Why it matters

Potential benefit: If successful, this study could enhance the quality of life and glycemic control for young children with type 1 diabetes.

How similar studies have gone: While there have been studies on older children and adults, this specific approach for the 2-6 year age group is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion 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).

Where it's running

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

Study contacts

  • Principal investigator: Céline Gouillard-Darnaud, MD — Fondation Lenval
  • Study coordinator: Aline JOULIE, PHD
  • Email: joulie.a@chu-nice.fr
  • Phone: +33492030520

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.