Automated insulin therapy for young children with type 1 diabetes
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
Fondation Lenval · NCT06875167
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 2 Years to 6 Years |
| Sex | All |
| Sponsor | Fondation Lenval (other) |
| Locations | 1 site (Nice, France) |
| Trial ID | NCT06875167 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are older than 6 years or those not initiating semi-closed loop treatment may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nice, France
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes, Closed Loop, Insulin, Quality of Life, Pediatric, Closed-loop insulin therapy, type 1 Diabetic, Quality of life