Automated insulin therapy for children and adolescents with newly diagnosed Type 1 diabetes
Assessment of the Efficacy of Automated Insulin Therapy (Artificial Pancreas) Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes: Randomized Comparison With Conventional Insulin Therapy on 1 Year, Followed by an Optional Extension on 1 Year
This study is testing if a new automated insulin delivery system can help children and teens with newly diagnosed Type 1 diabetes manage their blood sugar better than standard insulin treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 4 sites (Angers and 3 other locations) |
| Trial ID | NCT06283797 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of hybrid closed-loop (HCL) insulin delivery initiated shortly after the diagnosis of Type 1 diabetes in children and adolescents. Participants aged 2 to 17.9 years, diagnosed within the last 3 to 6 months, will be randomly assigned to receive either HCL therapy or standard insulin therapy. The study aims to determine if early HCL therapy leads to better blood glucose control, reduced hypoglycemia and hyperglycemia, and a lower burden of diabetes management over one year. An optional second year will assess the sustainability of these benefits.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 2 to 17.9 years who have been diagnosed with Type 1 diabetes within the last 3 to 6 months.
Not a fit: Patients with chronic diseases affecting glucose metabolism or those already using automated insulin delivery systems may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve blood glucose control and quality of life for children and adolescents with Type 1 diabetes.
How similar studies have performed: Other studies have shown promising results with automated insulin delivery systems, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged between 2 and 17.9 years * Diagnosis of type 1 diabetes since at least 3 months and up to 6 months based upon WHO criteria * Identification of at least one positive plasma auto-antibody among anti-GAD, anti-IA2, anti-ZnT8 and anti-insulin * Treatment by multiple-daily insulin injections or insulin pump. An insulin pump with a function of stopping the pump in case of predicted hypoglycaemia is allowed. * Patient and/or parents/guardians trained in carbohydrate counting * Patient and/or parents/guardians must have a smartphone that supports the Dexcom G6 app download and participants must be willing to use Dexcom G6 sensor and app throughout the study Exclusion Criteria: * Unwillingness of one parent or the legally responsible party to participate in insulin treatment * Any associated chronic disease or therapy (except insulin or L thyroxin at stable dose) affecting glucose metabolism * Therapy by automated insulin delivery using an insulin pump connected to continuous glucose monitoring sensor with a control algorithm (hybrid closed-loop system) * Cutaneous allergy or contact dermatitis to device (CGM or pod) adhesives * Insufficient vision and/or hearing to recognise all the functions of the Omnipod 5 system, including alerts, alarms and reminders in accordance with the instructions of utilization * Impaired cognitive or psychological abilities of the patient and/or his/her parents or the legally responsible party which may result in defective adherence to study procedures * Active enrolment in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date * Subject who is in a dependency or employment with the sponsor or the investigator * No signed informed consent form by the patient and his/her parents/legally responsible party * Subjects unable to attend all scheduled visits and to comply with all trial procedures * Law protected or deprived of liberty subject * Pregnant and breastfeeding women * Subjects no covered by public health insurance
Where this trial is running
Angers and 3 other locations
- University Hospital, Angers — Angers, France (Recruiting)
- University Hospital, Montpellier — Montpellier, France (Recruiting)
- Robert Debré Hospital, AP-HP — Paris, France (Recruiting)
- University Hospital, Tours — Tours, France (Recruiting)
Study contacts
- Principal investigator: Eric RENARD, MD — University Hospital, Montpellier
- Study coordinator: Eric RENARD, MD
- Email: e-renard@chu-montpellier.fr
- Phone: 04 67 33 83 82
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.