Automated insulin therapy for children and adolescents with newly diagnosed Type 1 diabetes

Is this trial a fit for you?

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

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.