Early automated insulin delivery and brain development in children with type 1 diabetes

Evaluation of Neurodevelopmental Trajectories in Children According to the Glycemic Profile Associated With Different Early Treatment Modalities in Children With Type 1 Diabetes (T1DM)

We will test whether starting an automated insulin delivery system soon after diagnosis helps protect brain growth and thinking skills in 5–7‑year‑old children with type 1 diabetes.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 5 Years to 7 Years
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Locations: 1 site (Paris)
• Trial ID: NCT06461065 on ClinicalTrials.gov

What this trial studies

This is a prospective multicenter case-control cohort comparing young children with recent-onset type 1 diabetes who start an automated insulin delivery system (CamAPS with pump and Dexcom sensor) to children using the standard pump-plus-CGM setup with predictive shut-off and to age-matched healthy controls. Participants undergo brain MRI and neurocognitive testing at baseline, 6 months and 24 months to measure structural brain changes and cognitive trajectories. The study enrolls children aged 5–7, requires pump therapy and Dexcom sensor use for the diabetes groups, and excludes children with prior neurological or major psychiatric conditions or MRI contraindications. The goal is to link glycemic profiles (hypoglycemia, hyperglycemia, variability) with neuroanatomical and cognitive outcomes to see if early AID use alters those trajectories.

Who should consider this trial

Good fit: Ideal candidates are children aged 5–7 with type 1 diabetes diagnosed within the past 6 months who are on pump therapy, agree to wear a Dexcom sensor, and whose parents can give informed consent and speak French.

Not a fit: Children with prior neurological disease, major psychiatric disorders, prematurity, uncontrolled comorbid autoimmune conditions, inability to undergo MRI, or those outside the 5–7 age range are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, early use of an automated insulin delivery system could reduce harmful glucose excursions and help preserve brain structure and cognitive function in young children with type 1 diabetes.

How similar studies have performed: Previous trials show automated insulin delivery improves glycemic control in children, but evidence that early AID use preserves brain development is limited and this study is among the first to use longitudinal MRI and cognitive testing in this age group.

Eligibility criteria

Inclusion Criteria:

* 5 to 7 years old
* Informed consent of parental guardians
* Parents able to speak, understand and read French (verified by investigator)
* Social security affiliation
* Only for subjects with T1DM:

  * Insulin pump treatment and Dexcom sensor wear
  * Type 1 diabetes diagnosed less than 6 months ago
  * Insulin dose ≥ 0.5 IU/k/day
  * Patients agree to use the DEXCOM sensor

Exclusion Criteria:

* History of neurological disease
* History of child psychiatric disease
* Prematurity (birth before 37 SA)
* Wearing of internal metal parts contraindicating the performance of MRI
* Severe skin disease preventing the use of an insulin pump sensor or catheter
* Uncontrolled celiac disease
* Uncontrolled autoimmune thyroiditis
* Participation in another interventional research study or in the exclusion period thereof
* Refusal to participate by a minor after information adapted to his/her age and abilities

Where this trial is running

Paris

• Hôpital Universitaire Necker Enfants Malades — Paris, France (RECRUITING)

Study contacts

• Principal investigator: Jacques Beltrand, PHD — APHP
• Study coordinator: Jacques Beltrand, PHD

Conditions: Diabetes, Children, insulin therapy, cognitive development