Evaluation of Neurodevelopmental Trajectories in Children According to the Glycemic Profile Associated With Different Early Treatment Modalities in Children With Type 1 Diabetes (T1DM)
NCT Number: NCT06461065
Acronym: PROCEDE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes
Interventions: DEVICE: AIDS|OTHER: Brain MRI
Sponsor: Assistance Publique - Hôpitaux de Paris
Collaborators: Fondation Francophone pour la Recherche sur le Diabete|Ypsomed AG
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-15
Completion Date: 2027-09-15

Summary:
More than half of all new cases of type 1 diabetes (T1D) are diagnosed in the first decade of life. It has been reported that early onset T1D may be associated with deterioration in cognitive performance. It mainly affects working memory or the ability to perform complex tasks involving planning (executive functions) or decision-making. Brain magnetic resonance imaging (MRI) has reported alteration brain growth alteration related to impaired cognitive performance. Exposure to hypoglycemia, hyperglycemia and glycemic variability are thought to be responsible for these structural changes, especially in younger patients. Those changes can be detected early after diagnosis. Automatized insulin delivery systems (AIDS) can dramatically improve glycemic profile in children with T1D by reducing the occurrence of hypo and hyperglycemia. However, in France, market authorization are limited to children with unbalanced T1D who have failed to respond to other therapies and to the reinforcement of diabetes education. It therefore does not concern newly diagnosed patients. 60% of patients under 10 diagnosed with T1DM for less than 3 years are not treated in France by these systems. The aim of this study is therefore to determine whether early treatment of patients with AIDS would have a positive impact on cerebral growth and and on cognitive function in pediatric patients with T1DM.

Primary Outcome Measures: volume of total gray matter measured with high-resolution morphometric MRI, The primary endpoint will be changes in total gray matter volume measured with high-resolution morphometric MRI (vox based morphometry method).

It will be measured at randomization (within 6 months of diagnosis) and 18 months after randomization in the intervention group (treatment of T1DM with SADI), in a control group of T1DM patients (treatment of T1DM with insulin pump and blood glucose sensor) and in a group of non-diabetic control subjects in the same age range., at inclusion and at 18 months after inclusion
Secondary Outcome Measures: volume of total gray matter measured with high-resolution morphometric MRI, Variation in other morphometric measures (localized gray matter, total and localized white matter, measurement of anatomical connectivity) and resting brain function (measurement of cerebral blood flow by arterial label spin ALS) will be compared between the two groups of diabetic children between randomization and the end of the 18-month intervention, at month 6 and 24 months after diagnosis of T1DM|Intelligence score, Assessment of neurocognitive performance: Scale scores Wechsler Intelligence Scale for Children (WIPPSI-IV), at month 6 and 24 months after diagnosis of T1DM|glycemic variability indexes, Glycemic variability measured from data from continuous measurement of interstitial glycemia though the sensor worn by the patient. The standard deviation (SD) of the glycemic mean, the coefficient of variation (CV), the continuous overall net glycemic action (CONGA) 1 hour - 2 hours - 4 hours will be calculated from the full 72 hours recording closest to the visit. Their changes will be compared between the two measurement times between the groups., at month 6 and 24 months after diagnosis of T1DM|Score of test "attention go/nogo" of KiTAP scale, Behavioral control assessment and focused attention test, at month 6 and 24 months after diagnosis of T1DM|Score on BRIEF ((behavioral assessment inventory) scale, behavioral assessment inventory, at month 6 and 24 months after diagnosis of T1DM|Score of Stroop big small et Stropp fruits scale, Assessment of inhibitory control, at month 6 and 24 months after diagnosis of T1DM|Score of Nepsy II scale, Auditory attention test, at month 6 and 24 months after diagnosis of T1DM