Clinical trial NCT06461065: Evaluation of Neurodevelopmental Trajectories in Children According to the Glycemic Profile Associated With Different Early Treatment Modalities in Children With Type 1 Diabetes (T1DM)
Official title: Evaluation of Neurodevelopmental Trajectories in Children According to the Glycemic Profile Associated With Different Early Treatment Modalities in Children With Type 1 Diabetes (T1DM)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Children
insulin therapy
cognitive development
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Fondation Francophone pour la Recherche sur le Diabete
name: Ypsomed AG
First posted: 2024-06-14
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: The aim of the study was to evaluate the neuroanatomical damage to gray matter associated with type 1 diabetes in young children according to their glycemic profile (use of a AIDS or not) and compared with an age-matched control subject.

Prospective case-control cohort study (T1DM or not) and exposed/non-exposed (CL or not), multicenter with 2 visits at 6 and 24 months of T1DM and 2 parallel visits for the control group.

The AIDS system used is a "mylife CamAPS application", marketed by CamDiab Ltd. class III, (YpsoPump, marketed by Ypsomed, Dexcom G6 blood glucose sensor, used in their respective indications).

One experimental group (AIDS group) and two comparator groups, Standard treatment group (TS group): patients with T1DM treated with insulin pump + blood glucose sensors and group C (control): age-matched control subjects without T1DM.

The expected benefits are early access to an automated insulin delivery system for study participants, as well as evidence of the neurocognitive benefit of early use of AIDs leading to changes in care practices.

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

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

Primary outcomes:
measure: volume of total gray matter measured with high-resolution morphometric MRI
timeFrame: at inclusion and at 18 months after inclusion
Secondary outcomes:
measure: volume of total gray matter measured with high-resolution morphometric MRI
timeFrame: at month 6 and 24 months after diagnosis of T1DM
measure: Intelligence score
timeFrame: at month 6 and 24 months after diagnosis of T1DM
measure: glycemic variability indexes
timeFrame: at month 6 and 24 months after diagnosis of T1DM
measure: Score of test "attention go/nogo" of KiTAP scale
timeFrame: at month 6 and 24 months after diagnosis of T1DM
measure: Score on BRIEF ((behavioral assessment inventory) scale
timeFrame: at month 6 and 24 months after diagnosis of T1DM
measure: Score of Stroop big small et Stropp fruits scale
timeFrame: at month 6 and 24 months after diagnosis of T1DM
measure: Score of Nepsy II scale
timeFrame: at month 6 and 24 months after diagnosis of T1DM
Other outcomes:
Locations:
Study officials:
affiliation: APHP
name: Jacques Beltrand, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: APHP
name: Nathalie Boddaert, PHD
role: STUDY_CHAIR
References: