About this trial
Neurodevelopmental Outcomes among Offspring of women with Type 1 Diabetes: A Follow up Study of the CONCEPTT Randomized Control Trial (CONCEPTT Kids International). An international, multicentre prospective cohort study of child and mother pairs. The potential number of recruits is 225 and the main inclusion criteria is child's mother who participated in the CONCEPTT Trial.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children of women who participated in the CONCEPTT trial at selected recruiting sites
Disqualifiers
NA
Trial population
Children, ages 6 and up, of women with T1D who participated in the CONCEPTT trial
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Childhood executive function
The BRIEF2 (Behaviour Rating Inventory of Executive Function - Second Edition) is a parent-report 63 item questionnaire will be utilized to measure of executive function in school-aged children and adolescents (5-18 years of age). The BRIEF2 (Behaviour Rating Inventory of Executive Function - Second Edition) provides three broad index scores (i.e., Behaviour Regulation, Emotional Regulation, and Cognitive Regulation) and a General Executive Composite score. Results are provided in the form of T scores (mean=50, SD=10) with higher scores indicative of greater executive function difficulties; T scores of 65 are considered clinically elevated and indicative of executive function deficits.
Secondary outcomes
Significant associations between maternal pre-existing diabetes and ASD (Autism Spectrum Disorder)
The secondary outcome measures were chosen based on our systematic review and meta-analysis, which identified significant associations between maternal pre-existing diabetes and ASD (Autism Spectrum Disorder). The investigators will use a parent-completed questionnaire; the Social Responsiveness Scale-2 (SRS-2) for behaviours associated with ASD (Autism Spectrum Disorder).
Significant associations between maternal pre-existing diabetes and ADHD (Attention Deficit Hyperactivity Disorder)
The secondary outcome measures were chosen based on our systematic review and meta-analysis, which identified significant associations between maternal pre-existing diabetes and ADHD (Attention Deficit Hyperactivity Disorder). The investigators will use a parent-completed questionnaire; the ADHD Rating Scale-5 (ADHD-5) for ADHD (Attention Deficit Hyperactivity Disorder) symptoms.
Other outcomes
Maternal CGM (Continuous Glucose Monitor) percentage time in target
Primary Exposure: Maternal CGM (Continuous Glucose Monitor) percentage time in target range (3.5-7.8 mmol/L) during pregnancy. CGM (Continuous Glucose Monitor) percentage time in target range was chosen because it is the most accurate measure of fetal exposure to maternal glycemia during pregnancy. Additionally, percentage time in range has been associated with important neonatal outcomes such as neonatal hypoglycemia.
Sponsors and contacts
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University of Manitoba
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
SRI International
Collaborator