CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes

Neurocognitive Disorders Clinical Trial

— CONCEPTTKids  

Official title:

CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes: A Follow up Study of the CONCEPTT Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05754567
• Other study ID #: 4178
• Status: Recruiting
• Start date: September 7, 2023
• Est. completion date: December 2026

Study information

• Verified date: November 2023
• Source: University of Manitoba
• Contact: Sonya Mergler
• Phone: 416-480-5627
• Email: concepttkids[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

This is a multicentre, international prospective cohort study of child and mother pairs from sites in Canada, UK, Spain and Italy. The expected duration of the study is three years. Women who participated in CONCEPTT will be invited to participate in CONCEPTT Kids International. Once informed consent is obtained, mothers will be asked to complete forms and questionnaires that provide information on family socio-demographics and their children's executive functions and behaviour (i.e. social responsiveness and attention). Self-reported height and weight measures of the child and parent(s) will also be collected. Our primary outcome measure is childhood executive function measured by the Global Executive Composite of the Behaviour Rating Inventory of Executive Function - Second Edition (BRIEF2) 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 and ADHD. We will use two parent-completed questionnaires to assess symptoms associated with these disorders; the Social Responsiveness Scale-2 (SRS-2) for behaviours associated with ASD and the ADHD Rating Scale-5 (ADHD-5) for ADHD symptoms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: December 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Children of women who participated in the CONCEPTT trial at selected recruiting sites

Exclusion Criteria:

• NA

Related Conditions & MeSH terms

• Neurocognitive Disorders

Locations

Country	Name	City	State
Canada	Alberta Health Services	Calgary	Alberta
Canada	Mt Sinai Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	Canadian Institutes of Health Research (CIHR), SRI International

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	through study completion, an average of 2 year
Primary	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.	15 minutes
Secondary	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).	15 minutes
Secondary	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.	15 minutes