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

NCT05754567 | Recruiting

• 1 other identifier: 4178
• Study Type: observational
• Target: 225
• Locations: 3 countries
• Sites: 10

Brief 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.

Conditions

Neurocognitive Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Significant associations between maternal pre-existing diabetes and ASD (Autism Spectrum Disorder)

  15 minutes

• Significant associations between maternal pre-existing diabetes and ADHD (Attention Deficit Hyperactivity Disorder)

  15 minutes

Other Outcomes (1)

• Maternal CGM (Continuous Glucose Monitor) percentage time in target

  through study completion, an average of 2 year

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children, ages 6 and up, of women with T1D who participated in the CONCEPTT trial

You may qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• SRI International: collaborator

Study Sites (10)

Alberta Health Services

Calgary, Alberta, T2T 5C7, Canada

RECRUITING

IWK Health

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

The Ottawa Hospital - Riverside Campus

Ottawa, Ontario, K1H 7W9, Canada

RECRUITING

Mt Sinai Hospital

Toronto, Ontario, M5T 3L9, Canada

NOT YET RECRUITING

Hospital de la Santa Creu

Barcelona, Spain

RECRUITING

NHS Lothian Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4UX, United Kingdom

RECRUITING

Glasgow Royal Infirmary

Glasgow, PA2 7DE, United Kingdom

RECRUITING

Ipswich Hospital NHS Trust

Ipswich, IP4 5PD, United Kingdom

RECRUITING

St. James's Hospital, Leeds Teaching Hospitals Trust NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Kanthi Kavikondala

CONTACT

437-240-8273; concepttkids@sunnybrook.ca

Mariam Saleem

CONTACT

416-480-5628; mariam.saleem@sunnybrook.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 6, 2023
• Study Start: September 7, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

CA (4); GB (5); ES (1)