Neurodevelopmental outcomes in children of mothers with Type 1 diabetes
CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes: A Follow up Study of the CONCEPTT Randomized Control Trial
This study is testing how having Type 1 diabetes during pregnancy affects children's thinking skills and behaviors related to autism and ADHD, by gathering information from mothers in several countries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 225 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | University of Manitoba Academic / other |
| Locations | 10 sites (Calgary, Alberta and 9 other locations) |
| Trial ID | NCT05754567 on ClinicalTrials.gov |
What this trial studies
This international, multicentre prospective cohort study follows child and mother pairs from Canada, the UK, Spain, and Italy, focusing on neurodevelopmental outcomes among children of women who participated in the CONCEPTT trial. The study aims to assess childhood executive function and behaviors associated with autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) through questionnaires completed by mothers. The expected duration of the study is three years, with a target recruitment of 225 participants. Data collected will include socio-demographic information, child and parent height and weight, and behavioral assessments.
Who should consider this trial
Good fit: Ideal candidates for this study are children whose mothers participated in the CONCEPTT trial.
Not a fit: Patients who are not children of mothers who participated in the CONCEPTT trial will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the neurodevelopmental risks faced by children of mothers with Type 1 diabetes, potentially guiding interventions and support.
How similar studies have performed: Previous studies have shown associations between maternal diabetes and neurodevelopmental outcomes, indicating that this approach is grounded in existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children of women who participated in the CONCEPTT trial at selected recruiting sites Exclusion Criteria: * NA
Where this trial is running
Calgary, Alberta and 9 other locations
- Alberta Health Services — Calgary, Alberta, Canada (Recruiting)
- IWK Health — Halifax, Nova Scotia, Canada (Recruiting)
- The Ottawa Hospital - Riverside Campus — Ottawa, Ontario, Canada (Recruiting)
- Mt Sinai Hospital — Toronto, Ontario, Canada (Not_yet_recruiting)
- Hospital de la Santa Creu — Barcelona, Spain (Recruiting)
- NHS Lothian Royal Infirmary of Edinburgh — Edinburgh, Scotland, United Kingdom (Recruiting)
- Glasgow Royal Infirmary — Glasgow, United Kingdom (Recruiting)
- Ipswich Hospital NHS Trust — Ipswich, United Kingdom (Recruiting)
- St. James's Hospital, Leeds Teaching Hospitals Trust NHS Trust — Leeds, United Kingdom (Recruiting)
- Southampton General Hospital — Southampton, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Kanthi Kavikondala
- Email: concepttkids@sunnybrook.ca
- Phone: 437-240-8273
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.