Clinical trial Recruiting at 9 sites Observational Ages 6 and up

Neurodevelopmental outcomes in children of mothers with Type 1 diabetes

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

Run by University of Manitoba · NCT05754567 · Data updated 2026-11-12

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.

More Neurocognitive Disorders trials

Quick facts

Study typeObservational
Ages6 Years and up
SexAll
Enrollment225 (estimated)
SponsorUniversity of Manitoba
Academic / other
Locations10 sites (Calgary, Alberta and 9 other locations)
StatusRecruiting
StartedSeptember 7, 2023
Main results expectedAugust 2026
Study endsJanuary 2027
Registry record updatedMarch 20, 2026
Trial IDNCT05754567 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children whose mothers participated in the CONCEPTT trial.

Probably not a fit

Patients who are not children of mothers who participated in the CONCEPTT trial will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous studies have shown associations between maternal diabetes and neurodevelopmental outcomes, indicating that this approach is grounded in existing research.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

* NA

Where it's running

  • Alberta Health Services
    Calgary, Alberta, Canada
    Recruiting
  • IWK Health
    Halifax, Nova Scotia, Canada
    Recruiting
  • The Ottawa Hospital - Riverside Campus
    Ottawa, Ontario, Canada
    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
Show 4 more locations
  • 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
  • Mt Sinai Hospital
    Toronto, Ontario, Canada
    Not yet recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.