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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 6 Years and up |
| Sex | All |
| Enrollment | 225 (estimated) |
| Sponsor | University of Manitoba Academic / other |
| Locations | 10 sites (Calgary, Alberta and 9 other locations) |
| Status | Recruiting |
| Started | September 7, 2023 |
| Main results expected | August 2026 |
| Study ends | January 2027 |
| Registry record updated | March 20, 2026 |
| Trial ID | NCT05754567 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
- Study coordinator: Kanthi Kavikondala
- Email: concepttkids@sunnybrook.ca
- Phone: 437-240-8273
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Non-invasive brain stimulation plus computer-based memory training for mild cognitive impairment
This trial will test whether a short course of non-invasive brain stimulation combined with one of two computer-based brain-training programs helps people aged 60–85 with mild cognitive impairment improve memory, thinking, mood, and daily function.
-
Developing and testing the Liver Cirrhosis Cognitive Decline Scale (LiCCoS)
This project will test a short questionnaire called LiCCoS to see if it can spot thinking and everyday mental problems in adults with liver cirrhosis.
-
Carotid artery wall viscosity and memory problems in older adults
This project will test whether the viscous behavior of the carotid artery wall is linked to memory problems in people over 70 with memory complaints, Alzheimer's disease, or vascular dementia.
-
NeuroFirst brain protection for adults having heart bypass surgery
This trial tests whether a bundled anesthesia approach called NeuroFirst can help people aged 60 and older having planned heart surgery with cardiopulmonary bypass avoid silent brain infarcts and thinking or memory problems after surgery.
-
Nutrition-based interventions to prevent cognitive decline
This study is testing if a 6-month nutrition program can help adults at higher risk for dementia keep their thinking skills sharp.
-
Oral midazolam to help deliver care for older adults with neurocognitive disorders who refuse care
This study will try a short-acting oral midazolam to help nurses and caregivers give essential care to older adults with moderate to severe neurocognitive disorders who resist or refuse care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.