CONCEPTT kids
Research type
Research Study
Full title
Neurodevelopmental Outcomes among Offspring of women with Type 1 Diabetes: A Follow up Study of the CONCEPTT Randomized Control Trial
IRAS ID
324226
Contact name
Claire Meek
Contact email
Sponsor organisation
University of Manitoba
Clinicaltrials.gov Identifier
324226, IRAS ID; ID NCT05754567., ClinicalTrials.gov
Duration of Study in the UK
1 years, 6 months, 28 days
Research summary
This is a multicentre, international prospective cohort study following up a clinical trial cohort (Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial (CONCEPTT)). The study will focus on child health and will recruit mothers or parents/guardians of CONCEPTT children from sites in Canada, UK, Spain and Italy. The expected duration of the study is three years.
Women who participated in the CONCEPTT trial or parents/guardians of CONCEPTT children will be invited to participate in the CONCEPTT Kids International study. Once informed consent is obtained, mothers/guardians 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). One-off self-reported height and weight measures of the child and parent(s) will also be collected.
The study aims to find out if there an association between maternal glycemic measures (assessed by continuous glucose monitoring; CGM) during pregnancy and children’s executive function or behaviour at 6 years of age and up. Is the relationship between maternal glycemia (assessed by CGM) and childhood executive function or behaviour (i.e. social responsiveness and attention), directly related to maternal glycemia, or mediated by neonatal complications (specifically preterm delivery or neonatal hypoglycemia)?
This observational study poses no risk to the original participants of CONCEPTT or their children and includes the collection of questionnaire data, no biological samples.
REC name
North West - Haydock Research Ethics Committee
REC reference
25/NW/0060
Date of REC Opinion
8 Apr 2025
REC opinion
Further Information Favourable Opinion