At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 40 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
In plain English
This study follows the children of women who took part in an earlier trial called CONCEPTT, where the mothers had type 1 diabetes. It looks at how these children's brains develop, including their learning and thinking skills. The study is run by the University of Manitoba.
Who can take part
- Children whose mothers took part in the CONCEPTT trial at selected sites
Who may not be able to
- Not stated — ask the trial team
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 6 Years and over
- Who
- All
- Number of participants
- 225
- Started
- 2023-09-07
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for neurocognitive disorders
- • Clinical study - 225 participants
- • Neurodevelopmental Outcomes among Offspring of women with Type 1 Diabetes: A Follow up Study of the CONCEPTT Randomized Control Trial (CONCEPTT Kids International)
Who can take part?
- • Ages 6 Years and over
- • Diagnosed with neurocognitive disorders
Where?
- • Edinburgh - NHS Lothian Royal Infirmary of Edinburgh
- • Glasgow - Glasgow Royal Infirmary
- • Ipswich - Ipswich Hospital NHS Trust
- • Leeds - St. James's Hospital, Leeds Teaching Hospitals Trust NHS Trust
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
This is a multicentre, international prospective cohort study of child and mother pairs from sites in Canada, UK, Spain and Italy. The expected duration of the study is three years. Women who participated in CONCEPTT will be invited to participate in CONCEPTT Kids International. Once informed consent is obtained, mothers 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). Self-reported height and weight measures of the child and parent(s) will also be collected. Our primary outcome measure is childhood executive function measured by the Global Executive Composite of the Behaviour Rating Inventory of Executive Function - Second Edition (BRIEF2) The secondary outcome measures were chosen based on our systematic review and meta-analysis, which identified significant associations between maternal pre-existing diabetes, and ASD and ADHD. We will use two parent-completed questionnaires to assess symptoms associated with these disorders; the Social Responsiveness Scale-2 (SRS-2) for behaviours associated with ASD and the ADHD Rating Scale-5 (ADHD-5) for ADHD symptoms.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 6 Years and over
- Who can join: All genders
What the study is looking for
- ✓Children of women who participated in the CONCEPTT trial at selected recruiting sites
See the full criteria
Where Is This Study? (5 UK sites)
NHS Lothian Royal Infirmary of Edinburgh
Edinburgh EH16 4UX, United Kingdom
Glasgow Royal Infirmary
Glasgow PA2 7DE, United Kingdom
Ipswich Hospital NHS Trust
Ipswich IP4 5PD, United Kingdom
St. James's Hospital, Leeds Teaching Hospitals Trust NHS Trust
Leeds LS9 7TF, United Kingdom
Southampton General Hospital
Southampton SO16 6YD, United Kingdom
How to Get in Touch
Kanthi Kavikondala
Sponsor contactCONTACT
Mariam Saleem
Sponsor contactCONTACT
