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CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes

Sponsor: University of Manitoba

NCT ID: NCT05754567

View on ClinicalTrials.gov ↗

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.

Neurocognitive Disorders

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
Inclusion Criteria: * Children of women who participated in the CONCEPTT trial at selected recruiting sites Exclusion Criteria: * NA

Where Is This Study? (5 UK sites)

NHS Lothian Royal Infirmary of Edinburgh

Edinburgh EH16 4UX, United Kingdom

Recruiting
Site contact (verified)
Dr. Anna DoverPrincipal Investigator

Glasgow Royal Infirmary

Glasgow PA2 7DE, United Kingdom

Recruiting
Site contact (verified)
Dr. Robert LindsayPrincipal Investigator

Ipswich Hospital NHS Trust

Ipswich IP4 5PD, United Kingdom

Recruiting
Site contact (verified)
Dr. Zeenat BanuPrincipal Investigator

St. James's Hospital, Leeds Teaching Hospitals Trust NHS Trust

Leeds LS9 7TF, United Kingdom

Recruiting
Site contact (verified)
Dr. Eleanor ScottPrincipal Investigator

Southampton General Hospital

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)
Dr. Richard HoltPrincipal Investigator

How to Get in Touch

Kanthi Kavikondala

Sponsor contact

CONTACT

437-240-8273 concepttkids@sunnybrook.ca

Mariam Saleem

Sponsor contact

CONTACT

416-480-5628 mariam.saleem@sunnybrook.ca
Data sourced from ClinicalTrials.gov · Last verified: 2026-03