Recruiting

Observational Study

Sponsor:

University of Manitoba

Code:

NCT05754567

Conditions

Neurocognitive Disorders

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Neurocognitive Disorders

Study ID

NCT05754567

Start date

Sep 7, 2023

Status verified date

Mar, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • NA

Study Design

Enrollment

225 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Childhood executive function [ Time Frame: 15 minutes ]

Central Contacts and Locations

Central contacts

Kanthi Kavikondala

437-240-8273concepttkids@sunnybrook.ca

Mariam Saleem

416-480-5628mariam.saleem@sunnybrook.ca

Locations

Alberta Health Services

Recruiting

Calgary, Alberta, Canada, T2T 5C7

Contacts

Lois Donovan, FRCPC,MD,

403-955-8352lois.donovan@ahs.ca

Principal Investigator:

Lois Donovan, FRCPC,MD

IWK Health

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Contacts

Janet Slaunwhite

902-470-6464janet.slaunwhite@iwk.nshealth.ca

Principal Investigator:

Jillian Coolen, MD FRCSC

The Ottawa Hospital - Riverside Campus

Recruiting

Ottawa, Ontario, Canada, K1H 7W9

Principal Investigator:

Dr. Erin Keely

More Information

Sponsor

University of Manitoba

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2026-03-20.