Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT04098679

Conditions

Neurologic Disorder

Adiposity

Eligibility Criteria

Sex: All

Age: 3 - 7

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This is a follow-up study of children born to mothers who participated in the CONCEPTT Trial. CONCEPTT (a multicentre randomized controlled trial of continuous glucose monitoring (CGM) in women with Type 1 diabetes during pregnancy).

The purpose of this study is to examine the association of maternal glycemic measures on childhood intelligence quotient (IQ), behavioural outcomes, language scores and weight measures. The children of the women who participated in CONCEPTT will be assessed.

Conditions

Neurologic Disorder

Adiposity

Study ID

NCT04098679

Start date

Sep 30, 2019

Status verified date

Sep, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 7

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Children (of women who participated in the CONCEPTT trial) with major congenital anomalies will be assessed on a case by case basis to determine eligibility.

Study Design

Enrollment

174 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • IQ [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Sonya Mergler, BA

416-480-5627conceptt@sunnybrook.ca

Gail Klein, MSc

416-480-5632gail.klein@sunnybrook.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2T 5C7

Contacts

Lois Donovan, MD FRCPC

403 955-8358

Principal Investigator:

Lois Donovan, MD FRCPC

Lawson Health Research Institute

Recruiting

London, Ontario, Canada

Principal Investigator:

Selina Lui

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada

Principal Investigator:

Denice Feig

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada

Principal Investigator:

Ilana Halperin

More Information

Sponsor

University of Calgary

Last update posted

Oct 3, 2022

Last verified

Sep, 2022

Keywords

  • Type 1 diabetes
  • Offspring
  • Continuous glucose monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Calgary on 2022-10-03.