Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT05754567
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2023-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2023-03-03', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Maternal CGM (Continuous Glucose Monitor) percentage time in target', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'Primary Exposure: Maternal CGM (Continuous Glucose Monitor) percentage time in target range (3.5-7.8 mmol/L) during pregnancy. CGM (Continuous Glucose Monitor) percentage time in target range was chosen because it is the most accurate measure of fetal exposure to maternal glycemia during pregnancy. Additionally, percentage time in range has been associated with important neonatal outcomes such as neonatal hypoglycemia.'}], 'primaryOutcomes': [{'measure': 'Childhood executive function', 'timeFrame': '15 minutes', 'description': 'The BRIEF2 (Behaviour Rating Inventory of Executive Function - Second Edition) is a parent-report 63 item questionnaire will be utilized to measure of executive function in school-aged children and adolescents (5-18 years of age). The BRIEF2 (Behaviour Rating Inventory of Executive Function - Second Edition) provides three broad index scores (i.e., Behaviour Regulation, Emotional Regulation, and Cognitive Regulation) and a General Executive Composite score. Results are provided in the form of T scores (mean=50, SD=10) with higher scores indicative of greater executive function difficulties; T scores of 65 are considered clinically elevated and indicative of executive function deficits.'}], 'secondaryOutcomes': [{'measure': 'Significant associations between maternal pre-existing diabetes and ASD (Autism Spectrum Disorder)', 'timeFrame': '15 minutes', 'description': '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 (Autism Spectrum Disorder). The investigators will use a parent-completed questionnaire; the Social Responsiveness Scale-2 (SRS-2) for behaviours associated with ASD (Autism Spectrum Disorder).'}, {'measure': 'Significant associations between maternal pre-existing diabetes and ADHD (Attention Deficit Hyperactivity Disorder)', 'timeFrame': '15 minutes', 'description': 'The secondary outcome measures were chosen based on our systematic review and meta-analysis, which identified significant associations between maternal pre-existing diabetes and ADHD (Attention Deficit Hyperactivity Disorder). The investigators will use a parent-completed questionnaire; the ADHD Rating Scale-5 (ADHD-5) for ADHD (Attention Deficit Hyperactivity Disorder) symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurocognitive Disorders']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nOur primary outcome measure is childhood executive function measured by the Global Executive Composite of the Behaviour Rating Inventory of Executive Function - Second Edition (BRIEF2)\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children, ages 6 and up, of women with T1D who participated in the CONCEPTT trial', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children of women who participated in the CONCEPTT trial at selected recruiting sites\n\nExclusion Criteria:\n\n* NA'}, 'identificationModule': {'nctId': 'NCT05754567', 'acronym': 'CONCEPTTKids', 'briefTitle': 'CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes: A Follow up Study of the CONCEPTT Randomized Control Trial', 'orgStudyIdInfo': {'id': '4178'}}, 'contactsLocationsModule': {'locations': [{'zip': 'T2T 5C7', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Lois Donovan, FRCPC,MD,', 'role': 'CONTACT', 'email': 'lois.donovan@ahs.ca', 'phone': '403-955-8352'}, {'name': 'Lois Donovan, FRCPC,MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alberta Health Services', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Janet Slaunwhite', 'role': 'CONTACT', 'email': 'janet.slaunwhite@iwk.nshealth.ca', 'phone': '902-470-6464'}, {'name': 'Jillian Coolen, MD FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IWK Health', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'M5T 3L9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Silva Darrouj', 'role': 'CONTACT', 'email': 'Silva.Darrouj@sinaihealth.ca'}, {'name': 'Denice Feig', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mt Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Sonya Mergler', 'role': 'CONTACT', 'email': 'concepttkids@sunnybrook.ca', 'phone': '416-480-5627'}, {'name': 'Mariam Saleem', 'role': 'CONTACT', 'email': 'mariam.saleem@sunnybrook.ca', 'phone': '416-480-5628'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'SRI International', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}