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| Name | Class |
|---|---|
| SRI International | INDUSTRY |
| Juvenile Diabetes Research Foundation | OTHER |
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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.
The assessments will occur between the children's ages of 3-7 years. The assessment will include obtaining consent and child measurements including weight, height, waist circumference and skinfold thickness (at the triceps, subscapular, flank and quadriceps). Body mass index (BMI) and Waist-Height ratio will be calculated.
The other procedures will include:
Basic demographic questions will be asked regarding the child's mother and father including age, ethnicity, education, occupation, family arrangement, presence of major illnesses, and diabetes complications. Questions regarding maternal diabetes, maternal and paternal family history of diabetes and risk factors for heart disease will be collected at the clinic visit.
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| Measure | Description | Time Frame |
|---|---|---|
| IQ | IQ assessed by the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (WPPSI-IV) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ADHD | Attention Deficit Hyperactive Disorder (ADHD) Rating Scale-IV and Attention Deficit Hyperactive Disorder Rating Scale-IV Preschool Version. It is an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms. The respondent rates each item on a scale of 0 (not at all) to 3 (very often). The scale yields scores for an Inattentive, Hyperactive/Impulsive and Total Scale. The subscales are Inattention Factor and Hyperactive/Impulsive Factor. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants, aged 3 to 7 years
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonya Mergler, BA | Contact | 416-480-5627 | conceptt@sunnybrook.ca | |
| Gail Klein, MSc | Contact | 416-480-5632 | gail.klein@sunnybrook.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Yamamoto, MD MSc FRCPC | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Recruiting | Calgary | Alberta | T2T 5C7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28923465 | Result | Feig DS, Donovan LE, Corcoy R, Murphy KE, Amiel SA, Hunt KF, Asztalos E, Barrett JFR, Sanchez JJ, de Leiva A, Hod M, Jovanovic L, Keely E, McManus R, Hutton EK, Meek CL, Stewart ZA, Wysocki T, O'Brien R, Ruedy K, Kollman C, Tomlinson G, Murphy HR; CONCEPTT Collaborative Group. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017 Nov 25;390(10110):2347-2359. doi: 10.1016/S0140-6736(17)32400-5. Epub 2017 Sep 15. |
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There is no plan for individual level data to be shared with other researchers
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| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009765 | Obesity |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 2 years |
| ASD | Social Responsiveness Scale-2 questionnaire results for Autism Spectrum Disorder behaviours. It is an 65-item questionnaire that requires the respondent to describe the child's behaviour. The respondent rates each item on a scale of 1 (not true) to 4 (almost always true). The scale yields scores for autism spectrum disorders for total score discussion of social behaviour and social interactions. | 2 years |
| NEPSY-II | The NEPSY-II stands for "A Developmental NEuroPSYchological Assessment". Children's language skills assessed using the Speed Naming and Phonological Processing subscales of the NEPSY-II testing results. Phonological Processing is a subtest composed of phonological processing tasks designed to assess phonemic awareness. Speed Naming is a timed subtest designed to assess rapid semantic access to and production of names of colors, shapes, sizes, letters, or numbers. | 2 years |
| CCC-2/LUI | Parent reported language development on the Children's Communication Checklist-2 (CCC_2) for children over four years of age or the Language Use Inventory (LUI) for children 36 to 47 months of age questionnaire results. The Children's Communication Checklist - Seconda Edition has 70 Statements that refer to difficulties children may have that affect their ability to communicate. Rating key is 0 (less than once a week or never) to 3 (several times, more than twice, a day, or always). Total score is used. | 2 years |
| Demographics | Data form to be completed by parents will ask about their level of education, sex, gender, socioeconomic status, height, and any neurodevelopmental or other medical diagnoses in their enrolled child | 2 years |
| Adiposity | Childhood adiposity measures: weight, height, waist circumference and skinfold thickness (at the triceps, subscapular, flank and quadriceps). Body mass index (BMI) and Waist-Height ratio will be calculated using standardized procedures | 2 years |
| Lawson Health Research Institute | Recruiting | London | Ontario | Canada |
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| Mount Sinai Hospital | Recruiting | Toronto | Ontario | Canada |
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| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | Canada |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |