Pediatric Type 1 Diabetes and Neurocognitive Complications Cohort Study
Identifying Modifiable Risk and Protective Factors for Neurocognitive Complications of Pediatric Type 1 Diabetes
2 other identifiers
observational
12
1 country
1
Brief Summary
The proposed project will assess hypothesized risk factors (age of onset, Diabetic ketoacidosis (DKA) at presentation and glycemic control), as well as potentially modifiable protective factors (child sleep quality, caregiver distress, and use of diabetes devices). In addition, the study will optimize imaging protocols and processing tools to allow for harmonization of neuroimaging data across sites and scanners for the most robust analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2019
CompletedFirst Posted
Study publicly available on registry
October 22, 2019
CompletedStudy Start
First participant enrolled
January 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedNovember 1, 2022
October 1, 2022
1.8 years
October 17, 2019
October 31, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Cognitive Function: Full-scale IQ
To assess cognitive differences in full-scale IQ using the Wechsler Intelligence Scale for Children, fifth edition (WISC V) in children with T1D vs. comparison children. The Full-Scale IQ is an estimate of overall intellectual ability. The WISC-V takes approximate 48 minutes to administer. The FSQI uses a standard score metric with a mean of 100 and an Standard Deviation of 15.
12 months
Cognitive Function: Executive Function
To assess cognitive differences in executive function using the The NIH Toolbox Executive Function Tests in children with T1D vs. comparison children. 1\) NIH Flanker Inhibitory Control and Attention Test will be used to assess children's ability to inhibit visual attention. Average administration time is 4 minutes. A scoring algorithm integrates accuracy, a suitable measure in early childhood, yielding scores from 0 to 10.
12 monnths
Cognitive Function: Behavior Rating Inventory of Executive Function, Second Edition
Parent report of child's executive function, has been validated for use in children ages 5-18 years. Scaled T-scores are based on normative data for age and sex. The BRIEF2 consists of 63 items, and it yields a Global Executive Composite score, as well as a Behavior Regulation Index, Emotional Regulation Index, and Cognitive Regulation Index
12 months
Secondary Outcomes (1)
Imaging
12 months
Study Arms (2)
Pediatric T1D
A sample of 20 children with Type 1 Diabetes and their caregivers will be asked to stay after their diabetes clinic appointment to complete enrollment, or they may choose to come back for a study visit. Trained study staff will describe the study in detail to interested families. They will be encouraged to ask questions before giving consent. After obtaining informed consent/assent, children and caregivers will schedule time for a neurocognitive assessment and neuroimaging assessment. Children and caregivers will complete assessments again approximately 12 months later.
Comparison
Children with no known chronic medical conditions or intellectual disability will undergo the same procedure listed for the Pediatric T1D group
Interventions
Observational study therefore there are no interventions
Observational study therefore there are no interventions
Eligibility Criteria
The Children's Diabetes Program (CDP) at Vanderbilt University Medical Center in collaboration with strong multidisciplinary research collaborators is well poised to answer these questions with considerable local expertise in behavioral research in children with T1D, neurocognitive testing in youth with T1D, pediatric neurology and neuroimaging, and data science. Further, we bring unique expertise in sleep in youth with T1D, caregiver distress, and use of novel measurement tools. Finally, the CDP follows over 2,800 children with diabetes, 85% of whom have T1D, and there are about 250 new-onset cases of T1D annually.
You may not qualify if:
- are between 6 -11 years of age
- have no history of afebrile seizure (not related to hypoglycemia) or sleep disorders other than insufficient sleep or insomnia
- no contraindications to high quality MRI of the brain (no metal implants or braces)
- no premature birth (\<34 weeks) or low birth weight (\<2,000g).
- no known chronic medical conditions or intellectual disability
- no known history of concussion or traumatic brain injury
- no history of afebrile seizure; (4) no braces or metal implants
- (5) no premature birth (\<34 weeks) or low birth weight (\<2,000g).
- Parents or primary caregivers of all children will be eligible if they:
- live with the child
- read/speak English to allow use of validated parental questionnaires. The parent who is the primary caregiver of the child will be invited to participate.
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah S Jaser, PhD
Vanderbilt University Medical Center
- PRINCIPAL INVESTIGATOR
Lori Jordan, MD, PhD
Vanderbilt University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
October 17, 2019
First Posted
October 22, 2019
Study Start
January 18, 2021
Primary Completion
October 31, 2022
Study Completion
October 31, 2022
Last Updated
November 1, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available to external investigators within five years after study completion and after the publication of study results.
- Access Criteria
- Investigators are required to submit a proposal requesting: Investigator's name and affiliation; Hypothesis to be tested or investigation to be conducted; Background and relevant literature; Subjects eligible for inclusion in the analysis and dataset; List of variables of interest; Substantially detailed analysis plan; List of potential co-authors and collaborators. The proposal must be submitted to the Co-PI and will be reviewed by KSP. The PI and statistician will send a confidentiality agreement stipulating that the data file is to be used only for the purpose described in the proposal and that the requesting investigator must retain control over the file at all times. The requesting investigator is further obligated to supply quarterly progress reports on their analysis/investigation and to supply draft manuscripts. Prior to the release of the file, the contact PI and statistician will personally review the file and certify the level of de-identification.
All of our de-identified data will be stored in REDCap. Other researchers will be required to register with REDCap and agree to conditions listed in REDCap governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource. REDCap offers a mechanism to allow third parties to track de-identified data downloads and datasets to users with specific access granted. Data may be downloaded in several file formats including STAT, SAS, R, and Excel. The ability to share MRI data will be limited by file size, costs and time to transmit imaging. Our study imaging scientists will create methods for secure sharing of imaging data. If source imaging data is requested, any costs to share these data would need to be arranged by the requesting investigator.