Type 1 DiabetesNCT04135365
Pediatric Type 1 Diabetes and Neurocognitive Complications Cohort Study
An observational study of Type 1 Diabetes, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- neurocognitive assessment and neuroimaging assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2021to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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.
Who may be able to join
- Pediatric T1D sample: Children will be eligible if they meet the following inclusion/exclusion criteria:
- 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).
- Comparison sample: Children will be eligible if they meet the following inclusion/exclusion criteria:
Show all 13Show fewer
- 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
- 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.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Identifying Modifiable Risk and Protective Factors for Neurocognitive Complications of Pediatric Type 1 Diabetes
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.
Read the detailed description
The onset of type 1 diabetes (T1D) in childhood results in clinically significant deficits in neurocognitive functioning that manifest in adulthood. These deficits have implications for adaptive functioning and diabetes management. Studies of neurocognitive function and brain development in T1D suggest that factors such as age of onset, diabetic ketoacidosis (DKA) at time of onset, and exposure to chronic hyperglycemia or severe hypoglycemia may increase risk or severity of these deficits, but findings are mixed. The majority of previous studies were limited by the use of adult or older adolescent samples, cross-sectional designs or short duration of follow-up, lack of racial and ethnic diversity, and small sample sizes. Age-related changes in neurocognitive function and vascular complications associated with T1D in adults make isolating mechanisms more complex. The knowledge gaps are critical because individuals with T1D may live for decades with reduced neurocognitive function. Building on previous work, it is hypothesized that several risk and protective factors for neurocognitive deficits will be evident in youth with T1D. First, sleep is a critical and potentially modifiable risk or protective factor for youth. Prior work has shown that the majority of school-age children do not obtain sufficient sleep (67%), and that sleep disturbances are related to poor glycemic control and risk for DKA, both of which have been posited to increase risk for neurocognitive deficits. Second, caregiver distress (i.e., symptoms of anxiety and depression) is a significant risk factor for child wellbeing, as exposure to maternal depressive symptoms increases children's risk for cognitive deficits and abnormal white matter diffusivity. Third, improved glycemic control via use of continuous glucose monitors and hybrid closed-loop insulin delivery systems, are potential protective factors for youth with T1D, as these devices decrease glycemic variability and limit time spent in hypoglycemia and hyperglycemia. Thus, a prospective longitudinal cohort study of young children with T1D is needed to identify modifiable risk and protective factors for neurocognitive complications. If specific risk or protective factors for adverse or optimal neurocognitive outcomes are defined, treatment protocols could be developed to limit neurocognitive complications associated with T1D.
- Conditions
- Type 1 Diabetes
- Being tested
- neurocognitive assessment, neuroimaging assessment
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurocognitive assessmentBehavioural
Observational study therefore there are no interventions
neuroimaging assessmentBehavioural
Observational study therefore there are no interventions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: neurocognitive assessment; Behavioral: neuroimaging assessment | |
| Comparison | Children with no known chronic medical conditions or intellectual disability will undergo the same procedure listed for the Pediatric T1D group Receives: Behavioral: neurocognitive assessment; Behavioral: neuroimaging assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
- 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.
Measured: 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
Measured: 12 months
Secondary outcomes (1)
Imaging
Differences in brain volume and white matter microstructure in children with T1D vs comparison children.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start18 Jan 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Jaser, Vanderbilt University Medical Center
- Investigators
- Sarah S Jaser, PhD, Principal investigator, Vanderbilt University Medical CenterLori Jordan, MD, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135365
- Sponsor's protocol ID
- T1DCohortStudy
- Other IDs
- 1U34DK123895-01
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2019
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Modifiable Risk and Protective Factors for Neurocognitive Complications of Pediatric Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04135365
- Acronym / sponsor ID
- T1DCohortStudy
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The onset of type 1 diabetes (T1D) in childhood results in clinically significant deficits in neurocognitive functioning that manifest in adulthood. These deficits have implications for adaptive functioning and diabetes management. Studies of neurocognitive function and brain development in T1D suggest that factors such as age of onset, diabetic ketoacidosis (DKA) at time of onset, and exposure to chronic hyperglycemia or severe hypoglycemia may increase risk or severity of these deficits, but findings are mixed. The majority of previous studies were limited by the use of adult or older adolescent samples, cross-sectional designs or short duration of follow-up, lack of racial and ethnic diversity, and small sample sizes. Age-related changes in neurocognitive function and vascular complications associated with T1D in adults make isolating mechanisms more complex. The knowledge gaps are critical because individuals with T1D may live for decades with reduced neurocognitive function. Building on previous work, it is hypothesized that several risk and protective factors for neurocognitive deficits will be evident in youth with T1D. First, sleep is a critical and potentially modifiable risk or protective factor for youth. Prior work has shown that the majority of school-age children do not obtain sufficient sleep (67%), and that sleep disturbances are related to poor glycemic control and risk for DKA, both of which have been posited to increase risk for neurocognitive deficits. Second, caregiver distress (i.e., symptoms of anxiety and depression) is a significant risk factor for child wellbeing, as exposure to maternal depressive symptoms increases children's risk for cognitive deficits and abnormal white matter diffusivity. Third, improved glycemic control via use of continuous glucose monitors and hybrid closed-loop insulin delivery systems, are potential protective factors for youth with T1D, as these devices decrease glycemic variability and limit time spent in hypoglycemia and hyperglycemia. Thus, a prospective longitudinal cohort study of young children with T1D is needed to identify modifiable risk and protective factors for neurocognitive complications. If specific risk or protective factors for adverse or optimal neurocognitive outcomes are defined, treatment protocols could be developed to limit neurocognitive complications associated with T1D.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric T1D | – | Behavioral: neurocognitive assessment, Behavioral: neuroimaging assessmentA 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 | – | Behavioral: neurocognitive assessment, Behavioral: neuroimaging assessmentChildren with no known chronic medical conditions or intellectual disability will undergo the same procedure listed for the Pediatric T1D group |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (13 listed)
- Pediatric T1D sample: Children will be eligible if they meet the following inclusion/exclusion criteria:
- Comparison sample: Children will be eligible if they meet the following inclusion/exclusion criteria:
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurocognitive assessmentObservational study therefore there are no interventions | Behavioural | Comparison, Pediatric T1D |
| neuroimaging assessmentObservational study therefore there are no interventions | Behavioural | Comparison, Pediatric T1D |
Primary outcome
Cognitive Function: Full-scale IQ
Time frame: 12 months
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.
Cognitive Function: Executive Function
Time frame: 12 monnths
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.
Cognitive Function: Behavior Rating Inventory of Executive Function, Second Edition
Time frame: 12 months
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
1 secondary outcome
Imaging
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah S Jaser, PhD principal investigator
Vanderbilt University Medical Center
Lori Jordan, MD, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function: Full-scale IQ (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.