The Effects of High and Low Blood Glucose Values on the Brain in Children With Type 1 Diabetes Mellitus
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 3 - 10 |
| Updated: | 4/21/2016 |
| Start Date: | December 2006 |
| End Date: | December 2015 |
Neurocognitive and Neuroanatomical Studies in Young Children With Type 1 Diabetes Mellitus
Simplified Brochure
Neuropsychological Testing/Assessment is like games for the child. They are asked to
complete the sequence, identify pictures, explain what is happening, etc. There is no
personality testing involved. Part of the standard IQ testing is done but no IQ score is
obtained. Age appropriate testing is done for each child.
The MRI is an enclosed machine. We have the child sit in a simulator after the
neuropsychological testing to see what it will be like, including the sounds, etc. You will
be given a video about MRI testing to view as well. The staff that does this has been doing
this for years in a wide variety of children, young, developmental delayed, etc. The staff
does this WITHOUT sedation. Some children cannot sit still through the entire series. We
need to get six, 10 minute scans. Children are allowed movement such as the need to wiggle
their toes and move in between each scan.
The Neuropsychological Testing can be scheduled in the late afternoons if it is more
convenient for your family. This visit may take 3-4 hours. The MRI scanning can be scheduled
after 5pm and may take up to 2 hours depending on the child's cooperation. You maybe asked
to repeat the Neuropsychological Testing and MRI scanning 24 months later.
Neuropsychological Testing/Assessment is like games for the child. They are asked to
complete the sequence, identify pictures, explain what is happening, etc. There is no
personality testing involved. Part of the standard IQ testing is done but no IQ score is
obtained. Age appropriate testing is done for each child.
The MRI is an enclosed machine. We have the child sit in a simulator after the
neuropsychological testing to see what it will be like, including the sounds, etc. You will
be given a video about MRI testing to view as well. The staff that does this has been doing
this for years in a wide variety of children, young, developmental delayed, etc. The staff
does this WITHOUT sedation. Some children cannot sit still through the entire series. We
need to get six, 10 minute scans. Children are allowed movement such as the need to wiggle
their toes and move in between each scan.
The Neuropsychological Testing can be scheduled in the late afternoons if it is more
convenient for your family. This visit may take 3-4 hours. The MRI scanning can be scheduled
after 5pm and may take up to 2 hours depending on the child's cooperation. You maybe asked
to repeat the Neuropsychological Testing and MRI scanning 24 months later.
BROCHURE:
Name of Study: Neuropsychological and Neuroanatomical Studies in Young Children Study
Directors: Tandy Aye, MD; Bruce Buckingham, MD; Darrell Wilson, MD
About the Study: This study is being conducted to see if Type 1 diabetes mellitus has any
affect on learning, behavior and development in young children. Fifty to 60 children between
the ages of 3 to less than 10 years with Type 1 diabetes mellitus will have
neuropsychological testing and a nonsedated MRI scan of the head performed. The study will
compare the results from those with diabetes to a control group of 20-30 children between
the ages of 3 to less than 10 years without Type 1 diabetes mellitus. The control subjects
will have neuropsychological testing and a nonsedated MRI scan of the head performed as
well. All subjects maybe asked to repeat the neuropsychological testing and nonsedated MRI
scan of the head 24 months later. The children with Type 1 diabetes mellitus will not have
any changes made to their current diabetes regimen. The children with Type 1 diabetes
mellitus should continue to check blood glucose values as required by their doctors and
bring their meter(s) for downloading to each visit. The child should also tell his/her
doctor about the frequency of severe low and high blood glucose values to his/er doctor as
routinely asked.
Participant Schedule:
1. One visit for 3-4 hours at the Stanford Medical Center to complete neuropsychological
testing and to become familiar with the MRI scanner.
2. Subjects who need to become more familiar with the MRI scanning process will view a
video tape at home.
3. One visit for 1-2 hours at Stanford Medical Center to have the MRI scan of the head
completed.
4. Subjects may have the neuropsychological testing and MRI scan repeated 24 months from
time of the initial testing and scan.
Inclusion Criteria:
To take part in the study, the child must meet the following inclusion criteria:
1. Be between the ages of 3 to 10 years.
2. Have been diagnosed with type 1 diabetes for at least 6 months.
3. Do not have plans to move out of the area within the next 36 months.
Exclusion Criteria:
A history of head trauma with any loss of consciousness cystic fibrosis prematurity (born
less than 30 weeks of gestation) significant developmental delay (lack of single word speech
or ability to walk independently by 18 months of age) neurologic disease independent of
diabetes (eg seizure disorder or medical contraindication to MRI procedure (eg metal
appliances such as braces).
Compensation: There will be no cost to the subjects to participate in this research study.
Participants will be compensated for their time. If you are interested in participating in
this study and you meet the inclusion criteria, please contact:
Kim Caswell, APRN, BC (650)-724-1201 Email: kcaswell@stanford.edu Tandy Aye, MD
(650)-723-5791 Email: taye@stanford.edu
Name of Study: Neuropsychological and Neuroanatomical Studies in Young Children Study
Directors: Tandy Aye, MD; Bruce Buckingham, MD; Darrell Wilson, MD
About the Study: This study is being conducted to see if Type 1 diabetes mellitus has any
affect on learning, behavior and development in young children. Fifty to 60 children between
the ages of 3 to less than 10 years with Type 1 diabetes mellitus will have
neuropsychological testing and a nonsedated MRI scan of the head performed. The study will
compare the results from those with diabetes to a control group of 20-30 children between
the ages of 3 to less than 10 years without Type 1 diabetes mellitus. The control subjects
will have neuropsychological testing and a nonsedated MRI scan of the head performed as
well. All subjects maybe asked to repeat the neuropsychological testing and nonsedated MRI
scan of the head 24 months later. The children with Type 1 diabetes mellitus will not have
any changes made to their current diabetes regimen. The children with Type 1 diabetes
mellitus should continue to check blood glucose values as required by their doctors and
bring their meter(s) for downloading to each visit. The child should also tell his/her
doctor about the frequency of severe low and high blood glucose values to his/er doctor as
routinely asked.
Participant Schedule:
1. One visit for 3-4 hours at the Stanford Medical Center to complete neuropsychological
testing and to become familiar with the MRI scanner.
2. Subjects who need to become more familiar with the MRI scanning process will view a
video tape at home.
3. One visit for 1-2 hours at Stanford Medical Center to have the MRI scan of the head
completed.
4. Subjects may have the neuropsychological testing and MRI scan repeated 24 months from
time of the initial testing and scan.
Inclusion Criteria:
To take part in the study, the child must meet the following inclusion criteria:
1. Be between the ages of 3 to 10 years.
2. Have been diagnosed with type 1 diabetes for at least 6 months.
3. Do not have plans to move out of the area within the next 36 months.
Exclusion Criteria:
A history of head trauma with any loss of consciousness cystic fibrosis prematurity (born
less than 30 weeks of gestation) significant developmental delay (lack of single word speech
or ability to walk independently by 18 months of age) neurologic disease independent of
diabetes (eg seizure disorder or medical contraindication to MRI procedure (eg metal
appliances such as braces).
Compensation: There will be no cost to the subjects to participate in this research study.
Participants will be compensated for their time. If you are interested in participating in
this study and you meet the inclusion criteria, please contact:
Kim Caswell, APRN, BC (650)-724-1201 Email: kcaswell@stanford.edu Tandy Aye, MD
(650)-723-5791 Email: taye@stanford.edu
Inclusion Criteria:
- To take part in the study, you or your child must meet the following inclusion
criteria:
- Be between the ages of 3 to 10 years.
- Have been diagnosed with type 1 diabetes for at least 6 months.
- Do not have plans to move out of the area within the next 36 months.
Exclusion Criteria:
If the interested participant has a history of:
- head trauma with any loss of consciousness,
- cystic fibrosis,
- prematurity (born less than 30 weeks of gestation),
- significant developmental delay (lack of single word speech or ability to walk
independently by 18 months of age),
- neurologic disease independent of diabetes (eg seizure disorder or medical
contraindication to MRI procedure (eg metal appliances such as braces)
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