The Effects of High and Low Blood Glucose Values on the Brain in Children With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children between ages 3 to 10 with and without type 1 diabetes mellitus