Diabetes Research in Children Network (DirecNet)

Protocol: Cognitive and Neuroanatomical Consequences of Type 1 Diabetes in Young Children
Status: Closed
Start Date: 06/02/2010
End Date: 09/09/2013
Clinical Trial ID:  
Public Dataset:  

Cognitive and Neuroanatomical Consequences of Type 1 Diabetes in Young Children
 
Click Here to View Protocol
 
Study Objectives:
  • To characterize the neuroanatomical differences in very young children with T1DM and to prospectively determine the changes that occur over the course of two years in comparison with (1) results obtained from a demographically similar group of control children without diabetes, preferably siblings, and (2) publicly available normative data for the various measures.
  • To correlate these neuroanatomical changes with the level of hypo- and hyperglycemia exposure as measured with continuous glucose sensors as well as level of glycemia as measured by HbA1c.
  • To correlate these neuroanatomical findings with targeted measures of neuropsychological function at baseline and over 18 months in very young children with T1DM and controls.
To take part in the study, diabetic subjects will need:
 
  1. Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one month
  2. Age 4.0 to <8.0 years
  3. Positive antibody testing if onset of T1D < 1 year of age (At least one of GAD65, ICA512 or mIAA must be positive)
  4. Full-term birth (>34 weeks without complications)
  5. Parent/guardian understands the study protocol and agrees to comply with it
  6. Subject and primary care giver (i.e., parent or guardian if subject is a minor) comprehend written English (This requirement is due to the fact that some of the neuropsychological tests are only available in English)
  7. No expectation that subject will be moving out of the area of the clinical center during the next 18 months, unless the move will be to an area served by another study center.
  8. Willingness to use a blinded CGM at 3-month intervals or already using a CGM on a regular basis
  9. Informed Consent Form signed by the parent/guardian, with subjects signing the Child Assent Form when required by the local IRB.
 
Non-diabetic Subjects will need:
  1. Age 4.0 years to less than 8.0 years
  2. Full-term birth (>34 weeks without complications)
  3. Parent/guardian understands the study protocol and agrees to comply with it
  4. Primary care giver (i.e., parent or guardian) comprehends written English
  5. No expectation that subject/family will be moving out of the area of the clinical center during the next 18 months
  6. HbA1c <6.0% as measured by a DCA2000 or other local point of care device
  7. Fasting glucose <110 mg/dL as measured by a HGM
  8. For relatives of an individual with T1D, negative antibody testing within the last year (GAD65, ICA512, mIAA)
  9. Subjects who have not had a negative test in the last year will have a sample drawn to send to a central laboratory for testing
 
Study Procedures:
 
Diabetic Subjects
  • At baseline and at 18 months: HbA1c, brain MRI and cognitive testing
  • At baseline and every 3 months: HbA1c and blinded CGM used for one week to assess glucose levels
 
Non-diabetic Subjects
  • At baseline and at 18 months: HbA1c, brain MRI and cognitive testing


Back

© 2007 -2018 Jaeb Center for Health Research
All forms and reports on this site require Adobe Acrobat Reader. Click HERE to download a free copy of Adobe.
Although JCHR supports various web browsers, only Internet Explorer version 11 is fully tested and validated to function on this site.
This site utilizes popup windows.