Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT01753934
Brief Summary:
About the Study: This research study is being conducted to see if diabetic ketoacidosis has any impact on learning, behavior and development in children with Type 1 diabetes mellitus. If there is an impact, is it transient or persistent? Sixty to 80 children between the ages of 4 to 17 years with Type 1 diabetes mellitus will have neuropsychological testing and a non-sedated MRI scan of the head performed. The investigators will compare this to a control group of 30-40 children between the ages of 4 to 17 years without Type 1 diabetes mellitus. 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 your doctor and bring their meter(s) for downloading to each visit. The children with Type 1 diabetes mellitus should also tell your doctor about the frequency of severe low and high blood glucose values.
Detailed Description:
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 between 10 and 17 years of age will also be asked to complete two additional abbreviated neuropsychological tests at one week and one month from enrollment.
5. Subjects may have the complete neuropsychological testing and MRI scan repeated 15 months from time of enrollment.
Study:
NCT01753934
Study Brief:
Protocol Section:
NCT01753934