Diabetes, Diabetic Ketoacidosis
Conditions
Brief summary
This is a research study to understand how diabetic ketoacidosis may affect the brain and learning and to see if these changes are transient or permanent. The investigators hope to learn more about how diabetic ketoacidosis may cause changes in brain compliance (by wearing a non-invasive head band/helmet like device from Jan Medical: The Nautilus Neurowave System™ (NNS), learning, talking, behavior, or development. The investigators will compare those results from those with diabetes mellitus to those age and gendered matched healthy controls. Possible subjects in this study have diabetes mellitus and are between the ages of 10 to less than 17 years old OR do NOT have diabetes and are between the ages of 10 to less than 17 years old.
Detailed description
At enrollment, 1 week, 1 month, 3 month, 12 month Computerized neurocognitive testing Wear NNS MRI of the brain at 3 month and 12 months Formal neurocognitive testing at 3 months and 12 months
Interventions
Subjects will wear the headband/helmet-like device for approximately 10 minutes on four different occasions: t=0, t=1week, t=1month, t=3months. Of note, part of the device also involves electrodes that are worn to obtain an electrocardiogram or EKG.
DEVICEMRI
MRI study of the brain will be performed at t=3months.
Sponsors
Jan Medical, Inc.
Stanford University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
To be eligible for the study, all subjects must meet the following criteria: 1. Healthy control OR 2. Clinical new onset or established diagnosis of diabetes with diabetes ketoacidosis as defined by the Pediatric Endocrine Society Consensus Statement guidelines 3. Age 10 years to less than 17 years 4. Parent/guardian understand the study protocol and agrees to comply with it. 5. Primary care giver (i.e parent/guardian) comprehends written English. This is due to the fact that questionnaires and neurocognitive testing tools used as outcome measures do not have validated versions in Spanish or other language. Subject comprehends and speaks English.
Exclusion criteria
Subjects who meet any of the following criteria are not eligible for the study: 1. History of head trauma with any loss of consciousness 2. History of premature birth (less than 30 weeks of gestation) 3. History of significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age 4. History of neurologic disease independent of diabetes (seizure disorder)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unique signal measured in Hertz | 3 months | We will be using the brain compliance measurement device to see if there is a unique signal for those with DKA and if so, follow the duration of this signal. |
Countries
United States
Outcome results
None listed