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COMPLETEDNCT01753921

Evaluation of a Non-invasive Brain Compliance Measurement Device

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 ho...

Lead sponsor: Stanford University•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Stanford University

Collaborators

Jan Medical, Inc.

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

Age

10 - 16 years

Sex

ALL

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

•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)

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 13, 2019Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment14

Start dateNov 2011

Last updatedNov 13, 2019

Condition

Diabetes Diabetic Ketoacidosis

Locations shown

Stanford University

Stanford, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2019Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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