DiabetesNCT01753921
Evaluation of a Non-invasive Brain Compliance Measurement Device
An observational study of Diabetes and Diabetic Ketoacidosis, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetic Ketoacidosis
- What is being tested?
- this is not an intervention study and MRI
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children between 10-16 with DKA
Who may be able to join
- To be eligible for the study, all subjects must meet the following criteria:
- Healthy control OR
- Clinical new onset or established diagnosis of diabetes with diabetes ketoacidosis as defined by the Pediatric Endocrine Society Consensus Statement guidelines
- Age 10 years to less than 17 years
- Parent/guardian understand the study protocol and agrees to comply with it.
- 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.
Who cannot join
- Subjects who meet any of the following criteria are not eligible for the study:
- History of head trauma with any loss of consciousness
- History of premature birth (less than 30 weeks of gestation)
- History of significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age
- History of neurologic disease independent of diabetes (seizure disorder)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Diabetes, Diabetic Ketoacidosis
- Being tested
- this is not an intervention study, MRI
- Medical subject headings
- Diabetes Mellitus, Diabetic Ketoacidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
this is not an intervention studyOther
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.
this is not an intervention studyOther
Subjects will be asked to participate in both computerized and non-computerized tests to assess subjects' cognitive (learning, language and memory) abilities, developmental level, and behavior. Tests will take place at t=0, t=1week, t=1month, t=3months.
MRIDevice
MRI study of the brain will be performed at t=3months.
| Study group | Role | What they receive |
|---|---|---|
| DKA Group | Subjects who presented in diabetic ketoacidosis. Receives: Other: this is not an intervention study; Device: MRI | |
| Healthy control | Control subjects without diabetes. Receives: Other: this is not an intervention study; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unique signal measured in Hertz
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startNov 2011
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Jan Medical, Inc.
- Responsible party
- Principal investigator, Tandy Aye, Stanford University
- Investigators
- Tandy Aye, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753921
- Sponsor's protocol ID
- 22727
- Status last verified
- Nov 2019
- First submitted
- 18 Sep 2012
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Non-invasive Brain Compliance Measurement Device
- ClinicalTrials.gov ID
- NCT01753921
- Acronym / sponsor ID
- 22727
- Conditions
- Diabetes, Diabetic Ketoacidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Jan Medical, Inc.
- Study start
- Nov 2011
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DKA Group | – | Other: this is not an intervention study, Device: MRISubjects who presented in diabetic ketoacidosis. |
| Healthy control | – | Other: this is not an intervention study, Device: MRIControl subjects without diabetes. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children between 10-16 with DKA
Key inclusion criteria (6 listed)
- Healthy control OR
- Clinical new onset or established diagnosis of diabetes with diabetes ketoacidosis as defined by the Pediatric Endocrine Society Consensus Statement guidelines
- Age 10 years to less than 17 years
- Parent/guardian understand the study protocol and agrees to comply with it.
- 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.
Key exclusion criteria (5 listed)
- History of head trauma with any loss of consciousness
- History of premature birth (less than 30 weeks of gestation)
- History of significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age
- History of neurologic disease independent of diabetes (seizure disorder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| this is not an intervention studySubjects 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. | Other | DKA Group, Healthy control |
| this is not an intervention studySubjects will be asked to participate in both computerized and non-computerized tests to assess subjects' cognitive (learning, language and memory) abilities, developmental level, and behavior. Tests will take place at t=0, t=1week, t=1month, t=3months. | Other | DKA Group, Healthy control |
| MRIMRI study of the brain will be performed at t=3months. | Device | DKA Group, Healthy control |
Primary outcome
Unique signal measured in Hertz
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tandy Aye, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetic Ketoacidosis, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unique signal measured in Hertz (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.