Noninvasive Blood Glucose Monitoring Using Otoacoustic Emissions

NCT ID: NCT01073137

Last Updated: 2010-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-06-30

Brief Summary

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The purpose of the research is to determine whether a noninvasive hearing test may be used to predict blood glucose in people with diabetes.

Detailed Description

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Participation in the study will involve listening to sounds through earphones while blood glucose levels are measured by taking blood samples using a lancet. During the study, blood glucose levels will be increased by drinking a beverage containing sugar.

Up to five visits to the NCRAR will be needed over a six-month period to complete the study. Each visit lasts either two or four hours, and will be scheduled at your convenience. You will be paid $20 for the first 2-hour screening visit and $50 for each 4-hour visit. You will be paid $30 if you are selected to participate in a 2-hour Attention Correlation Test that a sub-set of 10 participants will complete.

Conditions

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Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic Subjects

No interventions assigned to this group

Non diabetic subjects

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* Diabetes
* Normal hearing
* Hemoglobin A1C of 5.5-8%

Exclusion Criteria

* Volunteers may not participate if they have peripheral neuropathy

* visual impairment due to diabetic retinopathy
* organ failure (kidney, liver heart, or lungs)
* severe or unstable cardiovascular disease
* active alcohol or drug abuse
* schizophrenia
* bipolar disorder
* active major depressive disorder
* active foot ulcerations
* active viral or other infections such as HIV
* hepatitis, or pneumonia
* serious renal
* cardiac or cognitive dysfunction.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Portland VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Oregon Health & Sciences University

Principal Investigators

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Eric A Wan, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Portland VA Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Peter G Jacobs, MSEE

Role: CONTACT

503-220-8262 ext. 55949

Facility Contacts

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Peter G Jacobs, MSEE

Role: primary

503-220-8262 ext. 55949

Other Identifiers

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1R21DK079283-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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