Noninvasive Blood Glucose Monitoring Using Otoacoustic Emissions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01073137
Recruitment Status : Unknown
Verified September 2009 by Portland VA Medical Center.
Recruitment status was:  Recruiting
First Posted : February 23, 2010
Last Update Posted : February 23, 2010
Information provided by:
Portland VA Medical Center

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

Condition or disease

Detailed Description:

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.

Study Type : Observational
Estimated Enrollment : 44 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Blood Glucose Monitoring Using Otoacoustic Emissions
Study Start Date : June 2006
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Diabetic Subjects
Non diabetic subjects

Primary Outcome Measures :
  1. Otoacoustic emissions change with blood sugar levels [ Time Frame: One 2-hour screening visit, and on 4-hour visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diabetese subjects with no hearing impairement.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01073137

Contact: Peter G Jacobs, MSEE 503-220-8262 ext 55949

United States, Oregon
Portland VA Medical Center Recruiting
Portland, Oregon, United States, 97239
Contact: Peter G Jacobs, MSEE    503-220-8262 ext 55949   
Sub-Investigator: Peter G Jacobs, MSEE         
Sponsors and Collaborators
Portland VA Medical Center
Principal Investigator: Eric A Wan, PhD Oregon Health and Science University

Responsible Party: Eric A. Wan, Oregon Health & Sciences University Identifier: NCT01073137     History of Changes
Other Study ID Numbers: 1R21DK079283-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: February 23, 2010
Last Verified: September 2009

Keywords provided by Portland VA Medical Center: