Noninvasive Blood Glucose Monitoring Using Otoacoustic Emissions

February 22, 2010 updated by: Portland VA Medical Center
The purpose of the research is to determine whether a noninvasive hearing test may be used to predict blood glucose in people with diabetes.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Portland VA Medical Center
        • Contact:
        • Sub-Investigator:
          • Peter G Jacobs, MSEE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetese subjects with no hearing impairement.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Diabetic Subjects
Non diabetic subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Otoacoustic emissions change with blood sugar levels
Time Frame: One 2-hour screening visit, and on 4-hour visit
One 2-hour screening visit, and on 4-hour visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portland VA Medical Center

Investigators

  • Principal Investigator: Eric A Wan, PhD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

February 22, 2010

First Submitted That Met QC Criteria

February 22, 2010

First Posted (Estimate)

February 23, 2010

Study Record Updates

Last Update Posted (Estimate)

February 23, 2010

Last Update Submitted That Met QC Criteria

February 22, 2010

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1R21DK079283-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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