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Noninvasive Blood Glucose Monitoring Using Otoacoustic Emissions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Portland VA Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Portland VA Medical Center
ClinicalTrials.gov Identifier:
NCT01073137
First received: February 22, 2010
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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
Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Blood Glucose Monitoring Using Otoacoustic Emissions

Resource links provided by NLM:


Further study details as provided by Portland VA Medical Center:

Primary Outcome Measures:
  • Otoacoustic emissions change with blood sugar levels [ Time Frame: One 2-hour screening visit, and on 4-hour visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: June 2006
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetic Subjects
Non diabetic subjects

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Diabetese subjects with no hearing impairement.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073137

Contacts
Contact: Peter G Jacobs, MSEE 503-220-8262 ext 55949 Peter.Jacobs@va.gov

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

No publications provided

Responsible Party: Eric A. Wan, Oregon Health & Sciences University
ClinicalTrials.gov Identifier: NCT01073137     History of Changes
Other Study ID Numbers: 1R21DK079283-01A1
Study First Received: February 22, 2010
Last Updated: February 22, 2010
Health Authority: United States: Federal Government

Keywords provided by Portland VA Medical Center:
diabetes

ClinicalTrials.gov processed this record on November 24, 2014