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Clinical Trials/NCT01073137
NCT01073137
Unknown
Not Applicable

Noninvasive Blood Glucose Monitoring Using Otoacoustic Emissions

Portland VA Medical Center1 site in 1 country44 target enrollmentJune 2006
ConditionsDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
Portland VA Medical Center
Enrollment
44
Locations
1
Primary Endpoint
Otoacoustic emissions change with blood sugar levels
Last Updated
16 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2006
End Date
June 2010
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 18 years or older
  • 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

Outcomes

Primary Outcomes

Otoacoustic emissions change with blood sugar levels

Time Frame: One 2-hour screening visit, and on 4-hour visit

Study Sites (1)

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