Noninvasive Blood Glucose Monitoring Using Otoacoustic Emissions

Portland VA Medical Center

Status: Unknown

Conditions: Diabetes

Study type: Observational

Funder types: Other U.S. Federal agency

Identifiers

NCT01073137

1R21DK079283-01A1

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

44 participants in 2 patient groups

Diabetic Subjects

Non diabetic subjects