Noninvasive Blood Glucose Monitoring Using Otoacoustic Emissions

Diabetes Clinical Trial

Official title:

Noninvasive Blood Glucose Monitoring Using Otoacoustic Emissions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01073137
• Other study ID #: 1R21DK079283-01A1
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2010
• Last updated: February 22, 2010
• Start date: June 2006
• Est. completion date: June 2010

Study information

• Verified date: September 2009
• Source: Portland VA Medical Center
• Contact: Peter G Jacobs, MSEE
• Phone: 503-220-8262
• Email: Peter.Jacobs[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
United States	Portland VA Medical Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Portland VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Otoacoustic emissions change with blood sugar levels		One 2-hour screening visit, and on 4-hour visit	No