NCT01073137

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

February 23, 2010

Status Verified

September 1, 2009

Enrollment Period

4 years

First QC Date

February 22, 2010

Last Update Submit

February 22, 2010

Conditions

Diabetes

Keywords

diabetes

Outcome Measures

Primary Outcomes (1)

  • Otoacoustic emissions change with blood sugar levels

    One 2-hour screening visit, and on 4-hour visit

Study Arms (2)

Diabetic Subjects

Non diabetic subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diabetese subjects with no hearing impairement.

You may qualify if:

  • years or older
  • Diabetes
  • Normal hearing
  • Hemoglobin A1C of 5.5-8%

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portland VA Medical Center

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Eric A Wan, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter G Jacobs, MSEE

CONTACT

503-220-8262Peter.Jacobs@va.gov

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 23, 2010

Study Start

June 1, 2006

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

February 23, 2010

Record last verified: 2009-09

Locations

US(1)