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Noninvasive Skin Spectroscopy...

Noninvasive Skin Spectroscopy for Diabetes Screening

NCT ID: NCT00358254

Last Updated: 2010-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-12-31

Brief Summary

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The objective of this study is to assess the performance of a noninvasive device for the early screening of Diabetes Mellitus.

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Detailed Description

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Approximately 18 million people have Type II diabetes, and of these, an estimated thirty-five percent are unaware of their condition. This translates to roughly 6.3 million undiagnosed cases worldwide in 2002. Many diagnoses are made years after the onset of the disease. This allows progression of the vascular lesions that arise during the time of uncontrolled glucose levels. As a result, microvascular retinopathy, nephropathy, and neuropathy are on the rise, as well as macrovascular complications such as: coronary heart disease, and cerebral vascular accidents. The prevalence and trends of diabetes underscore the need for effective and widespread screening. Our fluorescence based system under development will noninvasively measure skin glycation end products that are known to be strongly correlated with diabetes status and complications. Since the test would be painless and require no patient fasting, significant obstacles to screening compliance would be mitigated. The system offers hope for a screening test that is more sensitive and specific than the invasive tests currently used for diabetes screening (Oral Glucose Tolerance Test (OGTT) and the Fasting Plasma Glucose (FPG) test).

Conditions

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Prediabetic State Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Volunteers without Diabetes.
* Volunteers at risk for developing Type II diabetes.
* 18 years of age and older.

Exclusion Criteria

* Under 18 years of age.
* Those diagnosed with Diabetes.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VeraLight, Inc.

INDUSTRY

Sponsor Role collaborator

InLight Solutions

INDUSTRY

Sponsor Role lead

Principal Investigators

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Mark Rohrscheib, M.D.

Role: PRINCIPAL_INVESTIGATOR

UNMHSC

Locations

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InLight Solutions

Albuquerque, New Mexico, United States

Site Status

Tricore Reference Laboratory- Presbyterian Professional Building

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Related Links

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http://www.inlightsolutions.com

Related Info

http://www.veralight.com

Related Info

Other Identifiers

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ILS-04-262

Identifier Type: -

Identifier Source: org_study_id

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