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Noninvasive Skin Spectroscopy for Diabetes Screening

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ClinicalTrials.gov Identifier: NCT00358254
Recruitment Status : Completed
First Posted : July 31, 2006
Last Update Posted : July 22, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The objective of this study is to assess the performance of a noninvasive device for the early screening of Diabetes Mellitus.

Condition or disease Phase
Prediabetic State Diabetes Mellitus, Type 2 Phase 1

Detailed Description:
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).

Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Noninvasive Skin Spectroscopy for Diabetes Screening
Study Start Date : October 2004
Study Completion Date : December 2007
Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Those at risk for diabetes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358254


Locations
United States, New Mexico
InLight Solutions
Albuquerque, New Mexico, United States, 87106
Tricore Reference Laboratory- Presbyterian Professional Building
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
InLight Solutions
VeraLight, Inc.
Investigators
Principal Investigator: Mark Rohrscheib, M.D. UNMHSC
More Information

ClinicalTrials.gov Identifier: NCT00358254     History of Changes
Other Study ID Numbers: ILS-04-262
First Posted: July 31, 2006    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: November 2007

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases