Noninvasive Skin Spectroscopy for Diabetes Screening

This study has been completed.
Sponsor:
Collaborator:
VeraLight, Inc.
Information provided by:
InLight Solutions
ClinicalTrials.gov Identifier:
NCT00358254
First received: July 27, 2006
Last updated: July 21, 2010
Last verified: November 2007
  Purpose

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


Condition Phase
Prediabetic State
Diabetes Mellitus, Type 2
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Noninvasive Skin Spectroscopy for Diabetes Screening

Resource links provided by NLM:


Further study details as provided by InLight Solutions:

Estimated Enrollment: 1000
Study Start Date: October 2004
Study Completion Date: December 2007
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00358254     History of Changes
Other Study ID Numbers: ILS-04-262
Study First Received: July 27, 2006
Last Updated: July 21, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 23, 2014