Noninvasive Skin Spectroscopy for Diabetes Screening
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Purpose
The objective of this study is to assess the performance of a noninvasive device for the early screening of Diabetes Mellitus.
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Noninvasive Skin Spectroscopy for Diabetes Screening |
| Estimated Enrollment: | 1000 |
| Study Start Date: | October 2004 |
| Study Completion Date: | December 2007 |
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 |
Those at risk for diabetes
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| United States, New Mexico | |
| InLight Solutions | |
| Albuquerque, New Mexico, United States, 87106 | |
| Tricore Reference Laboratory- Presbyterian Professional Building | |
| Albuquerque, New Mexico, United States, 87106 | |
| 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 May 21, 2013