NCT00358254

Noninvasive Skin Spectroscopy for Diabetes Screening

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: InLight Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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).

Conditions

• Prediabetic State
• Diabetes Mellitus, Type 2

Timeline

• Start date: 2004-10-01
• Completion: 2007-12-01
• First posted: 2006-07-31
• Last updated: 2010-07-22

Locations

2 sites across 1 country: United States