Noninvasive Skin Spectroscopy for Diabetes Screening

Completed

• Conditions: Prediabetic State; Diabetes Mellitus, Type 2

• Registration Number: NCT00358254
• Lead Sponsor: InLight Solutions

Brief 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).

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2006-07-27
• Study First Submitted QC: 2006-07-27
• Study First Posted: 2006-07-31
• Status Verified: 2007-11
• Study Completion: 2007-12
• Last Update Submitted: 2010-07-21
• Last Update Posted: 2010-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Tricore Reference Laboratory- Presbyterian Professional Building; 🇺🇸 Albuquerque, New Mexico, United States

InLight Solutions; 🇺🇸 Albuquerque, New Mexico, United States