Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358254
Status:
COMPLETED
Last Update Posted:
2010-07-22
First Post:
2006-07-27
Brief Title:
Noninvasive Skin Spectroscopy for Diabetes Screening
Sponsor:
InLight Solutions
Organization:
InLight Solutions
Study Overview
Official Title:
Noninvasive Skin Spectroscopy for Diabetes Screening
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 63 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None