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Noninvasive Skin Spectroscopy for Diabetes Screening

Noninvasive Skin Spectroscopy for Diabetes Screening

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00358254
Enrollment
1000
Registered
2006-07-31
Start date
2004-10-31
Completion date
2007-12-31
Last updated
2010-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Prediabetic State

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).

Interventions

None listed

Sponsors

VeraLight, Inc.
CollaboratorINDUSTRY
InLight Solutions
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026