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CompletedNCT00358254Updated Jul 22, 2010

Noninvasive Skin Spectroscopy for Diabetes Screening

An observational study in Prediabetic State and Diabetes Mellitus, Type 2, sponsored by InLight Solutions. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-07-22.

Sponsored by InLight Solutions · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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).

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Conditions studied

  • Prediabetic State
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

InLight Solutions is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Exclusion Criteria:

  • Under 18 years of age.
  • Those diagnosed with Diabetes.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)
06

Study locations

2 sites
  • InLight Solutions
    Albuquerque, New Mexico 87106, United States
  • Tricore Reference Laboratory- Presbyterian Professional Building
    Albuquerque, New Mexico 87106, United States
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References and documents

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00358254
Lead sponsor
InLight Solutions
Collaborators
VeraLight, Inc.
First posted
Jul 31, 2006
Start date
Oct 2004
Completion
Dec 2007
Last update
Jul 22, 2010

Study contacts

Mark Rohrscheib, M.D.
principal investigator · UNMHSC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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