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Point of Service Diabetes Screening Evaluation (POSSE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669616
First Posted: August 21, 2012
Last Update Posted: January 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VeraLight, Inc.
  Purpose
The primary objective of the trial is to collect SCOUT DS, random capillary glucose and Hemoglobin A1c measurements from subject 18 years of age or older.

Condition
Diabetes Mellitus, Non-Insulin Dependent

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Point of Service Diabetes Screening Evaluation

Further study details as provided by VeraLight, Inc.:

Primary Outcome Measures:
  • To compare the accuracy of SCOUT DS versus random capillary glucose and several diabetes risk assessment questionnaires for detection of HbA1c-defined dysglycemia. [ Time Frame: one week ]

Enrollment: 667
Study Start Date: August 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Detailed Description:
The objectives of this study are to compare the accuracy of SCOUT versus random capillary glucose and several diabetes risk assessment questionnaires for detection of HbA1C-defined dysglycemia.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Attendees of Blue Cross Blue Shield Wellness Event
Criteria

Inclusion Criteria:

  • 18 years of age or older

Exclusion Criteria:

  • Known to be pregnant (self-reported)
  • Receiving dialysis or known renal compromise
  • Known to have photosensitivity
  • Taking medications that fluoresce
  • Have scars, any tattoos, rashes or other disruption/discoloration on the left volar forearm
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669616


Locations
United States, Louisiana
Blue Cross Blue Shield of Louisiana
Baton Rouge, Louisiana, United States, 70809
Sponsors and Collaborators
VeraLight, Inc.
Investigators
Principal Investigator: Andrea Barrack, MD Blue Cross Blue Shield of Louisiana
  More Information

Responsible Party: VeraLight, Inc.
ClinicalTrials.gov Identifier: NCT01669616     History of Changes
Other Study ID Numbers: VL-2723
First Submitted: July 23, 2012
First Posted: August 21, 2012
Last Update Posted: January 15, 2013
Last Verified: January 2013

Keywords provided by VeraLight, Inc.:
Type 2 Diabetes
Adults 18 years and older

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases