Point of Service Diabetes Screening Evaluation (POSSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VeraLight, Inc.
ClinicalTrials.gov Identifier:
NCT01669616
First received: July 23, 2012
Last updated: January 13, 2013
Last verified: January 2013
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: VeraLight, Inc.
ClinicalTrials.gov Identifier: NCT01669616     History of Changes
Other Study ID Numbers: VL-2723
Study First Received: July 23, 2012
Last Updated: January 13, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 25, 2014