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Bias Source of Signal in SCOUT DS (BSOS)

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.
ClinicalTrials.gov Identifier: NCT01550328
Recruitment Status : Terminated (Protocol no longer meets sponsor objectives)
First Posted : March 9, 2012
Last Update Posted : January 15, 2013
Information provided by (Responsible Party):
VeraLight, Inc.

Brief Summary:
The primary objective is to identify device characteristics, components or subsystems that manifest as screening score bias in SCOUT DS.

Condition or disease
Type 2 Diabetes

Detailed Description:

In the process of calibrating multiple SCOUT DS units, consistent inter-device score differences were found. These differences could create a bias in the measurement of Diabetes Risk scores (DRS) in human subjects. This study is intended to examine two of the various subsystems of the SCOUT DS to determine whether either of them might be capable of introducing bias into the measurements, with the ultimate aim of eliminating inter-device measurement variation.

The testing of human subjects in this trial is necessary to determine whether variability in the performance of these device subsystems actually affect DRS scores in a real world setting.

The trial will be a prospective, single site, investigational trial. The trial will utilize four SCOUT DS devices. Subjects will report to the investigative site for multiple visits. The number of visits will vary between three to seven visits.

Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bias Source of Signal in SCOUT DS
Study Start Date : April 2012
Primary Completion Date : September 2012
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Determine Device Bias [ Time Frame: Up to 1 year ]

    The primary objective of this study is to identify device characteristics, components, or subsystems that manifest as screening score bias in SCOUT DS.

    The study will switch subsystems between devices and if the bias differs by more than 3.5 Diabetes Risk Score units compared to the baseline score, we would conclude that the bias was contained within that particular subsystem

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
Subjects must be 18 years of age or greater.

Inclusion Criteria:

  • Males and/ or females greater than or equal to 18 years of age

Exclusion Criteria:

  • Have received investigational treatments in the past 14 days
  • Have psychosocial issues that interfere with an ability to follow study procedures
  • Are known to be pregnant
  • Have scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
  • Have been treated in the past month with oral steroid therapy or topical steroids applied to the left forearm. Inhaled steroid therapy is not a basis for exclusion
  • Are receiving medications that fluoresce (A list of excluded medications is located in Appendix H)
  • Are known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)

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): NCT01550328

United States, New Mexico
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
VeraLight, Inc.
Principal Investigator: Jon Aase, MD VeraLight, Inc.

Responsible Party: VeraLight, Inc.
ClinicalTrials.gov Identifier: NCT01550328     History of Changes
Other Study ID Numbers: VL-2721
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: January 15, 2013
Last Verified: January 2013

Keywords provided by VeraLight, Inc.:
Screening for Type 2 diabetes

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