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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
Sponsor:
Information provided by (Responsible Party):
VeraLight, Inc.

Tracking Information
First Submitted Date March 1, 2012
First Posted Date March 9, 2012
Last Update Posted Date January 15, 2013
Study Start Date April 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 6, 2012)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bias Source of Signal in SCOUT DS
Official Title Bias Source of Signal in SCOUT DS
Brief Summary The primary objective is to identify device characteristics, components or subsystems that manifest as screening score bias in SCOUT DS.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects must be 18 years of age or greater.
Condition Type 2 Diabetes
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: March 6, 2012)
25
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2013
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01550328
Other Study ID Numbers VL-2721
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party VeraLight, Inc.
Study Sponsor VeraLight, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Jon Aase, MD VeraLight, Inc.
PRS Account VeraLight, Inc.
Verification Date January 2013