Bias Source of Signal in SCOUT DS (BSOS)

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

Study Overview

• Status: Terminated
• Conditions: 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
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • VeraLight

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects must be 18 years of age or greater.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine Device Bias	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	Up to 1 year

Collaborators and Investigators

• Sponsor: VeraLight, Inc.
• Investigators: Principal Investigator: Jon Aase, MD, VeraLight, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (Estimate): March 9, 2012

Study Record Updates

• Last Update Posted (Estimate): January 15, 2013
• Last Update Submitted That Met QC Criteria: January 14, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Screening for Type 2 diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: VL-2721