Bias Source of Signal in SCOUT DS (BSOS)

This study has been terminated.
(Protocol no longer meets sponsor objectives)
Sponsor:
Information provided by (Responsible Party):
VeraLight, Inc.
ClinicalTrials.gov Identifier:
NCT01550328
First received: March 1, 2012
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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


Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bias Source of Signal in SCOUT DS

Resource links provided by NLM:


Further study details as provided by VeraLight, Inc.:

Primary Outcome Measures:
  • Determine Device Bias [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

    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



Enrollment: 25
Study Start Date: April 2012
Study Completion Date: January 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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.

  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

Subjects must be 18 years of age or greater.

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)
  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: NCT01550328

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

No publications provided

Responsible Party: VeraLight, Inc.
ClinicalTrials.gov Identifier: NCT01550328     History of Changes
Other Study ID Numbers: VL-2721
Study First Received: March 1, 2012
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 22, 2014