Bias Source of Signal in SCOUT DS

Type 2 Diabetes Clinical Trial

— BSOS  

Official title:

Bias Source of Signal in SCOUT DS

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01550328
• Other study ID #: VL-2721
• Status: Terminated
• Phase: N/A
• First received: March 1, 2012
• Last updated: January 14, 2013
• Start date: April 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: VeraLight, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: January 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	VeraLight	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
VeraLight, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No