NCT01550328

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
23 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 15, 2013

Status Verified

January 1, 2013

Enrollment Period

5 months

First QC Date

March 1, 2012

Last Update Submit

January 14, 2013

Conditions

Type 2 Diabetes

Keywords

Screening for Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects must be 18 years of age or greater.

You may qualify if:

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

You may not qualify if:

  • 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.
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VeraLight

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jon Aase, MD

    VeraLight, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 9, 2012

Study Start

April 1, 2012

Primary Completion

September 1, 2012

Study Completion

January 1, 2013

Last Updated

January 15, 2013

Record last verified: 2013-01

Locations

US(1)