Customer Support Response Study

NCT01547403 | Withdrawn

• 1 other identifier: VL-2719
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the CUSTOM study is to respond to customer support issues (outside of the US) and to assess the impact of a particular treatment or perturbation relative to an initial control measurement. Sequential subject measurements will be analyzed to determine if a given action or condition induces a score shift, an inflation of measurement variance or elevated outlier rates.

Conditions

Type 2 Diabetes

Keywords

Screening for Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint for CUSTOM Trial

  The primary objective of the CUSTOM study is to respond to customer support issues and to assess the impact of a particular treatment or perturbation relative to an initial control measurement. Sequential subject measurements will be analyzed to determine if a given action or condition induces a score shift. Subjects will undergo measurements and a diabetes risk score is generated from the SCOUT device. The scale of the score is 0-100. Subjects are not provided with this score as the device is still investigational in the US.

  Up to 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 500 volunteers age 18 and above, of either sex and of any ethnic background, will be recruited at one site.

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)

Sponsors & Collaborators

• VeraLight, Inc.: lead

Study Sites (1)

VeraLight

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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: February 27, 2012
• First Posted: March 7, 2012
• Study Start: August 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

US (1)