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Customer Support Response Study (CUSTOM)

This study has been withdrawn prior to enrollment.
(Protocol no longer meeting sponsor objectives)
Sponsor:
Information provided by (Responsible Party):
VeraLight, Inc.
ClinicalTrials.gov Identifier:
NCT01547403
First received: February 27, 2012
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Customer Support Issues, Questions, or Alleged Complaints Regarding Use of Approved Commercially Distributed Scout DS Product in the Field

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by VeraLight, Inc.:

Primary Outcome Measures:
  • Primary Endpoint for CUSTOM Trial [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

    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.



Enrollment: 0
Study Start Date: August 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Detailed Description:

The SCOUT DS device is not yet approved by the FDA for sale in the United States, but currently is being marketed in Canada and other countries. Customers who are using the device have contacted the sponsor with questions about testing conditions which might affect the reproducibility of measurements.

The objective is to obtain information to allow the Sponsor to address these issues. The concerns fall into three broad categories:

• Factors affecting the interface between the skin and the test sensor

These would include the effects of skin care products applied to the forearm, subject activity that changes perfusion to the skin and subject movement during the test procedure.

  • General operating conditions Issues such as ambient temperature, lighting, and height of the table on which the SCOUT DS device rests have been questioned as possible factors influencing accuracy.
  • Rare subject disorders

Included here would be subject skin abnormalities or physiologic changes which occur so infrequently that they were not well represented in previous data sets. Examples of such rare conditions would include scleroderma, capillary angiomata, and Raynaud phenomenon.

  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

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

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 on 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547403

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: NCT01547403     History of Changes
Other Study ID Numbers: VL-2719
Study First Received: February 27, 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 June 18, 2013