Clinical trial NCT01547403: Customer Support Response Study
Official title: Evaluation of Customer Support Issues, Questions, or Alleged Complaints Regarding Use of Approved Commercially Distributed Scout DS Product in the Field
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Type 2 Diabetes
Keywords: Screening for Type 2 Diabetes
Lead sponsor: VeraLight, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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)

Primary outcomes:
measure: Primary Endpoint for CUSTOM Trial
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: VeraLight
state: New Mexico
Study officials:
affiliation: VeraLight, Inc.
name: Jon Aase, MD
role: PRINCIPAL_INVESTIGATOR
References: