Customer Support Response Study

VeraLight, Inc.

Overview

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.

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.

Study Type

OBSERVATIONAL

Conditions

Type 2 Diabetes

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

VeraLight

Albuquerque, New Mexico, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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