Customer Support Response Study

Type 2 Diabetes Clinical Trial

— CUSTOM  

Official title:

Evaluation of Customer Support Issues, Questions, or Alleged Complaints Regarding Use of Approved Commercially Distributed Scout DS Product in the Field

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01547403
• Other study ID #: VL-2719
• Status: Withdrawn
• Phase: N/A
• First received: February 27, 2012
• Last updated: January 14, 2013
• Start date: August 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: VeraLight, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	VeraLight	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
VeraLight, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No