User Performance of the TV4 BGMS

Exclusion Criteria

• •Subjects without diabetes that are not naïve to Blood Glucose Monitoring System.
• •Hemophilia or any other bleeding disorder
• •Pregnancy (self-reported)
• •Physical, visual or neurological impairments that would make the person unable to perform testing with the BGMS.
• •Previous use of the Ascensia Contour Thunder V3 (TV3), or Thunder PLUS (T-PLUS), or Thunder V4 (TV4) BGMS.
• •Working for a medical laboratory, hospital or another clinical setting that involves training on, or clinical use of blood glucose monitors.
• •Being in this trial during or soon after xylose absorption testing (Xylose in the blood is known to cause interference). However, subjects can be enrolled as soon as 2 days after the test is performed (25 gms of oral xylose administered during this test is cleared within 480 mins or 8 hours).
• •A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk. The reason for exclusion will be clearly documented by investigator or designee on the subject disposition form.
• •Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.
• •* Immediate family members are the subject's parents, spouse, children, and siblings, including the parent's spouse; step-children and adopted children and their spouses.
• •* A competitive medical device company is a company that provides a medical device or components of a device that is related to diabetes.
• •People who are eligible are those who work for companies associated with products such as wound dressings, medications or dietary products.