Evaluation of an Ascensia Diabetes Care ONYX PLUS Investigational Blood Glucose Monitoring System

Exclusion Criteria

• •Hemophilia or other bleeding disorder
• •Pregnancy
• •Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM
• •Previously participated in a BG monitor study using the ONYX PLUS BGMS
• •Working for a medical laboratory, hospital, or other clinical setting that involves training on or clinical use of blood glucose monitors
• •Working for a competitive medical device company, or having an immediate family member who works for such a company
• •A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk
• •The enrollment goal for the intended use population:
• •1. At least 70% of subjects will be younger than age 65
• •2. At least 20% of subjects will have type 1 diabetes