Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation

Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation

Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of a new Blood Glucose Monitoring System.

Summary of Inclusion Criteria:

• Able to voluntarily provide written informed consent to participate in the study.
• User Performance Accuracy Testing Only: Self-Monitoring - Subject is currently performing unassisted self-monitoring of blood glucose.

Exclusion Criteria:

• Female subjects who are pregnant or lactating.
• Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.
• User Performance Accuracy Testing Only -Prior involvement with the investigational BGMS being used in this study.