Clinical Evaluation including System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation.

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.
• For subjects participating in the In Vivo Glucose adjustment procedure age range is 18 - 45.

Summary of 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.