Study of an Investigational Glucose Meter System

Clinical Study of the Apollo Evolution BGMS With Tatsu Blood Glucose Test Strips

The purpose of this study is to demonstrate that untrained subjects who have diabetes or pre-diabetes can operate the investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Inclusion Criteria:

• Have a diagnosis of diabetes or pre-diabetes.
• Be 18 years of age or older
• Be able to speak, read and understand English and understand the Informed Consent document.
• Be willing to complete study procedures

Exclusion Criteria:

• Pregnancy
• Infections or skin disorders at the site of the venipuncture (at the discretion of the phlebotomist).
• Hemophilia, bleeding disorder, or clotting problems. Persons taking aspirin (81 mg or 325 mg) daily or Plavix® are not reason for exclusion.
• Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGM (at the discretion of the site professional staff).
• A condition, in the opinion of the Investigator, would put the subject at risk or influence the conduct of the study or interpretation of the results. The reason for exclusion will be documented by the professional staff.
• Previously participated in a blood glucose monitoring study using a similar device or use a similar device for personal use when monitoring blood glucose.
• 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
• Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors