Performance Evaluation of Blood Glucose Monitoring System Using ISO Study Design

Performance Evaluation of the Contour TS BGMS Using ISO/DIS 15197:2011 Section 8 Study Design and Performance Criteria

The purpose of this study is to determine if untrained subjects who have diabetes can operate the Blood Glucose Monitoring System (BGMS) and obtain acceptable glucose results.

Inclusion Criteria:

• Have a diagnosis of 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 puncture site (at the discretion of the site professional staff).
• 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 Contour TS system or use the Contour TS 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