Performance of an Investigational Blood Glucose Monitoring System

Performance of the Ninja 3 Plus Blood Glucose Monitoring System

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

• Inclusion Criteria:

  1. Males and females, 18 years of age or older.
  2. People with type 1 or type 2 diabetes.
  3. Able to speak, read and understand English.
  4. Willing to complete all study procedures.

• Exclusion Criteria:

  1. Hemophilia or any other bleeding disorder.
  2. Pregnancy.
  3. Physical, visual or neurological impairments that would make the person unable to perform testing with the BGM.
  4. Previously participated in a blood glucose monitoring study using the Ninja 3 Plus BGMS.
  5. Working for a medical laboratory, hospital or other clinical setting that involves training on or clinical use of blood glucose meters.
  6. Working for a competitive medical device company, or having an immediate family member who works for such a company.
  7. A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk.