Ninja 2 User Performance Evaluation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Ascensia Diabetes Care
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to demonstrate that untrained subjects with diabetes can use an investigational Blood Glucose Monitoring System (BGMS) with capillary blood obtained from fingerstick and from Alternative Site (AST) Palm .
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females, 18 years of age and above
- •Diagnosed as having type 1 or type 2 diabetes
- •Currently self-testing blood glucose at home
- •Able to speak, read, and understand English
- •Willing to complete all study procedures
Exclusion Criteria
- •Blood Borne infections like hepatitis or HIV or infections such as tuberculosis
- •Hemophilia or any other bleeding disorder
- •Employee of competitive medical device company,immediate family member of such, or living within the household of such
- •Pregnancy
Outcomes
Primary Outcomes
Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method
Time Frame: 1 hour
Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Meter (BGM). BGM results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results \<75mg/dL) or within +/- 20%(for reference BG results \>=75mg/dL) of the reference method results (YSI capillary plasma).
Secondary Outcomes
- Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method(1 hour)