Clinical Trial Protocol for NINJA 2 System With CONTOUR Sensor
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Ascensia Diabetes Care
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 15mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the performance of an investigational blood glucose meter with the Contour sensor strip. It was decided that this investigational monitoring system would not be part of a regulatory submission and it will not proceed to marketed product.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females, 18 years of age and above
- •Type 1 or type 2 diabetes
- •Currently self-testing blood glucose at home at least twice daily
- •Able to speak, read, and understand English
- •Willing to complete all study procedures
Exclusion Criteria
- •Currently Pregnant
- •Hemophilia or any other bleeding disorder
- •Employee of competitive medical device company
- •Cognitive disorder or other condition which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
Outcomes
Primary Outcomes
Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 15mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method
Time Frame: 2 hours
Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results \<75mg/dL) or +/- 5 to 20% (for reference BG results \>=75mg/dL) of the reference method results.
Secondary Outcomes
- Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method(2 hours)
- Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)(2 hours)
- Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method(2 hours)