At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Trial Protocol for NINJA 2 System With CONTOUR Sensor
In Brief
A clinical study evaluating Ninja 2 Investigational Blood Glucose Meter for Diabetes. Completed, enrolled 98 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.