Tatsu/Tradewind System User Performance Evaluation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Ascensia Diabetes Care
- Enrollment
- 118
- 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
This clinical trial is designed to assess an investigational blood glucose monitoring system with fingerstick blood in the hands of untrained intended users.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 1 or type 2 diabetes
- •18 years of age and older
- •Able to speak, read, and understand English
- •Willing to complete all study procedures
Exclusion Criteria
- •Previously participated in a study using this investigational system
- •Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
- •Pregnancy
- •Hemophilia or any other bleeding disorder
- •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
- •A condition which, in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).
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 tested self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS), which included an investigational meter and sensor. BGM results were compared with capillary plasm BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results were used to calculate the number of BG results within +/- 15 mg/dL (for reference BG results \<75mg/dL) or +/- 20% (for reference BG results \>=75mg/dL) of the reference method results (YSI capillary plasma).
Secondary Outcomes
- Number of Study Staff Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method When Testing Subject Blood Glucose (BG)(1 hour)