Performance of the CONTOUR® PLUS Blood Glucose Monitoring System With CONTOUR® PLUS Strip
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Ascensia Diabetes Care
- Enrollment
- 220
- Locations
- 2
- Primary Endpoint
- Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/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 who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females, 18 years of age and older
- •Type 1 or type 2 diabetes
- •Able to speak, read, and understand English
- •Willing to complete all study procedures
Exclusion Criteria
- •Pregnancy
- •Hemophilia or any other bleeding disorder
- •Previously participated in a study using the CONTOUR PLUS system
- •Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors.
- •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
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
Time Frame: 1 hour
Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma) of the reference method results.
Secondary Outcomes
- Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method(1 hour)
- Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method(1 hour)
- Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method(1 hour)
- Percent of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method When Tested by Study Staff(1 hour)
- Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements(1 hour)