Performance Evaluation of an Investigational Blood Glucose Monitoring System
| Status: | Completed |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2012 |
| End Date: | May 2012 |
Performance of the CONTOUR® PLUS Blood Glucose Monitoring System With CONTOUR® PLUS Strip
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.
operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose
results.
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).
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