Performance of an Investigational Blood Glucose Monitoring System in a Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Subjects with diabetes and study staff used an investigational blood glucose monitoring system.

Official Title
-----------------
Clinical Trial Protocol for Contour Link System With Contour Sensor

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: Contour Link Investigational Blood Glucose Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, 18 years of age and above Diagnosed as having type 1 or type 2 diabetes Currently self-testing blood glucose at home for at least three months Able to speak, read, and understand English Willing to complete all study procedures Exclusion Criteria: Gestational Diabetes Hemophilia or any other bleeding disorder Employee of competitive medical device company

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intended Users of the System<br>Subjects with diabetes used Contour Link Investigational Blood Glucose Monitoring System | Device: Contour Link Investigational Blood Glucose Monitoring System<br>* Subjects with diabetes and study staff each performed Blood Glucose tests from the subject's capillary blood obtained from fingerstick using the Contour Link investigational meter.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Fingerstick Blood Glucose (BG) Results Within +/-20%(>=75 mg/dL) and Within +/- 15mg/dL (<75 mg/dL) of Laboratory Glucose Method | Subjects with diabetes and study staff 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 +/- 20% (for reference BG results >=75mg/dL) and within +/- 15mg/dL(for reference BG results <75mg/dL) of the reference method results. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation) | Subjects read User Guide(UG)to learn to use the system and performed meter tasks. Study staff observed, then rated subjects' success (1 to 4) at performing tasks. Scale: 1.Performed tasks correctly without assistance. 2.Performed tasks correctly, but was directed to a specific part of the UG by the study staff as in a Customer Service call. 3.Performed tasks correctly, but required additional review/assistance similar to review of a specific function during a Customer Service call. 4.Subject incorrectly performed part of the testing regimen and was unaware of the error. | 1 hour |