Clinical Trial Protocol for Contour Link System With Contour Sensor

Ascensia Diabetes Care1 site in 1 country78 target enrollmentDecember 2010

ConditionsDiabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes
Sponsor: Ascensia Diabetes Care
Enrollment: 78
Locations: 1
Primary Endpoint: Percent of Fingerstick Blood Glucose (BG) Results Within +/-20%(>=75 mg/dL) and Within +/- 15mg/dL (<75 mg/dL) of Laboratory Glucose Method
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Subjects with diabetes and study staff used an investigational blood glucose monitoring system.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

December 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ascensia Diabetes Care

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Percent of Fingerstick Blood Glucose (BG) Results Within +/-20%(>=75 mg/dL) and Within +/- 15mg/dL (<75 mg/dL) of Laboratory Glucose Method

Time Frame: 1 hour

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.