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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: Contour Link Investigational Blood Glucose Monitoring System

• Registration Number: NCT01328717
• Lead Sponsor: Ascensia Diabetes Care

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-01
• Study First Posted: 2011-04-05
• Results First Submitted: 2012-04-27
• Results First Submitted QC: 2012-04-27
• Results First Posted: 2012-05-31
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intended Users of the System	Contour Link Investigational Blood Glucose Monitoring System	Subjects with diabetes used Contour Link Investigational Blood Glucose Monitoring System

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation)	1 hour	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.

Trial Locations

Locations (1)

Bayer HealthCare LLC, Diabetes Care; 🇺🇸 Mishawaka, Indiana, United States