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

Clinical Trial Protocol for Contour Link System With Contour Sensor

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

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: Contour Link Investigational Blood Glucose Monitoring System

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Mishawaka, Indiana, United States, 46544
      • Bayer HealthCare LLC, Diabetes Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intended Users of the System; Subjects with diabetes used Contour Link Investigational Blood Glucose Monitoring System	Device: Contour Link Investigational Blood Glucose Monitoring System; 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.

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

Collaborators and Investigators

• Sponsor: Ascensia Diabetes Care

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: April 1, 2011
• First Submitted That Met QC Criteria: April 1, 2011
• First Posted (Estimate): April 5, 2011

Study Record Updates

• Last Update Posted (Estimate): February 29, 2016
• Last Update Submitted That Met QC Criteria: January 29, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: R&D-2010-2011.09