Performance of an Investigational Blood Glucose Monitoring System in a Clinical Trial
Clinical Trial Protocol for Contour Link System With Contour Sensor
1 other identifier
interventional
78
1 country
1
Brief Summary
Subjects with diabetes and study staff used an investigational blood glucose monitoring system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
April 5, 2011
CompletedResults Posted
Study results publicly available
May 31, 2012
CompletedFebruary 29, 2016
January 1, 2016
Same day
April 1, 2011
April 27, 2012
January 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation)
1 hour
Study Arms (1)
Intended Users of the System
EXPERIMENTALSubjects with diabetes used Contour Link Investigational Blood Glucose Monitoring System
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Gestational Diabetes
- Hemophilia or any other bleeding disorder
- Employee of competitive medical device company
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bayer HealthCare LLC, Diabetes Care
Mishawaka, Indiana, 46544, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Daniel Brown
- Organization
- Ascensia Diabetes Care
Study Officials
- PRINCIPAL INVESTIGATOR
David Simmons, MD
Ascensia Diabetes Care
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2011
First Posted
April 5, 2011
Study Start
December 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
February 29, 2016
Results First Posted
May 31, 2012
Record last verified: 2016-01