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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT01328717
First received: April 1, 2011
Last updated: August 2, 2012
Last verified: August 2012

April 1, 2011
August 2, 2012
December 2010
December 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
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Complete list of historical versions of study NCT01328717 on ClinicalTrials.gov Archive Site
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation) [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
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.
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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.

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Interventional
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Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes
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.
Experimental: Intended Users of the System
Subjects with diabetes used an investigational blood glucose monitoring system.
Intervention: Device: Contour Link Investigational Blood Glucose Monitoring System
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01328717
R&D-2010-2011.09
No
Bayer HealthCare, Diabetes Care
Bayer HealthCare, Diabetes Care
Not Provided
Principal Investigator: David Simmons, MD Bayer HealthCare, Diabetes Care
Bayer HealthCare, Diabetes Care
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP