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Performance of a New Glucose Meter System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT01264016
First received: December 18, 2010
Last updated: April 4, 2012
Last verified: April 2012

December 18, 2010
April 4, 2012
November 2010
December 2010   (final data collection date for primary outcome measure)
  • Percent of Capillary Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood. 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 +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5 to 20% (for reference BG results >=75mg/dL) of the reference method results.
  • Percent of Venous Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Healthcare professionals (study staff) used an investigational blood glucose monitoring system (BGMS) with subject venous blood. 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 +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.
Not Provided
Complete list of historical versions of study NCT01264016 on ClinicalTrials.gov Archive Site
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects (1 to 4) on their success at performing five tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.
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Performance of a New Glucose Meter System
Performance of the TATSU/Tradewind Blood Glucose Monitoring System

The purpose of this study is to evaluate the performance and acceptability of a new blood glucose monitoring system, which includes meter and sensor strip.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes
Device: Investigational Blood Glucose Monitoring System
Untrained subjects with diabetes performed Blood Glucose (BG) tests with subject's capillary fingerstick using the investigational Tradewind meter and investigational sensor. Study staff tested subject venous blood. All BG Results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.
Experimental: Intended Users of the Monitoring System
Untrained subjects with diabetes use an investigational blood glucose monitoring system.
Intervention: Device: Investigational Blood Glucose Monitoring System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 or 2 diabetes
  • Age 18 years or older
  • Routinely performs blood glucose self testing at home, at least once per day
  • Able to speak, read, and understand English.
  • Is willing to complete all study procedures

Exclusion Criteria:

  • Currently pregnant
  • Hemophilia or any other bleeding disorder
  • Taking prescription anticoagulants or has clotting problems that may prolong bleeding. Taking aspirin daily is not excluded
  • Subject employee of competitive medical device company
  • Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01264016
CTD-2010-004-01
No
Bayer HealthCare, Diabetes Care
Bayer HealthCare, Diabetes Care
Not Provided
Principal Investigator: Timothy Bailey, MD AMCR Institute
Bayer HealthCare, Diabetes Care
April 2012

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