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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT01268488
First received: December 29, 2010
Last updated: September 14, 2012
Last verified: September 2012

December 29, 2010
September 14, 2012
December 2010
December 2010   (final data collection date for primary outcome measure)
Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 15mg/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 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 +/- 5 to 15 mg/dL (for reference BG results <75mg/dL) or +/- 5 to 20% (for reference BG results >=75mg/dL) of the reference method results.
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Complete list of historical versions of study NCT01268488 on ClinicalTrials.gov Archive Site
  • Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 15 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 ]
    Subjects with diabetes used an investigational blood glucose meter (BGM) with subject capillary blood obtained from the palm. 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 15 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.
  • 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 the 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.
  • Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 15 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 ]
    Subjects with diabetes used an investigational blood glucose meter (BGM) with subject capillary blood obtained from the forearm. 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 15 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.
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Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting
Clinical Trial Protocol for NINJA 2 System With CONTOUR Sensor

The purpose of this study is to evaluate the performance of an investigational blood glucose meter with the Contour sensor strip. It was decided that this investigational monitoring system would not be part of a regulatory submission and it will not proceed to marketed product.

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Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes
Device: Ninja 2 Investigational Blood Glucose Meter
Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. 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 System
Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor. This BG monitoring system will not proceed to marketed product.
Intervention: Device: Ninja 2 Investigational Blood Glucose Meter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females, 18 years of age and above
  • Type 1 or type 2 diabetes
  • Currently self-testing blood glucose at home at least twice daily
  • Able to speak, read, and understand English
  • Willing to complete all study procedures

Exclusion Criteria:

  • Currently Pregnant
  • Hemophilia or any other bleeding disorder
  • 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
 
NCT01268488
CTD-2010-008-02
No
Bayer HealthCare, Diabetes Care
Bayer HealthCare, Diabetes Care
Not Provided
Principal Investigator: Michael Caswell, PhD Consumer Product Testing Company
Bayer HealthCare, Diabetes Care
September 2012

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