User Performance Evaluation of an Investigational Blood Glucose Monitoring System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT01410773
First received: August 3, 2011
Last updated: August 31, 2012
Last verified: August 2012
Results First Received: July 31, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Diabetes
Intervention: Device: Ninja 2 Investigational Blood Glucose Monitoring System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intended Users of the System

Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.

Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor.


Participant Flow:   Overall Study
    Intended Users of the System  
STARTED     110  
COMPLETED     110  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Intended Users of the System

Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.

Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor.


Baseline Measures
    Intended Users of the System  
Number of Participants  
[units: participants]
  110  
Age, Customized  
[units: years]
Mean ( Full Range )
 
Mean (Full range of ages)     53.1  
  ( 19 to 86 )  
Gender  
[units: participants]
 
Female     58  
Male     52  
Region of Enrollment  
[units: participants]
 
United States     110  



  Outcome Measures
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1.  Primary:   Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method   [ Time Frame: 1 hour ]

2.  Secondary:   Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method   [ Time Frame: 1 hour ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jane Wallace
Organization: Bayer Healthcare, Diabetes Care
phone: 574-257-3063
e-mail: jane.wallace@bayer.com


No publications provided


Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT01410773     History of Changes
Other Study ID Numbers: R&D-2010-2011.32
Study First Received: August 3, 2011
Results First Received: July 31, 2012
Last Updated: August 31, 2012
Health Authority: United States: Institutional Review Board