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
Results First Received: April 4, 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: 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 Monitoring System Untrained subjects with diabetes use an investigational blood glucose monitoring system.

Participant Flow:   Overall Study
    Intended Users of the Monitoring System  
STARTED     96  
COMPLETED     94  
NOT COMPLETED     2  
Withdrawal by Subject                 1  
Felt faint at sight of blood                 1  



  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 Monitoring System Untrained subjects with diabetes use an investigational blood glucose monitoring system. One subject withdrew voluntarily; one subject was withdrawn. One subject hematocrit measurement was missing so subject data was not evaluable.

Baseline Measures
    Intended Users of the Monitoring System  
Number of Participants  
[units: participants]
  93  
Age  
[units: years]
Mean ( Full Range )
 
Mean age (range of ages)     37.8  
  ( 18 to 73 )  
Gender [1]
[units: participants]
 
Female     47  
Male     46  
Region of Enrollment [2]
[units: participants]
 
United States     93  
[1] 94 subjects completed study; 93 subjects had evaluable blood glucose data as described in outcome measure results
[2] One subject withdrew voluntarily; one subject was withdrawn. 94 subjects completed the study.



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Secondary:   Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)   [ Time Frame: 2 hours ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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: NCT01264016     History of Changes
Other Study ID Numbers: CTD-2010-004-01
Study First Received: December 18, 2010
Results First Received: April 4, 2012
Last Updated: April 4, 2012
Health Authority: United States: Institutional Review Board