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
Results First Received: April 27, 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: Contour Link 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 Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.

Participant Flow:   Overall Study
    Intended Users of the System  
STARTED     78  
COMPLETED     77  
NOT COMPLETED     1  
Adverse Event                 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.
No text entered.

Reporting Groups
  Description
Intended Users of the System Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.

Baseline Measures
    Intended Users of the System  
Number of Participants  
[units: participants]
  77  
Age, Customized  
[units: years]
Mean ( Full Range )
  55  
  ( 20 to 85 )  
Gender  
[units: participants]
 
Female     41  
Male     36  
Region of Enrollment  
[units: participants]
 
United States     77  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation)   [ 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: Dr. Daniel Brown
Organization: Bayer Healthcare, Diabetes Care
phone: 574-256-7754
e-mail: daniel.brown@bayer.com


No publications provided


Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT01328717     History of Changes
Other Study ID Numbers: R&D-2010-2011.09
Study First Received: April 1, 2011
Results First Received: April 27, 2012
Last Updated: August 2, 2012
Health Authority: United States: Institutional Review Board