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Evaluation of a Diabetes Data Management System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT00694070
First received: June 6, 2008
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
Results First Received: July 1, 2009  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Cross-Sectional
Condition: Diabetes

  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
Health Care Professionals and Lay Users h= 8 health care professionals p= 43 lay users

Participant Flow:   Overall Study
    Health Care Professionals and Lay Users  
STARTED     51  
COMPLETED     51  
NOT COMPLETED     0  



  Baseline Characteristics
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  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program)   [ Time Frame: 1-2 hours ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants Rated as <= 3 (Success in Using the Program)   [ Time Frame: 1-2 hours ]
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3.  Primary:   Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports)   [ Time Frame: 1-2 hours ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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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 NOT 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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Clinical Research Scientist
Organization: Bayer Healthcare, Diabetes Care
phone: 574-257-3063


No publications provided


Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT00694070     History of Changes
Other Study ID Numbers: CTD-2008-11
Study First Received: June 6, 2008
Results First Received: July 1, 2009
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board