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

Baseline Measures
    Health Care Professionals and Lay Users  
Number of Participants  
[units: participants]
 		  51  
Age  
[units: years]
Median ( Full Range ) 		  53  
  ( 18 to 82 )  
Gender  
[units: participants]
 		 
Female     29  
Male     22  



  Outcome Measures
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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 ]
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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 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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