Blood Glucose Testing and You

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT01453413
First received: September 30, 2011
Last updated: February 21, 2013
Last verified: February 2013
Results First Received: November 12, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Diabetes
Intervention: Other: Blood Glucose meter

  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
People With Type 2 Diabetes Perceived BG value versus measured BG for people with type 2 diabetes who are in attendance at a diabetes conference

Participant Flow:   Overall Study
    People With Type 2 Diabetes  
STARTED     297  
COMPLETED     297  
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
People With Type 2 Diabetes People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on Contour® Blood Glucose meter, subjects were informed of their BG value. Three subjects were excluded from all analyses due to inconsistencies in responses to inclusion / exclusion questions. So 294 subjects were included in demographics analyses.

Baseline Measures
    People With Type 2 Diabetes  
Number of Participants  
[units: participants]
  294  
Age  
[units: years]
Mean ( Full Range )
  59  
  ( 19 to 86 )  
Gender  
[units: participants]
 
Female     177  
Male     117  
Region of Enrollment  
[units: participants]
 
United States     294  



  Outcome Measures
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1.  Primary:   Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose   [ Time Frame: 1 visit 15-20 minutes ]

2.  Secondary:   Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose   [ Time Frame: 1 visit 15-20 minutes ]


  Serious Adverse Events


  Other Adverse Events


  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.


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: Dr. Steven Edelman, MD
Organization: Taking Control of Your Diabetes
phone: 858-755-5683
e-mail: svedelman@vapop.ucsd.edu


No publications provided


Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT01453413     History of Changes
Other Study ID Numbers: CTD PRO 2011-003-01
Study First Received: September 30, 2011
Results First Received: November 12, 2012
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board