A New Glucose Meter With Alternative Site Testing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT00797212
First received: November 24, 2008
Last updated: January 26, 2012
Last verified: January 2012
Results First Received: November 12, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Diabetes Mellitus
Intervention: Device: Apollo 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
Subjects With Diabetes Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.

Participant Flow:   Overall Study
    Subjects With Diabetes  
STARTED     50  
COMPLETED     50  
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
Subjects With Diabetes Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm

Baseline Measures
    Subjects With Diabetes  
Number of Participants  
[units: participants]
  50  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     41  
>=65 years     9  
Gender  
[units: participants]
 
Female     26  
Male     24  
Region of Enrollment  
[units: participants]
 
United States     50  



  Outcome Measures
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1.  Primary:   Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results   [ Time Frame: One hour ]

2.  Secondary:   Percentage of Participants Rated as <=3 (Labeling Comprehension)   [ Time Frame: One hour ]

3.  Secondary:   Percentage of Participant Ratings for Overall Testing Experience With This Meter   [ Time Frame: One 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:  
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 more than 60 days but less than or equal to 180 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: Carmine Greene, Clinical Research Scientist
Organization: Bayer Healthcare, Diabetes Care
phone: 574-257-3040
e-mail: carmine.greene.b@bayer.com


No publications provided


Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT00797212     History of Changes
Other Study ID Numbers: CTD-2008-19
Study First Received: November 24, 2008
Results First Received: November 12, 2009
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board