Navigator II Continuous Glucose Monitor Home Use Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care
ClinicalTrials.gov Identifier:
NCT01455064
First received: October 15, 2011
Last updated: May 13, 2013
Last verified: May 2013
Results First Received: February 7, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Diabetes
Intervention: Device: FreeStyle Navigator II Continuous Glucose Monitoring System

  Participant Flow


  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
Observational Group Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).

Baseline Measures
    Observational Group  
Number of Participants  
[units: participants]
  31  
Age, Customized  
[units: years]
Mean ( Full Range )
  48.4  
  ( 21 to 71 )  
Gender  
[units: participants]
 
Female     15  
Male     16  
Weight  
[units: kilograms]
Mean ( Full Range )
  90.4  
  ( 52.6 to 163.7 )  
Height  
[units: meters]
Mean ( Full Range )
  1.70  
  ( 1.50 to 1.93 )  
Years since diagnosis  
[units: years]
Mean ( Full Range )
  19.6  
  ( 5 to 47 )  
Daily total insulin dosage  
[units: units]
Mean ( Full Range )
  72.8  
  ( 22 to 186 )  
Total number of injections per day  
[units: injections (N subjects = 18)]
Mean ( Full Range )
  3.6  
  ( 2 to 5 )  



  Outcome Measures

1.  Primary:   Clarke Error Grid Analysis   [ Time Frame: 15 days sensor wear ]


  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