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Navigator II Continuous Glucose Monitor Home Use Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01455064
First Posted: October 19, 2011
Last Update Posted: July 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abbott Diabetes Care
Results First Submitted: 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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Hide 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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  More Information