We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from within the patient population of two US diabetes clinical centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

Participant Flow:   Overall Study
    Observational Group
STARTED   31 
COMPLETED   30 
NOT COMPLETED   1 



  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.
No text entered.

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


  More Information