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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
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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
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
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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
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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.
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  
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
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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.


Results Point of Contact:  
Name/Title: Shridhara A. Karinka, Ph.D., Director of Clinical Affairs
Organization: Abbott Diabetes Care
phone: 510-749-6393
e-mail: SHRIDHARA.ALVA@ABBOTT.COM


No publications provided


Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT01455064     History of Changes
Other Study ID Numbers: ADC11-106
Study First Received: October 15, 2011
Results First Received: February 7, 2013
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration