Navigator II Continuous Glucose Monitor Home Use Study

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. Identifier: NCT01455064
Recruitment Status : Completed
First Posted : October 19, 2011
Results First Posted : July 22, 2013
Last Update Posted : July 22, 2013
Information provided by (Responsible Party):
Abbott Diabetes Care

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Diabetes
Intervention: Device: FreeStyle Navigator II Continuous Glucose Monitoring System

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

Participant Flow:   Overall Study
    Observational Group

  Baseline Characteristics

  Outcome Measures

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

  Serious Adverse Events

  Other Adverse Events

  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