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

October 15, 2011
May 13, 2013
October 2011
December 2011   (final data collection date for primary outcome measure)
Clarke Error Grid Analysis [ Time Frame: 15 days sensor wear ] [ Designated as safety issue: No ]
Percentage of CGM results in the clinically accurate Zone A and percentage of CGM results in the clinically acceptable Zones A and B of the Clarke Error Grid versus blood glucose reference.
Not Provided
Complete list of historical versions of study NCT01455064 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Navigator II Continuous Glucose Monitor Home Use Study
FreeStyle Navigator II Continuous Glucose Monitor Home Use Evaluation (FSNv2)

This research study will test a new investigational continuous glucose monitoring system (System). The purpose of this study is to find out about the performance of the System in a home use environment over a 15 day period, in people with diabetes.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with type 1 or 2 diabetes requiring multiple daily insulin injections or using an insulin pump

Diabetes
Device: FreeStyle Navigator II Continuous Glucose Monitoring System
This is not an interventional study. Subjects must maintain their own diabetes treatment regimen throughout the study duration
Type 1 or 2 diabetes, MDI or pump
Intervention: Device: FreeStyle Navigator II Continuous Glucose Monitoring System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
January 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

The subject must:

  • Have type 1 or 2 diabetes for at least 2 years prior to enrollment.
  • Require insulin therapy administered through an insulin pump or multiple daily injections (MDI) for at least 6 months prior to enrollment.
  • Be at least 18 years of age.
  • Be able to read and understand English.
  • In the investigator's opinion, be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
  • Be available for all study visits.
  • Be willing to provide written signed and dated informed consent.

Exclusion Criteria:

The subject must not:

  • Be pregnant or likely to become pregnant during the study duration.
  • Have skin abnormalities at the insertion sites.
  • Have known allergy to medical grade adhesive or skin disinfectant.
  • Be using a continuous glucose monitor currently or within the past 6 months
  • Have a concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject.
  • Be participating in another clinical trial.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01455064
ADC11-106
No
Abbott Diabetes Care
Abbott Diabetes Care
Not Provided
Study Director: Shridhara A Karinka, Ph.D. Abbott Diabetes Care
Abbott Diabetes Care
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP