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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
  Purpose
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.

Condition Intervention
Diabetes Device: FreeStyle Navigator II Continuous Glucose Monitoring System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: FreeStyle Navigator II Continuous Glucose Monitor Home Use Evaluation (FSNv2)

Resource links provided by NLM:


Further study details as provided by Abbott Diabetes Care:

Primary Outcome Measures:
  • Clarke Error Grid Analysis [ Time Frame: 15 days sensor wear ]
    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.


Enrollment: 31
Study Start Date: October 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Type 1 or 2 diabetes, MDI or pump 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with type 1 or 2 diabetes requiring multiple daily insulin injections or using an insulin pump
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01455064


Locations
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30309
United States, New Mexico
Southwest Clinical Research Center
Santa Fe, New Mexico, United States, 87505
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
Study Director: Shridhara A Karinka, Ph.D. Abbott Diabetes Care
  More Information

Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT01455064     History of Changes
Other Study ID Numbers: ADC11-106
First Submitted: October 15, 2011
First Posted: October 19, 2011
Results First Submitted: February 7, 2013
Results First Posted: July 22, 2013
Last Update Posted: July 22, 2013
Last Verified: May 2013