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
  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 ] [ 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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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

ClinicalTrials.gov processed this record on September 18, 2014