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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: FreeStyle Navigator II Continuous Glucose Monitoring System

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Atlanta Diabetes Associates
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • Southwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clarke Error Grid Analysis	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.	15 days sensor wear

Collaborators and Investigators

• Sponsor: Abbott Diabetes Care
• Investigators: Study Director: Shridhara A Karinka, Ph.D., Abbott Diabetes Care

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: October 15, 2011
• First Submitted That Met QC Criteria: October 15, 2011
• First Posted (ESTIMATE): October 19, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 22, 2013
• Last Update Submitted That Met QC Criteria: May 13, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: ADC11-106