FreeStyle Navigator II Continuous Glucose Monitor Home Use Evaluation (FSNv2)

Abbott Diabetes Care2 sites in 1 country31 target enrollmentOctober 2011

ConditionsDiabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes
Sponsor: Abbott Diabetes Care
Enrollment: 31
Locations: 2
Primary Endpoint: Clarke Error Grid Analysis
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

January 2012

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Abbott Diabetes Care

Responsible Party

Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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.