Navigator II Continuous Glucose Monitor Home Use Study

Completed

• Conditions: Diabetes
• Interventions: Device: FreeStyle Navigator II Continuous Glucose Monitoring System

• Registration Number: NCT01455064
• Lead Sponsor: Abbott Diabetes Care

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-15
• Study First Submitted QC: 2011-10-15
• Study First Posted: 2011-10-19
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Results First Submitted: 2013-02-07
• Status Verified: 2013-05
• Results First Submitted QC: 2013-05-13
• Last Update Submitted: 2013-05-13
• Results First Posted: 2013-07-22
• Last Update Posted: 2013-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 1 or 2 diabetes, MDI or pump	FreeStyle Navigator II Continuous Glucose Monitoring System	-

Primary Outcome Measures

Name	Time	Method
Clarke Error Grid Analysis	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.

Trial Locations

Locations (2)

Atlanta Diabetes Associates; 🇺🇸 Atlanta, Georgia, United States

Southwest Clinical Research Center; 🇺🇸 Santa Fe, New Mexico, United States