Navigator II Continuous Glucose Monitor Home Use Study

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455064
• Other study ID #: ADC11-106
• Status: Completed
• Phase: N/A
• First received: October 15, 2011
• Last updated: May 13, 2013
• Start date: October 2011
• Est. completion date: January 2012

Study information

• Verified date: May 2013
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Southwest Clinical Research Center	Santa Fe	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No