Navigator II Continuous Glucose Monitor Home Use Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Type 1 or 2 diabetes, MDI or pump

FreeStyle Navigator II Continuous Glucose Monitoring System

Intervention Type DEVICE

This is not an interventional study. Subjects must maintain their own diabetes treatment regimen throughout the study duration

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No