Navigator II Continuous Glucose Monitor Home Use Study

Completed

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT01455064

Run by

Abbott Diabetes Care

People needed

31

Starts

2011-10-01

Expected to finish

2012-01-01

Last updated by the study team

2013-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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