Status:
COMPLETED
Navigator II Continuous Glucose Monitor Home Use Study
Lead Sponsor:
Abbott Diabetes Care
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
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 environmen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01455064
Start Date
October 1 2011
End Date
January 1 2012
Last Update
July 22 2013
Active Locations (2)
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1
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30309
2
Southwest Clinical Research Center
Santa Fe, New Mexico, United States, 87505