Navigator II Continuous Glucose Monitor Home Use Study

Abbott

Status: Completed

Conditions: Diabetes

Treatments: Device: FreeStyle Navigator II Continuous Glucose Monitoring System

Study type: Observational

Funder types: Industry

Identifiers

NCT01455064

ADC11-106

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

31 participants in 1 patient group

Type 1 or 2 diabetes, MDI or pump

Treatment:

Device: FreeStyle Navigator II Continuous Glucose Monitoring System