NCT01076218

Navigator 1.5 Accuracy Study

In Clinic Evaluation of the FreeStyle Navigator® Continuous Glucose Monitoring System Version 1.5

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 57 (actual)
• Sponsor: Abbott Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to confirm that the accuracy and safety of Version 1.5 of the FreeStyle Navigator Continuous Glucose Monitoring System are not impacted by the updates to the system algorithm and minor changes to the user interface and sensor delivery unit, such as adhesive sterilization method. It is anticipated that information collected will be submitted as a supplement to Premarket Approval Application (P050020) to the US Food and Drug Administration for approval to market this version of the system.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	FreeStyle Navigator Continuous Glucose Monitoring System Version 1.5	This is not an interventional study. Subjects must maintain their own diabetes treatment regimen throughout the study duration.

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2010-02-26
• Last updated: 2024-06-17

Locations

2 sites across 1 country: United States