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Navigator 1.5 Accuracy Study

NCT01076218 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 57

Last updated 2024-06-17

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Abbott Diabetes Care

    lead INDUSTRY

Principal Investigators

  • Shridhara K Alva · Abbott Diabetes Care

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01076218 on ClinicalTrials.gov