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NCT01076218 · ClinicalTrials.gov registry record

Navigator 1.5 Accuracy Study

A clinical trial, sponsored by Abbott Diabetes Care.

Completed
Registry status
57
Enrollment target

NCT01076218: Completed study, sponsored by Abbott Diabetes Care.

NCT01076218 is a clinical trial that has completed, run by Abbott Diabetes Care. The registered enrollment target is 57 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01076218 has completed, sponsored by Abbott Diabetes Care.

COMPLETED
Registry status
57 participants
Enrollment target

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.

Interventions

  • DEVICE FreeStyle Navigator Continuous Glucose Monitoring System Version 1.5

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2008-04
Est. Completion 2008-07
Abbott Diabetes Care

26 total trials

What the finished NCT01076218 record still lists

NCT01076218 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 57 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which FreeStyle Navigator Continuous Glucose Monitoring System Version 1.5 is the first listed.

NCT01076218 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01076218 about?

NCT01076218 is a clinical study titled "Navigator 1.5 Accuracy Study". 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 ...

What is the current status of trial NCT01076218?

This trial is currently completed. The enrollment target is 57 participants. The study started on 2008-04. Estimated completion is 2008-07.

What interventions are being tested in trial NCT01076218?

The interventions under investigation include: FreeStyle Navigator Continuous Glucose Monitoring System Version 1.5 (DEVICE).

Who is sponsoring clinical trial NCT01076218?

This trial is sponsored by Abbott Diabetes Care, which has 26 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01076218, the US trial registry maintained by the National Library of Medicine. NCT01076218 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.