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Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System

NCT00920881 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2009-06-15

No results posted yet for this study

Summary

To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System with respect to a reference standard.

Conditions

Interventions

DEVICE

FreeStyle Navigator Continuous Glucose Monitoring System

Subjects wore 2 Navigator sensors for approximately 122 hours. Subjects and clinical staff were masked to continuous glucose data. During the time the subjects wore the continuous sensor, they were instructed to continue with their current diabetes management plan. Subjects stayed at the clinic for approximately 50 hours during the study period. While in the clinic, venous blood samples were collected every 15 minutes to determine whole blood reference glucose concentrations using the Yellow Springs Instrument. Subjects were also asked to obtain up to 50 FreeStyle finger blood glucose measurements using the system in the Navigator receiver for comparative analysis and system calibration. This was not a treatment study.

Sponsors & Collaborators

  • Abbott Diabetes Care

    lead INDUSTRY

Principal Investigators

  • Joe Bugler · Abbott Diabetes Care

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2005-12-31
Completion
2005-12-31

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 NCT00920881 on ClinicalTrials.gov