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

June 11, 2009 updated by: Abbott Diabetes Care

Protocol #TS05-066 Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research
    • Texas
      • San Antonio, Texas, United States, 78229
        • Diabetes & Glandular Disease Clinic
    • Washington
      • Renton, Washington, United States, 98055
        • Ranier Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects recruited from clinical research centers which specialize in diabetes-related therapies.

Description

Inclusion Criteria:

  • History consistent with type 1 diabetes
  • At least 18 years of age
  • Available and capable of following the protocol instructions provided by the healthcare professional
  • Signed and dated informed consent form

Exclusion Criteria:

  • Pregnancy
  • Type 2, gestational, or secondary diabetes
  • Known allergy to medical grade adhesives
  • Skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin
  • Seizure disorder
  • Myocardial ischemia
  • History of stroke
  • Severe hypoglycemia unawareness
  • Other concomitant medical conditions that in the opinion of the investigator, would affect the evaluation of device performance and/or safety

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetes
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Diabetes Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (ACTUAL)

December 1, 2005

Study Completion (ACTUAL)

December 1, 2005

Study Registration Dates

First Submitted

June 11, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (ESTIMATE)

June 15, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 15, 2009

Last Update Submitted That Met QC Criteria

June 11, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TS05-066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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