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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00920881
Recruitment Status : Completed
First Posted : June 15, 2009
Last Update Posted : June 15, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System with respect to a reference standard.

Condition or disease Intervention/treatment
Diabetes Mellitus Device: FreeStyle Navigator Continuous Glucose Monitoring System

Study Design

Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protocol #TS05-066 Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System
Study Start Date : November 2005
Primary Completion Date : December 2005
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose
U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects recruited from clinical research centers which specialize in diabetes-related therapies.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00920881


Locations
United States, California
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Texas
Diabetes & Glandular Disease Clinic
San Antonio, Texas, United States, 78229
United States, Washington
Ranier Clinical Research
Renton, Washington, United States, 98055
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
Study Director: Joe Bugler Abbott Diabetes Care
More Information

Publications:
Responsible Party: Deryck Wade, Director Clinical Affairs, Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT00920881     History of Changes
Other Study ID Numbers: TS05-066
First Posted: June 15, 2009    Key Record Dates
Last Update Posted: June 15, 2009
Last Verified: June 2009

Keywords provided by Abbott Diabetes Care:
Continuous glucose monitoring
Accuracy
Continuous glucose-error grid analysis

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases