Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System - Full Text View

Purpose

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

Condition	Intervention
Diabetes Mellitus	Device: FreeStyle Navigator Continuous Glucose Monitoring System

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Protocol #TS05-066 Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by Abbott Diabetes Care:

Enrollment:	58
Study Start Date:	November 2005
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

Groups/Cohorts

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Weinstein RL, Schwartz SL, Brazg RL, Bugler JR, Peyser TA, McGarraugh GV. Accuracy of the 5-day FreeStyle Navigator Continuous Glucose Monitoring System: comparison with frequent laboratory reference measurements. Diabetes Care. 2007 May;30(5):1125-30. Epub 2007 Mar 2.

McGarraugh G, Bergenstal R. Detection of hypoglycemia with continuous interstitial and traditional blood glucose monitoring using the FreeStyle Navigator Continuous Glucose Monitoring System. Diabetes Technol Ther. 2009 Mar;11(3):145-50.

Responsible Party:	Deryck Wade, Director Clinical Affairs, Abbott Diabetes Care
ClinicalTrials.gov Identifier:	NCT00920881 History of Changes
Other Study ID Numbers:	TS05-066
Study First Received:	June 11, 2009
Last Updated:	June 11, 2009
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013