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

This study has been completed.
Sponsor:
Information provided by:
Abbott Diabetes Care
ClinicalTrials.gov Identifier:
NCT00920881
First received: June 11, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  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:


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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 September 18, 2014