Navigator 1.5 Accuracy Study (FSNQS)

This study has been completed.
Sponsor:
Information provided by:
Abbott Diabetes Care
ClinicalTrials.gov Identifier:
NCT01076218
First received: February 24, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

The purpose of the study is to confirm that the accuracy and safety of Version 1.5 of the FreeStyle Navigator Continuous Glucose Monitoring System are not impacted by the updates to the system algorithm and minor changes to the user interface and sensor delivery unit, such as adhesive sterilization method. It is anticipated that information collected will be submitted as a supplement to Premarket Approval Application (P050020) to the US Food and Drug Administration for approval to market this version of the system.


Condition Intervention
Diabetes Mellitus
Device: FreeStyle Navigator Continuous Glucose Monitoring System Version 1.5

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: In Clinic Evaluation of the FreeStyle Navigator® Continuous Glucose Monitoring System Version 1.5

Resource links provided by NLM:


Further study details as provided by Abbott Diabetes Care:

Enrollment: 57
Study Start Date: April 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Diabetes
Patients with type 1 diabetes requiring multiple daily insulin injections or using insulin pumps
Device: FreeStyle Navigator Continuous Glucose Monitoring System Version 1.5
This is not an interventional study. Subjects must maintain their own diabetes treatment regimen throughout the study duration.

  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

Patients with type 1 diabetes requiring multiple daily insulin injections or using an insulin pump

Criteria

Inclusion Criteria:

  • History consistent with Type 1 diabetes for at least 2 years prior to enrollment;
  • For at least 6 months prior to enrollment, insulin pump user or multiple daily insulin injections;
  • 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 or skin disinfectant;
  • Skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin;
  • Blood donation within 6 weeks prior to beginning study activities;
  • Within past 6 months, severe hypoglycemic episode(s) resulting in hospitalization or loss of consciousness;
  • Active myocardial ischemia;
  • Previous history of stroke;
  • Any other concomitant medical condition that in the opinion of the principal investigator would likely affect the evaluation of device performance and/or safety;
  • Current participation in another clinical trial.
  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: NCT01076218

Locations
United States, California
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Washington
Rainier Clinical Research
Renton, Washington, United States, 98057
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
Study Director: Shridhara K Alva Abbott Diabetes Care
  More Information

No publications provided

Responsible Party: Misrak Daniel, Senior Regulatory Affairs Specialist, Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT01076218     History of Changes
Other Study ID Numbers: ADC08-075
Study First Received: February 24, 2010
Last Updated: February 24, 2010
Health Authority: United States: Food and Drug Administration
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