Navigator 1.5 Accuracy Study (FSNQS)

In Clinic Evaluation of the FreeStyle Navigator® Continuous Glucose Monitoring System Version 1.5

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: FreeStyle Navigator Continuous Glucose Monitoring System Version 1.5

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• United States
  • California
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research

Participation Criteria

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

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

Collaborators and Investigators

• Sponsor: Abbott Diabetes Care
• Investigators: Study Director: Shridhara K Alva, Abbott Diabetes Care

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ACTUAL): July 1, 2008
• Study Completion (ACTUAL): July 1, 2008

Study Registration Dates

• First Submitted: February 24, 2010
• First Submitted That Met QC Criteria: February 24, 2010
• First Posted (ESTIMATE): February 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 26, 2010
• Last Update Submitted That Met QC Criteria: February 24, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; Accuracy; Continuous Glucose Error-Grid Analysis
• Other Study ID Numbers: ADC08-075