Navigator 1.5 Accuracy Study

NCT01076218 | Completed

• 1 other identifier: ADC08-075
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Diabetes Mellitus

Keywords

Continuous Glucose Monitoring; Accuracy; Continuous Glucose Error-Grid Analysis

Study Arms (1)

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

Interventions

FreeStyle Navigator Continuous Glucose Monitoring System Version 1.5 DEVICE

This is not an interventional study. Subjects must maintain their own diabetes treatment regimen throughout the study duration.

Diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Diabetes Care: lead

Study Sites (2)

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Rainier Clinical Research

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Shridhara K Alva

  Abbott Diabetes Care

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 26, 2010
• Study Start: April 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: June 17, 2024

Record last verified: 2010-02

Locations

US (2)