Navigator 1.5 Accuracy Study

Diabetes Mellitus Clinical Trial

— FSNQS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076218
• Other study ID #: ADC08-075
• Status: Completed
• Start date: April 2008
• Est. completion date: July 2008

Study information

• Verified date: February 2010
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Rainier Clinical Research	Renton	Washington
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diabetes Care

Country where clinical trial is conducted

United States,