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

Completed

Conditions studied: Diabetes Mellitus

In brief

To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System with respect to a reference standard.

Key facts

Study ID

NCT00920881

Run by

Abbott Diabetes Care

People needed

58

Starts

2005-11-01

Expected to finish

2005-12-01

Last updated by the study team

2009-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Diablo Clinical Research — Walnut Creek, California, United States
• Diabetes & Glandular Disease Clinic — San Antonio, Texas, United States
• Ranier Clinical Research — Renton, Washington, United States

Full record on ClinicalTrials.gov

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