Status:
COMPLETED
Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System
Lead Sponsor:
Abbott Diabetes Care
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Brief Summary
To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System with respect to a reference standard.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00920881
Start Date
November 1 2005
End Date
December 1 2005
Last Update
June 15 2009
Active Locations (3)
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1
Diablo Clinical Research
Walnut Creek, California, United States, 94598
2
Diabetes & Glandular Disease Clinic
San Antonio, Texas, United States, 78229
3
Ranier Clinical Research
Renton, Washington, United States, 98055