Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System
Completed
- Conditions
- Diabetes Mellitus
- Interventions
- Device: FreeStyle Navigator Continuous Glucose Monitoring System
- Registration Number
- NCT00920881
- Lead Sponsor
- Abbott Diabetes Care
- Brief Summary
To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System with respect to a reference standard.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Diabetes FreeStyle Navigator Continuous Glucose Monitoring System -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Ranier Clinical Research
🇺🇸Renton, Washington, United States
Diabetes & Glandular Disease Clinic
🇺🇸San Antonio, Texas, United States