NCT00920881
Completed
Not Applicable
Protocol #TS05-066 Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System
ConditionsDiabetes Mellitus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- Abbott Diabetes Care
- Enrollment
- 58
- Locations
- 3
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System with respect to a reference standard.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
Study Sites (3)
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