Proven highly accurate on the Clarke1
and Consensus2 error grids
The median absolute relative difference is 9.3% and the mean absolute relative difference is 12.8%.
Definition of Clarke Error Grid
A: Clinically accurate; would lead to correct and safe treatment
B: Benign Error; would lead to benign decisions or no treatment decisions
C: Overcorrection; would lead to overcorrection of normal glucose levels
D: Failure to detect; would lead to failure to detect and treat high or low glucose levels
E: Errors; would lead to erroneous treatment decisions
Study Design:
The FreeStyle Navigator In-Clinic Study was a multicenter, prospective, nonrandomized study to evaluate the accuracy of FreeStyle Navigator compared with a standard laboratory-reference method, the YSI blood glucose analyzer. Each of the 58 subjects wore 2 sensors: 1 on the arm and 1 on the abdomen over a 5-day period.
The FreeStyle Navigator® system is highly accurate and precise
The sensor reproducibility (Coefficient of Variation) is 10% as measured between the arm and abdomen.
Event detection 3
| Successful event detection | |
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| 1 | Clarke W.L. et.al. Evaluating clinical accuracy of system for self-monitoring blood glucose. Diabetes Care 1987; 10:622-628 |
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| 2 | Parkes J.L. et.al.A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood-glucose. Diabetes Care 2000; 23:1143-1148. |
| 3 | Events are defined as being > 15 minutes. |
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| 4 | Data on file, Abbott Diabetes Care Inc. |
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| 5 | Readings are within 15 mg/dL of the YSI value. |
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| 6 | Readings are within 20% of the YSI value. |
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Indications and Important Safety Information for the FreeStyleNavigator® System
Safety Information: Users should read all of the instructions in the User's Guide before using the FreeStyleNavigator® Continuous Glucose Monitoring System. Adjustments to treatment should be done under the guidance of the user's health care team.
Indications for Use: The FreeStyle Navigator Continuous Glucose Monitoring System is indicated for continually recording interstitial fluid glucose levels in people (ages 18 and older) with diabetes mellitus for the purpose of improving diabetes management. Readings and alarms about glucose levels from the FreeStyle Navigator Continuous Glucose Monitoring System are not intended to replace traditional blood glucose monitoring. Before adjusting therapy for diabetes management based on results and alarms from the FreeStyle Navigator Continuous Glucose Monitoring System, traditional blood glucose tests must be performed. The FreeStyle Navigator Continuous Glucose Monitoring System provides a built-in blood glucose meter to confirm the continuous glucose result.
The FreeStyle Navigator Continuous Glucose Monitoring System provides real-time readings, graphs, trends, and glucose alarms directly to the user.The FreeStyle Navigator Continuous Glucose Monitoring System is intended to be used in home settings to aid people with diabetes in predicting and detecting episodes of hypoglycemia and hyperglycemia and in clinical settings to aid health care professionals in evaluating glucose control. The FreeStyle Navigator Continuous Glucose Monitoring System is available only by prescription.
Contraindications: The FreeStyle Navigator Continuous Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging (MRI).
Prescription Device: Federal law restricts the sale of this device by or on order of a physician.
Warnings/Precautions: Infection, inflammation, or bleeding at the glucose sensor insertion site are possible risks of inserting a sensor into your skin. If you believe your results are not reliable, or are inconsistent with how you feel, perform a blood glucose mode test to measure your glucose. If the problem continues, discard the old sensor and insert a new sensor. Performance of the system under conditions of fluctuating hydration levels such as during renal dialysis has not been evaluated. Unintended dislodging of the sensor due to excessive perspiration, exercise, or bumping, may cause unreliable or no results without warning. Performance of the FreeStyle Navigator system has not been evaluated in pregnant women.
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