A Special Note for Insulin Pumpers

You strive to keep glucose levels as close to your target goals as possible. Life is much easier once those high and low glucose fluctuations are smoothed out. It’s no secret that each insulin dose involves some guesswork along with mathematical calculations as all the variables of daily living are factored in – meal timing, carbohydrates, and activity, to name a few.

Supporting your insulin pump with the FreeStyle Navigator^® Continuous Glucose Monitoring System may help you in these ways:

• Reduce some of the guesswork because you will know if your glucose is trending up or down and how quickly it is moving in either direction.
• Fine-tune your basal rates faster and easier as you have continuous minute-by-minute glucose readings available to you.

See a more complete picture of your glucose patterns over time – as opposed to the “snapshot” provided by tests with traditional blood glucose meters, so you may be able to make faster and more informed decisions about your insulin therapy.

• Feel comfort and security from the alarm features that alert you in advance of high or low glucose levels and rapid changes.

Consider the possibilities of using the FreeStyle Navigator system with an insulin pump.

Check with your health care team to see how insulin pump therapy and the FreeStyle Navigator system can help you.

Please be sure to visit our insulin pump friends, Smiths Medical, manufacturer of the Deltec Cozmo^® Insulin Pump.

Call us 24 hours a day, 7 days a week: 1-866-597-5520

Indications and Important Safety Information for the FreeStyle Navigator^® System

Safety Information: Users should read all of the instructions in the User's Guide before using the FreeStyle Navigator^® 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.