FreeStyle Navigator(R) - FAQs - What is the Freestyle Navigator Continuous Monitoring System?
Answers to Frequently Asked Questions
What is the FreeStyle Navigator® system?
- What is the FreeStyle Navigator Continuous Glucose Monitoring System?
- How is continuous glucose monitoring different from traditional blood glucose monitoring?
- How does the FreeStyle Navigator system work? What are its components?
- How do you separate the transmitter from the sensor support mount?
- How do the features of the FreeStyle Navigator system compared to other continuous glucose monitoring systems?
- What is a TRU Directional Arrow™ Indicator?
How does the FreeStyle Navigator system work?
How can I get a FreeStyle Navigator system?
Additional Information for Healthcare Professionals
What is the FreeStyle Navigator system?
What is the FreeStyle Navigator® Continuous Glucose
Monitoring System?
The FreeStyle Navigator® Continuous Glucose Monitoring System is a
glucose monitoring device that continuously measures, displays, and records the
glucose levels in the fluid found between the cells under the skin
(interstitial fluid). It provides you with a glucose reading once every minute.
It does this by using a small, thin, plastic sensor that is inserted about 5 mm
(one-fifth of an inch) under your skin. A transmitter that is attached to the
sensor sends the glucose data through wireless communication to a compact
handheld display unit called the receiver.
TopHow is continuous glucose monitoring different from traditional
blood glucose monitoring?
Traditional blood glucose monitoring provides you with glucose readings that
represent distinct points in time when you perform a finger-stick test. You do
not get comprehensive information regarding how your glucose levels have been
changing, nor do you get information about where your glucose levels are
headed. Without such information, even people who check their glucose levels
often miss significant glucose fluctuations – the ups and downs.
Continuous glucose monitoring provides a more complete picture of your glucose fluctuations by providing glucose values each minute. Understanding how your glucose levels have been changing makes it possible for you and your healthcare team to take appropriate actions and make therapy adjustments that are tailored towards improved control. Furthermore, with the FreeStyle Navigator system, you can now know in advance about glucose highs and lows and take action to reduce and to hopefully prevent severe glucose fluctuations.
How does the FreeStyle Navigator system work? What are its
components?
The FreeStyle Navigator system contains three main components:
A disposable sensor that is inserted under the skin. The sensor can be applied to the back of the upper arm or the abdomen and can be worn on the body continuously for up to 5 days. The sensor is inserted under the skin and adhered to the skin with an adhesive. It measures glucose continuously in the interstitial fluid. Only a small (5 mm long) filament is inserted under the skin.
A reusable wireless transmitter that attaches to the sensor and sends the glucose readings to the receiver anywhere within a 10-foot range. The transmitter is suitable for everyday activities including exercise, bathing, and swimming. The size of the transmitter is 2.05" x 1.23" x 0.43".
A compact handheld receiver that receives the glucose readings from the transmitter and displays them on the screen. The receiver also contains a built-in FreeStyle® Blood Glucose Meter for convenient calibration and confirmatory blood glucose tests. The size of the receiver is 2.50" x 3.24" x 0.88".
In order to measure glucose levels continuously, the sensor is placed under your skin. Each FreeStyle Navigator® Sensor comes in a sterile package called the Sensor Delivery Unit. This unit contains a spring-loaded insertion device that places the sensor under your skin. The sensor delivery unit is fully automatic and disposable. Simply press a button to insert the sensor and after insertion, you throw away the sensor delivery unit. The sensor is held in place by a plastic support mount.
As you slide the transmitter onto the support mount, the transmitter snaps into place on the sensor support mount and makes contact with the sensor. The support mount is held on the skin by an adhesive. The transmitter sends glucose readings wirelessly from the sensor to the handheld receiver once every minute. The receiver then displays the glucose readings and other information. The sensor can be worn on your body for up to 5 days. After the 5 days, remove the old sensor and insert a new one. Each transmitter and receiver pair is designed to work with only one sensor at a time. You will not be able to wear two sensors simultaneously using a single system.
How do you separate the transmitter from the sensor support
mount?
Sometimes the adhesive has pulled away and it is harder to get them apart.
If the adhesive is still intact:
- As you can view in this video, pull down on the adhesive at the bottom of the sensor support mount (the end farthest from the sensor).
- You will hear a soft click as the transmitter separates from the support mount.
- Lift and slide the support mount off of the transmitter.
If the adhesive has separated from the support mount:
- Gently put your fingernail between the support mount and the transmitter at the opposite end from the sensor. There is a little “latch” surface on the transmitter that connects it to the support mount.
- Lift the transmitter off the support mount and hear the click as the transmitter latch separates from the support mount.
Discard the sensor support mount (with the sensor attached).
Do NOT discard the transmitter and NEVER reuse the sensor support mount and sensor.
How do the features of the FreeStyle Navigator system compare to
other continuous glucose monitoring systems?
FreeStyle Navigator system provides customizable early-warning alarms** 10 to
30 minutes in advance of glucose highs and lows. This means that you may take
action before reaching a potentially dangerous low or high glucose
condition.
Knowing that your glucose is 100 mg/dL now and knowing that your glucose will be 60 mg/dL in 20 minutes can help you decide whether or not to get behind the wheel of your car, do strenuous exercise, eat before a meeting, and the like, so you can avoid the worry that often accompanies life with diabetes. While other devices with similar early-warning features have been approved by the FDA, no other system provides continuous glucose readings every minute.
The FreeStyle Navigator Sensor uses exclusive Wired Enzyme™ technology that enables the system to measure glucose very accurately. This unique technology provides you with stable, reliable glucose readings.
The FreeStyle Navigator Sensor can be worn for up to 5 days.
The system is entirely wireless for added convenience. There are no wires or cables. You will get continuous glucose readings once every minute as long as the receiver is within a 10-foot range of the transmitter.
The system uses batteries that can be changed easily without having to replace the entire device.
The sensor insertion process is simple and automatic. You can insert the sensor by pressing a button on the sensor delivery unit and then can simply throw it away. You don’t see the needle or the sensor. Simple and Safe!
Only the FreeStyle Navigator system includes a built-in FreeStyle® Blood Glucose Meter for convenient calibration and confirmatory blood glucose tests. With the world’s smallest blood sample size, the FreeStyle meter’s patented technology offers its own distinct set of advantages.
What is a TRU Directional Arrow™ Indicator?
The FreeStyle Navigator system provides TRU Directional Arrow™
Indicators with each glucose reading that tell you which way and how
quickly your glucose levels are changing. So, at any given time, you not only
know what your glucose level is currently, but also which way your glucose
level is heading. There are a total of five arrows that tell you whether your
glucose levels are changing gradually, changing moderately, or changing
rapidly.
Tired of questions?
Want to see FreeStyle Navigator system in action?
Call us 24 hours a day, 7 days a week: 1-866-597-5520
| * | Note: Movement of the sensor support mount or excessive perspiration at the sensor insertion site due to activities like vigorous exercise or bumping against objects may lead to poor adhesion of the support mount to the skin and cause the sensor to dislodge. If the sensor dislodges due to the sensor support adhesive failing to adhere to the skin, you may get unreliable results or no results. The system may not provide a warning in such circumstances. Choose the proper sensor insertion site when inserting the sensor and prepare the site by following the instructions for site preparation. |
| ** | The FreeStyle Navigator® system has a projected alarm that can be set at a low, medium or high sensitivity to alert the user ~10 to 30 minutes before glucose levels reach the high or low glucose threshold settings, assuming glucose keeps changing at the same rate. Projected Alarm High Setting = maximum detection; more alarms; earliest warning (~30 minutes). Projected Alarm Low Setting = minimum detection; fewer alarms with less advanced notice (~10 minutes) The performance of the projected alarms has not been established. Projected alarms increase the overall ability to detect high and low glucose conditions. Using the projected alarms AND threshold alarms provides maximum notification of high or low glucose conditions. Always perform a traditional blood glucose test before adjusting therapy based on system results and alarms. |
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.
