Mar 14, 2008

FreeStyle Navigator CGMS Approved

Tara Dairman

A new continuous glucose monitoring system (CGMS), the Freestyle Navigator manufactured by Abbott Diabetes Care, has been approved by the U.S. Food and Drug Administration (FDA) for people with diabetes who are 18 and older.

Continuous glucose monitors are devices that help people track their glucose levels continually. While some details vary from system to system, all systems consist of a sensor worn under the skin that transmits information about the body’s glucose levels to a receiver. The receiver displays frequently updated glucose readings and stores information about changes in glucose levels over time. CGMS devices can also be programmed to set off alarms when glucose levels become too low or too high.

The FreeStyle Navigator, which was approved in Europe last June, has the following features.

Equipment:

• One sensor can be worn for up to five days on the back of the upper arm or on the abdomen.
• The sensors are water-resistant in up to three feet of water for 30 minutes and can be worn during exercise, bathing, and swimming.
• The receiver can receive wireless transmissions from up to 10 feet away, so it does not have to be on the body at all times.
• The system incorporates a built-in FreeStyle blood glucose meter to be used for system calibration and to confirm blood glucose levels before making treatment decisions.
• The system uses two AAA batteries.

Function:

• Glucose levels are measured once per minute.
• Adjustable high and low glucose alarms can be set to warn users 10, 20, or 30 minutes before they are likely to be too high or too low.
• The display uses five directional arrows to help users see which way their glucose level is trending.
• The system stores up to 60 days of glucose information.

According to a press release from Abbott, a study of 123 people using the Freestyle Navigator system at home found that people with Type 1 diabetes experienced less hypoglycemia (low blood glucose) and people with Type 2 diabetes experienced less hyperglycemia (high blood glucose) when using the system.

The Freestyle Navigator is projected to become available for purchase in the second quarter of this year; according to company representatives, the system will cost approximately $1,000, and a one-month supply of sensors (six per pack) will cost approximately $375. People can learn more about the system and begin the purchasing process (which includes getting a doctor's prescription) at www.continuousmonitor.com.

Other continuous glucose monitors currently on the market are the Seven Continuous Glucose Monitoring System made by DexCom, the Guardian REAL-Time Continuous Glucose Monitoring System made by by Medtronic MiniMed, and the Paradigm REAL-Time Continuous Glucose Monitoring system, also from Medtronic MiniMed, in which the receiver is combined with an insulin pump.

You can find more information about continuous glucose monitoring in the following articles and news stories on Diabetes Self-Management.com:
"Continuous Glucose Monitoring: Getting Started"
"Seven-Day Continuous Glucose Monitor Approved"
"Continuous Glucose Monitoring Approved for Kids"
"Continuous Glucose Monitoring Improves Diabetes Control"

For firsthand accounts of continuous glucose monitoring, check out the blog entries ”New Monitoring Technology Brings Movies Instead of Snapshots” by Jan Chait and ”Continuous Glucose Monitoring and Me” by Eric Lagergren. In addition, the blog Diabetes Self-Care is written by Wendy Morgan, who participated in a trial of the FreeStyle Navigator. Scroll down to read her entries from 2006 and 2007, which contain many descriptions and pictures of her experience with the device.

If you have used the Freestyle Navigator or any of the other continuous glucose monitoring systems, we'd love to hear about your experience in the comments section below.

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