Thursday, March 13, 2008

Abbott FreeStyle Navigator is approved

Today Abbott reported that the FDA has (finally) approved the FreeStyle Navigator continuous glucose monitor(CGM) for sale in the US.

This is one of the most anticipated CGM devices. Many people I've spoken with have expected that this CGM will solve all the shortcomings of the Dexcom and Minimed devices. I've also talked with several people who have been using the Navigator. My take is that this is no more perfect that the existing CGM alternatives.


Abbott, who even has a special site for the Navigator, says that it will be available in the second quarter of 2008. Like all CGMs you will need a prescription to get hold of one.

A few interesting aspects of the Navigator:
  • Five-day sensor.
  • Five direction arrows to indicate rising or falling blood sugar
  • The receiver has a built-in FreeStyle meter.
  • Designed to 'accomodate' swimming. Does that mean the receiver is waterproof?
  • The receiver can be up to 10 feet from the transmitter
You can see a short movie illustrating how the system works. It's available on the Abbott site.

One part of this animation shows the sensor being worn on the back of the arm. That's a very different location that is currently recommended for CGM sensors.

I'll post more news about the FreeStyle Navigator as I learn about it.

Update: My understanding is that the built-in FreeStyle meter is used to calibrate the Navigator. I do not think they support manual input of the values. I'll try to confirm this and update the page when I learn more.

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posted by Bernard @ 9:16 AM 13 Comments Links to this post  

Saturday, April 28, 2007

Accuracy of the FreeStyle Navigator

The latest issue of Diabetes care has published an article on the accuracy of the FreeStyle Navigator system.

The authors did a comparison between the FreeStyle (reading every 1 minute) and a system to measure venous blood glucose (reading every 15 minutes).

And the conclusion?
Measurements with the FreeStyle Navigator system were found to be consistent and accurate compared with venous measurements made using a laboratory reference method over 5 days of sensor wear (82.5% in the A zone on day 1 and 80.9% on day 5).

This article also contains pointers to two interesting FDA summary of safety and effectiveness documents. One for the Dexcom STS system(PDF), and one for the Medtronic Guardian RT system(PDF).

Has anyone out there used this system and can post about it? I'm especially interested in what the software does.

Update: They've finally received FDA approval for the Navigator. I've posted on my blog with the details.

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posted by Bernard @ 5:17 AM 2 Comments Links to this post  

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