Wow, that's what I get for sleeping late once in a blue moon. While I was enjoying my pillow this a.m., the much-rumored and long anticipated has finally occurred: Abbott Diabetes has received FDA approval of its FreeStyle Navigator® Continuous Glucose Monitoring System. Hooray!

According to the press release, this CGM is approved for people ages 18 and older, OK for 5 days of continuous wear on the body (I'm assuming one can "cheat" and restart the sensor). The system also stores up to 60 days worth of glucose information that can be downloaded and analyzed using the company's software package (I couldn't locate any details on this?) What makes the Navigator stand out from competitors DexCom and Medtronic Guardian RT are:

  • It contains a built-inFreeStyle® meter for convenient calibration (minimum of 4calibrations averaged over the total 5 day period -- that's a little less hassle)
  • Wireless transmitter sends glucosereadings to the receiver anywhere within a 10-foot range (that's a plus for those of us who don't always wear the receiver right on the bod)
  • Customizable early-warning alarms10, 20, or 30 minutes in advance to significantly reduce hypoglycemic andhyperglycemic episodes (anything customizable is a plus in my mind!)

According to the Wall St. Journal, it will be available by prescription beginning in the 2nd quarter of this year.

You've seen the product here before. Here's a nice view I found of the sensor insertion procedure:

Figure5

News nuggets from around the diabetes community

NEWSFLASH: FDA Clears Dexcom Share Direct
Dexcom gets regulatory approval of its 'on-the-go' mobile apps for CGM data-sharing.
Snail Uses Insulin to Poison Fish
New study shows these slow-moving creatures use toxic form of insulin to capture prey.
A New Square Patch Insulin Pump
TouchéMedical's new Bluetooth-enabled patch pump is supposedly the world's smallest and cheapest.

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According to a company spokesman, the estimated retail price for the FreeStyle Navigator System kit is $960. Each one month supply of sensors (six per pack) is $360. As with other CGMs on the market, insurance coverage will be on a "case-by-case basis." If you're interested in being first on the list for purchase, you can sign up and follow the steps HERE.

I'm still working on obtaining a few more details on availability and the software package for you all. In the meantime, view a virtual product demonstration HERE.

** UPDATE 3/14/08 **

The new CoPilot software for the Navigator remains under wraps for now. "Pricing and distribution have not yet been determined," the company tells me. So will it be included in the starter kit, or sold separately? Your guess is as good as mine.

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