NEWS FLASH: Abbott Navigator Approved by the FDA

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-in FreeStyle^® meter for convenient calibration (minimum of 4 calibrations averaged over the total 5 day period -- that's a little less hassle)

• Wireless transmitter sends glucose readings 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 alarms 10, 20, or 30 minutes in advance to significantly reduce hypoglycemic and hyperglycemic 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:

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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Comments

[Rob]

Didn't we hear once upon a time that the Abbott CGM was going to be marketed as a replacement for the finger-sticks you need to do in order to bolus?

I think this implied a much greater need for accuracy compared with DexCom and Medtronic but I'm not seeing any of the articles reference any performance distinction.

[Hannah]

Well, so much for that comment I made on my own blog a week and a half ago. We thought we'd never see the day!

[Bernard Farrell]

Nice illustration Amy.

It does make the sensor look much chunkier that the Dexcom one. I'll have to get a real life picture.

[Barbara]

I'm excited! Had used a dexcom for a couple months. It annoyed me.

[christmasx2]

1 downside is that it takes 10 hours before you get glucose readings.

[George]

Their user guide located at http://tinyurl.com/37g3dd
states that only 4 calibrations need to be performed over the 5 day sensor life.

[Ed]

Are they still planning on pairing this with the omnipod?

[Bob]

Seems like a big non-event. Medtronic and Dexcom are on their second versions. Would have been more interesting a year ago.

[Wendy Morgan]

The thing I loved the most about the Navigator when I wore it in a three month trail was the early warning system of lows and highs.

I had many times when I would get a
Projected Low Alarm and the CGM would say I was currently 120. I learned that if I didn't go ahead and drink a juice, I would drop like a rock and be low within 20-30 minutes.

This warning system allowed me to AVOID lows and highs, whereas the Minimed I currently wear just alarms when I AM Low or High.

I did a lot of documenting on my blog while part of this trial if you'd like some more details.

[Bernard Farrell]

Amy

Interesting change to the Abbott site. They took down the PDF of the Getting Started Guide and User's Guide. I wonder if they're making some changes.