Update: MiniMed’s Stand-Alone Guardian CGM Approved by the FDA

Ah, the rumor has panned out! I read just now that Medtronic has indeed secured FDA approval for its stand-alone Guardian RT continuous glucose sensor. This is the sensor/transmitter portion of the MiniMed Paradigm system — the Guardian combined with the company’s 522/722 pump — that has been shipping as a combo unit since June 19.

Medtronic_logo_1 A few details, per diabetes consultancy Close Concerns:

* This wireless Guardian sensor won’t be available to patients till the end of the year, so it won’t immediately compete with the DexCom. Also, no pricing info is available yet.

* It will be shown at the upcoming AADE (American Association of Diabetes Educators) conference Aug. 9-12 in Los Angeles.

* Attractive new features include:
- it’s waterproof (wow, no shower patches necessary?!)
- it shows extended trend graphs for 3, 6, 12, and 24 hours (DexCom only shows 1, 3, and 9)
- calibration is necessary only every 12 hours, and sensors are “typically” used for 3 days (which means you can also wear them longer, I assume)

* In terms of outcomes, Medtronic is claiming that CGM (continuous glucose monitoring) technology “identifies four-times more glucose excursions requiring therapy adjustment than just fingerstick monitoring alone” and their REAL-Time alarms “help reduce the duration of hypoglycemic (low blood sugar) episodes by 48 percent.”

As an early adopter of CGM myself, all I can say is: Hooray! Within just a few weeks, I’ve found CGM to be an ENORMOUS HELP in understanding and controlling your glucose levels. So more, ever-better products are extremely good news all-around!!

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3 Responses

  1. Alexis
    Alexis July 17, 2006 at 3:18 pm | | Reply

    Certainly good news to see that CGMs are making some progress. I wondered if Medtronics was going to be making some big announcement considering that Dexcom’s stock has been cut in half since the last Diabetes conference. Medtronics is a huge company and definitely affects Dexcom wuite a bit. The Guardian seems to be much bigger than the Dexcom unit so here’s hoping that the next versions from both companies get a little smaller.

  2. carol
    carol July 18, 2006 at 9:43 am | | Reply

    How long do you think it will be until this is approved for kids?

  3. Roger
    Roger September 1, 2006 at 7:21 am | | Reply

    Hi – I placed an order in the middle of August for the Guardian RT and was just told that it is back-ordered for 12 weeks! I am surprised that they are marketing the Guardian RT so agressively while not being able to deliver the product for so long. I received no indication of this delay from anyone at Minimed before my purchase decision. I am disappointed and would like to know whether anyone else has received this news, or better yet, whether anyone has found a way to get the Guardian RT faster after receiving the “backorder” news.

    Roger

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