MiniMed Guardian monitor

Discussion in 'Health and medical' started by William C Biggs, Feb 11, 2004.

  1. MiniMed announced FDA approval for their home continuous glucose monitor.

    http://www.minimed.com/common/ci_press_10.html

    http://www.minimed.com/patientfam/pf_ipt_guardian_overview.shtml

    I haven't seen this up close and personal yet, but it appears to be identical to the CGMS unit we
    have used in our office for the last 3 years, with a few differences.

    Most notably, a display of the current blood glucose, and an alarm system for lows.

    I have no info on the cost. The marketing appears to be directed at situations where an insurance
    company could be compelled to approve the device. For us, the biggest cost is the cost of the
    disposable sensor itself. Pricing for the home version should be very interesting.

    WCB
     
    Tags:


  2. thanks! I'm in the process of registering for an update from Minimed.

    dave

    William C Biggs MD wrote:

    > MiniMed announced FDA approval for their home continuous glucose monitor.
    >
    > http://www.minimed.com/common/ci_press_10.html
    >
    > http://www.minimed.com/patientfam/pf_ipt_guardian_overview.shtml
    >
    > I haven't seen this up close and personal yet, but it appears to be identical to the CGMS unit we
    > have used in our office for the last 3 years, with a few differences.
    >
    > Most notably, a display of the current blood glucose, and an alarm system for lows.
    >
    > I have no info on the cost. The marketing appears to be directed at situations where an insurance
    > company could be compelled to approve the device. For us, the biggest cost is the cost of the
    > disposable sensor itself. Pricing for the home version should be very interesting.
    >
    > WCB
    >
    >
     
  3. Guy

    Guy Guest

    I submitted the form tonight. i am the one that has been making noise for years. Hope it works out
    and will be covered. Guy

    On Thu, 12 Feb 2004 03:19:47 GMT, Bay Area Dave <[email protected]> wrote:

    >thanks! I'm in the process of registering for an update from Minimed.
    >
    >dave
    >
    >William C Biggs MD wrote:
    >
    >> MiniMed announced FDA approval for their home continuous glucose monitor.
    >>
    >> http://www.minimed.com/common/ci_press_10.html
    >>
    >> http://www.minimed.com/patientfam/pf_ipt_guardian_overview.shtml
    >>
    >> I haven't seen this up close and personal yet, but it appears to be identical to the CGMS unit we
    >> have used in our office for the last 3 years, with a few differences.
    >>
    >> Most notably, a display of the current blood glucose, and an alarm system for lows.
    >>
    >> I have no info on the cost. The marketing appears to be directed at situations where an insurance
    >> company could be compelled to approve the device. For us, the biggest cost is the cost of the
    >> disposable sensor itself. Pricing for the home version should be very interesting.
    >>
    >> WCB
    >>
    >>
    >
     
  4. On Wed, 11 Feb 2004 20:47:22 -0600, "William C Biggs MD"
    <[email protected]> wrote:

    >MiniMed announced FDA approval for their home continuous glucose monitor.
    >
    >http://www.minimed.com/common/ci_press_10.html
    >
    >http://www.minimed.com/patientfam/pf_ipt_guardian_overview.shtml
    >
    >I haven't seen this up close and personal yet, but it appears to be identical to the CGMS unit we
    >have used in our office for the last 3 years, with a few differences.
    >
    >Most notably, a display of the current blood glucose, and an alarm system for lows.
    I don't believe that it has a display. The press release I saw mentions an alarm for highs and lows,
    and the ability to download to a computer.
    >
    >I have no info on the cost. The marketing appears to be directed at situations where an insurance
    >company could be compelled to approve the device. For us, the biggest cost is the cost of the
    >disposable sensor itself. Pricing for the home version should be very interesting.
    >
    I've seen one set of figures, but I don't know where the poster got them, so I can't guarantee their
    accuracy -- $1000 for the transmitter and monitor, and $35 PER SENSOR (to be replaced every 3 days).
    If that turns out to be the case, I'm going to be angry.....

    >WCB
    >
    >
    >
    >
    Mark Davies
     
  5. got it from MiniMed, Mark.

    dave

    Mark S. Davies wrote:

    > On Wed, 11 Feb 2004 20:47:22 -0600, "William C Biggs MD" <[email protected]> wrote:
    >
    >
    >>MiniMed announced FDA approval for their home continuous glucose monitor.
    >>
    >>http://www.minimed.com/common/ci_press_10.html
    >>
    >>http://www.minimed.com/patientfam/pf_ipt_guardian_overview.shtml
    >>
    >>I haven't seen this up close and personal yet, but it appears to be identical to the CGMS unit we
    >>have used in our office for the last 3 years, with a few differences.
    >>
    >>Most notably, a display of the current blood glucose, and an alarm system for lows.
    >
    > I don't believe that it has a display. The press release I saw mentions an alarm for highs and
    > lows, and the ability to download to a computer.
    >
    >>I have no info on the cost. The marketing appears to be directed at situations where an insurance
    >>company could be compelled to approve the device. For us, the biggest cost is the cost of the
    >>disposable sensor itself. Pricing for the home version should be very interesting.
    >>
    >
    > I've seen one set of figures, but I don't know where the poster got them, so I can't guarantee
    > their accuracy -- $1000 for the transmitter and monitor, and $35 PER SENSOR (to be replaced every
    > 3 days). If that turns out to be the case, I'm going to be angry.....
    >
    >
    >>WCB
    >>
    >>
    >>
    >>
    >
    > Mark Davies
     
  6. does anyone know how often it takes a reading? my wife thought it is only every 20 minutes. I'm
    hopeful it is every 5 min or so.

    dave

    Guy wrote:

    > I submitted the form tonight. i am the one that has been making noise for years. Hope it works out
    > and will be covered. Guy
    >
    >
    > On Thu, 12 Feb 2004 03:19:47 GMT, Bay Area Dave <[email protected]> wrote:
    >
    >
    >>thanks! I'm in the process of registering for an update from Minimed.
    >>
    >>dave
    >>
    >>William C Biggs MD wrote:
    >>
    >>
    >>>MiniMed announced FDA approval for their home continuous glucose monitor.
    >>>
    >>>http://www.minimed.com/common/ci_press_10.html
    >>>
    >>>http://www.minimed.com/patientfam/pf_ipt_guardian_overview.shtml
    >>>
    >>>I haven't seen this up close and personal yet, but it appears to be identical to the CGMS unit we
    >>>have used in our office for the last 3 years, with a few differences.
    >>>
    >>>Most notably, a display of the current blood glucose, and an alarm system for lows.
    >>>
    >>>I have no info on the cost. The marketing appears to be directed at situations where an insurance
    >>>company could be compelled to approve the device. For us, the biggest cost is the cost of the
    >>>disposable sensor itself. Pricing for the home version should be very interesting.
    >>>
    >>>WCB
    >>>
    >>>
    >>>
    >>>
     
  7. On Thu, 12 Feb 2004 20:40:34 GMT, Bay Area Dave <[email protected]> wrote:

    >got it from MiniMed, Mark.
    >
    Hi Dave - I'm not sure what you're saying you got from MiniMed....

    The information I was passing on about the lack of blood glucose display and pricing is from a
    frequent (and accurate) poster on the Islet Foundation message board named Ellen, who reported

    "I spoke with Minimed a day or so ago about this. The Guardian is essentially the CGMS but the
    patient cannot see the bgs at all (just like the CGMS). The patient (really the sensor) needs to be
    within 6 feet of the Guardian to function...so don't leave it on your bedside and flip sides on a
    kingsize bed?)

    They estimate the cost will be $1000.00 U.S. and $35.00 per sensor. Sensor can probably stay in 3
    days. It simply alarms for highs and lows.

    MY SON IS NOT going to wear this in addition to the pump."

    There was a picture that went with this info. It looks like there are 3 parts to the system 1 -
    sensor - about the size of an infusion set (inch or so square), which is connected by wire to a 2 -
    transmitter pod - which looks to be adhesive backed, and a good 4 or five inches around, which
    transmits wirelessly to a 3 - monitor - which looks to be a good 4 by 6 inches just by itself. It
    does have a display, but presumably it's used for programming and error displays.

    >dave
     
  8. It is odd that the sample rate isn't on the specification page. I
    would suspect it is the same as the office version, one sample every
    10 seconds averaged over 5 minutes. The specifications for the office
    model are at
    http://www.minimed.com/doctors/md_products_cgms_specifications.shtml

    --
    -------
    Charly Coughran [email protected]

    Bay Area Dave <[email protected]> wrote in news:[email protected]:

    > does anyone know how often it takes a reading? my wife thought it is only every 20 minutes. I'm
    > hopeful it is every 5 min or so.
    >
    > dave
    >
    > Guy wrote:
    >
    >> I submitted the form tonight. i am the one that has been making noise for years. Hope it works
    >> out and will be covered. Guy
    >>
    >>
    >> On Thu, 12 Feb 2004 03:19:47 GMT, Bay Area Dave <[email protected]> wrote:
    >>
    >>
    >>>thanks! I'm in the process of registering for an update from Minimed.
    >>>
    >>>dave
    >>>
    >>>William C Biggs MD wrote:
    >>>
    >>>
    >>>>MiniMed announced FDA approval for their home continuous glucose monitor.
    >>>>
    >>>>http://www.minimed.com/common/ci_press_10.html
    >>>>
    >>>>http://www.minimed.com/patientfam/pf_ipt_guardian_overview.shtml
    >>>>
    >>>>I haven't seen this up close and personal yet, but it appears to be identical to the CGMS unit
    >>>>we have used in our office for the last 3 years, with a few differences.
    >>>>
    >>>>Most notably, a display of the current blood glucose, and an alarm system for lows.
    >>>>
    >>>>I have no info on the cost. The marketing appears to be directed at situations where an
    >>>>insurance company could be compelled to approve the device. For us, the biggest cost is the cost
    >>>>of the disposable sensor itself. Pricing for the home version should be very interesting.
    >>>>
    >>>>WCB
    >>>>
    >>>>
    >>>>
    >>>>
    >>
    >
     
  9. On Thu, 12 Feb 2004 20:55:08 GMT, [email protected]
    (Mark S. Davies) wrote:

    >On Thu, 12 Feb 2004 20:40:34 GMT, Bay Area Dave <[email protected]> wrote:
    >
    >>got it from MiniMed, Mark.
    >>
    >Hi Dave - I'm not sure what you're saying you got from MiniMed....
    >
    I hate doing follow-ups to myself, but I wanted Bay Area Dave to know his message with the
    information from MiniMed posted at the same time my previous message did - and well after the one
    where he said he meant "sensors" rather than "strips". Probably there'll be people that will see
    this message before my last one - such is the nature of the beast, and I need to keep that in
    mind..... Mark Davies
     
  10. your info is correct.

    dave

    Mark S. Davies wrote:

    > On Thu, 12 Feb 2004 20:40:34 GMT, Bay Area Dave <[email protected]> wrote:
    >
    >
    >>got it from MiniMed, Mark.
    >>
    >
    > Hi Dave - I'm not sure what you're saying you got from MiniMed....
    >
    > The information I was passing on about the lack of blood glucose display and pricing is from a
    > frequent (and accurate) poster on the Islet Foundation message board named Ellen, who reported
    >
    > "I spoke with Minimed a day or so ago about this. The Guardian is essentially the CGMS but the
    > patient cannot see the bgs at all (just like the CGMS). The patient (really the sensor) needs to
    > be within 6 feet of the Guardian to function...so don't leave it on your bedside and flip sides on
    > a kingsize bed?)
    >
    > They estimate the cost will be $1000.00 U.S. and $35.00 per sensor. Sensor can probably stay in 3
    > days. It simply alarms for highs and lows.
    >
    > MY SON IS NOT going to wear this in addition to the pump."
    >
    > There was a picture that went with this info. It looks like there are 3 parts to the system 1 -
    > sensor - about the size of an infusion set (inch or so square), which is connected by wire to a 2
    > - transmitter pod - which looks to be adhesive backed, and a good 4 or five inches around, which
    > transmits wirelessly to a 3 - monitor - which looks to be a good 4 by 6 inches just by itself. It
    > does have a display, but presumably it's used for programming and error displays.
    >
    >
    >>dave
     
  11. I hope you are right and my wife has a wildly incorrect idea about sampling frequency. Come to think
    of it, now that you mention those numbers, I vaguely remember that being the case. Thanks, Charly!

    i got ahold of MiniMed: the unit will record every 5 minutes from readings taken more often than
    that, but I couldn't get them to pin it down exactly. There is NO ONSCREEN DISPLAY of bg readings AT
    ANY TIME!.

    The sensors are $35 EACH and must be changed every 3 days. The unit needs to be calibrated 2X a day.
    The sensors are similar to the Silhouette sets.

    The unit is $1000 and insurance is unlikely to cover the cost of the unit or strips for the
    time being.

    There is no release date, as of today.

    dave

    Charly Coughran wrote:

    > It is odd that the sample rate isn't on the specification page. I would suspect it is the same as
    > the office version, one sample every 10 seconds averaged over 5 minutes. The specifications for
    > the office model are at http://www.minimed.com/doctors/md_products_cgms_specifications.shtml
     
  12. not to worry; we are both on the same page now. :)

    dave

    Mark S. Davies wrote:

    > On Thu, 12 Feb 2004 20:55:08 GMT, [email protected] (Mark S. Davies) wrote:
    >
    >
    >>On Thu, 12 Feb 2004 20:40:34 GMT, Bay Area Dave <[email protected]> wrote:
    >>
    >>
    >>>got it from MiniMed, Mark.
    >>>
    >>
    >>Hi Dave - I'm not sure what you're saying you got from MiniMed....
    >>
    >
    > I hate doing follow-ups to myself, but I wanted Bay Area Dave to know his message with the
    > information from MiniMed posted at the same time my previous message did - and well after the one
    > where he said he meant "sensors" rather than "strips". Probably there'll be people that will see
    > this message before my last one - such is the nature of the beast, and I need to keep that in
    > mind..... Mark Davies
     
  13. I didn't mean "strips"; I meant sensors! :)

    Bay Area Dave wrote:

    >
    > The unit is $1000 and insurance is unlikely to cover the cost of the unit or strips for the
    > time being.
     
  14. Guy

    Guy Guest

    Thank you for the info. The cost you quote does not seem excessive to me. Almost in the range of my
    present program. I am sure this device could improve my control. Presently I have to operate very
    loose and tolerate peaks because the fear of the 911 type hypos.

    I am sure it will be covered in the near future for some people. A 911 run costs me about $700 and
    the past poor control cost in the hundred of thousands in the medical procedures. The powers are
    slow to wake up sometimes. But they will finally get it. I will use a decent device if I have to pay
    for it out of pocket. Guy

    On Thu, 12 Feb 2004 18:20:57 GMT, Bay Area Dave <[email protected]> wrote:

    >I hope you are right and my wife has a wildly incorrect idea about sampling frequency. Come to
    >think of it, now that you mention those numbers, I vaguely remember that being the case.
    >Thanks, Charly!
    >
    >i got ahold of MiniMed: the unit will record every 5 minutes from readings taken more often than
    >that, but I couldn't get them to pin it down exactly. There is NO ONSCREEN DISPLAY of bg readings
    >AT ANY TIME!.
    >
    >The sensors are $35 EACH and must be changed every 3 days. The unit needs to be calibrated 2X a
    >day. The sensors are similar to the Silhouette sets.
    >
    >The unit is $1000 and insurance is unlikely to cover the cost of the unit or strips for the
    >time being.
    >
    >There is no release date, as of today.
    >
    >dave
    >
    >Charly Coughran wrote:
    >
    >> It is odd that the sample rate isn't on the specification page. I would suspect it is the same as
    >> the office version, one sample every 10 seconds averaged over 5 minutes. The specifications for
    >> the office model are at http://www.minimed.com/doctors/md_products_cgms_specifications.shtml
     
  15. Bay Area Dave <[email protected]> wrote in
    news:[email protected]:

    > I hope you are right and my wife has a wildly incorrect idea about sampling frequency.

    She may be confusing it with the GlucoWatch which, I believe, has a 20 minute averaging interval.

    --
    -------
    Charly Coughran [email protected]
     
  16. I think you are right, Charly. I know she spent a lot of time perusing the Glucowatch literature
    some time ago...

    dave

    Charly Coughran wrote:

    > Bay Area Dave <[email protected]> wrote in news:[email protected]:
    >
    >
    >>I hope you are right and my wife has a wildly incorrect idea about sampling frequency.
    >
    >
    > She may be confusing it with the GlucoWatch which, I believe, has a 20 minute averaging interval.
     
  17. Mark,

    I haven't seen the actual unit in operation.

    If this device doesn't have the actual glucose on it's display, I will be really disappointed.

    In the past, warning devices used exclusively for detection of hypos have not done very well.

    The Teledyne Sleep Sentry works for some people, and has been available for many years. The cost is
    a tiny fraction of a glucowatch or the MiniMed system. However it doesn't work for everybody, and is
    virtually worthless during the day because of false alarms.

    I will need to see if the data is downloadable into a computer in real time. You might be able to
    get a current reading that way.

    Otherwise, the number of people who would be interested in this device just dropped by about 99% .

    Thanks for the correction.

    WCB


    "Mark S. Davies" <[email protected]> wrote in message
    news:[email protected]...
    > On Wed, 11 Feb 2004 20:47:22 -0600, "William C Biggs MD" <[email protected]> wrote:
    >
    > >MiniMed announced FDA approval for their home continuous glucose monitor.
    > >
    > >http://www.minimed.com/common/ci_press_10.html
    > >
    > >http://www.minimed.com/patientfam/pf_ipt_guardian_overview.shtml
    > >
    > >I haven't seen this up close and personal yet, but it appears to be identical to the CGMS unit we
    > >have used in our office for the last 3
    years,
    > >with a few differences.
    > >
    > >Most notably, a display of the current blood glucose, and an alarm system for lows.
    > I don't believe that it has a display. The press release I saw mentions an alarm for highs and
    > lows, and the ability to download to a computer.
    > >
    > >I have no info on the cost. The marketing appears to be directed at situations where an insurance
    > >company could be compelled to approve the device. For us, the biggest cost is the cost of the
    > >disposable sensor itself. Pricing for the home version should be very interesting.
    > >
    > I've seen one set of figures, but I don't know where the poster got them, so I can't guarantee
    > their accuracy -- $1000 for the transmitter and monitor, and $35 PER SENSOR (to be replaced every
    > 3 days). If that turns out to be the case, I'm going to be angry.....
    >
    > >WCB
    > >
    > >
    > >
    > >
    > Mark Davies
     
  18. Doc,

    I spoke at length to Medtronic/Minimed about the Guardian and they confirmed there is no plan to
    include a display at this time. They DID say that you can reprogram the alarms in a jiffy so you
    could deduce what your approximate numbers are by resetting the alarm to a slightly higher/lower
    setting as the case may be. It sounds as though the idea is to prevent folks from sleeping through a
    serious hypo. The alarm is supposed to be audible in an adjacent room so that parents can hear their
    kid's glucose alarm without the need for a room monitor to amplify the sound. They don't advocate
    the Guardian to be a replacement for a bg meter; it's an adjunct to one.

    If I had a continuous read-out meter, I'd probably over insulinize (sp??) myself into a coma anyway,
    so it may be a good idea that they eschew the display of bg's.

    dave

    William C Biggs MD wrote:

    > Mark,
    >
    > I haven't seen the actual unit in operation.
    >
    > If this device doesn't have the actual glucose on it's display, I will be really disappointed.
    >
    > In the past, warning devices used exclusively for detection of hypos have not done very well.
    >
    > The Teledyne Sleep Sentry works for some people, and has been available for many years. The cost
    > is a tiny fraction of a glucowatch or the MiniMed system. However it doesn't work for everybody,
    > and is virtually worthless during the day because of false alarms.
    >
    > I will need to see if the data is downloadable into a computer in real time. You might be able to
    > get a current reading that way.
    >
    > Otherwise, the number of people who would be interested in this device just dropped by about 99% .
    >
    >
    > Thanks for the correction.
    >
    >
    > WCB
    >
    >
    >
    >
    >
    >
    >
    > "Mark S. Davies" <[email protected]> wrote in message
    > news:[email protected]...
    >
    >>On Wed, 11 Feb 2004 20:47:22 -0600, "William C Biggs MD" <[email protected]> wrote:
    >>
    >>
    >>>MiniMed announced FDA approval for their home continuous glucose monitor.
    >>>
    >>>http://www.minimed.com/common/ci_press_10.html
    >>>
    >>>http://www.minimed.com/patientfam/pf_ipt_guardian_overview.shtml
    >>>
    >>>I haven't seen this up close and personal yet, but it appears to be identical to the CGMS unit we
    >>>have used in our office for the last 3
    >
    > years,
    >
    >>>with a few differences.
    >>>
    >>>Most notably, a display of the current blood glucose, and an alarm system for lows.
    >>
    >>I don't believe that it has a display. The press release I saw mentions an alarm for highs and
    >>lows, and the ability to download to a computer.
    >>
    >>>I have no info on the cost. The marketing appears to be directed at situations where an insurance
    >>>company could be compelled to approve the device. For us, the biggest cost is the cost of the
    >>>disposable sensor itself. Pricing for the home version should be very interesting.
    >>>
    >>
    >>I've seen one set of figures, but I don't know where the poster got them, so I can't guarantee
    >>their accuracy -- $1000 for the transmitter and monitor, and $35 PER SENSOR (to be replaced every
    >>3 days). If that turns out to be the case, I'm going to be angry.....
    >>
    >>
    >>>WCB
    >>>
    >>>
    >>>
    >>>
    >>
    >>Mark Davies
    >
     
  19. On Sat, 14 Feb 2004 11:25:27 -0600, "William C Biggs MD"
    <[email protected]> wrote:

    >Mark,
    >
    >I haven't seen the actual unit in operation.
    >
    >If this device doesn't have the actual glucose on it's display, I will be really disappointed.
    >
    >In the past, warning devices used exclusively for detection of hypos have not done very well.
    >
    >The Teledyne Sleep Sentry works for some people, and has been available for many years. The cost is
    >a tiny fraction of a glucowatch or the MiniMed system. However it doesn't work for everybody, and
    >is virtually worthless during the day because of false alarms.
    >
    >I will need to see if the data is downloadable into a computer in real time. You might be able to
    >get a current reading that way.
    >
    >Otherwise, the number of people who would be interested in this device just dropped by about 99% .
    >
    >
    >Thanks for the correction.
    >
    >
    >WCB
    At this point, I'm hoping that the Sugar Trac will come out this year and work somewhere close to
    the current promotional statements.

    Non-invasive, much smaller, readout, and a pricing of $350 basic unit and $1 per day for the
    consumable (the earclip) vs. Invasive, 2 bigger pieces, no readout, and a pricing of $1000 and $12
    per day? Even if the Sugar Trac doesn't have alarms, the only real advantage of the Guardian doesn't
    come until it can be hooked to the pump to close the loop....

    Mark Davies
     
  20. I disagree with you on the Guardian's usefulness. Alarming, especially during sleep is a big
    feature. I was a bit low all night (not dangerously) and woke with a headache. I'd have preferred to
    be awakened to slow down my pump or have a tiny snack. Then I'd wake up more refreshed.

    As far as "closing the loop", the loop is gonna have to be PERFECT for me to buy into the
    technology. Pumping is quite reliable; bg readings are NOT. Look at how the Guardian REQUIRES that
    you calibrate it as LEAST twice a day to another meter. That's not too reassuring, now is it??

    dave

    Mark S. Davies wrote:

    >
    > Non-invasive, much smaller, readout, and a pricing of $350 basic unit and $1 per day for the
    > consumable (the earclip) vs. Invasive, 2 bigger pieces, no readout, and a pricing of $1000 and $12
    > per day? Even if the Sugar Trac doesn't have alarms, the only real advantage of the Guardian
    > doesn't come until it can be hooked to the pump to close the loop....
    >
    > Mark Davies
     
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