World’s First Integrated Insulin Pump with Continuous Monitor Approved by the FDA

Extra! Extra! Read All About It… if you haven’t already…

MiniMed’s exciting new combo of the MiniMed Paradigm insulin pump and the company’s REAL-TimeMinimed_combo_system_1 Continuous Glucose Monitoring (CGM) System was approved by the FDA this week. As the JDRF will tell you, this is the closest we’ve gotten to an artificial pancreas — minus the fully automated “closed loop” portion — but still a huge step forward.

Now I know why my local D-research center hasn’t returned my phone calls about participating in clinical trials for this system (we’d heard rumors they were looking for adults not yet on the pump); I guess they were finished testing (!)

But I have seen the MiniMed Paradigm REAL-Time System up close and personal, because a teenager in my local support group was part of the youth study. Essentially it’s the MiniMed Paradigm 522 or 722 insulin pump, worn along with a separate three-day sensor that takes continuous glucose readings and sends the data to the pump via advanced radio frequency (RF) wireless technology.

Despite the huge advantages of real-time glucose readings that your pump can display, we didn’t think the system looked too comfortable. That’s a bunch of technology adhered to your tummy! (see photo). But the kid wearing it was not perturbed by the double-infusion-site issue. He says it’s been fantastic knowing what’s happening when with his glucose. The alarm’s apparently even beeped him awake at night before he got dangerously low — one of the biggest ongoing problems for active Type 1 children, I understand.

Anyway, MiniMed’s again validated its position on the cutting edge of insulin-delivery technology.

The REAL-Time continuous glucose monitoring kit will not be available until summer (sold separately as a cash pay item, not covered by most insurance plans). But the company’s offering a special upgrade program for anyone who purchased a Paradigm 522 or 722 pump between April 10 and June 19 of this year. For $1,000, those folks can get started with the CGM add-on right away. I’m sure we’ll be hearing reports from one of my fellow OC bloggers on this soon.

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15 Responses

  1. Nick
    Nick April 15, 2006 at 9:34 am | | Reply

    Yes, Amy, that is exciting. I’m glad you brought it to my attention. I do hope the CGM has user-settable high and low BS alarms. Wouldn’t that be great?!

    It sounds as if this new MM sensor will kill two birds with one stone:

    (1) allow automatic blood glucose monitoring

    (2) discourage people like me from sterilizing & reusing their cannulas

    It is very exciting to hear that periodic, automatic blood sugar monitoring may be coming this year!

  2. AnnaQ
    AnnaQ April 15, 2006 at 10:30 am | | Reply

    Amy,
    Thanks as always for being in the forefront of breaking news. I was debating between getting a Dexcom now or waiting for FDA approval of the Freestyle Navigator, but this beats both!
    Did you mean that if I buy a Paradigm 522 or 722 pump before June 19 2006, I can get the add-on immediately?

  3. DensityDuck
    DensityDuck April 17, 2006 at 7:08 am | | Reply

    Nick: The hardware for the Guardian is entirely separate from the insulin pump. They’re basically two different systems, except that the pump receives radio signals from the Guardian. You don’t even need to have them in the same place on your body–you could put the pump on your stomach and the Guardian on your leg, for example.

    I can’t understand why insurance companies wouldn’t cover this piece of equipment.

  4. Sam Gellman
    Sam Gellman April 18, 2006 at 8:50 pm | | Reply

    I think insurance companies will cover it… it’s just a matter of time, takes a little while for the word to get out. If they don’t they’re fools. I am thinking about getting the Dexcom STS, I’ve heard really positive things. has anyone heard anything about their product? Thanks.

  5. ComputerZen.com - Scott Hanselman
    ComputerZen.com - Scott Hanselman April 18, 2006 at 10:31 pm | | Reply

    New integrated real-time glucose meter and pump coming THIS SUMM

  6. ComputerZen.com - Scott Hanselman
    ComputerZen.com - Scott Hanselman April 25, 2006 at 8:46 pm | | Reply

    New integrated real-time glucose meter and pump coming THIS SUMMER

  7. Ben
    Ben July 17, 2006 at 9:17 am | | Reply

    I noticed on their website it states that “The transmitter has a life of approximately 9 months under anticipated continuous-use conditions.” Apparently, you will need to purchase anothe sensor for ~$1000 once your battery dies. Does anyone know more details about this?

    -Ben

  8. Michelle McCotter
    Michelle McCotter February 6, 2007 at 11:08 am | | Reply

    Hi. I have the CGMS from MiniMed. It’s been great, as it has woken me up overnight with rising or falling blood sugars. I can set my low alarm, and my pump will go off if my BG dips below that value. I can also set my low “snooze”–and the pump will wait that length of time before alarming me again, should my BG still remain below the low threshhold. There’s an equivalent feature for high BGs.

    Yes, the system is kind of bulky. The transmitter is kind of a pain sometimes, as it’s heavy and can tend to slip when I’m running.

    Also, the BG levels on the pump screen don’t always directly correlate with the actual BG values. There’s still a need to test, even though I have the sensor. I have to calibrate 2 hours after insertion, and then again within 4 more hours. Then, I have to calibrate at least once every 12 hours. Calibration is best done when the BG levels are steady; it makes the readings from the sensor more accurate.

    A note on where the sensor can be placed…I’ve found that the pump sometimes displays a weak signal warning if the transmitter isn’t really close to the pump. This happens at the gym, and in other locations where other frequencies interfere with my pump communication.

    And a random note…you have to disconnect the sensor from the transmitter when you fly, as it uses RF technology, which you’re not allowed to use while planes are in flight. I don’t travel much, so this has affected me twice in the last 3 months (flight out and flight back home).

    On Ben’s question…the transmitter is supposed to last 9 months with continuous use. With the starter kit, you get the transmitter and 10 sensors. 20 more sensors (continuous use) would last you through 2 more months, at which point the transmitter would die. And then you’d shell out $999 for a while new kit and repeat the cycle again.

    I can answer more questions if people have them.

  9. lois tunell
    lois tunell February 28, 2007 at 7:01 am | | Reply

    I have been wearing the CGMS since 7/06. My transmitter starting saying low (battery) yesterday. Mini-Med only guarantees the transmitter for 6 months, so I’m just past the warranty at 7 months. The system is convenient for night-time lows or highs — but I”m not sure it is worth $1k every 7 months for basically a battery replacement — and that doesn’t include the cost of the sensors (the cost for continuous use is about $3800/yr if you use the sensors for 6 days and your transmitter lasts 7 months). I know Mini-med has another transmitter that is supposed to last 2 years – but they haven’t released that to the public yet. So if you have a lot of lows or highs it may be worth it, but remember you have to pay for this out of pocket. But I won’t be buying another transmitter until they improve the longevity.
    BTW – I have flown many times since I started wearing it and you don’t have to shut off the transmitter – it doesn’t interfere and isn’t detected.

  10. Sukh Thiara
    Sukh Thiara May 21, 2007 at 8:28 am | | Reply

    Dear Sir

    Please can you tell me if the CGM can be used during pregnany?

    Could the RF waves have any effect on an unborn baby?

  11. Chat
    Chat August 6, 2007 at 3:42 am | | Reply

    theme site lince looks nice

  12. Jan
    Jan December 2, 2007 at 12:58 pm | | Reply

    does anyone have any comments on the Omnipod by Insulet?

  13. Diabetes Mine - the all things diabetes blog » Blog Archive » A Closer Look at Medtronic’s New MiniLink — and Beyond

    [...] Medtronic’s ground-breaking Paradigm Real-Time combo insulin pump and CGM system has been reintroduced with the amazing new tiny wireless and [...]

  14. NL
    NL January 29, 2009 at 1:08 pm | | Reply

    thank you

  15. sohbet odalari
    sohbet odalari February 25, 2010 at 2:25 pm | | Reply

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