13 Responses

  1. Mary Dexter
    Mary Dexter September 27, 2011 at 7:14 am | | Reply

    Last night I turned off the low alarms on my CGM so my husband and I could get a night’s sleep. I got my CGM in July and am still learning how to calibrate it. Too often, with a new sensor, we are continually woken up by low prediction alarms, falling rate alarms, and low alarms. At the same time, my meter will say I am anywhere between 120-180. With luck, the CGM becomes accurate 24 hours later and stays so for 24-72 hours, if I’m able to reboot the sensor, which I can do 50% of the time.

    I have been talking with Medtronic’s Help Line and working with my CDE. Tonight I am going back for more training. CGM users seem to fall into 2 categories: those who wear it for a few months and then give up; and those who have been wearing them for years and adore them. I am working very hard to become the latter. However, Medtronic needs to manufacture a CGM that can be accurately calibrated both quickly and easily by an average person. Right now, my life revolves around this technology. I want my life.

  2. Mary Dexter
    Mary Dexter September 27, 2011 at 7:26 am | | Reply

    Manufacturers need to improve CGMs so they can be accurately calibrated more quickly and easily. I’ve had mine since July. With almost every new sensor, my husband and I are woken up by numerous low prediction, falling rate, and low alarms. I’ll get up to check and my meter will say 120-180. I can’t recalibrate because of the arrows. I’m going back for more training tonight, but can understand the FDAs concerns.

  3. Ann B
    Ann B September 27, 2011 at 7:39 am | | Reply

    Great article! Sadly, this is not a new problem. In the 70′s my dad and I went to England to get a bg meter because FDA would not approve them over here. From the time we got ours to the time they became available here was 5 years. England had already been selling bg meters to the public for 2 years, prior to our buying one.

    Last year, I attended the Medical Innovations conference at the Cleveland Clinic, which focused on diabetes. 9 diabetes drugs went thru clinical trials and failed to make the marketplace only because of FDA concerns over unknown variable: Would they be Avandia? (pharma investment in drug development is $1.4B/ drug)

    In the global sphere of medical innovations, US ranks 6th out of 50, but in getting new therapies to the marketplace we rank 49. Something needs to change!

  4. Michael Ratrie
    Michael Ratrie September 27, 2011 at 9:03 am | | Reply

    I have written to the FDA re: LGS. To say it is frustrating is to put the best face on it.

    FWIW, here is what I posted over on Bernard’s link:

    “Good stuff!

    Seeing all these links and reading what you have posted has to make me wonder if the FDA has been given too many things to do by Congress without enough funding, or if we need to re-think the way we regulate food, drugs and medical devices?

    It also makes me wonder not only how long we can wait to make a change, but how we will make the changes necessary without grinding everything to a halt?”

    Changes can be made, but they will require the political will of politicians of every stripe to ensure they are true and effective changes. It will assuredly take additional money.


  5. Bernard Farrell
    Bernard Farrell September 27, 2011 at 12:35 pm | | Reply

    Amy, thanks for the shout outs on my FDA-related posts. I think it’s going to be critical for the DOC (Diabetes Online Community) to engage with the FDA so we can assist and provide advice where appropriate.

    I testified at the FDA Humalog advisory committee meeting in 1996. If that had not been approved I was planning to start importing Humalog from Europe. I’d hate to have to do that for devices because of warranty and units (mg/dL versus mmol/L) issues, but it appears medically as if we’re falling far behind other countries. As a US citizen I find that really disappointing.

  6. Chris Lee
    Chris Lee September 27, 2011 at 2:04 pm | | Reply

    This makes it hard for us to believe in “the system”, when constantly the system is what is standing in the way of us seeing advancement in technology and having better control of our lives as diabetics. I have had Type 1 for 17 years and have been on a pump for the last 9 years of my life. It would be amazing to be able to have these “updates” on my control so that I can take better care of myself.

    This is why I am taking matters into my own hands and doing a juice fast that has better control of my insulin intake and overall blood sugars. Basically, what I am doing is only drinking blended up fruits and veggies for 60 days. I am on day 8 and it has done wonders for my bloodsugars! My boluses are down by 90% and my basal rate has decreased by 30%. Amazing what fruits and veggies with a low glycemic index can do! Not to mention, I have already lost 8 pounds of unwanted fat. If you are interested, you can follow me on my blog

  7. Natalie Hodge
    Natalie Hodge September 27, 2011 at 2:09 pm | | Reply

    Hi Amy, great post!! Go JDRF!!!!

    It’s getting really heated now isn’t it? Hard to be patient. On the flip side I did get my daughter’s Omnipod orders last friday and she will go live over the weekend!!

    But we also found out her celiac antibodies are through the roof! So she has to get endoscopy week after next and a biopsy.

    When it rains it pours…

    Best, Natalie

  8. Casabby
    Casabby September 27, 2011 at 5:26 pm | | Reply

    To Mary Dexter: after using the Medtronic CGMS for 2-1/2 years, I am using the Dexcom and find it incredibly accurate compared to the current Medtronic system. However, I still use the Revel pump and really miss the integration of my pump and CGMS.

    Medtronic has a new generation of CGMS which is more accurate and less painful. But guess what! It’s not approved by the FDA and is only being used in Europe….

  9. Mary Dexter
    Mary Dexter September 27, 2011 at 7:06 pm | | Reply

    Back from the meeting with the Medtronic rep (+ 2 CDEs and another LADA).Seems the false lows are caused by my warped body (scoliosis) pressing against the sensor while I sleep. Weak Signal is when the sensor briefly tips out (why do they put the most important part right at the skin’s surface) because the sensor isn’t at the perfect angle. Everything must be perfect for this mechanism to work. Unfortunately, neither I nor my life is perfect.

    Also, remember all the complaints we’ve read from Europeans about them not being able to get pumps over there because pumps are not covered by their national health system. Many of them are still on syringes and fighting for test strips and meters. Perspective.

  10. Jacqui
    Jacqui September 29, 2011 at 2:31 am | | Reply

    I have two sons using pumps and CGMS fully funded through the NHS. We don’t pay for insulin, pens, needles, strips, meters, infusion sets, reservoirs, tegaderm, cavilon etc etc etc, you know the everyday stuff we use :) The problem here is not that pumps are not covered by the NHS (they have their own technological approval which means if a consultant says you need one, your Primary Care Trust have to fund one); its that old chestnut of teaching old dogs new tricks (how long does a trick have to be ‘new’ is a good question to ask – 40 years and counting it seems) and getting commissioners to see that saving a pound here loses lots of pounds later on down there. My goodness yes, they are big issues here still but we have many fantastic centres of excellence where pump use is very high and those in the know travel to such teams to get the best care. And those in the know who care also travel to sit in on national meetings trying to get the bigger picture message out there.
    Your FDA problems are in a different realm to the NHS issues here. We have freedom to choose a full range of tech, and have to fight to get it funded by our health system. You have to do most of the funding and don’t get the full choice… I wouldn’t be liking them apples!
    I don’t think this is a ‘count yourself lucky’ issue is it?
    I have found the US families I have met equally as motivated, clever and caring as any one in any other country. This is about access to new technology which is being approved in other places and not for you at home. Maybe you have your own ‘old dogs’ but they are just a little higher up in the system?
    Perspective is useful but not when it is used to excuse localised (in global terms) limitations in care.

  11. Mary Dexter
    Mary Dexter October 3, 2011 at 2:35 pm | | Reply

    Just read on TuDiabetes about a woman who just got the CGM for her Veo. On the drive home, after “successfully calibrating”, it decided to repeatedly turn off her insulin due to false low alarms. She kept having to turn her insulin back on.

  12. DensityDuck
    DensityDuck January 17, 2012 at 3:44 pm | | Reply

    The problem is that there’s an ‘established successful treatment’ for diabetes–finger-stick testing and injectable insulin. Trying to do anything else is gonna be very, very hard, because you’ll need to do one study to convince the FDA that it’s no worse than the baseline, and then another completely new study to convince them that it’s *better*.

  13. Tuesday Tidbits: Artificial Pancreas. | Bleedingfinger

    [...] to develop this technology.     Another issue in moving the Artificial Pancreas ahead is the FDA. Sorry to report this but is true. The LGS (low glucose suspend) is available in 40 other [...]

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