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  1. Tweets that mention » FDA Artificial Pancreas Hearing: Beating a Path to the Real World - DiabetesMine: the all things diabetes blog -- Topsy.com

    [...] This post was mentioned on Twitter by Kerri / Diabetes, DiabetesMine, Bernard Farrell, Ellen Hoenig Carlson, JCampbell and others. JCampbell said: DiabetesMine: FDA Artificial Pancreas Hearing: Beating a Path to the Real World http://bit.ly/8ZCJiB #diabetes [...]

  2. Paul
    Paul November 16, 2010 at 7:54 am | | Reply

    With meters and CGM’s in their present form I can’t see how the FDA could approve an artificial pancreas. Meters right now only have to be 80% accurate and this is what we use to calibrate the CGM? To me that is not acceptable. I have been using a CGM for about 2 years now and I’m a very active person. I have found that the CGM is fairly accurate when I’m not doing much but when I’m active the accuracy goes out the window. I am a avid cyclist and there has been many times when the CGM says I’m 80 when I’m 180 according to my meter. I also had times when the opposite is true CGM says 180 meter says 80. I think the FDA is going to say get the meters and CGM’s close to 100% accurate then we’ll talk.

  3. Cindy
    Cindy November 16, 2010 at 8:12 am | | Reply

    I’m the mom of an 11 year old with type 1 diabetes. I’m certainly not a scientist, but I gotta believe we can solve the low/high management problem and improve the quality of life for people with diabetes. I guess this is my way of saying I’m chomping at the bit to get this thing started. The current system is far far from perfect; maybe by taking the leap of faith with an artificial pancreas type system we can move in that direction of making that reasonably safe.

    I could rant for hours…..frustrations run high.

    I listened to some of the webcast, and I wonder if I was being overly sensitive in one aspect. I felt like the speakers were implying that “compliance = good control” and “high A1C number = non-compliance”. (Whatever compliance is). Anyway, I know with my son that we can do everything “right” and end up with a high blood sugar, and other times realize we’ve counted carbs totally wrong and end up with a blood sugar of 100! Was I being too sensitive?

    Love your blog.

  4. Doug
    Doug November 16, 2010 at 8:42 am | | Reply

    Everyday diabetics are getting themselves in trouble and going to the ER with the tools we have. Either because of bad decisions or equipment failure or just bad luck. If you view that as your control group then whats the harm of doing some careful testing on willing participants. Diabetics are already making big mistakes.

    If we wait for the FDA – Sensors will NEVER be accurate enough, insulin will NEVER work fast enough and algorithms will never be smart enough if we dont get some real world testing started.

    The FDA and the JDRF live in a bubble – they dont realize how often the average type 1 takes a wild guess at insulin adjustments. The world is NOT perfect and never will be. We need to make incremental improvements.

    I’m willing to help anyway I can. I meet the criteria listed. I understand the risks.

    rant:
    One thing that definitely benefits from this is JDRF fund raising – its cool to be associated with this kind of technology. Medtronic loves it and the cash is flowing to JDRF.

  5. Lorraine
    Lorraine November 16, 2010 at 8:56 am | | Reply

    Thanks for always keeping us up to date, Amy!

  6. Laura
    Laura November 16, 2010 at 11:12 am | | Reply

    I agree with Doug above…if we wait till FDA approves everything we won’t even have Dexcom linked with Omnipod…what is up with that? I am truly disappointed with recent FDA decisions regarding diabetes drugs and device approvals. Is there an agenda here? Seeing as these more justified drugs/devices were put on hold again I see no hope for a closed loop system anytime soon.

  7. Jan
    Jan November 16, 2010 at 11:47 am | | Reply

    The extent to which I would like an Artificial Pancreas to intervene would be if blood sugars hit the high 50s, a suspension so the child/adult does not drop further (which can be overridden if treated) and automatic correction for high blood sugars over 200. For safety’s sake, I would like the correction of the high by the AP to bring her down to a target of 130 or whatever target number is determined safe by the parent or adult. I do not trust the sensor 100 percent, I trust it about 75 to 80 percent. Personally, I would want some wiggle room and would not want the AP to bring her back to her actual target. If the AP can help keep overnight numbers somewhat stable — and I have every confidence that it can — we can do the rest. I would like to be able to either turn the AP feature on at the time I go to bed, however late that may be, or if she is in school and away from home sometimes. I absolutely would not want to turn over all management to the AP. I would like an AP FEATURE on the pump that can be utilized as necessary, still allowing users to control the pump when they want to. Need help at certain times of the night, do not want to turn over management to an AP 24/7.

  8. Sasha
    Sasha November 18, 2010 at 1:08 am | | Reply

    The FDA should approve the Veo for use in the United States as quickly as possible. It’s use in alleviating nightime lows would be wonderful.

    You asked “So is it prudent to wait for the technology to be “perfect”? If it ever will be?” It has been said quite often that perfection should never be the enemy of the good. Voltaire must have been thinking of the Veo.

    We want to join the rest of the world in using the Veo. The FDA needs to fast-track this approval NOW.

  9. Brian Riviere
    Brian Riviere November 19, 2010 at 5:11 am | | Reply

    The automated insulin pump is a very interesting read http://wps.pearsoned.co.uk/ema_uk_he_sommervill_softeng_8/48/12401/3174834.cw/content/index.html

  10. susan
    susan November 20, 2010 at 11:16 am | | Reply

    I am extremely sensitive to IOB when exercising to the extent that I eat virtually NO CARBS until AFTER boot camp. Seriously, I do best blood sugar wise under intense exercise if I haven’t eaten any carbs for SIX HOURS prior. So I can’t fathom how an artificial pancreas could ‘plan’ to exercise the same way I do unless it also could deliver glucose.

    It may work for largely sedentary folks who don’t have rapid changes in energy expenditure, but alas, I would never give it to an athlete without a 100% manual mode.

  11. Doug
    Doug November 20, 2010 at 1:04 pm | | Reply

    Susan
    Exercise is only one challenge

    Another is the difference between the speed that BG increases when you eat and the time it takes insulin to work. Even if insulin that worked in 5 min was available the CGMS is still 10 min behind so, in the fairy land that is “artificial pancreas” the patient will still have to count carbs and tell it what was eaten and due to the variability of high fat meals have on absorption combo boluses and the other complexities will be around for decades to come…

    Unless they can figure out how to stop the auto immune response to the Beta cells without killing the rest of your immune response…

    The good news is that through all this cash will still be flowing in truck loads to Minimed and JDRF ..

  12. Gary
    Gary December 6, 2010 at 9:30 am | | Reply

    There is always a risk of technical malfunction and I suppose as with all devices- there will be an increasing role for individuals to monitor, calibrate and maintain their equipment. As with DCCT studies and others, increased involvement and attention to self-management can vastly improve control, A1c’s, etc. Add to that the use of CGM and pumps with proper education and the likelihood is even better control.
    My concerns are more with the variable absorption issues with subcutaneous insulin delivery as well as glucose monitoring. I’ve heard many lectures on the “artificial pancreas” and many begin with a historic perspective of the biostator- a system that could monitor glucose levels and deliver insulin to maintain a stable, target blood sugar level. It worked beautifully. The difference was there were two IV lines used to sense glucose and deliver insulin.-And it was the size of a refrigerator.
    Subcutaneous measurement of glucose and insulin delivery in response to those levels is fairly crude. If patients should not rely on CGMS readings for adjustments, why is there such a push to push this through FDA? It seems there are inherent conflicts of interest and the families living with diabetes are desperate for solutions.

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