Closed-Loop Progress Report

Further to Aaron Kowalski’s recent JDRF update here on developing a closed-loop system for treating diabetes — and of course the new OmniPod/DexCom deal — I ought to share some official updates from the recent Global Diabetes Summit in Ohio, courtesy of Close Concerns:

• “In a session on continuous glucose monitoring (CGM), Dr. Alan Marcus, Vice President and Global Director of Medical Affairs for Medtronic Diabetes, revealed that Medtronic Diabetes will release an enhanced senor-augmented pump that shuts off insulin delivery in response to a low alarm if the patient fails to act.” The editors say this is the first of a series of important “interim steps” toward achieving a closed-loop system. Medtronic definitely believes that “the future of diabetes management is an integrated insulin pump and CGM system,” they say, and they are hard at work on the “incremental addition of automatic features” including improvements in the way these devices gather data, talk to each other, respond, and ultimately automate. A sensor-augmented pump will be released in 2008 in Europe (only). No introduction yet in the US, presumably because it takes so much longer to get through the US regulatory system. Thank you, FDA?

Dr. Barry Ginsberg estimates that closed-loop systems would become available at the earliest in 2013-2015, based on testimony of numerous independent experts. Close Concerns reports:

“Great progress has been made toward a closed-loop system, but numerous challenges remain.” The current generation of continuous monitors has a mean inaccuracy of about 12%. The 95% confidence limits are ± ~30%, meaning that a blood glucose reading of 200 indicates that blood glucose has a 95% chance of being between 140 and 260. Frequent samples partially overcome this problem, as do slow corrections (more readings during correction period). For a closed-loop system, accuracy will need to increase to at least 99%. It will also be difficult to detect when a meal is eaten, and it will be impossible to tell how much or what is eaten. Patients will need to enter some information into the device. A final challenge is that insulin bio-availability {aka absorption} varies (for regular insulin, action varies by ±35% for 95% confidence interval) and duration of insulin action (i.e. insulin on board) changes. It will be necessary to know how much insulin is present to avoid overdosing.” Them’s lots of challenges, I’d say.

Paradigm_ouch

Oooh, no thanks… if it looks like that, I’m willing to wait a bit.

By the way, Close Concerns also reported results from it survey of 525 medical school students this month. Conclusion? “This is probably the most dispiriting story we’ve reported on in 75 issues of Diabetes Close Up — our main finding was that virtually none of these students plans to pursue diabetes as a specialty. There are several reasons why — the money is one thing, the hours are another, the lack of success in working with patients is yet another. We were struck not only by the declining interest in treating diabetes but also by declining interest in general medicine. Where will patients go in 20 years?” I don’t know, either. Time for something to change.

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25 Responses

  1. Scott
    Scott January 8, 2008 at 1:19 pm | | Reply

    I will go on the record as saying that I never expect to see a fully-closed loop system (meaning it never requires patient input), and the note that accuracy will need to increase at least 99% is quite telling.

    Why are we continuing to try and outsmart nature — its never been done before, and from my own way of thinking, isn’t likely to emerge in the immediate future, either.

    Instead, we should be backing research into autoimmunity, cell regeneration and perhaps increasing the efficacy of islet transplantation. I’d bet on that over a machine run on batteries any day!

  2. Titos
    Titos January 8, 2008 at 3:32 pm | | Reply

    I disagree with Scott. it is precisely because we have been “outsmarting” nature since millions of years that we exist today and why T1D does not lead to a quick and painful death like 100 years ago. But I also disagree with Minimed. A closed loop system based on external supply of insulin can only be an interim solution and while probably better than human interventions is based on far too crude algorithms and equipment to qualify as an artificial pancreas. No, the artificial pancreas will be much more like the real thing: nano-material protected insulin factories (cells), either from animals or stem cells placed in the body and able to react normally and immediately, even preemptively to glucose variations . I would predict this solution will be available within 10 years. Clinical trials are already under way in Russia with New Zealand technology (Living Cell Technologies)and Sernova Corp has been working also on a similar solution. For another alternative check out http://www.smartinsulin.com for a type of insulin that releases itself according to sensed glucose levels.
    The solutions involving immune system modulation or genetic re-engineering will take longer and the issues are not yet well understood. But a “cure” for practical purposes does not require that. It requires putting insulin and possibly amylin and c-peptide in the body at the right time and the right amounts. That is a bio-engineering / molecular biology problem / nano-tech problem rather than a real medical problem. This technology has just taken off. Watch it develop

  3. Adam Becker Sr
    Adam Becker Sr January 8, 2008 at 4:26 pm | | Reply

    What are the best technologies for measuring insulin levels in blood?

    I know that if I could get a home insulin-o-meter with, say, $10 or less test strips – my family would be using it a lot.

  4. Christine
    Christine January 8, 2008 at 7:44 pm | | Reply

    Bad plan. I frequently can’t hear the alarms at night- making me “fail to react” and it frequently reads falsely low.

  5. Sarah
    Sarah January 9, 2008 at 3:19 am | | Reply

    I’m with Scott…AND Titos. All I can say is that if all we have by 2012-15 is an inaccurate semi closed loop system, we are wasting our time.

    A true “artificial pancreas” is a pipe dream.

    I believe LCT and xenotransplantaion using encapsulation technology is going to make bigger and better progress sooner (if Big Pharma, JDRF, etc. doesn’t try to stop or limit them).

    I also believe we are closer to putting the pieces of autoimmunity together. Instead of seeing it as the complex immune reaction it is, let’s look at it from 10 steps back. Autoimmunity looks much like an allergic reaction to something in the environment, like a food protein or virus. Remove that trigger, and help those beta cells regenerate in those who can, and we have a cure.

    While I welcome diabetes technology, let’s not lose sight of a cure.

    I can’t help but feel put off when every “diabetes breakthrough and research session” I attend is sponsored by Medtronic and Lifescan, all trying to woo me with their products.

    I’m cheering for LCT. With the power of the web, we’ll make sure they get ahead.

  6. Sarah
    Sarah January 9, 2008 at 3:23 am | | Reply

    Also, I’m having enough problems with absorption with my current pump. The last thing that will help me is another sensor and another 20 years of tissue damage.

    And an implantable pump is also risky and requires regular surgery for “fills”.

    I don’t want any more tubing hanging off me, maintenance, equipment failures, or maintenance costs to live.

    Put that money towards a cure…in some cases (i.e. LCT), we are closer than most people think.

  7. Clinton
    Clinton January 9, 2008 at 6:35 am | | Reply

    Great post, Amy. But, the very nice big-ass picture was a little disturbing! :-)

    Thanks!

  8. Jonathan
    Jonathan January 9, 2008 at 8:41 am | | Reply

    I agree completely with Christine. I have many night-time alarms for being low and the CGM is usually lower than I am in reality. Plus, absorbtion and lag time can be a big issue – it takes 1 1/2 to 2 hours for the Novolog to have an effect on my BG, so shutting it off now is not going to help a low when it needs to be helped.
    This is just another teaser to get us to become excited about the latest technological gadget which the industry has spent millions working on that will just continue to maintain us as customers for as long as we have money and/or insurance. The incremental value is so small. Spend the money for a cure! Win immortality for curing this disease, as Jonas Salk did for polio. That legacy will live longer than the profits from separating PWDs from their money.

  9. Bernard Farrell
    Bernard Farrell January 9, 2008 at 11:05 am | | Reply

    Amy

    The picture is a little strange, and maybe out of context. But moving on…

    I’m sure the first few versions of a closed loop system won’t be great. Think of the new version of anything you know. But I expect we’ll see big changes within a relatively short time. The big question I have is, how easy will it be to get this approved by the FDA? Personally I expect to see such a system overseas before we see it here in the US.

    I’d certainly enroll to trial one. But I’d probably wait until V2.0 or later before actually going on one.

  10. Karen
    Karen January 9, 2008 at 3:59 pm | | Reply

    I feel the need to post just about the picture as that looks like me except on my tummy. I was just hooked up to the CGM yesterday and after seeing all those bad sites on that person’s a$$, I am rethinking my long fought appeal for the CGM. The pump I don’t get scar tissue, but I can see it happening on the CGM. What is a diabetic to do? :(

  11. Dennis
    Dennis January 9, 2008 at 8:31 pm | | Reply

    Lack of interest by Students to be Endo’s/Treat Diabetics…. I think what has been overlooked is not the Lack of Money( they earn more than a GP ) but more closer to the fact of most of these students are under the impression of treating mostly T2′s, ie: Obese people with Eating Disorders, etc… that in itself would discourage any Person, let alone a Younger one..

    The T2′s are over loading our Endo’s , when most don’t really need them ( To get Metformin and be told to Diet and Exercise) but none the less when I go to my endo’s office, 9 out of 10 are T2′s and I talk to them, since I have ave of 2 hrs! And most don’t need the Endo.. Some were referred by their GP’s since they couldn’t get them to Conform to the program and thought they could get better ‘Bedside” manners from an Endo..

    Granted, some have to go on Insulin, but the vast amajority do not and are over loading our Endo’s and something has to be done to slow this problem down..

    Hopefully the Insurance Co.’s will come up with a Discouraging plan..

  12. Andy
    Andy January 10, 2008 at 1:35 pm | | Reply

    Actually if my opinion would count, I wouldn’t go for fully automated closed loop system…
    Having system, where you have both pump and glucose meter is great, but for me it would be enough if values for BG are displayed so that I can act on them, not that pump itself would react to this values…

  13. John
    John January 11, 2008 at 6:39 am | | Reply

    Amy, For Medtronic to say “they are working hard” is a bit of a nis-nomer. They are in it for the money. Cure it? What for, it’s my living!
    A pacemaker can sell for ten times what the company sells it to the hospital for. It’s just business to many of our healthcare companies. They often apppear to be more concerned about me now that I have insurance(HA!).
    As always, thanks for Amy making us think about the answers we all look for! Great blog.
    Best, John

  14. Marty
    Marty January 11, 2008 at 11:58 am | | Reply

    Don’t worry about how that looks. Most of us pull our pants back up after attaching our sets and sensors, certainly before leaving the house!

  15. Lauren
    Lauren January 11, 2008 at 12:56 pm | | Reply

    I am type 1 and a first-year medical student. The main thing deterring me from entering the field of endocrinology is parents of young type 1′s. First, they have trouble recognizing that the disease did not happen to them, it happened to the kid. Secondly, it’s just common sense to avoid passing on your genes if type 1 runs in your family. The parents make a selfish choice to reproduce and pass on bum genes, thereby saddling kids with a lifetime marred by a disease they never asked for. My brother and I are both type 1 diabetics. If we ever decide to become parents, we will do the right thing and adopt.

    My classmates tend to find diabetes “boring” and run of the mill, so maybe that is a contributing factor as well. Managing diabetes requires a lot of patience and willingness to plod along, for both the patient and the doctor.

  16. AmyT
    AmyT January 11, 2008 at 1:43 pm | | Reply

    Wow, Lauren, that’s quite a story. I’m surprised that you feel like your parents made a mistake in having you. Isn’t life worth living, even with the diabetes?

  17. Lauren
    Lauren January 11, 2008 at 6:24 pm | | Reply

    I’m not sure that because I don’t want to pass on my disease, it logically follows that I’m suicidal. My life is a fait accompli, but when it comes to having kids, there’s choice involved.

    Surely I’m not the first person to avoid biological reproduction because of a strong genetic component to my illness. My type 1 aunt did exactly that. I hear a lot about the “heartbreak” of having sick kids, the guilt of passing something on. I’d want a better life for my kids. I’d like to stop the type 1 gene in its tracks.

  18. Karen
    Karen January 12, 2008 at 1:13 pm | | Reply

    Lauren and Amy,

    I have been Type 1 for 41 years and I chose not to have kids because I did not want to pass on this awful disease. Lauren, I understand your thought process. I love my nieces and nephews to death, but the thought of them getting this disease is something I don’t think I could endure, so I know I made the right choice.

  19. Jan
    Jan January 13, 2008 at 6:16 am | | Reply

    Amy, as an avid reader of your blog, which IMHO has the most current, up-to-date info. available in an easy-to-read format, I would like to voice an objection to the flip comment “Oooh, no thanks, if it looks like that, I’m willing to wait” along with the accompanying picture of a young child’s tush area. Firstly, I believe some of the child’s tush area should have been covered, exposing only the area around the site. (I realize you are probably just reproducing a picture already taken and distributed). Secondly, we are dealing with a ten year old in puberty with the accompanying crazy, fluctuating blood sugars, due to growth and other hormones. Who TF CARES what the minilink LOOKS like! Appearance is not the reason we are using it! We have used ours since Dec. 18th and had to disconnect on January 5th due to a pump problem (MM sent us a brand new pump promptly). We had an endo appointment on Jan. 7th and during that short time her A1c had dropped from 6.9 to 6.5. We had an A1c drawn 6 weeks ago when we were at endo anyway for another appointment. And we had not changed any basals yet, as we wanted the info before changing. This technology will allow us to get her A1c WAY down; more importantly, will allow us to control the constant BS fluctuations. That is why we use it. By the time she is 18, she will have had Type 1 for 10 years. Puberty and teen years being the most difficult to control Type 1 diabetes, without it, she may very well have complications after those ten years are up — at 18! The scars on the tush area are most likely from the sets to the child’s insulin pump. We use sils and we have pimples upon removal of the site, which do heal. We have worn our minilink in the arm. We used the first one for 10 days straight. Second one a little less. She had a slight mark which is no longer evident. Minilink looks like a seashell, and is relatively small. I am aware that the Dexcom is smaller. My huge complaint about the minilink is the ridiculously large introducer needle. Minimed needs to get on the ball here. Wait two more years to start cgms until Animas and Dexcom and/or Omnipod and Dexcom get their act together? I don’t think so. P.S. We still have our Animas pump under warranty so if Dexcom and Animas start communicating, we could reconsider and use the Dexcom. The Minilink has been accurate for us. It does not catch quick rises or quick drops accurately, i.e., you may get a high alarm at 180 with an arrow up and she’s 240, but at the point of the alarm we check BS by fingerstick and correct. Or alarm at 90 and she’s 60. Low alarm we pushed up to 100 to avoid this problem. Too many alarms so we may push low alarms back down again. I AM THRILLED WITH THIS TECHNOLOGY. THRILLED BEYOND BELIEF. Two more years of roller-coaster blood sugars? Who knows how much damage can occur in two years time? We do not have the luxury of being willing to wait.

  20. AmyT
    AmyT January 13, 2008 at 9:21 am | | Reply

    Hi Jan,

    I didn’t believe the photo to be a child’s tush at all, or I wouldn’t have run it. It looks like a young man to me — aged 18 or 20ish?

    Also, I was simply pointing out that the sites don’t look too comfortable. I’m not knocking the technology, believe me! (which you’ll know if you read this blog regularly).

    Thanks,
    AmyT

  21. Jan
    Jan January 13, 2008 at 9:55 pm | | Reply

    Upon second glance, it DOES look like an older teen’s tush…. my apologies! She just had her third sensor insertion (minilink) in the arm today, with EMLA, and no complaints. She is ten with very, very little fat, in fact, none. The other two sites look very clean, more tape residue than anything else. No scars. Once the sensor is in, she does not notice it. I know come summer, she may protest about the arm site but for now sensor site is covered by a long sleeve shirt. I am very glad there will be competition in the cgms field, the more choices the better for us. I DO read your blog and read about your experiences with the Dexcom with much interest. xenotransplantation, smart insulins, even the closed loop most likely are years away, as in TEN. Our only choice is to work with what we’ve got, warts and all. I also believe part time use of cgms can be very beneficial if it proves too difficult or awkward to wear it all the time. P.S. Whatever happened to the promised Nano-pump Animas was supposed to be bringing out?

  22. Chuck
    Chuck April 21, 2008 at 11:21 am | | Reply

    I’m interested in hearing more people’s opinions about LCT’s breakthroughs and how Big Pharma is going to react. I’m a type 1 that’s had diabetes for 26 years. For something that is safe as LCT’s product, why can’t this be taken to market faster. I’m sure that there are a lot of factors. It seems as if LCT is the only company out there that is actively trying to make diabetecs lives easier rather than just treat it with new products that do the same things as the old ones.

  23. Diane
    Diane June 16, 2008 at 10:32 am | | Reply

    I have had type 1 for 35 years, I now have 3 children of which 2 have type 1. My children are full of love and life and for those of you who say you would adopt or not have kids for the fear of passing it on, I myself and my children ask you this, would you have prefered not to be born. ask yourself the question, if I had the choice hmmm diabetes or not be here I think I would prefer to be here and have the chance to love life than never experience. I have not had it easy with the eye prdobs and that but I still love being alive, and so do my children. Regards Di

  24. Alan Marcus
    Alan Marcus February 21, 2009 at 4:55 pm | | Reply

    I am very intrigued by the responses to the what a major corporation in the area of diabetes technology had in mind for their product future.
    The success of their products is definitely linked to economic well being but that creates a competitive atmosphere that hopeful drives improvement in the tools available to provide care.
    A company that fails to meet the needs of its customers is a company that ceases to exist.
    Since I have returned to clinical care I realize how much I depend on others (patients and corporations and health care providers of all types) to provide me with the tools that allow me to assist in hoping to approach achieving improved care for those who pay me the highest complement of trusting me to be part of their life.
    It is impossible to have a one size fits all answer to the needs of people in dealing with a disease that although common genetically in so many ways is individualized in its expression ultimately requiring each patient to be managed with the focus on the n of one rather than by group think.
    Alan

  25. Peter
    Peter November 13, 2009 at 1:24 pm | | Reply

    I would like to speak to those who have chosen to not have children because they may pass on their diabetes. I have type 1 diabetes and have had it for 13 years. None of my family has diabetes and no records of any of my extended family with diabetes. I will choose to have children and hope for the best possible health for my child as I would with any child if I had diabetes or not. I don’t think because I have diabetes my children will immediately be diagnosed with it, just my opinion.
    Peter

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