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26 Responses

  1. Mary Dexter
    Mary Dexter April 28, 2011 at 6:15 am | | Reply

    I guess what swayed me was their descriptions of a return to a normal life, the chance to actually feel good again. I’m so tired of working so hard, of trying to figure out things only to fail, of dragging myself through life, of being patted on the head and told how wonderful I’m doing just because I haven’t been hospitalized, yet. If I am going to live the rest of my days in fear of something dreadful happening, I might as well get the payoff of a shot at happiness.

  2. Elijah M
    Elijah M April 28, 2011 at 7:18 am | | Reply

    I would take an implantable pump in a heartbeat, and never look back.

  3. Bernard Farrell
    Bernard Farrell April 28, 2011 at 7:35 am | | Reply

    I’d really like to know more about this technology, and I know that several other companies have worked on it. It also makes me want to know more about the FDA process and how it works for something like this where you have both a new device and a new insulin formulation.

    It would be nice to free up a hip and not have to worry about tubing snags (and yes I do know about Omnipods). But I wonder about microdosing with concentrate insulins – can I really give myself 0.2 units of an insulin like this, does it even make sense.

    However give me one of these loaded with smart insulin and I’d implant myself – my penknife is ready. :-)

  4. Scott S
    Scott S April 28, 2011 at 8:34 am | | Reply

    For me, the key is a time-activity profile for insulin delivered this was measured in MINUTES, not the hours it takes all existing rapid-acting analogues (and at least one non-analogue now pending FDA approval). Rather than wait for pharma to come up with something faster, this would accomplish the same thing today. That’s compelling for a number of reasons. However, not knowing all the details, its hard to say I would or would not without having more information.

  5. Eric
    Eric April 28, 2011 at 9:00 am | | Reply

    Based on what the people in the article are saying, their quality of life has gone up dramatically. It’s a real shame this technology hasn’t been developed further. The difference in results using direct insulin administration vs subcutaneous sounds like night and day. It’s a shame more people don’t have a chance to experience this. Where the hell is JDRF on this technology??? Why is it no part of the AP discussion? I don’t get it. Kowalsky??? Kowalsky???

  6. Lauren
    Lauren April 28, 2011 at 11:05 am | | Reply

    I would like to learn more first too. Also, surgery four times a year doesn’t sound great…if life would improve greatly then I really do think it’s all worth it.

  7. Elijah M
    Elijah M April 28, 2011 at 12:08 pm | | Reply

    No matter how I look at it, I can’t imagine a scenario where minor surgery four timers a year for the rest of my life doesn’t feel like a vast improvement over what I do now. Performing several finger sticks a day and maintaining a pump are far less invasive, but they’re also remarkably high maintenance.

    Get cut open, refilled, and then forget about it for three months? Sign me up. Sign me up now.

  8. Elijah M
    Elijah M April 28, 2011 at 12:22 pm | | Reply

    No matter how I think about it, I can’t imagine a scenario where surgery four times a year isn’t preferable to what I do now. Granted, ten finger sticks a day and constantly maintaining a pimp regimen are far less invasive by comparison, but they require my constant attention. Being cut open four days of the year, so I can forget about it the other 361 days strikes me as a great bargain. Sign me up. Sign me up NOW.

  9. Anne Findlay
    Anne Findlay April 28, 2011 at 12:47 pm | | Reply

    might be cool if they got it really tiny and it was a closed-loop system. otherwise, no.

  10. Elijah M
    Elijah M April 28, 2011 at 3:23 pm | | Reply

    If it’s a legitimately low-maintenance system, I think it will be an easier sell than a pump. It took me 17 years to warm up to the idea of a pump, because until I experienced it, the liabilities didn’t sound like they outweighed the benefits. I still had to prick my fingers, I still had to inject (albeit in a more passive manner), and I would have the added indignity of having a contraption attached to me 24/7. That’s what makes it a hard sell. On paper, it doesn’t sound any more appealing than traditional shots.

    On paper, four invasive refills a year, and little else sounds like an easy sell, compared to shots or pump therapy. Not even the same ball park.

  11. Mike Hoskins
    Mike Hoskins April 28, 2011 at 4:43 pm | | Reply

    No, I wouldn’t – I’d opt to wait at least a year or two and let it “ripen.” Regardless of the evidence that any safety issues exist or not. I’m just naturally skeptical, and would want to see this play out at least a little before diving into something headfirst like that.

  12. mcityrk
    mcityrk April 28, 2011 at 6:57 pm | | Reply

    Kind of curious as to what kind of clinical trial you would have to pass to be able to claim an 8 year extended lifetime for any medical device. Seems like every time there was a burp in the testing, you would be dropped back to time zero to start up again and prove you had fixed any previous problem. Wouldn’t that be extremely expensive, time intensive [to the point where other shorter duration devices may surpercede this technology], and as a result incredibly risky to sell to company management let alone the marketplace??

  13. Elijah M
    Elijah M April 28, 2011 at 7:30 pm | | Reply

    I’m not sure how you attach a concrete amount of average years added to life for anything; although I would imagine such data exists for pump therapy.

    Maintaining a system of injections and carb counting is difficult for anyone; and I don’t think anyone questions that getting it wrong too many times shortens a person’s life considerably (and there is ample data on that). Automating that system, in turn, would lengthen that person’s life.

    If I were a skilled statistician, I could probably come up with a way to leverage existing data on bad control shortening life to quantify the possibility of almost perfect control lengthening life without having to wait eight years for a result.

    I’m totally guessing, of course.

  14. Scott K. Johnson
    Scott K. Johnson April 29, 2011 at 7:22 am | | Reply

    I’m on the same wavelength as Scott Strumello here. If this thing is delivering into my bloodstream, or anything faster than subcutaneous tissue, then yes, I’d do it.

    Dealing with highs that take hours to come down as we wait for insulin to be absorbed through the subq tissue sucks. Maybe that absorption delay is also what leads to the post meal spikes in many cases?

  15. Reed G.
    Reed G. April 29, 2011 at 2:51 pm | | Reply

    When I first started pump therapy in 1989, my Endo in Atlanta said I could go on an implantable pump by Minimed (before Medtronic bought them) or the 509c external pump. I opted no due to size (he said you could see it sticking out of your tummy) and he later told me that the while the device was taken off the market in the U.S. due to complications (tissue was growing around the metal device), it was still offered in Europe. So, I’m curious how much the device has evolved. To me, this is how the technology should evolve . The artificial pancreas is in clinical trials, but still using external devices. Day in day out compliance is tough … especially with the sensors. I envision both the sensor and the insulin delivery device to be implanted in the future.

  16. Elaine D.
    Elaine D. April 29, 2011 at 6:43 pm | | Reply

    The implantable pump delivers insulin directly to the liver, which mimics what the pancreas does. If the four people travel 30 hours every three months for a 15 minute procedure, it must be really worth it! We should really make our voices heard that we want this technology here in America! The technology is there, we should have access to it!

  17. Greg & Anne
    Greg & Anne May 2, 2011 at 8:36 pm | | Reply

    Comment to Diabetes Mine blog

    From Anne and Greg:

    We were intrigued by your poll about the Diabetes Health Implantable Pump article and the comments that followed. So we thought we’d post some additional information about our journey with the implantable pump.

    We got our first implantable pumps in January of 1992 and over the past 20 years and have first-hand experienced the fantastic benefits and the trials and tribulations of a new technology evolving through difficult times. Bottom line, in our opinion the hard times were worth the trouble and a lot more. The knowledge gained over those years has taught the scientists, surgeons and physicians how to implement this technology in a very effective manner.

    The diabetes professionals in France – where there are hundreds of patients on the implantable insulin pump – know how to implant the pump and how to manage it for years of performance. This is a monumental success story that is unknown to most of the medical world and it is about to become a story of regrettable failure.

    We are travelling to France 4 times a year because several years ago Medtronic cancelled the U.S. studies and all of the U.S. patients with implantable pumps were offered explants surgery and an external pump and continuous glucose sensor at Medtronic’s expense. Anne and Greg refused and went to France where the technology was still available (although at first it appeared that Europe would be cancelled as well – except that an intense effort by the European doctors who value this technology highly helped to delay cancellation in Europe.) We have been travelling to France for 4 years at our own considerable cost and we know that most diabetics regrettably do not have this option.

    We tried to convince Medtronic to keep going with the pump and we failed. We tried to start a company to acquire the rights to build a pump and we failed. The road has been rocky and painful and costly but we would do it all again if it meant that this technology could be saved for all of us. We have started a web site for informational purposes – to tell the story of the implantable insulin pump – the early technical problems, the amazing benefits, the current state and the danger of the loss of what we believe is a remarkable advantage for diabetics that is on the eve of great success and in danger of extinction. This website should also clear up some possible misconceptions about what exactly is involved in our 4 pump refills a year. We think you may be surprised by how simple the procedure really is! Visit our site http://theiipump.com/ or send us an email at info@theiipump.com and we’ll keep tying to get the word out.

    We are not trying to make anybody the villain here but we are trying to convince those who can bring this technology to the next level to do so with deliberate speed and conviction. There must be some company out there has the means and will to get this done.

    Thanks, Greg and Anne

  18. Karrie Hawbaker
    Karrie Hawbaker May 3, 2011 at 11:22 am | | Reply

    Hi Everyone,

    You might be interested in some further information about the implantable pump from Dr. Francine Kaufman, Chief Medical Officer for Medtronic. You can find her comments below or at http://www.loop-blog.com.

    Best,
    Karrie Hawbaker
    PR Manager, Medtronic


    Almost two years ago, I left my three-decade long position in academic medicine to come to Medtronic to be part of the effort to develop an artificial pancreas, a fundamental goal for all of us in diabetes research. With all of the work currently underway, Medtronic is committed to bringing innovation and advancement to diabetes therapy.

    We have made significant progress on our ultimate goal to provide patients with a fully-implanted, fully-automated pump – a true artificial pancreas. Our work in this area represents the reason I came to Medtronic and why our entire group is committed to helping people with diabetes live a better life.As we work toward that goal, we are also focused on what we can do today and in the near future to improve the overall health and quality of life of people with diabetes. We are making significant advances in our pump and sensor technology, refining the algorithms that direct our devices to do what we design them to do, and updating our offerings to be more adaptable in today’s constantly changing technology environment.

    I tell you this because it’s important to understand the breadth and depth of our work when you consider what Medtronic is doing for people with diabetes. We noted with great interest the recent story in Diabetes Health about our implantable insulin pump and the online discussion that followed. We read first-hand the stories of people who have gone to great lengths to avail themselves of our implantable insulin pump.

    As you know, the implantable insulin pump is not approved by the FDA in the United States. It has been made available outside the U.S., most notably in France.

    The comments that followed the posted story covered a number of areas, mostly advocating for its broader use and questioning why we have not brought it to the market in the U.S. One thing that we would like to point out is that the implantable pump is not a closed loop system. The people in Europe who use this product still need to test their blood sugar multiple times per day, count carbs and calculate and administer bolus dosages using the pump’s external remote.

    In addition, included in those comments were a number of insinuations that we are somehow withholding this device from patients. That is completely untrue.

    The reasons why the implantable pump is not available in the U.S. are as follows:

    • There are many technical, scientific, clinical, regulatory and healthcare system hurdles. We regularly manage through these, but in some instances, and the implantable insulin pump is one, we need to consider not only our device, but the insulin that is provided through that device. Having one component approved is challenging, having two components is doubly so.

    • The implantable pump – in its present form – is difficult to adopt. It is a complex device that requires meticulous attention and care. Refilling and readjusting it is a challenge. We’re working to make the pump smaller and easier to adopt.

    • A particular type of concentrated insulin must be used in the implantable pump to provide the best opportunity for an efficacious and safe treatment for the patient. That formulation is still being developed and refined, and the original formulation is no longer available.

    • Our research and development budget is robust, but has limits. We work on the innovative advances we believe we can bring to the market quickest so that we can have a more significant impact on the care of people with diabetes.

    Developing the next generation of implantable pumps will take significant time and resources. We know there are many innovations that we can bring to people sooner to reduce the burden of diabetes management and improve outcomes. As supported by the roadmap developed by the JDRF, it is within our grasp to have pumps/sensors/algorithms that determine how to deliver insulin automatically, and that can start making big differences in the lives of people with diabetes now and in the years to come. That is where Medtronic is placing the bulk of its resources and efforts, while at the same time it continues to invest in the implantable pump program.

    Of course, we are pleased to hear stories from people who report success with our devices. We remain committed to supporting the patients who currently benefit from the implantable pump. However, no device is right for everyone. That’s why we create a portfolio of devices that will suit the broad spectrum of people with diabetes.

    We remain committed to listening and engaging with the diabetes community. You are a passionate, informed and motivated group of people who have brought about great change in how this disease is treated and we have no doubt you will continue your tireless advocacy. Your words and deeds motivate us everyday to develop innovative treatments which help improve the lives of diabetics everywhere.

    I’ve seen a lot of positive changes in diabetes technology in the 32 years I’ve been practicing medicine. It’s exciting to see how far we’ve come. But, knowing how much talent and resources are currently dedicated to developing an artificial pancreas, it’s even more exciting to think about what technology patients might have in the near future.

    -Dr. Francine Kaufman

  19. debra bond
    debra bond May 15, 2011 at 1:47 pm | | Reply

    I am currently using the Medtronics infusion pump. I was diagnosed almost two years ago, my doctor started with pills alone, then injections along with the pills, neither.

    After a year of not being able to function at all, I started using the pump,I do have more good days now than bad but I have a ways to go yet.

    If the implant worked the way the pancreas does or even 99%, I would jump at the chance to have one.

  20. Jerry Tarpey
    Jerry Tarpey June 11, 2011 at 12:24 pm | | Reply

    I must presume that somewhere between the glowing reports of the participants and the somewhat dire concerns and issues presented by the possible manufacturer the truth is simply sitting there waiting to be discovered.
    As a T1 diabetic for 44 years I will state unequivocally that when (if!) this technology is made available I will run to wherever I need to go to pursue it.
    The fact it is currently not a ‘closed loop system’ is, to me, meaningless. I can easily continue to test BG readings and estimate carbs. The method of insulin delivery is the key ingredient in this discussion and that should be what’s concentrated on.
    Has the FDA chimed in at all on this?

  21. Uzma
    Uzma August 8, 2011 at 6:31 pm | | Reply

    Interesting. Thank you, Dr. Kaufman, for the enlightening comments. I have my own set of gripes about Medtronic, but unfortunately lack the energy to type them. What I really want to know is, how close are we? How close?

  22. Heather Payton
    Heather Payton August 16, 2011 at 8:48 am | | Reply

    I currently using a Medtronic insulin pump. I have had diabetes for over 30 years now. If this was an option to get the implant I would like to be on that list. Life would be a little bit easier for me and my family.

  23. Lesia McKenzie
    Lesia McKenzie October 23, 2011 at 6:38 pm | | Reply

    I am a Registered Nurse with over 16 years nursing experience.

    Not only am I a nurse, but my husband is a type 1 diabetic dependent on insulin since he was 13. We have to endure swings in blood sugars which have led to diabetic seizures in the middle of the night. Thankfully, he does not sleep alone and is married to a nurse. How many diabetics are in that situation?

    The number one reason for non-compliance with insulin therapy is discomfort. It hurts. We have many patients that refuse sliding scale coverage because they simply do not want to be stuck again.

    Its my understanding that there is a blood glucose monitoring watch. This, in addition to an implanted insulin pump would significantly increase compliance with diabetes management. Increased compliance will only lead to decreased complications from long term mismanagement of the condition, thus decreasing discomfort, complications, and medical expenses down the road for millions of diabetic patients.

    This seems like a no brainer to me. Why is the Juvenile Diabetes Association NOT all over this technology? Why are our American doctors not pushing this? What about Medtronic-don’t you think someone, somewhere needs to poll the diabetics and ASK them if they want this instead of taking for granted that they have the right to make those decisions for them? Give them a choice. JUST give them a choice.

  24. April Mauk
    April Mauk April 27, 2012 at 8:32 pm | | Reply

    As a 20+ year diabetic I would be glad to be a “guinnea pig” for an implantable/artificial pancreas. What is the worst that can happen. I have been from shots everyday to now a pump for 11 years and I would be glad to experiment on the next available treatment to get a “normal life”. Pick me.

  25. CARA
    CARA June 10, 2012 at 7:31 pm | | Reply

    I’ve been Type 1 for 43 years. The choice of treatment is what works for that person. Everybody is different, what works for some, does not work for everyone. After over 10 years of collecting data for the internal insulin pump, if medtronic can not get FDA approval, let somebody that will work with the FDA for approval. The last 3 years, I have called, and emailed medtronics for information or updates on the internal insulin pump, I’m told the email will be forwarded to the correct person, or they have never heard of the internal insulin pump, or medtronics does not have an internal pump, I must mean the external pump. I order pump supplies every 3 monthes, each time I ask and or email, still no respone. If medtronics is working on, why no responce? I also was in the study with Anne and Greg, but could not financially go to France for refills. The day it was removed was awful. Not only would I wake up without it, I felt I was taken a huge step backwards in diabetic care. Diagnoised in the late sixties, I used to test my urine for sugar, there were no meters. My mother had to weigh, measure, and calculate each meal I ate. All through school, there was not another classmate with diabetes. So yes, I have seen much impovement in care and knowledge. Not a closed loop system, still checking blood sugar, counting carbs and using a external control, thats nothing to me, I miss the more basic things, going to bed and getting up with nothing attached, not having to find an unused area, wearing clothes and not worring where the pump goes, feeling normal. The internal insulin pump gave that to me. I not only felt great, I felt normal. Yes, it is not the answer for every diabetic, but it was for me, Its worked in Frane all this time, Why not the US?

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