Medtronic Responds to "A Miracle Technology for Type 1s: Can It Be Saved?"

The Medtronic Implantable Insulin Pump

| May 5, 2011

Recently, we published an article about the implantable pump "A Miracle Technology for Type 1s: Can It Be Saved?" Following the appearance of this article on the Diabetes Health website, over 100 readers commented, most of them expressing a heartfelt desire for access to this technology in the U.S.A. To read the original article click on link below:
A Miracle Technology for Type 1s: Can It Be Saved?

In response to their comments, Medtronic provided the following letter by Dr. Francine Kaufman. We are publishing it here in its entirety:

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 every day 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.

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Categories: Artificial Pancreas, Blood Sugar, Community, Complications & Care, Diabetes, Diabetes, Health, implantable pump, Insulin, Insulin Pumps, Medtronic, Research, Technology, Type 1 Issues

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Posted by Anonymous on 5 May 2011

This article makes a lot of sense. The unfortunate thing is that once we in the USA are on Medicare; we will not be able to get most of the current technologies available to those under 65.The same is true if our secondary insurance follows Medicare rules.

Posted by Anonymous on 5 May 2011

Thank you for publishing this follow-up. I had been wondering about this since reading the original piece. As a parent dealing with a teen who has Type 1, I find Dr Kaufman's commitment and thoughtful commentary to be very helpful.

Posted by Anonymous on 5 May 2011

I am currently a Medtronic Pump user and am very happy with it. It has changed my life. I used to take 5 shots per day. I have been a type 1 Diabetic for 36 years. My concern with an implantable type pump would mainly be in the a possibiliy of concentrated insulin leaking into my body due to breakage, mulfunction or accident. I wouldn't even consider an implantable at this point.

Posted by Anonymous on 5 May 2011

Why do we need another insulin for this implantible pump? Humalog and Novolog should be ideal for this use!

Posted by Anonymous on 5 May 2011

Waaaooo! This is GREAT news ! When I read the article....i thought "my GOd... how can something SO good for diabetics simply be put away????" My 2 sons are you can imagine HOW MUCH I want to see the day in which this disease ENDS or is made so SIMPLE it will not be a threat to life EVER!!!!!

Posted by Anonymous on 5 May 2011

I will wait for the closed loop system. I can not see any advantage in having the pump implanted without a closed loop for the glucose reading. Medtronic is working on this and I believe it will be available in the next year or so. I've waited for over 60 years for a cure, I can wait a while longer for a closed loop system.

Posted by popee on 5 May 2011

I was diagnosed with Type 1 diabetes in 1965. I'd given birth to girls in 1963 and 1966. As they were worridly watching me take the daily insulin injections, I always told them they shouldn't worry because by the time they were grown diabetes would be cured. It's now 46 years since my diagnosis and there is still no cure. It sounds as though medtronic is taking the right path, hopefully, but as I am in the medicare circut, It's likely I will not be afforded an artificial pancreas. As my husband always says, "They will probably never cure diabetes because it is a billion dollar business."

Posted by shosty on 6 May 2011

Is this commenter saying that the pump is not available for Medicare recipients?

To Dr. Kaufman: It may surprise you, but our daughter will never, ever use your closed loop "artificial pancreas" system. Her insulin needs change all the time, for a variety of reasons, and there is no way that Medtronic is going to be able to provide an automatic system that is safe for her.

If you think that dealing with insulin/refilling for the implantable pump is difficult, then try using a continuous blood glucose monitor, calibrating it, and even try relying on it with its delay in readings, effects of sweat, etc.

I don't know why JDRF teams with Medtronic to go down this garden path. Does Medtronic give them money?

Your company is already committed to the artificial pancreas, which, it seems, will never approach the implantable pump for the latter's physiological naturalness, and for the way it makes patients feel.

After reading about the implantable pump, my daughter is already saving up for France, and we are not donating to JDRF anymore either, until they advocate more for patients who want this choice.

Posted by Anonymous on 6 May 2011

Still 5 yrs. away? We will never see it.

Posted by tallydl on 6 May 2011

I've had diabetes since I was 8 years old. The doctor at that time, told me not to worry about it, since there would be a cure any day. After having diabetes for almost 52 years, I'm not waiting for a cure and haven't for a long time. Instead I will take care of my diabetes. Diabetes treatment has come a long way in those 52 years. Insulin pumps are wonderful. If and when the artifical pancreas becomes available, I'm sure many people will want to be the first in line and I understand that, but I won't be one of them. Since I have the brain, I will control/run my diabetes, instead of letting my diabetes, with no brain, control me!!! But devices such as this artifical pancreas can and will help others.

Posted by Anonymous on 6 May 2011

The week after Christmas I "celebrated" 60 years with type I diabetes with no complications. I found this article interesting largely because in 1989 I was part of a group who field-tested a Mini-Med implanted insulin pump. It amazes me that 21 years later, nothing has been approved here.

Posted by Anonymous on 6 May 2011

Dr. Kaufman is telling the honest truth about this technology. The general public has no idea how difficult and complex it is to develop a fully implantable system. It is very expensive and has multiple layers of complexity (pump and sensor) -- and that's just in the research and development. Getting clearance in the US is a whole different (and complex/expensive) component. The project also includes a unique type of highly concentrated insulin that must be developed, manufactured and cleared through the FDA. Developing the insulin, which is only used in this pump, is by itself a daunting and expensive task. (If they use the same fast acting insulin as the external pump you'd have to refill it every 3 days or so, which is just not practical for a fully implanted device.)

Making this pump available to anyone who wants it is not practical. Don't forget it takes a major surgery as well. And the changing rules of US healthcare, especially given the new reform law, leaves no incentives whatsoever for Medtronic to continue real commercialization efforts.

The good news is that the same results can be achieved by their external pump. And every year it is and will get "smarter".

And no, I don't work for the company. But my kid wears their pump.

Posted by Anonymous on 6 May 2011

Why can't the external CGSM also work with the implantable pump, hence a closed loop system? Why can't we fill the insulin pump ourselves? I have been injecting insulin since I was 12 and from what I understand the pump lies just beneath the skin (you can see its outline) and the insulin is drawn into it via a vacuum effect. So, it isn't injected. If pacemakers can be implanted and tied to the heart then making this work is having the righ people doing it. It comes down to revenue streams, plain an simple.

Posted by popee on 6 May 2011

In answer to Shotsy's question: In 2009 when I received my external insulin pump medicare provided a choice of two brands of pumps. In my post I meant with the probable cost of the implantable pump and the different lnsulin, it may not be available to people on medicare.

Posted by chanson3633 on 7 May 2011

Thank you, Dr. Kaufman for your letter.

One point that has not been emphasized is the main advantage of the implanted pump - the quick action of the internal injection versus the skin injection. The external pump can only inject insulin into the skin - it takes a while to be absorbed and there are many variables regarding the absorbtion process. The internal pump is much faster actin, according to the comments of those who have used it.

Posted by Anonymous on 7 May 2011

I am encouraged by any progress truly. For 50 years with type 1 I would dream about knowing the levels of my blood sugar and whether it was rising and or falling. The Continuous Glucose Monitor has been like a miracle to me. And to the previous poster; it's is all in the calibration and that determines good reading/results.
I don't think in my lifetime that a cure will be found but I do believe living with and controlling the disease will get easier.
Go Medtronics....

Posted by Anonymous on 8 May 2011

Try thinking outside the box! Who ever said the implantable pump had to be a fully implanted closed loop system? Why couldn't the CGMS work with the implantable pump? If the implantable pump can receive a signal to give insulin then why can't it speak with an external CGMS? Then, its simply a matter of size, programming and insulin type; requiring the occasional month 1/2 fill-up that even I could do, no need to see the doctor. To me, this is a classic case of over working a problem to the point where everyone throws up their collective hands into the air and says it can't be done. Open your minds, it doesn't always need to be a straightforward solution. To the anonymous person about the difficulty in developing an implantable pump, it was developed over 20 years ago, I believe its not so much about the tech as it is some other obstacles. The reasons put forth on why we CAN'T aren't credible but you all can continue to drink the corporate cool-aide.

Posted by Anonymous on 9 May 2011

From the comments I see that most people are missing the point of why the implantable pump is such a success. The delivery of insulin to the peritoneal cavity, thus entering directly into the liver makes this implantable pump a superior way to manage diabetes. The issue is not the fact that it is an open or closed system. The liver is responsible for regulating blood sugar as well. This delivery of insulin to the liver makes the most sense in allowing the body to use insulin in the natural way it is supposed to. No matter how the insulin is delivered, or what type of insulin, what needs to be continued and further explored is the delivery of insulin into the peritoneal cavity rather than subcutaneously as in a pump or with injections.

Posted by Anonymous on 9 May 2011

Yes, I agree! We need to find a way for any type of device that will allow insulin to be delivered into the peritoneal cavity. This is why the people using this technology felt so good! Their bodies were using insulin in a way that they are supposed to - allowing the liver to do its job with insulin. That is why they experience much fewer lows and much more stable blood sugars in general. We must urge Medtronic or any company to continue to explore ways to deliver insulin into the peritoneal cavity!!!!!!!

Posted by Anonymous on 9 May 2011

I am not interested in a closed-looped system for my 13-year-old son! I would much rather he test his blood sugar and do injections. What does interest me is how great these patients feel while not doing sub-Q insulin! I can only hope there is a smart company that will see that people with diabetes will take feeling better over the "convenience" of a closed-looped pump. Please continue with this technology!!!! It looks like I will have to take my son to France!!!!

Posted by Anonymous on 9 May 2011

These people are willing to travel to France to feel good for God's Sake!!! That surely is not convenient!! It doesn't matter if it's closed, opened, injections, an implantable or a regular pump. It doesn't matter if I have to test my blood sugar ten times a day. What matters is that this technology will allow me to feel good!! This technology will make me get fewer lows!! I am waiting for it by whichever company continues it!!

Posted by Anonymous on 9 May 2011

My son uses Lantus. A pump seems too intrusive to him - having to wear it all day and night, having a catheter inserted into his skin 24-7, having to tape it down to his skin or wear clothing to allow it. A pump is a constant reminder to him all day and night that he has diabetes. He loves the freedom of being unattached to anything. He'd rather inject when he eats. However, reading about this technology made him want an implantable pump. Not because it seems more convenient, but because to him it's about less "lows" and feeling great. With this type of technology, he would wear a pump - implantable or not!!!!

Posted by Anonymous on 10 May 2011

I don't think the readers have missed the point regarding how the insulin is delivered. On the contrary, its Medtronic and the JDRF that are bent on pursuing a more cost effective, revenue generous, external closed loop system or "ARTIFICIAL PANCREAS". What upsets me the most is how we all know just how life threatening and dangerous hypoglycemic events can be and yet sub-q is the only available delivery system, "for various reasons". Since 1922, we have delivered insulin sub-q, its time to move beyond it. I don't believe its too difficult. Just no revenue in it.

Posted by Anonymous on 10 May 2011

Unfortunately, people need to remember that Diabetes and most all other diseases are a business and the medical profession is built on treating symptoms, not necessarily providing cures.

Posted by Anonymous on 11 May 2011

Hmmmm..... sounds like a bunch of words without actions to me....blah blah blah blah to translate that NOTHING is really going to be done.

Posted by Anonymous on 11 May 2011

Nothing will be done because in the end we are a captive revenue stream and so illness and it's insults dependencies upon big pharma shall live on.

Posted by Anonymous on 13 May 2011

Nothing will be done because, in the end, we are a captive revenue stream. This illness and it's treatment (insulin) dependencies (on big pharma) shall live on.

Posted by Anonymous on 20 May 2011

Example of how diabietes is a revenue stream: my animas 2020 pump cost $5,000; the supplies that must be purchased on a regular basis cost a lot (go to animas.corp to find prices), and then the cost of insulin. Why would they create something that won't require us to continuously depend on their products?!!

Posted by rightmuch on 23 May 2011

Sadly, it is all about the money. A Metronic rep as much as alluded to it when I contacted the company.

Posted by Barry on 1 June 2011

LIke said above, money is the all driving factor behind medical research. If there's the possibility for huge profits, the drug makers are all for it. It's not about making the lives of people better. THe implantable pump is a huge step in the right direction with diabetes. I have had it since 1965 and all the complications also. I have an external tubeless pump ( Omnipod )now and have seen a big improvement in my A1C after one month. But, it's still a long way from a implantable pump or a transplant. THe government should take the money we're wasting in 2 wars and use it for research. Maybe then we'll get closer to managing this disease with better devices. All medical research would be the better for it. Shake up the FDA and get rid of the non progressive thinkers there and replace them with people who want better for the country. No more politics and lobbyists in medicine. Put the money into the cure and not in pork!

Posted by Anonymous on 6 June 2011

As a clinician with type 1, I cannot unknowingly question your evaluation of scientific and clinical results that may lead you away from the current implantable pump. However, I believe you also have a moral and business obligation to meet the needs of type 1 patients.

From a business perspective, the type 1 population (although only 10% of the type 2 population) is still large enough to support a device such as this. From a moral perspective, the type 1 population has great costs from risks and costs caused by not having a high-quality, automated delivery device available to place a continually correct type and amount of insulin directly into the peritoneal cavity. Creation of this type of device is imperative for type 1 patients.

I understand your need to perform cost effectiveness and cost utility analyses when developing products and programs. However, I hope you separate the type 1 population from the type 2 population in all of those analyses. As you know clinically, these are two completely separate diseases, with no more connection than that between many cardiac diseases - only the signs and symptoms are similar. As you know from a revenue perspective, though, the much larger type 2 diabetes population makes any product focused on type 1 patients to look much less attractive. Thus, I hope your budgets are not assigned based upon a combination of the two diseases and their population sizes.

Finally, while the current technology in your existing implantable pump may not be fully effective, you must have made research and technology gains that allow completion of FDA approval for such a device in a less expensive manner than starting over.

I hope you consider these factors in your decisions.

Posted by bigsargswife on 13 June 2011

I've read the whole article and the response from Minimed. I can't shake the overwhelming feeling that it's all a bunch of bureaucratic B.S.
I understand it's risky and maybe even scary for them to take this on. But while they're spending their time and resources on other avenues (which is code for "things that are less risky) I'm getting older and struggling daily with a disease I hate.
I wonder how many of them have their lives---every SINGLE aspect of their lives affected by this disease?
I don't remember what it's like to FEEL healthy. I'm doing well A1C-wise, I almost always have. But it's my life; not just part of my life. I don't want to be "the diabetic". It's not fair that it should be what defines me.
I got Type 1 when I was 8 years old. I am now 30. I don't remember health. I would greatly like to.
Please take this risk, Medtronic! I would MUCH rather you leave the current pump technology as is (because it probably won't get better anyway!) and spend your resources on the implantable pumps. I want to live again and I'm not taking "we're working on it" as a viable excuse. GET ON IT.

Posted by Anonymous on 22 August 2011

This article is not a real response to the original article. The original article made it that the four people are currently using the technology, and 800+ people are using it at hospital of Montpellier in France.
So the answer about technological hurdles is out of scope, in my opinion.
The real question was: if it is approved in France, why isnt it in the US? Europe and US have differences in their approval systems, but they are usually slight differences. It would be interesting that Medttonic clarifies what exactly the FDA wants more than the European instances.
Second, about the required insulin not being available on the market anymore: why is that? And how come are the French people able to use the pump anyway? Is the insulin available there, if yes where is it produced and by who? Otherwise, are the French using another insulin, which Dr Kaufmann seems to imply is not possible.

I thouht there are probably good reasons for this difference between France and US, on a regulatory level was I hinking. Making a response based on technological hurdles, while the systemnis used by 1000's people "in production" now makes me think they're trying to take our attention away...

Posted by Anonymous on 12 December 2011

I have had diabetes for 42 years of my life. It is a daily struggle. I am on the pump but I still do not have good control. The doctors want it at one certain level but it is impossible to do that. I get so frustrated at times I feel like chucking it all. I would love to see an implantable pump here in the US. They have an implantable pump for pain so why noit one for insulin.

Posted by Anonymous on 19 April 2014

Please continue efforts to make the implantable pump available to type one diabetics! Evidentally it does really help many as evidenced by their many trips to France where it is available. Some things are just simply the right thing to do even though not as cost effective. You need a good PR dept who can advertise how wonderful your company is because they are taking the morally high road......the one less traveled! marilyn

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