A Miracle Technology for Type 1s: Can It Be Saved?

Implantable Pump Patients: Sheila, Anne, Chris, Professor Renard, and Greg

| Apr 17, 2011

What if there were a technology that could make people with type 1 diabetes feel absolutely wonderful, completely healthy, better than they ever realized was possible? And what if it were about to disappear? Well, there is such a technology, and it is in serious jeopardy. It's called the implantable insulin pump, currently made by Medtronic. This is the story of four people who have been using this device for 20 years, and their desperate crusade to keep it from disappearing forever.

Chris Witkowski, age 58, is a lawyer who has had type 1 diabetes since the age of 14. Greg Peterson is a successful 61-year-old entrepreneur who was diagnosed with type 1 diabetes at the age of eight. Anne Nordyke, a technical supervisor who is 48 years old, got diabetes when she was 22. And Sheila Klaesius is a retired nurse, age 58, who got diabetes at the age of 19. The first three used subcutaneous insulin, by injections or pump, until about 20 years ago, when they entered the implantable pump clinical study being run by MiniMed. Sheila used injections until 2003, when she got her first implantable pump as part of a clinical trial being run by Medtronic.

Greg Peterson says, "Before I received my first implantable pump in 1992, I was the poster child for diabetes care. My control was superb, and I thought I was doing quite well. But the day after I had my implantable pump installed, it was as if I were a new person. It absolutely changed my life. As I said to a friend of mine, ‘Holy Toledo, I feel incredibly good. Is this what normal is?' The difference is not describable to a person who hasn't experienced it, unfortunately, but all of us will tell you this: It's a phenomenal difference."

The key difference between the implantable pump and typical forms of insulin delivery is that the implantable pump does not deliver insulin subcutaneously, or below the skin. Instead, it delivers insulin directly to the peritoneal cavity just like a normal pancreas. Greg says, "Subcutaneous insulin is life-saving, but it is also very, very abnormal. In the normal human, insulin is released from the pancreas and goes directly to the liver via the portal circulation. The liver, which is the primary organ for maintaining normoglycemia, extracts at least 50 percent of that insulin for itself. The peripheral circulation, on the other hand, normally has a lower level of insulin. It's called a positive portal-peripheral gradient of insulin."

"When you inject insulin subcutaneously, inject it intravenously, or inhale it, that positive portal-peripheral gradient is reversed. Now you have a higher concentration in the peripheral tissue than coming into the liver. This is nonphysiologic and abnormal, and it leads to a raft of problems. For one thing, it makes control more difficult. If you're controlling diabetes with sub-Q insulin, you can do one heck of a good job, as I've proved, but you just cannot do the job that you can do with intraperitoneal insulin. Sub-Q insulin just does not normalize the abnormal metabolic condition of diabetes very well. Something profound is going on metabolically in our bodies with the implantable technology."
"This is a technology that is phenomenally effective. I have over 500 research papers that address different aspects of the physiology of intraperitoneal (IP) insulin versus sub-Q, and the information is incontrovertible. It's just not well known. Part of the reason it's not well known is that early on in the developmental path of this pump, there were some serious technical problems. Short battery life, catheter obstruction, precipitation of the insulin, infection at the implantation site, and a very small supply of pumps: All those things got in the way of doing coherent large scale studies of the technology."
"But what we do have is a lot of information from animal studies, which are very indicative of the superiority of IP insulin, and we have a lot of individual human studies from researchers around the world who experimented with IP insulin when they had pumps to do it. The results are astounding: the changes in lipid patterns that should help prevent atherosclerosis, the decrease in the hyperinsulinemia that is common with sub-Q insulin, the amazing reduction in severe hypoglycemia. When you try to control diabetes well with sub-Q insulin, there is a disastrous rise in the incidence of severe hypoglycemia. This does not happen with IP insulin. I can go on and on. The thing that is astounding is that this is simply not known, and the reason is that the technology had those bumps. But it had those bumps because several aspects of the technology were just not adequate to the task. These pumps were first developed in the early 1980s, and very little development has been done in recent years. If they were to revisit it now, it would be a different story."

The implantable pump is a small, battery-powered device that looks a lot like a metal hockey puck. It is stitched into a pocket of tissue directly under the skin and has a catheter that pokes through the peritoneal wall to deliver a constant stream of insulin directly into the body cavity. It's like having a titanium pancreas that provides a basal amount of insulin 24/7. At mealtimes, patients just punch a few buttons on a hand-held communicator, instructing the pump to deliver a bolus of insulin. Four times a year, patients must return to the hospital for a 15-minute process during which the pump is refilled with a highly concentrated form of special insulin. At this time, the refills are available only in Europe. Because they believe so strongly in the benefits of the implantable pump, Anne, Chris, Greg, and Sheila travel to France every three months for a refill, at significant financial and personal cost.

The era of implantable insulin pumps began in 1980, when in one short year, several research groups implanted the first pumps in human subjects. In 1986, the first MiniMed implantable insulin pump was implanted in a patient by Dr. Christopher Saudek. In 1995, MiniMed received CE mark approval, the EU's equivalent of FDA approval, which meant that it could market the implantable pump throughout Europe. In 2000, it received CE mark approval for its next generation implantable pump, the Model 2007-A, which had an improved memory and a longer battery life. In 2001, Medtronic acquired MiniMed. In 2007, Medtronic discontinued its clinical trial of the pump in the US.

The supply of pumps available for implantation in Europe is currently severely limited. To all outward appearances, Medtronic is showing little enthusiasm for preserving this technology, and the future of the implantable pump may be in serious jeopardy. Medtronic attributes the limited number of pumps available for implantation in Europe to "supplier changes for part of the mechanism and also the requirement to change the formulation of insulin." Despite their profession of "clear commitment to ensure continuation of the current technology for the many patients who are benefiting from this therapy," they also say that "the future of the new implantable pump technology is currently not defined."

"Throughout those early years, there were a lot of technical problems because miniaturizing the circuitry was not as possible as it is now. Battery life was nowhere near sufficient. They knew little about how to do the implantation procedures and post-surgery follow-up care to prevent infection, and catheter technology was very crude. Most importantly, there was only one insulin back in those days, a very special insulin that could tolerate body temperature and constant movement, as is the environment for the implantable pump."

When that insulin had to be altered due to environmental concerns related to its manufacturing, the pumps began to plug up. It took a few years to solve that problem, but Sanofi-Aventis has since developed a replacement version that works very well, and they are now in studies with a human version of that insulin. Greg says, "Over the 20-year span that I've had this pump, all the technical problems have reached the very cusp of being solved. The French, particularly in the hands of Professor Eric Renard, have been very good at figuring all these problems out, so the technology is on the verge of just exploding if it gets the right moves."

"When Medtronic decided to cancel the technology in the US, they did so, I imagine, for business reasons. But I believe there is a very strong business case to be made for the implantable pump. If you're looking at it purely from the standpoint of the risk return ratio, you can see why some businesses might shy away from it. But what amazing technology was ever developed without somebody saying, ‘Well, that's worth it, let's take the risk and do it.'"

"We're already at the point where it's possible to develop algorithms and control systems that can make an artificial pancreas a reality. But we're trying to do this with both hands tied behind our backs, by using a subcutaneous delivery route. We've squeezed everything we can out of sub-Q insulin already. There are dozens of different formulations for time of onset, duration and speed of onset. Amazing work has been done with sub-Q insulin, but it is fundamentally limited."

"In the 1990s, the DCCT finally gave us the proof we needed that tight control is crucially important to preventing long-term complications. Yet here we are 20 years later, and how many type 1 diabetics are superbly well controlled on sub-Q insulin? It's just not possible. A few rare individuals can control type 1 diabetes extremely well with sub-Q insulin, but it's only because we're obsessive-compulsive about it. Most people don't have that capability, and so they can't do it. Even if they can do it, they end up with severe hypoglycemic problems. And they still have this abnormal physiological situation going on in their bodies, where they're not getting the benefits that they would have if insulin were delivered directly to the liver."

"I don't want to be jaded and say that the problem is that wealthy companies don't want to endanger their revenue from their current insulins, pumps, and so on. That may or may not be the case. What I do believe is that companies are not fully aware of just how profoundly important and invaluable this technology is."

"I was perfectly controlled on sub-Q insulin if you use the standard of blood glucose alone. I ran ultra-marathons, I built my own company and I traveled all over the world. I figured, I've got this thing nailed. I thought I was feeling good and doing great. And then I got IP insulin, and it was like giving sight to a blind person. I know that there are champions of external pumps, but those people don't know what they're missing. They could not possibly know. They're doing the best they can and fighting the good fight, and they think they're okay, but they don't know what they're missing. Massive amounts of research data show how superior IP insulin is at a basic metabolic, biological level."

"This is a situation where there needs to be a groundswell of interest and demand created. Unless something dramatic occurs, this technology is going to blink out and disappear. I'm 61 years old. I can go back on sub-Q insulin and make it work, but there are millions of people who deserve this technology, and I'm sitting here watching it die."

Chris's Testimony:
With the implantable pump, I feel normal. I don't feel like I have diabetes, and it's because of getting a direct insulin flow that goes into the peritoneal cavity and then right to the liver. To really appreciate this phenomenon, you have to be a diabetic who's been on subcutaneous delivery, and then you switch to the internal pump. I came back and I said, "I feel like a new man. This feels totally different. I feel normal again."

I would much rather have the implantable pump and test manually than have a sub-Q delivery with a continuous loop because you're just not getting the benefit of that delivery into the peritoneal cavity. I wouldn't touch sub-Q with a ten-foot pole when I've got this. Even though I'm of limited means and it's a sacrifice, my family fully supports my going to France to get the insulin refills every three months.

The feeling you get using the peritoneal delivery is just so much better. When people are on sub-Q and their blood sugars are under control, they get used to how they feel and they think that it's normal. But when you switch from the sub-Q to IP, it's a totally different feeling.

The quality of life is so much better, it's just unbelievable. I can even go a day or two without eating anything, and my sugars stay 85, 90 or 95 all the time. It's just like being a person without diabetes. You don't have those swings, those high highs and low lows, that really reduce your productivity, decrease your ability to work and think properly, and increase the risk of complications.

Anne's Testimony:
When I got the implantable pump, it was fantastic. For me, it was a feeling of independence, freedom. I felt really healthy, even a little bit euphoric. The change is just so striking: You feel better as soon as you wake up from the surgery, and as the days go by, you just feel better and better. It's so hard to quantify a quality of life, but I can remember telling my friend one day after I got my pump, "You know what, even if I die because something goes wrong with this pump, it will have been worth it." I felt that much better.

All four of us have to go to France four times a year for insulin refills, and it's just a chore, about 30 hours of traveling for a 15-minute procedure. But all I need to do is think, "Are you ready to give it up?" and the answer is always "Nope." We're all very down to earth, smart people, not people who do this on a whim. There's just something very different about it.

When I talk to people who have come off of the implantable pump because Medtronic discontinued the program here in America, they are really suffering. But when Medtronic tried to terminate the program in France, the French doctors stood up to the company and told them (I'm paraphrasing) "No!" because this technology has helped far too many people lead a better life with diabetes.

When I was on subcutaneous insulin, I had three severe insulin reactions where I actually passed out. With the implantable pump, you feel more confidence because you have fewer and fewer lows. You can begin to really bring your blood glucose into much tighter control without that constant fear of hypoglycemia.

This is my fourth pump. The only time I was off of it for any extended period was when they had to change the insulin formulation, and it took about two years for them to get the new insulin going. Eventually you adjust to sub-Q, but then you go back on the implantable pump, and you feel great again! You didn't think you felt badly when you were off of it, but when you get back on it, you get that feeling of "This is good."

It really does get down to quality of life. Physiologically, you're getting insulin the way you're supposed to get insulin. Neither Greg nor I has any complications at all from diabetes. I've had diabetes for 26 years, and he's had it for 50, and when we go to our doctors, they're amazed that we don't have any complications. I have to attribute a lot of that to the implantable pump.

There's very little information out there about this technology. I don't think it ever got out what a great product this is. All people ever saw was the other pumps that failed in this same arena. But if people out there who have diabetes, or who have children with diabetes, could see what this technology would mean for them, I just can't imagine that they wouldn't choose it.

Sheila's Testimony:
I was one of the last ones to get the implantable pump. I got my first one in January of 2003 as part of a clinical trial being run by Medtronic. When I started the study, as hard as I tried, my A1Cs were 9% to 10%, but shortly thereafter I was down to 7%.

We were notified in 2007 that they were stopping the study and wanted to explant all the pumps. At the time I had some health problems unrelated to diabetes, so they were kind enough to let me keep it for another year or so past when everybody else had theirs taken out.

I was very unhappy about having to lose the pump. When Ann and Greg got in touch with me, they said I might be able to get it refilled in France, so I started doing that in November of 2008. For the three months before I could get the refill, I had to use an external pump, and I absolutely hated it. It is so much more obvious, and the tape always irritated my skin and ripped it off. I don't sleep soundly, so the catheter always got in my way. And it just wasn't as good as the implantable pump in the way it delivered the insulin and how I reacted to it.

The implantable pump is much more predictable than the external pump. It's more comforting to have it. I feel better, I feel safer, I feel more in control of what I'm doing and I'm feeling all around physically better. With the implantable pump, I managed to make it through some really serious surgeries. When I get sick, it's much easier to manage.

In August, I got a new pump implanted by Dr. Renard in France. I guess that tells you how much I like it, because that was very, very expensive. It's an enormous financial drain to go to France, but it's worth it. I won't give it up. It's less obtrusive and just so much easier. I feel more comfortable both not eating and eating, and it's just a whole lot more flexible.

I have great hopes that maybe Medtronic will realize what they have. I think there are a lot of people who would really benefit from it if they just knew about it.

Comments of Dr. Eric Renard, University Hospital of Montpellier, France:
The experiences and feelings reported by Greg, Chris, Anne, and Sheila clearly illustrate the benefits of being treated by an implantable pump using intraperitoneal insulin delivery. My colleagues and I hear the same testimonies from the 380 or so of our French patients who are using this technology to control their diabetes, some of them since 1990 when the first MiniMed implantable pumps became available. As underscored by the patients, the reliability and reproducibility of insulin absorption, as well as the quicker action of insulin thanks to its first distribution to the liver, demonstrate the superiority of intraperitoneal insulin infusion when compared to subcutaneous infusion.

Intraperitoneal insulin allows patients to reach near-normal glucose levels without increasing the risk of hypoglycemia, especially in its severe form. Most diabetic patients report that they fear unexpected glucose swings more than persistent hyperglycemia. This badly tolerated glucose variability is solved by avoiding the non-reproducible insulin absorption that occurs when insulin is delivered under the skin, a place where physiological insulin is not expected in large amounts.

For patients with visible reactions at their subcutaneous insulin injection or infusion sites (for example, lipodystrophy), bypassing the skin obstacle by intraperitoneal infusion is vital. Getting a reliable effect of insulin is, however, a benefit for all diabetic patients because they can safely tune their insulin delivery according to their changing needs related to their various activities and food intakes. It allows for reaching glycated hemoglobin levels close to 6%, similar to non-diabetic persons, with a minimized risk of mild hypoglycemia.

I have examples among my female patients who succeeded in giving birth to several babies thanks to the glucose control they reached with an implantable insulin pump. Without it, any pregnancy would have been an unachievable dream. Other highly benefited patients are those who have lost awareness of hypoglycemia, resulting in recurrent hypoglycemic coma. The lower level of insulinemia when insulin is delivered through the peritoneum minimizes the occurrence of hypoglycemia, restores the awareness of glucose lowering, and revives the physiological glucagon response to low blood glucose levels.

Recent trials that we have led using implantable pumps connected to glucose sensors to create a new model of the artificial pancreas have clearly shown the usefulness of this technology to reach the "holy grail" for all diabetic patients treated by insulin.

All these accumulated arguments support our efforts in France, Sweden, Belgium, and the Netherlands to keep this therapy available for our patients who cannot be safely treated by subcutaneous insulin. Our national health insurance systems reimburse this therapy because it dramatically reduces the time spent in the hospital by these difficult cases.

Due to the multiple benefits in terms of glucose control and quality of life offered by this technology, we cannot understand how it might be endangered. Instead, it should be considered a reference for the treatment of diabetes by insulin. It is even more incredible to realize that these implantable devices are made in the US but are not approved there to treat diabetes. Consequently, the American patients who recognize its benefits must come to us several times per year at their own expense to get them! It is hard to believe that this therapy would not be profitable to its manufacturer if promoted on a large scale in America. Let's hope the rationale will ultimately prevail for a better, "closer to normal" life for many diabetic patients. We in Europe will never, never give in!

To read Medtronic's response to this article click on the link below:
Medtronic Responds to A "Miracle Technology for Type 1s"


Click Here To View Or Post Comments

Categories: A1c Test, Blood Glucose, Blood Sugar, Diabetes, Diabetes, Food, Health Care, Health Research, implantable insulin pump, Infusion Sets, Injection, Insulin, Insulin Injection, Insulin Pumps, Low Blood Sugar, Noninvasive Monitors, Subcutaneous Delivery, Technology, Type 1 Issues, Women's Issues

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Posted by Anonymous on 17 April 2011

Fascinating. They are spending millions on the artificial pancreas project that would require T1's to wear TWO catheters. How is this better? How is this worth pursuing? I have been a pump user for over 14 years and hate it and my last two doctors were pushing the CGSM. Between the artificial pump project, stem cells that are decades away from any practical application, they are lost. The implantable pump is a technology that could be perfected if they redirected their efforts into it. Now they are willing to walk away from it. It's a joke and i'm disgusted.

Posted by Anonymous on 18 April 2011

Amazing technology. So sad and thoroughly disgusted by the fact that US trials were stopped. My fiance' has been a T1 for 26 years. The insulin pump, while not perfect, was quite the advance for him. I can only imagine what this technology could do in terms of quality of life, life expectancy etc. Is there any possibility of receiving more information about how to acquire the implantable pump abroad?

Posted by Anonymous on 18 April 2011

I agree with the other person who said that if we concentrated on this implantable pump, we can at least live our lives somewhat normally until a cure is found. I have an external pump & I hate it too. Does anyone think that the FDA will ever approve the implantable pump in the USA? Can someone give more info about the pump? Do you have to count carbs like you have to with injections/the external pump?

Posted by Anonymous on 18 April 2011

The carb counting and finger sticks would still be required but it also sounds like the way in which the insulin is delivered is not counterproductive to achieving tighter control. I just can't believe that a closed loop system would be viable in real world conditions. Everything I have read about CGMS would still require finger sticks each day to validate that it's working correctly, so fingersticks never go away? I can only imagine what it would feel like to have insulin delivered the right way than sub-q which is also wrought with problems and side effects. I gave up on a cure 20 years ago but a better treatment must be found and made available. The reasons against the implantable pump are political and total nonsense.

Posted by Anonymous on 18 April 2011

My daughter was 4 when she was diagnosed and is now 7 and everyday is a battle. This would be wonderful to continue only those that live with this everyday know the true struggles. Everyone needs to work together to make t1 lives better

Posted by Anonymous on 18 April 2011

I've had diabetes for 40 years. I'd never heard of this technology until now. If it were available in the U.S. I'd do it right now!

Posted by Anonymous on 18 April 2011

so everyone who is so "Disgusted" with medtronic should know that the main reason it was halted was because the concentrated insulin used in the implantable pump is not and will not be available in our country due to the FDA not Medtronic. If the FDA would allow us this insulin here, we would have implantable pumps here. so the person who wrote this article is making it out to be the "money hungry" device company's fault and this isn't true at all. even the JDRF has redirected its efforts towards the artificial pancrease project bc it is possible here. i am really tired of the "money hungry" companies always getting the bad rap! bring on the closed loop medtronic. thanks for what you do. you chnaged my life!

Posted by Anonymous on 18 April 2011

Please please continue your research and do not let politics stop you. Provide hope to a 10 year who was just diagnosed. PLEASE.

Posted by Anonymous on 18 April 2011

My beautiful 19 year old daughter was diagnosed with Type 1 two months ago. She is currently giving herself 4 injections a day. To us, the external pump sounds great ....but now to know about THIS pump!! I'm amazed!! But she can't have this?? She has so many years with diabetes ahead of her. Her quality of life is EVERYTHING!! What can we do? Who do we write? How can we make a difference?

Posted by Anonymous on 18 April 2011

You must work for the JDRF or Medtronic. Sub-Q is flawed and it's our job to push the status quo or it will be another 80 years and we'll still be injecting insulin under the skin. Follow the money and do the math. If you could provide a substandard product with a constant and predictable money stream, why change? The current pumps provide just that. Don't get me wrong, I do blame the FDA anthereof politically influenced agendas. Insulin manufacturers too, changing analogs so we can't get a generic. Total BS and it's about money, money, money.

Posted by Momofdiabetic on 18 April 2011

I have two type 1's in my family and we struggle with highs and lows every minute of every day. Implantable technology sounds too good to be true and sadly this seems to be the case in this country. Why would JDRF re-direct to the artificial pancreas which sadly sounds a hundred times better than what it really is--a pump AND a CGM and glucose monitoring by hand as well. Why would all resources not go into perfecting the insulin if this is the crux of the problem? Why would this system be bypassed in favor of an inferior one? Does anyone have any idea if an implantable pump could be used in children? I see a trip to France in our near future!

Posted by Anonymous on 19 April 2011

This is incredible! Here we are with possibilities which can improve our lives and yet decisions are made by the FDA that limit our choices. If this isn't a human rights violation issue by the FDA I don't know what really is. Concentrated insulin classified as being "dangerous" is holding back the well being of millions. Since the French have been doing this for so many years, I would be really interested to find out the statistics. What %-age of users of the implanted insulin pump have had problem? How frequent are hypos? I am sure all these numbers are available by the French. France has a great state run medical system that should be used as an example for the rest of the western world.

Posted by Anonymous on 19 April 2011

The best thing we can do is continue to ask the tough questions and press for answers. I have written to the FDA asking for a detailed explanation regarding u400 insulin and why it isn't available here. No answer! But, I will continue to press forward. I am not one to simply accept routinue run of the mill responses like, "That's just how it is!", "It's just not available here!" "We're pursuing all options (as long as its stem cells). I have been a type 1 for 29 years, my sister for 40 years and my father for 39 years. So, I will not stop questioning the JDRF, ADA, FDA and any other company that continues to ignore or sidestep the tough questions. I have been a pump user for 14 years and while its had its positives there are also a host of negatives that go along with it. In the end, whether you are on a pump or multiple injections YOU still have to do all of the work!

Posted by Anonymous on 19 April 2011

Type 1 since 1994...I don´t believe in miracles anymore...

Posted by Anonymous on 19 April 2011

My seven year old son was diagnosed with Type I just a month ago. He has many years to go with this disease and I can't understand why a good technology that is successfully working would not be continued. You can't help but think it's a money issue. I plan on writing to Medtronic and the FDA. If we all band together and not throw up our hands we can do something about it. Don't ever give up hope! Hope there will be a cure in my son's lifetime or hope for an easier life with diabetes is what helps me get out of bed every morning. Diabetes management is work, but it can be done. You can't focus on the negative. Let's pull together and fight for what we want. Start writing and calling or whatever it takes. I'm contacting the JDRF and ADA as well!

Posted by Anonymous on 19 April 2011

I have a daughter who is type 1 diabetic and she has had diabetes since she was 4 years old. She is currently 16 years old and is having a hard time dealing with her diabetes. The new technology of having an implantable pump or an artificial pancreas has been our hope for many years now. We are anxious to see these available here in Canada so that we can use this to control our Daughter's diabetes better.

Posted by jlnhjm on 19 April 2011

Why all the focus on type 1s? If this technology can help them so much with quality of life, it can also help me, a type 2, diagnosed in 1983, using insulin as my only diabetic medication. My A1c runs between 5.6 and 6.0, and, yes, it is a lot of work. I do have complications even with these good A1c numbers and I don't want any more. If type 2s were informed about this technology, we could storm the ADA, which in turn can pressure congress. As for the FDA, it is all politics and money, making them a farce in terms of protecting people.

I have the aforementioned complications, old age, fibromyalgia and am a four time cancer survivor. The fight is not up to me, but up to people with the energy to devote resources to this issue. Hope died within me a long time ago, nevertheless I devote a lot of time and much of my precious energy to control.

Another thought: many type 2 diabetics need to lost weight, but cannot because of their medications. This technology might allow for weight loss, thus combined giving diabetics a chance for a healthy life.

Posted by Anonymous on 19 April 2011

How sad that a company chooses the technology that will lead to more refills and more profit instead of pioneering a technology that would greatly improve the lives of its users. How incredibly short sighted.

I will hope that someone will take up the banner of this project and see that the greater good is worth something. Also, how loyal do you think patients with this type of device would be? I'm willing to bet that if my daughter was lucky enough to be able to live life with one of these fantastic devices, that we would never dream of using another company's product. As it stands now, we dream of another product every day.

Fingers crossed for now. . .

Posted by mrsensitive on 19 April 2011

I've also been a type 1 diabetic for 32 years without a trip to the emergency room. But I have had some scary nights, especially when my wife is out of town.

For me security comes from a continuous glucose monitor(Dexcom). It's alarm has often woken me in the middle of the night (I have it set to go off when it drops below 80). I will roll over, take a couple of glucose tabs, and go back to sleep.

The technology is far from perfect at this point, but it is a huge step in the right direction.

Posted by mrsensitive on 19 April 2011

this is unbelievable. I am so angry and frustrated in reading this article.

Companies like Medtronic try so hard to convince us that they are working hard to make our lives better. This seems to contradict that stated claim.

If Medtronic refuses to develop this treatment, I hope that they will at least pass it on to a company that cares.

Posted by Anonymous on 19 April 2011

I expect companies (Medtronic) to be driven by money. This internal pump sounds like it needs a bit of work to reap the profits. However, the work is being done by the patients at their own time and expense. What a powerful statement on the life changing effect this option has given these folks. Medtronics can't have better advocates on this technology. So come on Medtronics -- do the right thing and put some effort into this. This is technology that could be helping a member of your family one day. This is technology that changes lives for the better (not just better but as close to normal and healthy as all human beings want to feel). Stop focusing on your pocketbook and the easy path. You can do it!

I expect the FDA to be driven by bureaucracy so pulling in your local mayor, govenor, senator might be the only way to get their attention. But with so few people knowing about this -- that will be a tough road to travel. It will take a collective effort by Medtronics and JDRF and diabetes patients to push on the FDA.

I don't expect JDRF (an organization that I haved donated to because I wanted to help children and all those with diabetes to have a better quality of life) to stick their heads in the sand and not keep an open mind on this issue (as evidenced by the their weak defense of JDRF above). Basically, they are saying we follow the pancreas option because it is an easy path. The internal pump has too many hurdles to tackle and even though it would be an amazing option for diabetes patients, it is just too hard to do.

JDRF: How can you accept so much money from donors and not want to add this option to the arsenal a diabetes patient has to improve their lives? Why haven't you stepped in to help shed some light on this option -- and the hurdles to be tackled to make this option available in the US? I'm sure many parents would be very excited about getting more information on this new (old) life changing option -- and together as a large group can help affect change.

All: Maybe it is time to create a new diabetes donation organzation that will help pursue this option for the benefit of millions of people in the US/Canada.

Posted by brobinso on 19 April 2011

This technology seems so promising! I am a Type 1 that has had the pump for some time. I've had to recently stop because of how my skin was reacting. I also have the continuous glucose monitor but rarely wear it because my skin is already fighting for healthy spots with the pump.

Let's get rid of the external equipment and avoid that skin problem!

Posted by Anonymous on 19 April 2011

Guys, sorry to be selfish, we are Europeans and I think that hopefully under a more unified umbrella here in the European countries, some of the European controlled pharmaceutical companies will hopefully jump on that more advanced technology for diabetes care. problem is till now most of the companies providing everything related to diabetes are American, controlling insitutions such as the JDRF or FDA, who will never approve anything which will hurt their revenues, its called lobbying. We have a 5 year old daughter, diagnosed at 2 and Medtronic pump and CGMS users and both don't work. CGMS is not reliable and detects highs and especially low far to slow (shows 120, she is 37!!, not once) and the catheter in the skin always bends, has airpockets, insulin clogs up etc. Medtronic here in Europe is just ignorant to these issues, why, they are just puppets for their US bosses. So hopefully somebody will soon shift their focus and gets research done in a proper way. I think the implanted pump sounds like a real change, not sure if it works on children though. Hey, nothing against my American friends, I work for an US company and they are all great, just think your healthcare system is really screwed and not chance in sight anytime soon.

Posted by Anonymous on 19 April 2011

A type 1 for 10 years - 2 and 1/2 on the minimed pump. I never even heard of an implantable pump until I read this article - and I consider myself to be a pretty well educated diabetic. Goes back to my belief that "it's always about the money." I do believe that Medtronics is a good caring company - and I urge them to push for the best quality of life for diabetics - for it truly is quality... not quantity that makes a life in the end. We all know our FDA leaves much to be desired. Lives have been saved due to this system, but many have been lost as well. We will keep praying for everyone involved to "do the right thing." This article gives me hope that one day I too may feel more normal. Thank you.

Posted by Anonymous on 19 April 2011

I have had T1 diabetes for 55 years, and have frankly grown tired of hearing "hope is on the horizon". I have to say I no longer believe that. I think diabetes is too profitable for them to "allow" a cure. I think that could already have happened - except for greed.

Posted by Anonymous on 19 April 2011

There is alot of research going on throughtout the world concerning diabetes. The new technology in which a sensor is implanted below the skin (GLYSENZ ?) seems to be promising as well. The FDA has too much political pressure to get some of these new technolgies approved for everyday use by us diabetics. I'm a type 1 for 14 years and have shifted over to being a pumper 18 months ago. What a great decision that was for me and I thought I had good control then, but with numerous bouts of hypoglycemia. Being a pumper (external) has being great but it sure would be nice to have this internal pump ability available to us if we had a choice. There are alot of promising things in the R & D world but if we count on getting them soon we won't due to our governments requirements. The FDA should look at the sucess in this implantable pump and make it available to us here.

Posted by Anonymous on 19 April 2011

My son was diagnosed 4 years ago at the age of 15. I feel like an insatiable consumer of everything diabetes, and yet, this is the first time I 've ever heard of an internal pump. According to the article, Chris, Greg and Anne have been using an internal pump for 20 years! Here we have a method to enhance the lives of millions of diabetics who are challenged each and everyday and yet it is fraught with red tape and excuses as to why it cannot be available. It is my opinion that those who are in positions to make decisions have no direct experience with diabetes and therefore cannot possibly comprehend how beneficial this would be.

Posted by Anonymous on 19 April 2011

My wife has been on insulin therapy for over 50 years. This insulin delivery system is a technology of which we were not aware. The Medtronic pump she utilizes has been a blessing. If Medicare would approve CGM it would be even better. This device sounds so wonderful and it would drastically improve her quality of life. Reading this article caauses us to wonder why it has not progressed to the marketplace where most innovative scientific decisions are made. Our son works as a scientist and he says marketing determines whether it is feasible to continue research on new products and decisions are not based upon the health and well-being of the patient.

Posted by Anonymous on 19 April 2011

Diabetes is big business for big business.

Why on earth would big business want anything like a cure? It would kill their big business.

Much better to kill diabetics.

Posted by shosty on 19 April 2011

My 21 year-old daughter was diagnosed at 4, and has always been hard to manage. She went on a Minimed pump at age 8. The CGMS was a terrible experience for her,hard to calibrate, delayed numbers, inaccuracies. Apart from that, she would never want an automatic "closed loop" system: her blood sugars are idiosyncratic (possibly due to other autoimmune problems) and her brain will always be better than some system set up by Medtronic.

I was amazed at this article: after all these years of diabetes magazines, groups and sites, I have never heard of the implantable pump. The biology makes so much sense. And the testimonials were amazing.

What else can we do? Write Medtronic, or the FDA? JDRF should be making noise about this, but they won't.

Like other posters, we have become jaded about the next miracle promised around the corner. But it sounds like this one has already been tested and has been around for quite awhile.

I just told my daughter that if I can ever get the money together, she's going to France!

Posted by Anonymous on 19 April 2011

So do we mount a campaign toward Medtronic, the ADA, the FDA, the JDRF, or just who? As a T1 for 40 years, a pump user since 1984, a father of two T1 children, and a DCCT human research subject for 12 years, we NEED and deserve the most advanced technology in the world! How do we get it?

Posted by Richard157 on 19 April 2011

I was diagnosed with type 1 diabetes in 1945, when I was 6. I do not remember what it was like to not have diabetes, and be controlled by injections and a conventional pump. It would be so wonderful to experience the feeling and great control that the people in this article have seen. How could there not be a market for this implantable pump? Is the expense so great that no one could afford it? Is there a good reason for potentially scrapping the whole project?

Posted by Anonymous on 19 April 2011

The only way this will get passed by the FDA, is if the top ten people there have one of their kids diagnosed with type one. Maybe then they will have the insentive to look at it as a vital divce to help their children.

I'm a type one, was diagnosed at age 12 and have had it for 33 years now. It's a fight every day to manage it. I wish I would have had the chance to try this pump years ago. My life might have been so much easer.

Posted by Anonymous on 19 April 2011

Wow. I've had type 1 for almost 25 yrs, a pump for almost 13 yrs (my oldest son just turned 12), and a CGMS for 4+ yrs (my youngest son will be 4 in another month). Never heard of an implantable pump. What a godsend that would be. And a huge wardrobe improvement to not have to always have a pocket or a waistband and a place to stash the tubing! :) Come on, Minimed - let's do this in the US!

Posted by Anonymous on 19 April 2011

I am a T1 diabetic of 42 years and have endured a variety of glucose measurement techniques and changes in therapy. I had 4 sub-Q daily shots for many years, then the external pump for the past 3 years.

It seems like there is a stalemate regarding the implantable pump in the US. The FDA hasn't approved the insulin, the drug company is not pushing for approval (expensive) because there is little demand with no implantable pumps in the US. There are no implantable pumps in the US because there is no insulin available.

How can we break this deadlock, so we can benefit?

Posted by Anonymous on 19 April 2011

I just found out that my second child has type 1 he is 20 months old my first was diagnosed at the age of two after raising thousands of dollars for jdrf to find a cure.I ask the company leaders of medtronic if there kids had type 1 would they want this this research to stop.Also is it about the kids or making money and helping the kids a little bit sound right.

Posted by Anonymous on 19 April 2011

I live in Canada, and I can't ever remember hearing of this technology ever being available to us here. From what is written here it sounds just too good to beleive that it isn't being developed whole heartedly.

But I guess that would be counter productive to many of the current suppliers of our Insulin and supplies and treatments. Its big business and we are all small pawns in the overall picture of things.

If this works as well as what this article describes, it could only be a benefit and welcome relief from all the high's and lows we all go through daily and it would surely reduce overall medical expenses for every government for diabetic related problems.

Posted by Anonymous on 19 April 2011

Wow! I didn't even know this technology existed. PLEASE keep this technology going!!! FOR THE SAKE OF THE CHILDREN suffering with shots/pump changes/ highs/ lows etc! And for all diabetics in the world.

Posted by Anonymous on 19 April 2011

As the father of a 19-year old who was diagnosed with T1 at age 9, and being French myself, I am very tempted to to have my son travel back to my country of origin to have this pump implanted! Until this article, I was totally ignorant of the implantable pump and its benefits. Let's hope that greed and economic selfishness will not deprive those who suffer from T1 of such a promising technology.

Posted by markkoeks on 20 April 2011

I'd really hope to see this R&D continued. I have had 2 CGMS systems from Medtronic, both white elephants now due to hassle, insertion complications, accuracy yadda yadda. I'd much rather have a more effective insulin delivery method as described in the article, and test manually, than the current Sub-Q insulin problems and management.

That said, everyday we are able to perform miracles in our body with technology that is available, so thank you Medtronic - and I believe in your quest for lifting the burden of diabetes.

Posted by Anonymous on 20 April 2011

Type ! for 35+ years. On the Medtronic pump. Counting carbs, working-out, low blood sugars. What a balancing act!! Never really feel good.
Come-on Medtronic....help us get beyond that pump.
I volunteer now! Let us know when you will continue this program.
Thank you

Posted by Anonymous on 20 April 2011

I am confused as to why R&D is being halted for this type pump when Medtronic has been making implantable morphine pumps for years. The technology described seems remarkable similar. I can tell you that about 10 years ago, the instituition I worked in was able to implant the device with the patient staying overnight for observation and then fill the pump in an outpatient setting with a very low rate of infection or other complications. Again as most have echoed here, it seems the FDA and the type of insulin required seem to be the largest stumbling block. Next I would imagine that most insurance companies will be slow to get on board to cover the device implantation, insulin, etc...However for the first time in my 36 years as T1, I feel hopeful. While the type of device I now use has made many improvements in my life, I have only recently accepted that despite my best efforts, there will be many, many times I feel just awful with no explanation.I do not forsee a cure in my lifetime as there is no money to made in curing disease. To ignore the facts about IP insulin and how T1s are forced to subvert a natural physiologic process to stay alive when an acceptable, more natural alternative is available is almost criminal.
Sorry for the rant. Good luck to all of us!

Posted by Anonymous on 20 April 2011

I have had T1 for 37 years now.Started with the old Lente 2 times a day then progressed to rapid with muptile daily injections.I started using a pump 6 years ago and for the first time felt just incredible.If I feel like this now I can only imagine what it would be like with an implantable pump.Bring it on medtronic and give us a chance to really live life without constant fear,worry and living feeling not really healthy

Posted by Anonymous on 20 April 2011

This may not be the right post for this but during the Bush administration he banned federal funds for stem cell research; however, there was never a ban on the research itself. I say this because of all this talk of FDA and government, not one stem cell trial was brought in front of the FDA for any approvals during the ban. Whatever your religious beliefs are, I think we have to ask the question why weren't any trials brought forth. We have lost over 8 years and I wonder if companies just knew they would be rejected because the FDA is a puppet for the current administrations? The whole thing makes you wonder!

Posted by Anonymous on 20 April 2011

As a Diabetes Educator of 25 years I recognize , the fact that the implantable pump delivers insulin into the peritoneal cavity is a glaring difference and probably the most important difference between conventional external pump therapy and implantable. Subcutaneous delivery of insulin not only poses the challenge of slower delivery, many patients have erratic absorption from sites being scarred etc.
I fully support and encourage medtronic to pursue this form of therapy. I can't imagine it would be that difficult to produce the concentrated insulin necessary since it is available in France. However, I imagine the FDA limitations and need for extensive clinical trials is a great obstacle. This is a phenomenal break through in insulin therapy that occurred more than 30 years ago and it is a crime that it is not readily available to persons with type 1 diabetes currently.
Ellie Feddersen, RN, CDE
Evanston/Skokie , IL

Posted by Anonymous on 20 April 2011

This is crazy! Medtronic is a multi-billion dollar company with enough resources to spend multi-millions to pay physicians to be "consultants" who happen to implant their devices. How about spending some of that money to convince physicians here to implant devices that you KNOW would be successful?!! You just don't want to lose the money you've invested in pumps and CGMs. Take a chance. People are worth it!

Posted by Anonymous on 20 April 2011

The implantable pump gives testimony to more efficient absorption of insulin. It makes sense. I am very much in favor of bringing this research into the spotlight! One point, I wonder about the infection percentage?

Posted by Anonymous on 20 April 2011

Medtronic please continue your program in the United States...let us have a chance to try the pump, most of us don't have the money to go to France..even though we would do anything for our children with type 1.

Posted by Anonymous on 20 April 2011

I heard about this research in the early 90's at a Children with Diabetes Conference. There was actually a presentation on it, and it was the latest hope for the future. Since then, external pumps were developed, and I never heard any more about the implantable pump until now. If I remember correctly, during the presentation, they showed metrics of how the study candidates were doing, and it was phenominal. I always wondered what happened! I am losing hope here. I am losing hope in the FDA and all of the research companies who are working to cure this disease. I strongly believe that greed is what leads this country, and I agree with most comments - this disease probably won't be cured mainly because of greed. I use to have lots of hope. All of that hope is lost. I am now seeing where research that was done years ago is being republished as new research, all so people donate to the research. I have two kids with T1 diabetes, and it is the most difficult thing I have ever had to deal with. I cannot imagine what it must be like to have this disease. I only wish the research companies would understand this.

Posted by Anonymous on 20 April 2011

It's very sad that Medtronics would discontinue supporting this type of research. Apparently, U.S. greed and their "bottom line" is more important.

I hope the people in the article continue to get the support they need from our advanced overseas counterparts.

Posted by vaccin8 on 20 April 2011

Early on I was a participant in an implantable pump trial. Unfortunately, I was randomized to the control group so no pump for me. I was on an external pump and have been until last year when I found it increasingly difficult to find good sites. I am convinced of the superiority of insulin delivery directly to the portal (liver) circulation over the subcutaneous route. I have been following the progress of the implantable pump for some time; I was very distressed to hear of Medtronics' decision to discontinue support for the US program in 2007. I have been type I for 36 years and have now come to the conclusion that I need an alternate delivery route for my insulin. Inhaled insulin (Afreza) was not approved by the FDA in January and may never be. I am considering getting an implantable pump in Europe at my expense and going over four or more times a year if necessary.

Posted by SusanMaller on 20 April 2011

My friend has been a type 1 diabetic for over 40 years and needs this technology. Please if at all possible let her have it!

Posted by Anonymous on 20 April 2011

After 31 years as a type 1, I want an implanted insulin pump!! I have lost the ability to feel hypoglycemia. I need the superior control of peritoneal infusion.

It would be a crime to discontinue these pumps. It IS a crime to deny them to people living in the US!

Posted by Anonymous on 20 April 2011

Wow, This would be a Godsend for my 16 year old TYpe 1 Son. He has had diabetes for 6 years. WHy have we never heard of this before? This should be the wave of the future ! Medtronics MUST continue and allow others to benefit from this. I don't understand how this can not be a Great thing for diabetics??!!?!?!?!?

Posted by Anonymous on 20 April 2011

It is simply unconscionable that such a proven technology would not be supported by Medtronic. One would hope that the leading diabetes advocacy organization in the U.S., the ADA, would be pushing hard to make the availability of pumps and insulin a reality within the U.S.! What kind of a country are we becoming?

Posted by Anonymous on 20 April 2011

Very interested in this therapy - I have a teenager with T1, and would dearly like to have him out live me, and I plan to live to be 100

Posted by Anonymous on 20 April 2011

After reading this complete article I'm impressed that it would be a very worthwhile effort to keep this technology available to all those that would benefit from it. I am an elementary school nurse and know that there are many children that could benefit from this incredible technology. Keep it going!

Posted by Anonymous on 20 April 2011

Very informative article. As a Medtronic insulin pump user for almost 20 years, I hope the US (and Medtronics) will research and continue to look into this device for type 1 diabetics. I want to learn more about it.

Posted by Anonymous on 20 April 2011

Oh, yes, please. Scott Hanselman

Posted by Anonymous on 20 April 2011

One thing we can all do is contact Medtronic, JDRF and FDA directly and let them know that we are informed, and want to know why another option is being removed as a possible treatment of this insidious disease. Afterall, the sqeaky wheel gets the grease! It's all so ironic, the JDRF has on their website "Get Involved" well here we are, we are all involved now and its more than just writing a check or taking a walk.

United States - World Headquarters
710 Medtronic Parkway
Minneapolis, MN 55432-5604
Phone: (763) 514-4000
Toll-free: 1-800-633-8766
Fax: (763) 514-4879

Medtronic of Canada Ltd.
99 Hereford Street
Brampton, Ontario L6Y 0R3
Phone: (905) 460-3800
Fax: (905) 826-6620
Toll-free: 1-800-268-5346

Juvenile Diabetes Research Foundation International
26 Broadway, 14th Floor
New York, NY 10004
Phone: 1-800-533-CURE (2873)
Fax: (212) 785-9595
E-mail: info@jdrf.org

Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

or by telephone:

1-888-INFO-FDA (1-888-463-6332)—main FDA Phone Number (for general inquiries)

Posted by Anonymous on 20 April 2011

My 11 year old daughter was diagnosed at age 8. Her younger sister was 4 at that time. She said to me the other day that she gets sad sometimes because she is starting to forget about the times she played with her bigger sister and didn't have to worry about low blood sugar. What life would be like with an implant... I could only imagine.

Posted by Anonymous on 20 April 2011

I am all for a small implantable device, that improves BG control. i have been on the pump now for 11 years. I have never had a perfect day of BG control. I am in favor of something that works better than the sub Q insulin. There would be a huge market for great control. Let's get it here in the US fast!!!

Posted by Anonymous on 20 April 2011

I called Medtronic and was transferred multiple times until I was sent to someone in legal, to leave a voicemail. How nice, I guess I will try again tomorrow. I noticed the JDRF posted about the artificial pancreas and how it must move forward but they failed to comment upon how many catheters are needed, 1or 2? How does it compare to current pump tech, show us the metrics! What about some of the issues still associated with sub-q? I myself am finding it harder and harder to find sites that aren't scarred? They think this is for everyone and it isn't. What will the costs of supplies be as compared to current pump? If the pump does everything for you then I guess there wouldn't be any need to diet and we can all become obese because I believe sub-q influences weight gain, especially in well controlled type-1.

Posted by Anonymous on 20 April 2011

I am 14 yo old and have had Type 1 diabetes for 6 years and want this implantable pump "yesterday".

I am sad that this technology hasn't been available since I was diagosed... I hope to have this product in the next few months. :)

Posted by Rick on 20 April 2011

God bless everyone out there who are battling this disease. be sure of one thing. we are all expendable. they don't give a damn. it's all about money. they could have a cure today but that would kill the goose that lays the golden eggs. i have had type 1 for 46 years and most days i feel like crap. tired all the time. no energy. and my diabetes is well controlled. i exercise every day and hope for the best. a diabetics chances today are much better than 40 years ago to avoid complications. i have many of them. so i say to those who have type 1 for a short time, get on your computers and RESEARCH!! educate yourselves. right now i know as much as my doctor about diabetes. and there's a lot they don't know about diabetes. everyone reactes differently to this disease. learn everything you can and meet it headon. don't let it control you and how you live. YOU CONTROL IT. use everything science has to offer and don't be hoping for a cure. there's too much money involved. God bless you all.

Posted by Anonymous on 20 April 2011

These pumps have been available for the last 20 years!! There is no good reason why this device and the u-400 insulin should not be available now in the US.

In view of the success that has been documented and commented upon in the article by the users of the device, Medtronic needs to step-up and show that it is truly committed to helping T1's.

If you are listening Medtronic, please bring this device and insulin option to the US.

To all T1's and their families. Let's all do our part and get the word out about this technology and call Medtronic, JDRF, the FDA and even your elected congressman or congresswoman and let them know that this type of device needs to be approved.

Posted by Anonymous on 20 April 2011

My son is 24 and has suffered greatly with type 1 diabetes since his 12th birthday! A sub-q pump has helped although he has now developed severe neuropathy, which may have been avoided if an implant were available. Please don't let this go by the wayside. There are so many serious complications from prolonged diabetes. Please, help the millions that suffer from this terrible disease!!

Posted by Anonymous on 20 April 2011

Oh, how I want this to be available for our daughter! She was diagnosed 5 months ago. Today is her 5th birthday. If there is ANYTHING I can do to keep her healthy and let her live a full life feeling great without complications, I want to do it. I'm sure every other parent of a child with diabetes feels the same way. We NEED THIS TECHNOLOGY. I do hope it will be pursued with as much effort and funding as possible. I'd trade it for the artificial pancreas for sure.

Posted by Anonymous on 21 April 2011

I wish I knew the best way to urge Medtronic to move forward with this technology. Will a letter suffice? Don't know, wish this had more exposure. And more details as to why it is not approved in US.

Posted by Anonymous on 21 April 2011

What exciting technology! I can't believe I never heard about this before. Intraperitoneal delivery of insulin just makes more sense. I can see why large-scale trials are challenging, but I hope Medtronic and Sanofi-Aventis pursue expanding the implantable pump and not just supporting it for the few who already have one.

Posted by Anonymous on 21 April 2011

I am a Type 1 diabetic for nearly nine years. Diagnosed at age 37. I can hardly remember what life was like "before" being diagnosed. Reading through the "old timers" who have had it for 30 plus years brings tears to my eyes. We all suffer every single day of our lives. We never feel 100 percent. Highs, lows, carrying all the crap around with you. Do you have emergency food? Candy, pop? Extra insulin? Traveling is a nightmare because you have to make sure you have everything....going through TSA??? Geesh...

It disgusts me that this technology has been around for 20 some years and hasn't been made available to us. Americans. Who live in the greatest country in the world! And the technology was designed in this country!!

What to do? Call your congressman? Medtronic? FDA? Will they ever listen? I've decided that we are the "money makers" for all these companies. There ain't no way they are ever going to allow us, hard working Americans, have an opportunity for this technology. Very sad and disturbing.

Posted by Greg & Anne on 21 April 2011

We are not surprised by your strong reaction to this article, and we understand the feelings expressed in a number of the comments.  We wanted to let you know a little of the history of our own efforts to save the implantable pump, and then talk about what we can do as a group to bring the implantable pump to everyone with diabetes.  I believe that as a community, we can make this happen.
We have tried everything we can think of to save the pump on our own.
In 1995, when our pump implantation study group was threatened with cancellation we found a new doctor to take over our study group and run the study.
In 2007, when we learned that Medtronic was requiring all U.S. patients to be explanted, we lobbied Medtronic to reverse their decision to cancel the project in the U.S.  We were told that the decision had been made and would not be changed.
We then called Professor Renard and he agreed to treat us.  (We had been told that the European studies were also being canceled; however, a successful campaign kept Europe going.) 
Looking for any possible solution to bring the technology back to the U.S. and help to secure the future for Europe and worldwide, we formed IIP Technologies in 2008 and spent two years trying to find a way to raise capital, acquire technology rights, and build a new pump for the U.S. - including investing a quarter million dollars of our own money.  We were not successful and had to abandon that effort in early 2010. We also seriously considered starting from scratch, but the analysis indicated that this too was a non-starter. 
Within the next two years, Sheila and Chris joined our traveling crew, and they too are solidly behind the effort. 
Next, Anne and I spent a great deal of effort trying to convince JDRF to help us by setting up a special account to receive donations that we would go out and solicit for the pump. Our idea was that if we could raise enough money to send to Medtronic, and benefit from the name and prestige of JDRF being on our side, then Medtronic might really hunker down and get this done.  Or, alternatively possibly we could convince another company to accept our donations to help defray the costs of entering the market.  After months of back and forth, however, JDRF ultimately declined - saying they did not have the bandwidth to take on another issue.
So, what next?  They say you never fail until you stop trying. I am convinced that if we all work together to get the word out that we as a community need this technology, we will be successful.
For our part, we are in the process of trying to convert IIP Technologies from a regular corporation into a charitable 501 (c) (3) organization - we are looking for a law firm to do a little pro bono work to help with this.  We will then proceed to go out and beg for donations and do our best to collect enough money to make a difference, in the same way that we were hoping to work with JDRF.
Yes, companies are profit motivated - it is a fact of life.  But we can help them make the right choices by defraying some of the costs of those choices.  Yes, the FDA is a hurdle (but our talks with them lead us to believe that they are highly receptive - they just need the data presented in an appropriate way.)  Yes the insulin is critical - but it is now available and we believe that it will continue to be so (Anne, Chris, Sheila, and I are in the control group of an ongoing trial of the new insulin Sanofi has produced - good results are very likely and the new insulin should be available before the old insulin runs out). 
For those of you who mentioned going to France - this may not be an option any longer.  The supply of pumps is dangerously low - to our knowledge, no new patients have been implanted in France for some time, with the available pumps being used to replace those whose batteries have died.  We will get a definitive answer on this and let you know the result on this website.
Oh and by the way - to answer the person who wrote in about type 2 diabetes.  There is evidence that for type 2s who need insulin, IP insulin is superior. 
Finally, each of you may wonder what you can do.  To start, please be sure to let Medtronic and the JDRF know that this matters to you.  Check in with Diabetes Health for further comments and developments. Then the hard part: Keep informed, keep the pressure on, and do not get discouraged.  This will not be resolved tomorrow.  There is a lot of work to do - the pump has been slowly dying and we need to revive it, nurture it, and support it as it reaches its full potential. 
We have been at this for a long time and we did not know how to ask for help - we still don't know how to do that very well but we will learn. 
Stay in touch.  Anne and I have a selfish interest - we do not want to lose this technology but we are even more motivated to see that all diabetics have access to it - we know how hard it is to live with diabetes.
This is one of the good fights that come along so rarely - if we pull together we will win.
Greg and Anne

Posted by Rick on 21 April 2011

i hope that mary tyler moore, wherever she is, is reading these testimonials.let her appear before congress and let them know that there are millions suffering with this disease. the general public doesn't know about all the horrible complications. and most of all, the children who have to live with this. mary tyler moore, wherever you are, step up and speak for us. please.

Posted by Anonymous on 21 April 2011

I agree with the poster who said this:
"It's very sad that Medtronics would discontinue supporting this type of research. Apparently, U.S. greed and their "bottom line" is more important.

I hope the people in the article continue to get the support they need from our advanced overseas counterparts."

Posted by Anonymous on 21 April 2011

I have two Type 1 children each diagnosed as infants. I deeply hope that the FDA and Meditronic reevaluate their position on this technology in the United States. My children have their whole lives ahead of them. You try to tell you children that they can do and achieve whatever they set their minds to, especially in the United States. What a tragedy that this country that promotes free-thinking and a continual pursuit of ones dreams, would be the same country blocking a technical advancement that would allow diabetics to live better. I sincerely hope this technology is one day available in the United States. I read other posts where Type 1 diabetics have lost all hope and faith in these medical companies and the FDA after many years of waiting for something better. This is really sad and I ask that Meditronic and the FDA do the right thing. Don't let my kids and many other Type 1 diabetic children lose hope!

Posted by Anonymous on 22 April 2011

I was not aware of this technology until now, it sounds wonderful! I can't believe no one has pursued this further. I hope medtronic changes their minds or will allow another company to pick up where they left off. And offer this in the U.S. please.

Posted by Anonymous on 22 April 2011

Me and my family don't donate to the JDRF any more because they over promise and under deliver. But, they have the funds to pay their CEO in excess of $650,000 per year and that's based upon 2008 statistics. They are in bed with those they support and that's why they have done nothing to bring anything to the bedside. I'm frustrated, disgusted and have lost my faith in medical research. Mary Tyler more is a useless celebrity spokesperson that would rather write books. A joke! Maybe in 5 years there will be a cure. Afterall, they are "CLOSE TO A CURE".

Posted by Anonymous on 22 April 2011

As a diabetic for 6 years I think this technology should be offered. From the above comments its obvious that sub-q insulin DOES NOT WORK!!

Medtronic please keep making these pumps.

Money shouldn't be wasted on "research" from JDRF to make a glorified pump. Clearly this technology which some lucky diabetics already have now, should be known to every diabetic and the time and money should go into making MORE of these great new inplantable pumps.

This great new device shouldn't be kept in hiding and the millions of other diabetics should get to feel and live A LOT MORE normally and in a new manageable way which many haven't felt in their years of having diabeates.

This decison shouldn't be hard for Medtronic. Everyone is having possitive feedback to this new devise so why question what the people want. In this case, make more and bring this pump to America!!

Posted by Anonymous on 22 April 2011

Thank you Greg and Anne for your comments... please let us know if they are taking any new pts in France. IF someone knows of any connections to the media... please help.

We need to get this to the general public, dateline NBC, Good Morning America, Wall Street Journal, etc.

Posted by Anonymous on 22 April 2011

According to an article on Wiki, implantable pumps last 8 years so if that is true, it simply comes down to revenue and cash flow. Not to mention, medtronic's sales have been soft for their new implantable pacemaker that, according to Internet articles, has a 75% profit margin. Let's fleece the sick! In the end, it comes down to money and after Medtronic bought minimed they now had the rights to the implantable pump and could mothball it to push a pump that lasts 4 years and requires constant purchasing of proprietary disposable parts/attachments.

Posted by Anonymous on 22 April 2011

When I was diagnosed with type 1, at age 16, in 1968, my doctor hopefully opined that he felt they'd have a cure within perhaps 15 years. They don't, of course, and it's been now 43 years for me. But it's galling and angering indeed to find how much better the treatment could have been if this technology had been more fully explored, especially here in the U.S., and if the FDA had found a way to cooperate with the research instead of apparently pretty much blocking it. I used to think the FDA was there to protect us. But the politics of the last decade has pretty much proven that political clout, lobbyists, corporate money, and wall street, call the shots, not the actual good of the people. In this case, no doubt the FDA gets blocked from allowing more research in this area simply because lobbyists and money from competitors (Lilly Perhaps? dunno..)has no interest in loosing their share of existing market profits. Call me a cynic. Yes, perhaps. But too many logical and good ideas get shelved because they're not profitable or convenient (word borrowed from Al Gore's book title, another fine example of the same principal) No doubt there are people in the FDA and at Minimed who're passionate and in favor of following these research directions, but they simply cannot be in the majority, or we'd have heard more about it, and there would be more push to get this information out, and the research in progress.

Eventually, I expect that this treatment, and perhaps more advanced ones, closed loop systems, or perhaps a true cure, will come around. But I rather expect that the U.S. just might get dragged to it kicking and screaming, rather than leading the pack, unless the medical establishment can figure out a way to sell it as a potentially more profitable road for the industry to follow.

And I also expect that these enhanced treatments and especially an eventual cure, are most likely to be announced the day after my own funeral...

Posted by Anonymous on 23 April 2011

My son has been diabetic for three years now.We live in Canada and had to fight to get him an insulin pump at three months since healthcare people here think kids needs to do MDI for at least a year before they start pumping! This is the first I have heard/read about an internal pumping system. I have always wondered why we can have pacemakers to make our hearts beat "normally" and why no one has been on this trail of thought for the wounded pancreas. And now I find that it is here and in jeopardy. Obviously those who want to discontinue this have not been diagnosed with diabetes and had to struggle day to day with trying to lead a "normoglycemic" lifestyle. As a mother the costs of traveling to France every three months would be worth every penny to ensure that your child could lead a healthy active lifestyle.

Posted by Anonymous on 23 April 2011

I read this and cried. I read these testimonials and it made me so hopeful that I could one day feel normal again. I would love to find out more research on this pump. I have tried looking and information seems little. I think medtronic needs to relook at this situation. It is not always about making money, but a company can gain loyalty of the people by bringing genuine care and help to those who need it.

Posted by Anonymous on 23 April 2011

Meditronics please continue to work on this program. The technology sounds amazing. You have the power to help so many diabetic patients. I've had Type 1 Diabetes for 37 years and this is the first thing that actually makes sense to me.

Posted by Anonymous on 23 April 2011

I'm T1 for 48 yrs, pumping since 1982. I would pay anything for this. Can a US citizen still get the implanted pump in France? If so, how? Please don't let this issue die!

Posted by Anonymous on 24 April 2011

I have had type 1 for 54 years (dx'd at 7yrs old) and, like others who have had it for over 50 years, I am completely over waiting for a cure, or, anything that sounds too good to be true. In 1957 my parents were told by hospital physicians, "we are on the threshold of discovering a cure"...54 years later, I'm still waiting.
I have been using a pump for the past 9 years and,for me, this is as good as it gets. Compared to what we had to do to stay alive in the 1950's (and before), pumping is the "ultimate" in my opinion. I am grateful for my pump and am looking no further...I just can't believe it will ever happen! If they come up with technology that might eventually lead to a cure or even make life easier for us, think of the future $$$ these huge companies stand to lose - sorry....they just ain't gonna do it!

Posted by Anonymous on 25 April 2011

My Daughter was diagnosed at 16 month and she is now 12. I would jump on an implantable pump in a minute if this technology was available for her. I have never heard of the type of technology until I read this article and I am appalled that it it not an option for every T1 person. It really seem that the US is not headed in the right direction at this time. Medtronic need to keep this technology alive. It is sad that T1 do not get to choose the options that work best for them. Rather big companies and Boards determine how T1 should car for themselves and what should be covered. Medtronic should be ashamed of themselves for taking this type of technology away.

Posted by Anonymous on 25 April 2011

My son is 11 and was diagnosed 3 years ago. I think this technology is amazing, it is really sad that they are not willing to keep trying for something that would be so life changing

Posted by Anonymous on 25 April 2011

Companies follow the path that leads to the most profits. Diabetics' continued reliance on Medtronic's products, and its every- couple-of-years "exciting improvements" follows that model. Currently, we're supposed to be impressed by the Revel's improvements over the Paradigm. Big deal. The pump is still as large as a 1980s pager, is tethered to you with insusion set tubing, and despite a person's expertise with insulin/carb ratios and carb counting, THE BODY IS UNPREDICATABLE. The food/insulin/body interaction is in constant flux. The same food eaten at the same time each day plus the same insulin dose doesn't equal the same post-parandial blood sugar each time.

We need something that constantly calculates ITSELF like a real pancreas how much insulin is needed.

Posted by Anonymous on 25 April 2011

Son was diagnoese with T1 at age 4; 13 years ago. This technology would be a lifechanger. Keep pursuing!

Posted by Anonymous on 25 April 2011

I have had many Med tronic pumps over 20 years all have had issues .Please as a Mother who has had Diabetes for over 25 years please get this done!!!

Posted by Anonymous on 25 April 2011







Posted by Anonymous on 26 April 2011

Seems Like A No Brainer To Me! If All The Users Favor This Approach Why Question It's Approval? Greater Use Should Help To Bring It's Cost Down.

Posted by Dannew on 27 April 2011

Thanks to Amanda Sheldon and Dr. Francine Kaufman at Medtronic for posting their encouraging reply above.

It sounds like the implanted pump may have life after all, though Medtronic may approach it from another route, by first focusing on the "closed loop" with a continuous glucose monitor and then moving towards an implantable version. Does that sound right?

There must be a workable business model for an implantable pump. From an income standpoint, it's no different from an external pump: either could be made to work with test strips or a CGM. And if it's as good as it sounds, preventing long-term complications of diabetes is a net health-care savings. That's of financial value to the company that makes it, as much as it is of personal value to those who use it.

Do keep researching the implantable pump!

Posted by Anonymous on 27 April 2011

I have been a Type 1 for 38 years and using insulin pump therapy for the past 8 years. I have "good control" but my quality of life is often compromised by periods of hyperglycaemia or hypoglycaemia and I rarely feel entirely well and at ease. I urge Medtronic to persist and see the business risks as justifiable. This is vital for those children who may never reach their full potential professionally or personally without IP technology.

Posted by Bernfarr on 28 April 2011

I would love to get some insight into the challenges of getting FDA approval for this. The FDA seems to come up as a constant roadblock for advances in diabetes treatment. From this story, and I know these are anecdotal experiences, it appears that the implanted pump is safer and provides far better control. I know the story is not that simple, but why are the FDA not approving this life-saving technology?

Posted by Anonymous on 28 April 2011

Someone above listed the addresses for Medtronic and the FDA, but there are no names listed. Without a name, or at least a department, any letters are likely to get filed in the circular file.

Greg, Anne, Sheila, and Chris,

Do you have a name or at least a department that we can all send letters to? How about the names of congressmen on the appropriate committees?

Thanks for posting the article.

Brent Powell

Posted by Anonymous on 28 April 2011

My 13-year-old son has had type 1 for the past eight years. I can only hope that by the time he reaches adulthood, there will be an implantable pump he can use. More attention needs to be paid to insulin delivery to the peritoneal cavity! It makes much more sense that delivery of insulin almost directly to the liver makes blood sugar control more exact since that is the responsibility of the liver.

If we all write to Medtronic - it just might make a difference. Our persistence could keep the IP Pump alive. I am going onto the Medtronic website right now. I urge you to do the same!!

Posted by Anonymous on 28 April 2011

Mary Tyler Moore, Bret Michaels and Haley Berry need to know about this! Anyone who can pass this email along to them must do so.

Posted by Anonymous on 28 April 2011

Great article! Will Diabetes Health be covering this issue more in the future?

Posted by Anonymous on 30 April 2011

As the mother of two T1 diabetic sons I feel that all people concerned must contact the company,JDF and our government representatives and voice our complaints. We have to force them to do the right thing for our children and all diabetics.

Posted by Anonymous on 1 May 2011


Posted by Anonymous on 2 May 2011

My son has been a Type 1 for 10 years. He cannot remember what it's like to feel normal. I would do anything to provide him with the opportunity to realize the benfits of this technology. This sounds like a win-win-win for the pump users, manufacturers and insurance companies. It's frustrating to feel so helpless.

Posted by amsheldon on 3 May 2011

Given the amount of discussion around this article, we asked Medtronic's chief medical officer, Dr. Francine Kaufman, to respond on Medtronic's blog, The LOOP. We have included the response here. Amanda Sheldon, director of PR for diabetes business unit of 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.

Posted by Anonymous on 4 May 2011

Very disappointed in Dr. Kaufman's response. There is absolutely no mention of the clear advantages of intraperitoneal insulin delivery. She says it would take years of additional development, and conveniently ignores the fact that the haven't done any development on it in ten years. And finally, she pins the blame on the FDA, when Medtronic has made no effort to update the product (or even keep it in production) for the countries where it is approved.

Disappointed, but not at all surprised.


Posted by Anonymous on 4 May 2011

Oh, and they don't seem to be accepting any comments on her blog :)

Posted by Anonymous on 5 May 2011

The reasons against the implantable pump are political and total nonsense.

Posted by Anonymous on 6 May 2011

As a mother of a 10-year old boy with Type 1 diabetes, it's painful to watch what he has to go through everyday to manage his diabetes. He is currently on the pump and it certainly has made a big difference in how we manage his care. But this implantable insulin pump (even with some of it's issues), sounds like it could provide better control, something we struggle with daily even on the pump. I've always said to my close friends that watch us struggle w/ this disease that I just can't imagine how my son must feel on a daily basis. If there is technology out there that can make him feel more like the rest of us ...I'm all for it. He and the millions of other Type-1 diabetics deserve that opportunity. Please move forward with developing this technology in the U.S.

Posted by HoundMom on 6 May 2011

I have had Type 1 diabetes for 41 1/2 years and I would LOVE to try an implantable insulin pump. I have been on insulin pump therapy since 1981 and have seen great positive changes to this technology. I wish I could say my control is very good, but pumps are tools to help us manage our diabetes...not to cure it. I urge Medtronic to reconsider making available the implantable pump. I am holding out for a cure and hope it comes sooner rather than later for all of us who need it but am willing to try whatever would make me feel like a normal person again.

Posted by Anonymous on 6 May 2011

**LONG, but WORTH IT** Greg and Anne, thank you for your relentlessness in pursuing this venture, very noble and commendable. Instead of waiting for more approval of devices that won't cure DM, I turned my focus to what Lee Iocca is doing. He lost his wife to Type 1 in the 80's and then promised to help find a cure. He researched who was pursuing the most promising development for a cure and put his "eggs" in the basket of a reseacher at Boston Mass General named Dr. Denise Faustman. She cured Type 1 DM in mice, by stopping the immune system attack on the pancreas AND as a side benefit discovered that the Islets actually regenerated and produced insulin once again. The implications for all autoimmune diseases are great as this approach is FIXING the immune system. With all the variables of diabetes management I find it hard to believe that a device (such as a closed loop system) could replace all that a human body does normally in response to glucose control. And, as evidenced by Medtronic's response, they're predicting several MORE years til anything "closed-looped" is available. (personally they can keep the closed-loop idea, testing blood sugars by fingerstick is not as bad as not having the benefits of IP insulin). Instead of hitting a double (advancing the implantable pump) they want to skip that and go for the homer (closed-looped system). I believe this is in response to other companies joining the race to develop the first closed-loop system. (How would their standing in the diabetes world's eye look if Animas beat them to it. It'd be financial suicide to let that happen). I visited Dr. Faustman in Boston (I live in STL) and was very impressed with her and came away feeling very hopeful about the possiblity of a cure, instead of the usual doom and gloom. Check out her study's website (faustmantrials.org, I believe?) and donate any money you can because she is on the path to making history. Before I left her lab, I asked, "So, do you think there'll be a cure in my lifetime?" I'm 40. She replied, almost giddily,"Oh, well I'm counting on it within my lifetime!!" She's in her 50's or 60's. Money is the answer, unfortunately. But fortunately we have strength in numbers and in how much we hate having diabetes. Spread the word, people....... Fighting til the end, Angela R

Posted by Anonymous on 6 May 2011

The technology has changed so much from the initial implant, and it is constantly changing, the device companies need to race to find the "cure" If medtronic is not going to pursue it then maybe Animas will beat them to it. I agree with the previous poster we can get involved, Juvenile Diabetes Research Foundation has an advocacy page to get lawmakers and communities involved.

Posted by Anonymous on 6 May 2011

Having T1 for 45 years and going through all the "advances" in treatment, I find it ridculus that the FDA would keep the ultimate treatment from us until a cure can be found!!

Posted by Anonymous on 7 May 2011

A technology like this, that could greatly improve the quality of life of my son, increase his life span, and potentially save him from type 1 complications, to be abandoned at the curb side is just criminal.

Posted by Anonymous on 13 August 2011

Any updates on this????

Posted by Anonymous on 29 November 2011

Where did everybody go on this?Look people we have to stick together,if we dont there is never going to be this pump here are anything to cure diabetes.I have gave to JDF all my life and so has my family.I have been a type 1 diabetic near all my life 30 years now I remember growing up I was always told there would be a cure for me one day well it hasnt happened yet!you better believe it is a money thing,I know people have bad diet methods this day and time but come on have you ever researched how many people in the united states have this?It would be worth checking out.I dont want to get anyones hopes and dreams down.Lets start standing together and demand this here are a cure for ourselfs and our love ones.And stop giving our money away I bet they cant tell you where all the money has went in 30 years that theses people has got!!!!And why shouldnt they it was our money given to hope for a cure!!!!!If there is technology to clone a human being then this could be done.I mean look at the money in the big houses they would lose.Im sorry dont want to hurt anybodys feelings but i quit giving money 3 years ago for a cure and I'll be dang if I give another red cent!!!

Posted by Anonymous on 23 December 2011

There seems to be a new system on the European market which is similar to the implantable pump called diaport.

Posted by Anonymous on 21 April 2012

Mother always told me "if you have nothing nice to say, say nothing at all." Sorry mom, but I have to say "I've never owned a mini med sub-q and never will after reading this!" All about the money.

Posted by Anonymous on 5 August 2014

How do I get an implantable pump? I'm sick of being sick!

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