We received a whopping 210 responses to our reader survey* about the possibility of wearing an implantable insulin pump last week: Would You, If You Could? We thought you might like to know the results, below.
ALSO: we received some additional feedback from Medtronic’s Chief Medical Officer Dr. Fran Kaufman about the development of this device, sent to us by PR Manager Karrie Hawbaker. We decided this would be more visible if published in a stand-alone post, so don’t neglect to scroll down here and catch her take.
*Willing to Try An Implantable Pump?
The majority do want one! Yet nearly 50% of respondents said either no, or that they’d rather NOT be the guinea pigs. Hmm.
The “other” category was also interesting:
Dr. Fran Kaufman, on the Implantable Pump Situation:
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 US, 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 US. 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 US are as follows:
• There are many technical, scientific, clinical, regulatory and healthcare system hurdles. We regularly manage through these, but in some instances, and the implantable insulin pump is one, we need to consider not only our device, but the insulin that is provided through that device. Having one component approved is challenging, having two components is doubly so.
• The implantable pump – in its present form – is difficult to adopt. It is a complex device that requires meticulous attention and care. Refilling and readjusting it is a challenge. We’re working to make the pump smaller and easier to adopt.
• A particular type of concentrated insulin must be used in the implantable pump to provide the best opportunity for an efficacious and safe treatment for the patient. That formulation is still being developed and refined, and the original formulation is no longer available.
• Our research and development budget is robust, but has limits. We work on the innovative advances we believe we can bring to the market quickest so that we can have a more significant impact on the care of people with diabetes.
Developing the next generation of implantable pumps will take significant time and resources. We know there are many innovations that we can bring to people sooner to reduce the burden of diabetes management and improve outcomes. As supported by the roadmap developed by the JDRF, it is within our grasp to have pumps/sensors/algorithms that determine how to deliver insulin automatically, and that can start making big differences in the lives of people with diabetes now and in the years to come. That is where Medtronic is placing the bulk of its resources and efforts, while at the same time it continues to invest in the implantable pump program.
Of course, we are pleased to hear stories from people who report success with our devices. We remain committed to supporting the patients who currently benefit from the implantable pump. However, no device is right for everyone. That’s why we create a portfolio of devices that will suit the broad spectrum of people with diabetes.
We remain committed to listening and engaging with the diabetes community. You are a passionate, informed and motivated group of people who have brought about great change in how this disease is treated and we have no doubt you will continue your tireless advocacy. Your words and deeds motivate us everyday to develop innovative treatments which help improve the lives of diabetics everywhere.
I’ve seen a lot of positive changes in diabetes technology in the 32 years I’ve been practicing medicine. It’s exciting to see how far we’ve come. But, knowing how much talent and resources are currently dedicated to developing an artificial pancreas, it’s even more exciting to think about what technology patients might have in the near future.
-Dr. Francine Kaufman
NOTE: this statement was also posted yesterday at the company blog. And we remain curious — how is everyone feeling after reading this?
I feel they (Medtronic) are doing their best. Everyone is suspicious about whether progress in automation is with held in order to continue the flows of capital required to sustain most diabetics. If that were the true case of things I do not believe it could be hidden for ever. Let’s encourage and support the caring efforts of so many.
Very interesting, thank you for posting the results! It’s such a tough question, and I wonder if this question was really a reality if the answers would be different…I think Medtronic is trying their best with the FDA and many other issues in their way. I think soon enough there will be a new technology that is gonna blow us all away!
Here’s what I attempted to post as a comment to her blog (which they have not accepted yet):
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.
Brent
As one who actually uses a current generation of the pump they are trying to adapt. I will tell you my only response is HELL NO. I would never want one of these.
if the only advantage of the system is that it is in my body vs outside my body, then I would not use it. It seems the trade-offs for the new risks would not be worth it. If it works better somehow then perhaps I would consider it. How is the insulin absorption different with the implantable (if it is at all different)?
I totally believe this endeavor is a very expensive and complex. It makes sense that Medtronic has to simultaneously play the short-game of developing incremental products in the meantime. The economics don’t allow it any other way. Keep the dream alive!
@Anne, several people who have had pumps implanted report that they feel much better, day in, day out, I guess because insulin is delivered directly to the body’s blood stream and acts nearly like a normal pancreas with much better quality of life.
Thanks for the consolidation of the results of this. Anything new like this elicits such interesting responses. I think this survey probably mirrors what the results of trials will be. It will help one population of patients, but not the whole group.
You ask what I’m feeling after reading this? I’m feeling like I’ll believe it when I see it. What happened to MySentry? What happened to the Comfort Sensor? What happened to the Patch pump? Millions of dollars of R&D down the tube, and we’re all using the same sensor and basically the same pump from years ago.
I read that MM just laid off a huge percentage of their diabetes division. I think they’re in completely disarray right now, and I’m not holding my breath for anything revolutionary from them for a long, long time. They simply can’t get any promised products to market. Period.
I, for one, can’t wait. It should have a CGMS built in though. I have a defibrillator so I’m used to implantable devices. It may or may not come from Medtronic though. They do seem a little slow from the gate sometimes.
I think Medtronic is greedy and opportunistic. I don’t believe for a minute that a completely effective implantable insulin pump can not be developed.
[...] (5/5): Diabetes Mine has posted a lengthy response from Medtronic as to why they aren’t investing in implanted pump technology [...]
I’m happy to read a response…it’s good to know Medtronics is listening. I hope Dr. Kaufman was truthful when stating there continues to be research in this area. I believe it would help many people live and feel much better than they do. Hundreds of people who wear the implantable pump state they feel 100 percent better receiving insulin directly to their liver as opposed to Sub-q.
What makes this technology worth continuing has nothing to do with whether it’s closed, opened, implantable or regular. It has to do with the fact that the insulin is delivered into the peritoneal cavity!! This allows the insulin to be delivered straight into the liver – the way it is with non-D people. This delivery of insulin into the peritoneal cavity is what makes the patients feel great!!! It’s why they experience very few lows!!! We need this technology to continue so that ways to deliver insulin into the PERITONEAL CAVITY is pursued!!
An artificial pump has never sounded appealing to me. A computer cannot do what the body does. The delivery of insulin into the peritoneal cavity allows the body to do what it normally does with insulin. It’s the way the bodies of people without diabetes work. This technology makes people feel so good they are willing to fly to France four times a year to keep it going! This technology must be the wave of the future for people with diabetes whether with Medtronic or any other company!!
Please continue exploring this technology! If Medtronic is looking in a different direction then another company must keep this technology alive!!! I will take my son to France if I have to – he deserves to feel the way these patients feel when they use this technology. Sub-Q insulin needs to be a thing of the past!!!!!!!!!
They (Medtronic) should talk to Casio because they make watches that are way more powerful and much smaller than the pumps they are making. Far too often, science and its researchers get stuck thinking inside the box and can’t seem to think on the other side. There needs to be a paradigm shift in how they approach insulin delivery. Insulin delivery is still done sub-q some 89 years later. Why? Is it because they can’t make it work any other way? There are only a few realistic options? I suggested to Medtronic that they use the CGMS with an internal pump to create a closed loop system! Why would all of it need to be internal? Again, be creative and change the way you problem solve. Now you just need to solve for size and insulin type. If infection is an issue, why not deliver insulin into the stomach? Would it still be as effective as the liver?
I feel that this is a bunch of corporate double-speak. Their pump technology is starting to show its age, compared to some of the alternatives.. Medtronic is all about making the most profitable technology, not the most innovative, durable, and user-friendly devices.. Frankly I think they are scared of devices which come closer to being excellent maintence, more thorough of a solution (Note I did not say cure)…
I wrote a letter to Medtronic and I was very surprised one day to receive a phone call from a very nice woman from the company. She said my letter had been passed around in the company, which told me they did listen to my concerns this technology would stop. She assured me Medtronic is NOT halting their research and production on a better version of the implantable pump. In the past there have been a lot of people the pump did not work for that developed infections, etc. There is also the FDA hurdle, as the implantable pump requires a special type of insulin that is NOT FDA approved. The ultimate goal would be to have an implantable pump that wold work in conjunction with a CGM. Our voices are heard and we have to speak up for what we want. My son is only seven years old and was diagnosed 2 months ago. I am his voice and plan on fighting for him until he can fight for himself. I was very impressed that Medtronic responded to me, they DO care and do listen. Don’t be silent, respectfully voice your concerns and what you want!
I have had Diabetes over 20 years and heard doctors state for almost 20 years that France has the implantable pump and that the US refuses to allow FDA to inniate a possible pump for the US.
I have had diabetes for over 30 years and would love to have the opportunity to try the implantable pump. I am a good canidate . Would I have the I am starting to pocket insulin and feel that the implantable pump would be a great option for better obsorbtion. Thank you
I was in a previous implantable pump study many yrears ago. It was GREAT , until pfizer pulled the funding for the study and it was explanted. I would love to go back to one. I have been using a pump since 1980, when pumps were an experimental tool.
Ed Rose
I am sure I am very late to this paerty, but I am a previous long term user of the implantable pump and since having it removed due to many of the constraints listed above I have had to use the “other” available insulin pumps. There is NO comparison between the implanted Medtronic pump and the more cumbersome & less reliable alternatives. The big factor missing in most discussions is the “quality of life” which with the implantable pump approached normalcy. Focus on the implantable pump more if you truly do want to help the current diabetic population live a more normal life.