Once viewed as the future of diabetes technology, implantable insulin pumps have mostly vanished over the past decade and one might say the technology is nearly extinct.

Yet even now in 2017, implantable pumps are still clinging to life.

There are currently just four people in the US using the outdated, discontinued MiniMed models that still exist, and roughly 450 still on them internationally. The technology's fate is far from certain, yet some are hoping -- even pushing -- for a rebirth of innovation in this space.

Chief among those is longtime type 1 Greg Peterson in California, who's been on an implantable pump since 1992 and recently launched a new non-profit called the Implantable Insulin Pump Foundation (IIPF). "The most frustrating aspect of all this is that we know that today it is possible to build a far superior implantable pump," he says. "The potential for dramatically improving our lives is real and within our reach."

There's also a San Diego startup called PhysioLogic Devices that's been quietly working on a new implantable insulin pump and is in the early stages of animal research, we're told. So the possibility is real that this type of tech could experience a resurgence.

Fascinating to think that this year marks the 10th anniversary of when Medtronic scrapped their implantable insulin pump research and turned their attention instead to the closed loop "artificial pancreas" tech that's all the rage these days.

Is there a future for implantable insulin pumps, given the state of the pump market, and how long this tech has been off the radar for so many in the D-Community?

 

Implantable Insulin Pumps, The Basics

First, a refresher on what this tech is all about:

What is an implantable pump? Not to be confused with a traditional insulin pump that you wear on a belt or carry around, that deliver insulin via a small needle infusion set inserted under skin... Nope, these are truly implanted devices, generally in the form of a small, battery-powered unit that looks a lot like a metal hockey puck. In a 15-minute surgical procedure, this hockey pock is stitched into a pocket of tissue directly under the skin and delivers basal insulin via an attached catheter directly into the system. It holds a three-month supply of 25ml of concentrated U-400 insulin, or a whopping 6,000 units, before needing to be refilled by a physician. The batteries can last anywhere from a couple years to several beyond that, according to patient testimonials, and at that point a new implantable pump is needed.

The patient carries a wireless controller that resembles a traditional Medtronic tubed pump unit, used to give bolus doses for food and corrections.

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How's it different than a traditional pump? It's all about where the insulin goes into the system. A key aspect of the implantable pump is that it more closely mimics a "normal" pancreas by infusing insulin into the peritoneal cavity, which goes directly into the liver -- resulting in faster and more effective insulin action than subcutaneous insulin pumps allow.

How long has it been around? Quite a while. Scientific research on proof-of-concept began in the 1970s and blossomed into early prototype and human clinical studies in the 80s. The first implantable insulin pump went into a live human patient in November 1980 at the University of Minnesota, and over the course of the next year others followed in New Mexico, Austria, and France. The first MiniMed implantable insulin pump came in 1986, but it wasn't until nearly a decade later that the device received regulatory approval in Europe. As Minimed improved its technology both here in the US and globally, more patients began using the devices. Minimed eventually released new models in 2000 that had improved memory and a longer battery life.

Everything changed when Medtronic bought MiniMed in 2001, and only minimal improvements were made in the years following that. Finally in 2007, Medtronic announced that it would be discontinuing its clinical R&D for the implantable insulin pump concept altogether. That forced users to either find other treatment options, or to travel someplace they could get the device refilled, or replaced as needed. Supplies have become increasingly limited as the years have gone on, as Medtronic is only supplying a small number of these implantable devices internationally, instead concentrating on its external insulin pumps and closed loop technology.

 

A Personal Advocacy Mission

With all of that in mind, it might seem the implantable pump is a concept of the past. So why all the fuss is about this technology now?

For Greg Peterson, implantable pumps are a huge life-changer and should not be abandoned. It's simply a matter of raising awareness about how great this technology is and motivating at least one leading company to invest in the concept, he says.

Peterson lives in the East Bay area of the greater San Fransisco Bay Area, where his IIPF is based. Diagnosed at age 8 back in 1957, he used all the "primitive" tools back in the day -- urine testing in a test tube with boiling water on the kitchen stove, glass syringes with a once-a-day injected regular and long-acting PZI insulin, and an unchanging meal regimen each day. As he grew up, he was on as many as 10 insulin shots per day once home glucose monitoring came around.

"I became interested in the science of diabetes at a fairly young age and that interest stayed with me throughout my life," Peterson says, noting that he started studying the much-debated issue of glycemic control in the 70s and that led him to finding two researchers exploring the idea of an implantable pump -- Dr. Peter Forsham, who founded the UCSF Metabolic Unit and Dr. John Karam.

Peterson studied the idea intensely over the years, but it wasn't until January 1992 that he got his first implantable insulin pump. He was No. 3 in a test group at a clinic in San Mateo, CA.

"Prior to this first implantable pump, I managed to tightly control my diabetes with some significant effort, and I thought I was doing very well and felt well... (but) the day after that first pump was implanted, I began to feel better than I ever remembered and the effort to maintain target blood sugars was vastly reduced," he says.

Put simply, Peterson says he remembers "not ever feeling that way before." And at times, he would even forget that he was living with T1D.

But then the pharma giant Medtronic bought MiniMed, and although the company didn't immediately cancel the technology as many feared, it eventually happened in 2007. That announcement kicked off an emotional roller-coaster for Peterson.

"Panic, disappointment, fear," he says about how it felt to hear the news. "The pump was in advanced prototype state in 2001 when MiniMed was acquired. Up until that point, development was robust and problems with the new technology were being addressed and improvements being made. After 2001, very little development was done. As a result, we were in a position of having a device that vastly improved our lives but was not yet fully developed. Many aspects of the pump still needed improvement (as do most new and advanced products)."

That forced Peterson and the other dwindling number of implantable device users to start traveling to France every three months to get their device refilled, or serviced. Over the years, problems can arise. They call Dr. Eric Renard with the Endocrinology, Diabetes & Metabolism of Montpellier Medical School in France that's still supporting the devices for advice and assistance if something happens -- catheter blockage, depleted pump battery, disruption in the communications process between the pump and controller -- and if it can be addressed that way, they handle it. Otherwise, it might mean going back on a traditional subcutaneous insulin pump or injections before the next visit overseas.

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As of mid-February, Peterson says he's on his 44th trip to Montpellier -- something that must happen every three months, usually for four-day trips. He admits that there may be a point where it's no longer feasible to keep this up in using the implantable pump because of all the cost and travel, and that he is "pretty tired of it" now, but he still thinks it's worth it.

"All in all when one considers the onerous travel requirements and the problems arising from a not-yet-fully developed pump it is hard to believe that we would continue to do this," Peterson admits. "We do, however, because of the remarkable improvement we experience. It is so much better that we willingly subject ourselves to the rigors and expense of travel."

 

Forming a New Foundation

Several years ago, Peterson began putting the pieces into place to create a new diabetes non-profit aimed at telling the story of this technology and to hopefully bring back the implantable insulin pump. He reached out to a Washington D.C. law firm in 2011 to start the process, and over the next few years he was able to obtain federal and state non-profit status as a 501(c)3.

The Implantable Insulin Pump Foundation launched in November 2016, with a new website that is still being fully fleshed out. The goal: to raise awareness about everything related to the implantable insulin pump, and hopefully spark interest for it to get more buy-in.

With all the developments over the years, from newer more accurate CGM sensors to what Dexcom-Google are developing for mini-diabetes tech, and the notion of implantable CGM devices that GlySens and Senseonics are making, it seems like a prime time to move forward on the long-overlooked implantable insulin pump, Peterson believes.

"The diabetes community and our medical community, for the most part, is simply unaware of this technology and the possibilities it represents," he tells us. "If our community becomes truly aware of this remarkable technology I believe that we can become the force to make it happen."

For it's part, Medtronic says it hasn't been actively working on the implantable insulin pumps in several years and it does not have a plan to pursue that anytime soon. It does continue supplying a small number of implantable pumps for maintenance purposes to doctors and hospitals in Europe, mainly France. Of course, MedT does still retain the intellectual property rights and could re-start that R&D at any point.

 

Not Dead Yet

Despite Medtronic's stance on not pursuing this tech any longer, others aren't so quick to dismiss it.

In San Diego, a company called PhysioLogic Devices is in the early development phase of a new implantable insulin pump. We understand this company was founded by Peter Lord, who was one of the first MiniMed employees and worked as chief engineer on the MiniMed implantable pump.

This new implantable pump would be far smaller than the current device and would incorporate the latest in diabetes tech -- including a CGM. PhysioLogic Devices has received NIH grants to conduct proof-of-concept clinical work on animals in 2017, and if that materializes the tech could move quickly into more advanced research phases in the coming years.

We were unable reach Lord by deadline for this story, but look forward to hearing more about this next-generation model of implantable insulin pump.

Meanwhile, we reached out to the JDRF's chief mission officer Aaron Kowalski, who says the concept remains an interesting one for that organization.

"We're still looking carefully at implantable insulin pumps, and yes it still is on the table," Kowalski tells us. "There are still hurdles to this, but there are dedicated people using this who are seeing tremendous benefits -- they're almost religious in how dedicated they are. But making this a reality is tough. Really, it whittles down to a lack of interest in the community, on top of the already-fragile regular insulin pump market and how less than 50% of people use pumps. That makes this a really tough road."