My phone rang and I saw that it was a good friend from another state, calling in the middle of a work day.
The time was odd, so I immediately thought: This must be some really good or really bad news of some sort.
Turns out, it was more of a ‘diabetes heads up’ from my friend, who saw an online news story about a new breakthrough in diabetes tech a few days following the American Diabetes Association’s 74th Scientific Sessions.
After some intro chat and small talk, he got to the point: “Hey Bud, just wanted to make sure you knew about this new ‘bionic pancreas’ that could apparently be great news for you! Have you heard about that, or tried it out?”
I had to smile. This was a close friend I went to college with, and back in those days, diabetes was never a big discussion item or focal point in my world. And after college, when we eventually moved to Indiana, our friendly conversations were never much about diabetes, but mostly catching up or hearing what was going on in the good ‘ol state of Michigan. So the fact that my friend was calling me now specifically about a diabetes development? It hit me what a big mainstream media impact this bionic pancreas has had!
“Yes, I know it well,” was my response. “It’s still being tested and I haven’t had a chance to use it, but some good friends have and they’ve loved it! The whole thing is pretty awesome, and I do think it will be a game-changer once it’s available.”
We in the diabetes community are no strangers to this technology, or the key researchers behind it, D-Dad Ed Damiano and his partner Dr. Steven Russell. But the trial results they presented at the recent ADA conference have catapulted this into the public eye, for better or worse (I’m going with better here).
I’ve seen dozens of news stories on the topic, from CNN to NPR and Yahoo to local newspapers, TV stations and online media hubs. And I’ve heard many other PWDs say the same about getting bombarded with notes from enthusiastic friends and family members spreading the news. Some have been a little off the mark, with people thinking this could be a “cure” to diabetes or the end-all, be-all kind of device.
The data presented by Damiano and Russell of Boston University and Massachusetts General Hospital during the ADA conference shows that PWDs using the bionic pancreas system they’ve developed, rather than traditional fingersticks or insulin pump delivery, were more likely to have blood sugars staying within normal range, with fewer lows or highs. In other words, the system worked — and it worked better than the tools we have now.
It’s all very exciting, indeed.
Here’s my take on the whole thing: This still-in-development tech has me more excited than pretty much anything else out there at the moment. I’m now in my 30th year of type 1, and I’ve heard about a lot of D-tools and potential cures and artificial pancreas research throughout the years. But unlike a lot of hoopla over tiny steps forward, the research by Damiano and Russell’s team gives me hope for real change.
It’s real and very tangible, not some far-off-in-the-distance device that we can only imagine. As long as I’ve been diabetic, there has been hope for a closed-loop system, but it seemed a pipe-dream, even after the JDRF started embracing the concept in ernest several years ago. But now, people I know and trust, like Kelly Close of Close Concerns, longtime PWD Anna Floreen, and Bill Woods of MyGlu have actually used the prototype and attest to how well it worked for them.
When Dr. Russell was presenting research at the ADA conference, I sat next to Bill and tried to keep tabs on how he reacted to that session. Afterward, he told me it was so much more significant seeing and hearing about the bionic pancreas after having worn the technology himself and had it impact his life. To him, this is more than just science — it’s something he’s held and used personally. Bill has summed up his experience in this post, and Anna’s talked about her adventures online, too. Yes, I get that this isn’t a final device and it’s still in that proof-of-concept phase. To me, that makes this even more exciting because we’re at this point already, and who knows what else will be perfected and improved in D-tech and this bionic pancreas in the coming years.
From the very start, these researchers mapped out a timeline and calculated their research methods to make that realistic. Ed is a D-Dad himself, and getting this to market by the time his son goes to college (or as close to that time as possible) has been his motivation from the beginning. He believes his team has the knowledge and experience to make that happen.
They are shooting for FDA submission by sometime in 2017, and with the way things are going, it looks like they’re on track. Especially since the FDA has come out with official guidance on these types of AP systems, there’s a chance this tech could fit into a special expedited track of regulatory review, signaling a genuine interest by the agency in making the closed-loop a reality asap. And based on the latest research, the National Institute of Health’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) took it to the next level, saying it would support larger multi-center trials in the coming years. See, the regulators are supporting this in a way we haven’t really seen before… Very encouraging!
The Boston researchers are collaborating with so many people across the D-Community, something we haven’t traditionally seen happen when it comes to diabetes device development. The JDRF is behind the project along with many other global AP collaborations, and companies like Tandem and Dexcom are right there in the ring, since they make the main devices being used. Despite some medical minds disagreeing about the need for glucagon or other hormones being used alongside insulin in these systems, it’s fascinating to see that being explored as novel glucagon formulations are being developed and weaved into the research. Yes, even Russell is doing an investigational-run of a new glucagon formula in the bionic pancreas and that should be considered a part of this collaborative approach because there are so many moving parts.
Cost and Access
This is a biggie. One of the biggest complaints I hear about AP tech of any kind is that it isn’t going to be accessible to most people, because of cost and the likelihood of no insurance coverage. Apparently, some insurers are already making moves to limit coverage of AP and bionic pancreas systems, according to online Facebook discussions like this one started by endo Dr. Stephen Ponder. This mentality seems to fit the mold of how insurers are always reluctant to cover the latest tools, labeling them too “experimental” or investigatory to warrant coverage.
This is where PWDs voices and patient advocates come in, I think. We can start making our case now, arguing that the pieces of this bionic pancreas are already out there and being covered. Maybe we start making our case to the ADA and JDRF, as well as our own insurance companies, about how we want to see these systems supported, and point to the Damiano-Russell research for substantiation. We can make the case of risk vs. benefit now, hoping to shape the conversation and decision-making early.
Sure, you have to be able to live with the whole “this device will be making decisions for me” mindset in order for any bionic or artificial pancreas to be something you’ll use. At this time, with the current state of CGM sensor accuracy, I’m not sure I’ve reached a point where I would trust unequivocally. But it’s encouraging to see CGM tech becoming more accurate, and I am confident that within the next five years — when this bionic pancreas might be available — we’ll see sensors accurate enough to convince me and many other skeptical PWDs to rely on this technology to take more control.
Tech vs. Cure
Obviously, everyone in the D-Community wants a cure. There’s no argument there. But we have fundamental and philosophical differences in what money and research efforts should focus on while we wait. Some believe all efforts should go to cure research, while others feel there should be treatment and tech advances like these artificial pancreas systems that fill the void until we can get to a cure.
There’s no right answer, because like everything else, opinions vary (just like diabetes). Those healthy debates have been going on for a long time, and they’ll continue for as long as this D-ride exists.
Our team at the ‘Mine agrees that there will someday be a cure, just not in our lifetimes — because there are so many moving parts to this puzzle and there’s so much researchers just don’t understand yet. In the meantime, we’re encouraged by these kinds of tech advances that can make quality of life better until we can completely prevent or eradicate diabetes.
Bottom line: We’re optimistic. If you wish to fault is for that, feel free.
And it may sound like an organizational tagline, but I really do believe what JDRF’s AP director Aaaron Kowalski (a longtime type 1 himself) says about this:
“For many years with the artificial pancreas, people have been saying, ‘Will this happen?’ It’s not a matter of ‘if’ anymore, but when. I think we’re going to see this moving quickly.”
While it may be a few years before this gets to regulators, I feel more confident than ever that this system will move forward.
** July 2 Update: We learned the Bionic Pancreas team is kicking off a fundraising campaign for their research and a pivotal trial planned for 2016. Ed Damiano and crew were giving out new flyers at the Friends For Life Conference happening July 1-4 in Orlando, FL. It’s called the 5K Bionic Pancreas Challenge, and it asks the type 1 community to raise $5,000 by Sept. 1, 2014.