One day soon, we'll be at the point where technology will be "as good as a cure" for many of us -- because a truly closed-loop automated diabetes management system is getting so close we can taste it.
Seriously, one project that gets our hearts pumping with excitement is called iLET, formerly known as the Bionic Pancreas being created by passionate D-Dad Dr. Ed Damiano and team at Boston University. Damiano's inspiration for this amazing insulin + glucagon combo device is of course his young son with living with type 1.
The system has been in the works for many years (and we've been geeked out about it) but is now getting tantalizingly close to market following a second generation prototype unveiled at the Friends For Life (FFL) conference this past summer in Orlando, FL.
That's when the Bionic Pancreas was dubbed the "iLET" -- a play on Apple-ish product naming for something that takes on the task of non-functioning islet cells (that are supposed to produce insulin but don't work in people with diabetes). And like Apple products, the new iLET aims to make our everyday lives easier.
"Diabetes is about numbers, but when the iLET's on the market, it's not going to be about the numbers anymore," says fellow D-peep Scott Scolnick, who's marking his 40th year with type 1 this year and just joined the iLET team early this year as a senior research scientist and key spokesman. "You'll find that the numbers aren't the issue anymore, as you'll be normoglycemic most of the time -- with BGs around 130 average, and A1Cs ranging from 6.2 to 6.6 on the higher side without significant hypos or hyperglycemia. The dynamics of diabetes will change, and while we don't know 100% right now, we have to wonder whether it will be about the maintenance of diabetes instead of the management."
Holy freakin' WOW, is that an exciting prospect or what?!
iLET Bionic Pancreas 101
As Scott describes it, the iLET "is worlds different than any other AP device" because it's the only dual hormone system in development. It just needs your body weight as the key piece of information, and with that it can interpret 288 distinct pieces of data each day to best manage your diabetes automatically.
I got to see the newest prototype up close at the FFL conference in July, albeit only for a quick look because of all that was going on at the FFL exhibit hall where waves of people flooded the iLET booth. But here are some parameters:
- This second-generation prototype device no longer uses two t:slim insulin pumps and a separate receiver, but combines all of that into one device.
- The new device is not only a combo insulin and glucagon infusion pump, but also has the CGM receiver built in, and is the same size as an iPhone 6 but about two-and-a-half times as thick. It has a touchscreen interface and an LED screen. What you see on the screen is a new user interface created by the brilliant minds over at Tidepool, which is all about designing a new open-source platform for diabetes data. The Tidepool team wrote a blog series earlier in the summer detailing what went into this iLET user interface.
- It will use two pre-filled cartridges to eliminate the need for any filling (see photo at top that looks like a box with two cigarettes). One pre-filled cartridge will contain stable glucagon, which the Bionic Pancreas team is working on with a couple of companies for use in this and other closed-loop devices.
- The two built-in cartridges for insulin and glucagon would each last 6 days. The two lines of tubing will eventually somehow combine safely into a single tubing line that connects to a future dual infusion set the iLET team is developing.We're told the infusion set will be roughly the size as those we have now.
- The homescreen will show your current Blood Glucose number displayed prominently on a CGM graph in the upper right, along with an easy view of how much insulin and glucagon you have on board. There will be an easy way to select "meal announcements" too.
- We're told the team is developing a new e-paper screen that looks like printed text on paper, as that would be much more visible in sunlight and sucks up less energy than LED. That would also allow the device to be thinner.
"It's very interactive and you're meant to talk with it and let it learn from what you're doing and how you're living," Scott tells us. Instead of asking how many carbs you're having by the number, iLET will ask whether the food amount is "typical," "smaller" than usual, "tiny" or "large." As you use these settings and navigate meals, the iLET would learn and be able to improve calculations as it goes."
"Using the algorithm from days' past, it understands what 'typical' means and all the dosing and BG trends that came with that last time. For example, if you're 74 and going down, and you bolus for a 'typical' dinner, it will give you a dose of 75% plus a mini-dose of glucagon to make sure you don't go low," Scott explains.
"We're getting rid of diabetes by numbers, and making this diabetes by qualitative measurement."
Since iLET has built-in Bluetooth Low Energy tech, there will likely be an app that lets users communicate all of the data automatically to a secure webserver much like the Dexcom SHARE and Nightscout platform. From there, iLET users can choose who sees that information. The team is also considering making the system compatible with existing CGM in the Cloud setups as they mature.
"We've talked and thought a lot about that, as to health care professionals or family who may want to follow someone remotely," Scott says.
Emotional and Human Factors
Of course, the psychological and social sides of using and wearing this complicated technology on a daily basis also need to be addressed.
"We're very mindful of the potential impact (on quality of life), and we're working with the best behaviorists to... assess the pyschosocial impact of those who are participating in the study -- the impact this is going to have on individuals and families is going to be dramatic."
Scott knows firsthand what it's like wearing this Bionic Pancreas, as he trial-tested the early prototype that used two Tandem t:slim pumps, and he says the 5 days and nights on that system were life-changing. In his 40 years since being diagnosed at age 15, he says it's one of the special moments in his life, like being able to walk his daughters down the aisle.
iLET Development Timeline
D-Dad Ed Damiano, who's the main force behind this system, has set his sights on getting this to and through the FDA by 2017 -- the year his own type 1 son goes off to college and would need it most.
Currently, as the R&D continues, the iLET team is fundraising and has raised more than $1.2 million in just the past several months alone.
The plan is to be ready by early 2017 to conduct a pivotal clinical trial at 16 sites across the U.S., involving 480 PWDs (people with diabetes) in total -- half pediatric, and a third on who were previously on Multiple Daily Injections.
The FDA has apparently indicated that the team can file for regulatory review based on early data once that pivotal trial is about nine months along.
"We're moving fast and furiously here!" Scott says.
The Business of Closed-Loop Tech
The big questions to ask here are: what commercial company will actually move this forward into production and market launch? And how accessible will it be for the masses, or will it remain out of the affordability range of most patients?
To the first question, the iLET org remains a group of researchers at the moment, but their counterparts have set up companies to take closed-loop systems to market. Cases in point: Type Zero Technologies, which bubbled up from the AP research going on for years at University of Virginia; and Bigfoot Biomedical, that bought up Asante Snap pump technology and recently set up shop in Silicon Valley.
While nothing's announced yet about iLET going corporate, they will have to compete with these groups, along with existing device companies including Insulet, JnJ/Animas, Medtronic, and Tandem Diabetes -- all developing their own closed-loop systems.
And to the question on accessibility, Scott says the iLET team is giving a lot of thought to the issue of insurance reimbursement.
"When I'm sitting to talk with insurance companies about coverage, I'll be looking at the cost of a hypo for hospitalization and paramedics, the cost of a DKA experience... and we'll have the data showing those figures and costs. Then, we'll compare th results of those who've worn the Bionic Pancreas over 6-12 months," he says.
Insurers don't typically offer care beyond the 18-month mark of coverage cycles, so long-term costs for cardiovascular risk or other diabtes complications don't matter as much to them. Scott says his team can use iLET data from trials and real-world experience to empower groups to examine particular issues, like how many workdays were missed or productivity impacted by glucose highs and lows, particularly for D-parents who have to take care of a child with diabetes.
"That can help put pressure on this issue, having the data to show what 'time in range' using this technology really amounts to in savings. Realistically, a larger challenge will be the payer standpoint and Medicare and Medicaid coverage. But that's already in the works by others, and hopefully it will be changing as we get to market," he says.
Honestly, among all the racket about new technologies right now, the iLET is something that gets us quite excited -- because the catch phrase "Go Bionic" appears to mean much more than just hooking up another expensive D-device to our bodies.
Rather, it's about taking some of the D-thinking and challenges out of our lives, letting the technology automate a lot of this so we aren't drowning in math and feeling like failing students all the time. In other words, it's about reducing the burden of diabetes for real.
I for one can't wait for the iLET to come to fruition.