One day before long, 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.
Indeed, one project that gets our hearts pumping is the iLet, under development 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.
You may remember that this "Bionic Pancreas" (as it's been formerly known) is now officially dubbed the iLet -- a play on Apple-ish product naming for a new age device that takes on the task of managing diabetes. In 2016, its creators formed Beta Bionics, a new Boston-based public benefit corporation that's the first of its kind in the med-tech space to merge corporate and non-profit structures.
It's been an entire decade since the initial iLet human trials began, but now it seems we're just about two years out from actually seeing a first iteration of this system come to market.
With the big CWD Friends For Life (FFL) conference happening in Orlando, FL, this past week, Beta Bionics followed its routine of announcing its latest developments.
Evolution of the iLet Bionic Pancreas
We've covered the "bionic pancreas" since the first human clinical trials started in 2008, followed their the real-world studies at camp and home settings, and the evolving prototypes that made this device look more sleek and modern.
At FFL in 2017, Beta Bionic unveiled its Gen 4 prototype. And then at this year's event this past week, they unveiled an actual product that is now refined and will be the base model for new functionality rolling out throughout this year.
Here are the Gen 4 iLet system specs:
- The fourth-generation prototype device no longer uses two Tandem t:slim insulin pumps and a separate receiver, but combines all of that into one device.
- The Gen 4 iLet is also 57% smaller and thinner, with an improved, curved touchscreen. It will have one cartridge pre-filled with glucagon and one pre-filled/manual-fill insulin cartridge. This model doesn't have traditional buttons on the device, but has a touchscreen display to operate the device along with the iPhone/Android smartphone interfaces.
- Instead of traditional AAA batteries or even a rechargeable port, the iLet will use the newer inductive charging technology with a rechargeable base with coils that you can just set the device on to recharge. And the iLet could last 5-7 days with a full charge!
- It will house a stable glucagon in development from Zealand Pharmaceuticals, which has been making progress on its formulation recently.
- The two built-in cartridges for insulin and glucagon would each last for about 6 days, typically. The plan is for the two lines of tubing to clip together for added convenience, and then unclip before connecting to a dual infusion set the iLet team is developing. We've seen prototypes of this duo set, and it's roughly the size as those we have now.
- The pump will be "agnostic," meaning it will work with any type of insulin and different CGM sensors; currently, Beta Bionics is partnered with Lilly and Novo on insulin, and they're using both Dexcom and the implantable Eversense CGM from Senseonics in the clinical trials.
- It will also feature Bluetooth for data-sharing with a mobile app.
- Like many devices these days, it will have remote updating capability so software updates and features can be upgraded without having to get a whole new gadget.
- The homescreen will show your current Blood Glucose number displayed prominently on a CGM graph, 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.
Baked right into the company's iLet development plans are scalability and an efficient manufacturing system that will keep costs down for Beta Bionics and eventually the patient. Damiano says they won't have to contract manufacturing out, but will be able to assemble the closed loop device themselves.
All of these developments can be traced back to the passion of D-Dad Damiano, who created the whole concept in order to help his son David who was diagnosed as a young child. Damiano envisioned having this on the market by the time his son went off to college, though it's taken a longer path, with all the changes in tech over the years. David is now a 19-year-old sophomore at Boston University.
The iLet team now plans for an initial FDA filing by mid-2019, with hopes of final approval and launch by the end of 2020 for the insulin-only version; and probably a year or two after that for the dual-hormone version including glucagon.
Clinical Trials Happening Now
Beta Bionics has been making headlines recently with exciting developments:
- Teaming up with Senseonics to include the Eversense CGM as one of the sensor options, making Beta Bionics the first to work with Eversense, just approved by the FDA in mid-June. Damiano got his own implanted sensor in early July and has been trying it out.
- Becoming the first to investigate a new pre-filled pump cartridge for Fiasp insulin, dubbed "PumpCart." This makes Beta Bionics not only the first to weave this new fast-acting insulin into its clinical closed loop trials but to use this pre-filled Fiasp cartridge that is not yet available anywhere at this time.
- Securing FDA approval to begin home-use clinical studies for its insulin-only configuration, expanding on the earlier FDA green light for this investigational work. Trials kicked off in mid-July at Stanford and Massachusetts General Hospital, as well as clinics in Colorado and Florida and will continue throughout the year for both kids and adults. They'll begin this month with kids using the Dexcom CGM, followed next month by adults using the Eversense CGM.
All of this adds to the expected pivotal trials in the years ahead, with plans to have research happening at 16 sites nationally (this was outlined in 2016, and the clinical trial locations will likely evolve and be announced as these studies get closer to starting).
Beta Bionics now has 17 employees (including some notable folk from the #WeAreNotWaiting DIY community), spread between Boston and a new 15,000-square-foot West Coast manufacturing facility in Irvine, CA. That's where they'll be doing the main production.
"When we launch, we'll be launching with the (Gen 4) device that I had originally thought would come a year after launch. So we're actually ahead of the game, relative to what I'd first thought," Damiano says.
Artificial Pancreas Systems - Race to Market
The race to develop a fully-automated closed loop device is as hot as it's ever been. iLet isn't the only one coming after the Medtronic 670G, which hit market in 2017. Others such as Tandem's Bolus-IQ and eventual InControl system will follow, as will the OmniPod Horizon and Bigfoot Biomedical's DIY-inspired Automated Insulin Delivery system in the coming years. More are also in the works, and we'll just have to wait and see how they pan out.
These new systems are of course meant to take some of the constant decision-making out of our D-lives, letting the technology automate a lot 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.
It's also not lost on us that Damiano and team are focusing on Access and Affordability as important tenets of their work creating the iLet -- because if people can't get their hands on these expensive devices, what are they worth?
We're excited for the iLet in particular to come to fruition, because if it can really deliver this full functionality at an affordable price point, it's going to be a game-changer in more ways than one.