While we will not see a true artificial pancreas (AP) – a closed-loop insulin pump and continuous glucose monitoring system – come to market in 2016, we are so close we can artificially taste it.
The major insulin pump players are all indeed working toward an AP, albeit more slowly than our community might like. As we highlight the progress these companies are making, we should clarify what we mean when we refer to an AP system, as many have argued that the concept lives along a spectrum. JDRF defines this spectrum as a six stage pipeline, shown in the figure below, with features added to each new step? to bring it closer to what we (the community of people with diabetes) envision as being a game changer in our diabetes care. First, companies must prove that they can respond to hypoglycemic events appropriately (stage 1) and predictively (stage 2), then the high end as well, to keep someone’s glucose within a defined target range (stages 3 and 4), and finally, automate meal bolusing (stage 5), and possibly also include a secondary hormone like glucagon for hypo management (stage 6).
Medtronic drew considerable flak in 2013 when they released their Minimed 530G as an “artificial pancreas system” as some people felt that a pump with a Low Glucose Suspend feature (stage 1) was not akin to a fully closed loop system and would confuse the public, but it was a stepping stone on their pipeline and FDA recognized that in allowing for the distinction.
So what’s next from Medtronic? We are hoping to see the Minimed 640G with predictive Low Glucose Suspend (stage 2) approved stateside late this year or early 2017. Their next phase, the much-anticipated 670G, will be a stage 4 – an automated “hybrid” closed loop system that still requires meal time bolusing and carb counting. They are currently recruiting for the 670G pivotal study at multiple study sites.
Like Medtronic, Tandem reported in their third quarter earnings call that they will roll out a hypoglycemia system (stage 2) first and then a hypo-/hyper-system (stage 3-4). Announcing in October that they were on track to submit an IDE (Investigational Device Exemption) application by end of 2015 in order to begin a feasibility study for their first gen AP product, which will then be followed necessarily by a pivotal study. The product will be a CGM-integrated tslim pump that will automate insulin delivery based on a predictive hypoglycemia algorithm (stage 2). Their second generation AP will include the hyperglycemia algorithm as well (stage 4).
Insulet has historically been pretty tight-lipped about their AP development, but has stated that they’ve chosen an algorithm partner, though they haven’t disclosed who that is,, and that they are in regular clinical and development meetings. We would wager right now that their system looks to still be several years away, as they continue development toward other innovations like an integrated PDM/CGM combo or smartphone-controlled pod.
In the meantime, our attention turns toward three of the most exciting newer contenders in the race to the artificial pancreas, all of whom we will be profiling in more detail in the months ahead – the Bionic Pancreas team out of Boston University, TypeZero Technologies, and Bigfoot Biomedical.
But just how close are they?
I reached out to each of the teams to find out.
Ed Damiano’s team unveiled their much-anticipated bionic pancreas, called the “iLet,” at the annual Children with Diabetes Friends for Life conference in Orlando, FL last July. It is a dual hormone (insulin plus glucagon) smartphone-esque device that is still in clinical trials. What will the Bionic team accomplish in 2016? First, they will complete what they call their “set-point” study with a study at Massachusetts General and another at Stanford. They are currently half-way through this trial. While the iLet device maintains a set-point glucose goal of 100 mg/dL, this trial is studying the effects of allowing a user to be able to define his or her target blood glucose levels on a closed loop system, with the dual hormone version set-points being studied at 115 mg/dL and 130 mg/dL and the single hormone version at 130 and 145 mg/dL. The team expects to be done with this study mid-2016.
From there, the Bionic team has received funding from NIH to complete their “bridging” study – the first outpatient study using the iLet device. This bridging study will see both adult and pediatric participants and take place across four research sites – Mass Gen, Stanford, Nemours in Jacksonville, FL, and the Barbara Davis Center in Southern California. What comes after “set-point” and “bridging” for the team that pledges to “Go Bionic” will be their pivotal trial in 2017.
TypeZero Technologies, the startup built on over a decade of promising AP development out of the University of Virginia, will be testing their closed loop software inControl in several clinical studies in 2016. This includes the long-awaited artificial pancreas trial funded through the NIH at the University of Virginia titled “Clinical Acceptance of the Artificial Pancreas: The International Diabetes Closed Loop (iDCL) Trial.” The study will test TypeZero’s inControl software with 240 participants utilizing the system in multiple, six month in-home studies. Sites include two in the States and three abroad (France, Netherlands, Italy). This trial will provide the necessary data to support a PMA submission in 2016-2017. (For those of you who don’t speak FDA, that stands for “pre-market approval.” MARKET, folks, as in potentially “coming to a pancreas near you.”) People who are interested in learning more about participating in the study can contact UVA at email@example.com.
The third AP startup we are excitedly watching is the team at Bigfoot Biomedical. Co-founded by Bryan Mazlish (the legendary “Bigfoot” who invented a working prototype of an AP for his wife and son), along with former JDRF CEO Jeffrey Brewer, former Medtronic chief engineer Lane Desborough, and former WellDoc CFO Jon Brilliant – all four of them dads of children with type 1 diabetes, they have already accomplished a great deal in their first year – leaping forward in their planned development with the purchase of the Asante pump platform, relocating from Manhattan to Silicon Valley, and building a team of over 35 of some of the best and brightest in the industry (disclosure: my husband is an employee of Bigfoot Biomedical). The Clinical Research Center study of the Bigfoot system is scheduled for the second quarter of 2016 and they hope to launch their pivotal study in 2017.
We will be highlighting the work of some of these initiatives in greater detail in the coming months, so check back regularly!
If you have particular interest in participating in a clinical trial for one of these endeavors, please visit clinicaltrials.gov for study site and contact information.