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The Artificial Pancreas

Artificial pancreas, Bionic Pancreas, closed-loop device – the development of automated insulin delivery comes with many names. While the name “artificial pancreas” may bring to mind the dream of an implanted pancreas-substitute that works just like a biological pancreas would, we are still not there yet. Current systems involve the use of devices - insulin pumpscontinuous glucose monitors (CGMs), and software algorithms that decide how much insulin (and in some cases, glucagon) to deliver.

See below for an overview of the artificial pancreas field, helpful links to articles on specific product and research updates, and our key questions for the artificial pancreas.

Who is Closing the Loop and How Fast Are They Moving?

Below we include a list of organizations working to bring automated insulin delivery products to market – this includes their plans for pivotal studies and plans for an FDA submission. The organizations are ordered from shortest to longest time to a pivotal study, though these are subject to change. It’s not clear how long the FDA process will take for these devices, but we assume ~12 months is a good estimate. Some organizations have not disclosed pivotal study plans and are included further down the list. 

Updated: 5.27.16

Company / Academic Group

Product

Latest Timing

Medtronic

- MiniMed 670G pump with built in hybrid closed loop algorithm (requires meal boluses)

- Enlite 3 CGM

FDA submission before end of June 2016; US launch hoped by April 2017

Tandem

 

- Tandem t:slim pump with built in predictive low glucose suspend algorithm; Dexcom CGM

- Tandem t:slim pump with built in Hypoglycemia-Hyperglycemia Minimizer algorithm; Dexcom CGM

- Pivotal trial in 2016, potential launch in 2017

 

- Pivotal study in 2017, potential launch by end of 2018

International Diabetes Closed Loop  (IDCL) Consortium (TypeZero, UVA, and nine other academic institutions)

Cellnovo + other undisclosed pump companies

- Commercial version of DiAs hybrid closed loop algorithm that can run on a pump or on a smartphone app.

- Dexcom CGM.

- Trial will use multiple pumps; Cellnovo has signed on thus far.

International Diabetes Closed-Loop Trial to begin later in 2016.

System recently tested in two ski studies in Wintergreen and Breckenridge

Beta Bionics

- Bionic Pancreas iLet device: dual chambered pump with built-in algorithm; hybrid or fully closed loop; insulin-only or insulin+glucagon; custom infusion set
- Dexcom CGM

- Likely to launch as insulin-only product, with glucagon to be optionally added later

Pivotal trial to start in mid-2017

Insulin-only FDA submission by end of 2017.

Insulin+Glucagon FDA submission potentially in 2019.

Bigfoot Biomedical

- Former Asante pump body (disposable), reusable Bluetooth-enabled controller (no screen or buttons) with built-in algorithm

- Dexcom CGM

- Smartphone app to serve as complete user interface.

Pivotal study in first half of 2017, FDA submission by the end of 2017.

Launch by the end of 2018.

Animas

- Animas pump with built-in Hypoglycemia-Hyperglycemia Minimizer algorithm

- Dexcom CGM

Pivotal study to begin in 2016, launch by November 2017.

Insulet

- OmniPod with hybrid closed loop algorithm and built-in Bluetooth

- Smartphone app and/or backup PDM handheld to communicate with pod

- Dexcom CGM

First clinical trials starting later in 2016, in market in late 2018.

Cellnovo

No design details disclosed, but algorithm likely to reside in wireless handheld that controls body-worn patch pump.

 

- IDCL Consortium Partner (see above)

- Diabeloop consortium partner

- IDCL study starting in 2016

- Diabeloop trials were expected to start at the end of 2015, with European approval programs to run until 2018

Roche

Working internally on a new CGM, with future potential application to an artificial pancreas device

“On our agenda”

CGM expected to launch in Europe in 2016

Cambridge

Upcoming long-term studies will use Medtronic’s MiniMed 640G/Enlite 3 + Android phone running Cambridge’s MPC.

Commercialization plans unknown. Three upcoming studies ranging from three to 24 months in length.

 

Helpful Links

The Bionic Pancreas:

Dr. Damiano and the bionic pancreas

The Bionic Pancreas is the work of Dr. Damiano, Dr. Russell, and their team at Boston University/Massachusetts General Hospital. Notably, this system uses insulin and glucagon, whereas most other systems only use insulin.  

test drive - The Bionic Pancreas. Kelly reflects on her transformative experience participating in the Beacon Hill trial of the bionic pancreas for five days.

learning curve - The "Bionic Kids" Put the Artificial Pancreas Through the Rigors of Summer Camp. We visit and report back on the bionic pancreas trials at Camp Clara Barton and Camp Joslin.

new now next - Dr. Ed Damiano Presents Encouraging Data on Two Bionic Pancreas Studies at CarbDM's Second Anniversary.

test drive - Our Bionic Pancreas Journey. A parent reflects on his experience as his daughter becomes the first 6-year old to test the bionic pancreas.

test drive - diaTribe Visits the "Bio-Panky" Kid Trial at Camp Joslin. We visit and report on the bionic pancreas trials, this time in the youngest group tested yet - 6 to 11 year olds.

Conference Updates:

conference pearls - The Human Side of the Artificial Pancreas from ATTD 2015.

conference pearls - Major Progress on the Artificial Pancreas at the American Diabetes Association's 74th Scientific Sessions in San Francisco. 

conference pearls - An update from the Advanced Technologies & Treatments for Diabetes (ATTD) Conference 2013.

conference pearls Workshop on Innovation Toward An Artificial Pancreas hosted by the FDA, NIH, and JDRF.

conference pearls The American Diabetes Association's 72nd Scientific Sessions - Philadelphia. An update from Dr. Ed Damiano and a closed-loop research meeting sponsored by JDRF and the NIH.

Regulatory News / A Pathway for the Artificial Pancreas:

thinking like a pancreas - You Call That An Artificial Pancreas? Gary Scheiner reflects on the steps toward an artificial pancreas, examines the pros and cons of each stage, and what we can do until it hits the market.

learning curve - Bringing an Artificial Pancreas to Market. 

thinking like a pancreas - Triple Your Pleasure: Three Pancreatic Hormones May be Necessary to Fully Close the Loop.

new now next - First-ever Artificial Pancreas Software Receives European Approval.

diaTribe dialogue - Medtronic’s MiniMed 670G Hybrid-Closed Loop – Exclusive Interview with 17-Year-Old Trial Participant.

trial watch - Medtronic’s Pivotal Trial of its 670G Hybrid Closed Loop System

Artificial Pancreas Trials and Studies:

test drive - UVA's Overnight Closed-Loop Makes for Great Dreams. Kelly participates in UVA's overnight closed loop trial and reports back on an incredible opportunity for the field to move fast, reduce anxiety, and beat timelines.

new now next Yale Researchers Dose First Patient in Artificial Pancreas Study with Halozyme's Hyaluronidase.

test drive - Kelly and Adam take UVA's DiAs artificial pancreas system home 24/7 for a three-month study. Their key takeaways, surprises, and next steps.

Key Questions for the Artificial Pancreas

Are patient expectations too high? If we expect too much out of first-generation artificial pancreas systems – e.g., “I don’t have to do anything to get a 6.5% A1c with no hypoglycemia” – we might be disappointed. Like any new product, early versions of the artificial pancreas are going to have their glitches and shortcomings. Undoubtedly, things will improve markedly over time as algorithms advance, devices get more accurate and smaller, insulin gets faster, infusion sets improve, and we all get more experience with automated insulin delivery. But it takes patience and persistence to weather the early generations to get to the truly breakthrough products. We would not have today’s small insulin pumps without the first backpack-sized insulin pump; we would not have today’s CGM without the Dexcom STS, Medtronic Gold, and GlucoWatch; we would not be walking around with smartphones were it not for the first brick-sized cellphones. This trial recalibrated our expectations a bit – these systems are going to be an absolutely terrific advance for many patients, but they will not replace everything out of the gate. Let’s all remember that devices need to walk first, then run, and it’s okay if the first systems are more conservative from a safety perspective.  

Overnight-only or 24-hour? There is some debate in the field on this topic, since some believe a night-only system brings additional challenges – e.g., What if someone wears the night-only system during the day? What about people who work the night-shift? Such challenges would not be present during the day, and as this study showed, 24-hour systems do work! However, daytime closed-loop brings higher patient expectations (we can see what the system is doing!) and other unique challenges, such as meals and exercise. The idea of an overnight-only system first is somewhat attractive, especially to build early experience and get an easy win – closed-loop systems at night pretty much always beat patients in the real world. For the most part, everyone in the field is developing 24-hour systems, though we imagine some patients will prefer to wear them at night-only.

Insulin-only or insulin+glucagon? Ultimately, we believe that the question is partially one of patient preferences. There will be some patients who may want the extra glycemic control offered by the dual hormone approach and will be willing to accept a bit more risk or a more aggressive algorithm. We believe the Bionic Pancreas could be especially helpful for those with hypoglycemia unawareness, a sizeable percentage of patients. If the Bionic Pancreas makes it to the market by 2018 with insulin and glucagon, some patients will want to give it a try – we believe a range of options is a good thing for people with diabetes, since all systems and products have pros and cons. Ultimately, cost considerations may present the largest factor in adoption. The Bionic Pancreas certainly brings multiple cost elements to consider – glucagon, a dual-chambered pump, custom infusion sets, potentially higher training, etc. It’s hard to know at this point how the relative costs/benefits will exactly compare.

What’s the right balance between automation and human manual input? The Holy Grail is a fully-automated, reactive artificial pancreas that requires no meal or exercise input. But insulin ideally needs to get faster to make that a reality. For now, daytime systems need to deal with balancing human input with automation, and as discussed above, there’s an associated patient learning curve. How much should artificial pancreas systems ask patients to do? How do we ensure patients do not forget how to manage their diabetes (“de-skilling”) as systems grow in their automation abilities?

How will academic groups commercialize their devices? This continues to be an open question for groups like the Bionic Pancreas and Cambridge – who will build and supply the devices, secure FDA approval, manufacture, support training and customer service, etc.? As noted above, TypeZero Technologies licensed DiAs to commercialize a closed-loop system. In mid-April, Medtronic also licensed DreaMed’s artificial pancreas algorithm, which was developed by an academic group (DREAM) that later formed the startup. Of course, Medtronic has an advantage, since it has both a pump and CGM in-house; other insulin pump companies will not only need an algorithm, but need to find a CGM supplier, such as Dexcom.

What fraction of patients will be willing to wear some type of artificial pancreas system? Right now, many estimate that ~30% of US type 1s wear a pump, and about 10%-15% wear CGM. There are a lot of reasons why that may be the case, including: cost; hassle factor; no perceived benefit; no desire to switch from current therapy; wearing a device on the body; alarm fatigue; etc. Will an artificial pancreas address enough of these challenges to expand the market?

Will healthcare provider embrace closed-loop systems? Today, healthcare providers lose money when they prescribe pumps and CGM. We need to make sure that closed-loop systems make providers’ lives easier, not more complicated.

Will there be a thriving commercial environment and reimbursement? It’s extremely expensive to develop and test closed-loop systems, and companies will only develop them if there is a commercial environment that supports a reasonable business. Reimbursement is a major part of that, and it’s hard to know if insurance companies will pay for closed-loop systems – we likely won’t know until there is longer-term data on these devices, especially changes in A1c or severe hypoglycemia. We are optimistic that reimbursement will be there, especially if systems can simultaneously lower A1c and reduce hypoglycemia.