If you pay attention to diabetes news at all, you’ve surely heard the terms 'Artificial Pancreas,' 'closed loop system,' or 'bionic pancreas’ a lot in recent years. And if you live with diabetes yourself, family and friends may even be asking if you have one of these yet.

This futuristic technology is now officially being referred to as AID (Automated Insulin Delivery) systems, and they are getting very close to truly changing the game for people whose lives depend on insulin.

To date, FDA has approved one early commercial AID system, the Medtronic Minimed 670G, and numerous other companies are working on their own versions that should be available soon.

Meanwhile, a vibrant diabetes patient do-it-yourself (DIY) community is developing their own homemade versions that are becoming widely used across the country.

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What Is an Artificial Pancreas?

Although ‘Artificial Pancreas’ sounds like a single appliance that you would just plug into your body, the fact is: we are not there yet.

It’s taken researchers decades to get to the point where they can connect various diabetes devices, using a combination of cables and wireless technology, to create a system that can mimic what a healthy pancreas does, by monitoring glucose levels and delivering insulin as needed.

So right now, a so-called ‘Artificial Pancreas’ is essentially an insulin pump connected to a continuous glucose monitor (CGM), controlled via some kind of receiver (usually a smartphone) using sophisticated software algorithms to make the whole thing work.

The idea is to automate blood glucose control as much as possible, so the wearer no longer has to take fingerstick blood sugar readings, and then do complex math to determine how much insulin to dose, or how much to reduce insulin delivery based on low readings. Some systems can even shut off insulin delivery automatically based on low blood sugar readings detected by the CGM. And some systems are experimenting with carrying glucagon in the pump alongside insulin, to bring blood sugar up when necessary.  

These systems are at various points in development, from clinical studies to early commercial products and even those "hacked" into by tech-saavy Do-It-Yourselfers who don't want to wait for FDA-approved products. Incredible strides are being made, and new groups and companies seem to be emerging all the time to work on this exciting advancement in diabetes technology.

Products included in current AP systems:

  • an insulin pump, which provides a continuous flow of insulin into the body via an “infusion site” or small cannula inserted in the skin
  • a continuous glucose monitor (CGM) that takes ongoing blood sugar readings via a little sensor worn on the skin, that has its own separate cannula from the pump. There are currently two CGMs on the market in the U.S., from Dexcom and Medtronic
  • a controller (usually an iPhone) that includes the display screen where users can see glucose data
  • algorithm software, the “brain” of the system, that crunches the numbers to predict where glucose levels are headed and then tells the pump what to do
  • sometimes glucagon, a hormone that rapidly increases blood glucose, used here as an antidote to hypoglycemia (low blood sugar)

 

How Much Will an Artificial Pancreas Cost, and When Is It Coming?

Some new systems are expected to hit market as early as late 2019, with many options to follow in the next few years.

Specific price tags are not available yet, but should not exceed the cost of the components: the insulin pump and CGM used. Some companies, notably Bigfoot Biomedical, are even working on a "package" subscription model, that will offer the user all the supplies they need on a monthly basis for one affordable monthly payment.

 

Who Invented the Artificial Pancreas?

There is no single inventor to thank, but rather a whole host of companies working on developing a market-ready AP system. They include, in alphabetical order:

Beta Bionics - Born out of the University of Boston iLet Bionic Pancreas Project, Dr. Ed Damiano and team have been working on this for more than a decade -- animal trials happened in 2005 and human trials began in 2008, and it's evolved in the years since. The "Go Bionic" team in 2016 formed a commercial, public benefit corporation to develop and bring their iLet system to market. This dual-chambered device will have a sophisticated user interfaces, and will include pre-filled cartridges of insulin and glucagon to eliminate the need for manual filling by the user.

Bigfoot Biomedical - Established in late 2014 by former JDRF CEO Jeffrey Brewer and a group of D-Dads, Bigfoot has hired some of the most prominent AP entrepreneurs and even purchased the IP (intellectual property) and Milpitas, CA, office space from now-defunct insulin pump company Asante Solutions. They have since teamed up with Abbott Diabetes Care to use a next-generation FreeStyle Libre Flash monitoring system with the device, and Bigfoot's also acquired Timesulin to create a smart pen version of their automated insulin delivery system. They are developing both a connected pen and pump version, internally referring to those products as Bigfoot Loop and Bigfoot Inject. The company received the FDA's expedited "breakthrough device designation" in November 2017. You can read the origin story here.

CellNovo & Diabeloop - a European pump company and French research consortium developing and testing new AP systems in the UK and France. They are using the Kaleido hybrid patch-tubed pump in the first version in development, but also hope to eventually integrate the Cellnovo hybrid pump and CGM technology already on the market.

Dexcom - the leading CGM sensor technology from this San Diego-based company is at the heart of a large majority of AP systems under development, including some DIY (do-it-yourself) systems being cobbled together by citizen hackers. To enable further development, Dexcom integrated an AP algorithm into their G4 product in 2014, and has signed device integration agreements with insulin pump makers Insulet (OmniPod). The latest G6 model will be used in closed loop systems coming down the road with Tandem's t:slim X2, Insulet's OmniPod Horizon, and more. In 2018, the CGM company acquired closed loop startup TypeZero Technologies with plans to offer those algorithms as an option to D-Tech companies going forward.

Dose Safety - a Seattle-based startup developing a sophisticated controller for use in AP systems.

DreaMed Diabetes - an Israel-based startup established in 2014 as a spin-off the DREAM International Consortium, in order to commercialize the Artificial Pancreas technology behind its Glucositter software. In 2015, Medtronic signed an agreement to use that Glucositter in its future closed loop technology.

EoFlow: This South Korean company is developing an automated insulin delivery system dubbed EoPancreas. This uses the "EoPatch" patch pump available in Asia, that will be integrated with a CGM sensor made by China-based POCTech. Eventually, the company hopes to build in other CGMs. It will use an Android phone-style locked down controller similar to the controller used by the most recent version of the OmniPod tubeless insulin pump, and the control algorithm will be one previously licensed by TypeZero Technologies. EoFlow received the FDA's "breakthrough device designation" in March 2019.

Insulet Corp. and Mode ACG - the Boston-based manufacturers of the tubeless OmniPod insulin pump announced integration with the Dexcom CGM in 2014, and recently struck a deal with AP software firm Mode AGC (Automated Glucose Control LLC) to develop and incorporate their advanced AP algorithm in the system.

Lilly Diabetes: The Indianapolis-based pharma giant insulin-maker announced in late 2017 that it has been working on its own automated insulin delivery system, one that will offer both a insulin pump as well as a connected insulin pen as options. They're collaborating with Dexcom on the CGM side , and the pump itself is a sort of hybrid that's about the size of a round tobacco tin that fits in the hand and will have both tubing or a self-adhesive to stick onto the skin.

Medtronic Diabetes - the insulin pump market leader and only company that manufacturers both a pump and CGM device, it famously launched its combo system with low-glucose suspend (530G) in 2014, the first product approved through a new FDA designation intended to smooth the regulatory path for these devices. Medtronic also signed an exclusive agreement in 2015 to use artificial pancreas software Glucositter in its future systems.

On Sept. 28, 2016, Medtronic’s Minimed 670G “hybrid closed looop” system was approved by the FDA -- becoming the first-ever approved system to automatically dose insulin based on CGM readings. It is therefore the first "early Artificial Pancreas" on the market. Using the company's fourth-generation CGM sensor called Guardian 3, it automatically adjusts basal (background) insulin to keep a user as close as possible to 120 mg/dL, limiting low and high blood sugars. The FDA in mid-2018 gave it a "pediatric indication" approval for use in kids as young as age 7. The product is the first of its kind worldwide, and future generations will be more automated and personalized.

Pancreum - a visionary startup established by a former Insulet engineer who aims to create a three-part modular design to make the AP system more flexible and useful for patients.

Tandem Diabetes Care - makers of the innovative iPhone-ish t:slim insulin pump are developing an integrated pump-CGM system featuring both the predictive hypoglycemia algorithm and a predictive hyperglycemia (high blood sugar) algorithm. Tandem received FDA approval for its basal-only adjusting "Basal-IQ" tech in 2018 that automatically shuts off insulin when a hypo is predicted, and by mid-2019 the company expects its automatic bolus-for-highs version, Control-IQ, to be available. The smart algorithm used in this first generation is based on those developed by TypeZero Technologies.

TypeZero Technologies - This began as a Charlottesville, VA-based startup that spun off from years of closed loop research and development of an AP system at the University of Virginia (UVA). The startup's work focused on commercializing what the UVA originally called DiAs (short for Diabetes Assistant system), and at first it was focused on integrating with the Tandem Diabetes closed loop technology. In 2018, CGM-maker Dexcom acquired TypeZero Technologies with plans to license those algorithms out to other players developing these AP systems.



Artificial Pancreas Lingo

Here’s the skinny on some of the key terminology involved:

Algorithms - in case you’re unfamiliar, an algorithm is a set of step-by-step mathematical instructions that solve a recurrent problem. In the AP world, there are a bunch of different approaches to this -- which is a shame actually, because standardizing the protocols and reporting metrics would be hugely beneficial to both physicians (for evaluating data) and patients (for getting access to systems that provide a choice of interchangeable components).

Closed Loop - per definition, an automatic control system in which an operation, process, or mechanism is regulated by feedback. In the diabetes world, a closed-loop system is essentially an Artificial Pancreas, where insulin delivery is regulated by feedback from an algorithm based on CGM data.

Dual Hormone - this refers to AP systems that contain both insulin and glucagon, the hormone that has the opposite effect on blood sugar levels.

UI (user interface) - a technology term that refers to everything designed into a device with which a human being may interact -- the display screen, colors, buttons, lights, icon characters, help messages, etc. Researchers have come to realize that a poorly designed UI could be the deal-breaker that could keep patients from using an AP system. Therefore, a great deal of effort is currently going into the design of the UI.

Low-Glucose Suspend (LGS) or Threshold Suspend - that feature allowing an AP system to automatically shut down insulin delivery in the case that a low blood sugar threshold is reached. This capability is key to creating an AP that can truly control glucose levels.

 

Do-It-Yourself (DIY) Artificial Pancreas Systems

Many in the Diabetes Community are turning to DIY tech to create their own data-sharing tools and so-called Automated Insulin Delivery (or "closed loop") systems. This tech-saavy movement is purely open source, meaning the community is constantly co-developing the tools collectively by gathering on Facebook and at developer site GitHub. The technology can be revised as needed based on the work others are doing and how the apps are found to be functioning in the real world.

Some terms to know:

#WeAreNotWaiting - the hashtag that has become a rally cry among citizen hackers moving ahead with medical device innovation without waiting for doctors, pharma, or the FDA to give them the go-ahead. This grassroots initiative has been very influential in accelerating innovation, including AP development.

#OpenAPS - a homemade “do-it-yourself” Artificial Pancreas system created by citizen hackers Dana Lewis and Scott Leibrand. Their incredible work has spawned a movement, as more and more patient entrepreneurs begin to use and iterate on this system. The FDA has acknowledged OpenAPS, and is still grappling with how to respond.

#AndroidAPS - this is largely the same as the above-mentioned OpenAPS, but is based in Europe, with the technology running on Android smartphone devices.

Looping - Sometimes used as a general term for anyone using an open source closed loop system. "Looping" also refers specifically to the Loop systems -- an app that works with an insulin pump, RileyLink device and iPhone. See below and also this good overview of those homemade closed loop systems.

RileyLink - a little decive that serves as a brain for Loop systems. It connects an iPhone to a Dexcom CGM and insulin pump to create the Looping systems. It was developed by D-Dad Pete Schwamb and named after his daughter Riley who lives with type 1 diabetes. The official site for more information and ordering is GetRileyLink.org.

LoopDocs -- an incredibly comprehensive online instruction guide on Looping, created by D-Mom Katie DiSimone who uses this DIY technology and keeps up on the latest developments. This resource also offers a range of other information that includes Facebook groups and other online tools to learn more and get involved.

Tidepool Loop - In 2018, the non-profit diabetes data platform startup Tidepool announced that it had obtained funding to start work on an "official" version of Loop that will be paired with the OmniPod insulin pump. This will take the DIY community version and build it into a product that can be reviewd by FDA through the official regulatory process for commercial availability. There is no set timeframe for launch, but the community is very anxious to see it materialize soon.

 

Are Artificial Pancreas Systems Safe?

Like many things in the diabetes universe, this is a bit of a loaded question. Research shows that in general, APs are safe and effective -- but just like with any medtech devices, these systems aren't perfect. Out-of-range blood sugars can still happen, so users need to proceed with caution. That's especially true for systems that are not FDA-regulated, as the algorithms are often still under construction.

In the Diabetes Online Community on blogs, Twitter, Facebook and Instagram, there are countless examples of people using this diabetes technology successfully and sharing their experiences.

Two of the newest trials, that kicked off in January of 2016, are expected to pave the way for FDA approval of a commercial product by proving the safety and efficacy of an AP system over the long-term (6 months to a year) “in the patient’s natural environment.”

 

More Things to Know About Artificial Pancreas Systems

Here are some important facts about AP development, in no particular order:

 

FDA and JDRF are Pushing Hard on AP Progress

Actually, they’ve been pushing on this for over a full decade now! 

Path to the AP: Back in 2006, JDRF established the Artificial Pancreas Project Consortium (APPC), a multi-year, multi-million dollar initiative to accelerate AP development. This got a big boost when that same year, FDA also named AP technology as one of its “Critical Path” initiatives to drive innovation in scientific processes.

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Guidance: Then in March 2011, JDRF proposed that the FDA issue guidance to help further accelerate development. JDRF worked with clinical experts to draft those initial recommendations, which were released in December 2011.

First Clinical Trial: In March of 2012, the FDA gave the green light to the very first outpatient clinical trial of an AP system.

Landmark Approval: A milestone moment came in September 2016, when the FDA approved the Medtronic Minimed 670G, a "hybrid closed loop" system that automatically adjusts basal insulin and can predict some hypo and hyperglycemia. This device partially closes the loop but is not a full AP that does everything for the user. This was the result of more than a decade's work on advocacy, policy, research and product development. This regulatory approval is expected to pave the way for other closed loop systems to follow.

Fast-Tracked Designations: As of Spring 2019, the FDA has granted its "breakthrough device designations" to four different closed loop technologies -- Bigfoot Biomedicals, EoFlow, and Medtronic's early closed loop products. These designations are for innovative devices that the agency views as needing quicker commercial launch, and it's designed to speed up the regulatory review process.

 

Clinical Trials for Artificial Pancreas Abound

As it stands today, there are several hundred sites around the country and around the world conducting AP clinical trials many of them in “outpatient” settings, meaning study participants are not confined to a hospital or clinic. You can review many of the current studies online at ClinicalTrials.gov.

 

There’s No Such Thing as “Non-Invasive”

Lots of folks unfamiliar with diabetes are surprised to hear that all this equipment still pierces our skin, because they keep hearing about breakthrough “non-invasive” diabetes technology.

While it is true that new inhalable insulin hit the market in the past year (MannKind’s Afrezza), so far that mealtime-only insulin has not been sufficient for use in an Artificial Pancreas system. Current AP systems use a pump that delivers insulin through a small “subcutaneous” (under the skin) cannula.

It’s also been a dream for many decades to create a way to measure glucose without poking the skin, but we are not there yet either. So far, attempts to measure BG through the skin itself, through sweat, and even through your eyes have not been successful. But the experts are still hard at work trying. Note that Google is investing in developing contact lenses for glucose measurement. Cross your fingers (or your eyes?) for that one!

 

 

Ongoing Coverage of Artificial Pancreas Progress

We at the ‘Mine have been covering AP development for as long as it’s been around. Here’s a selection of some of our articles over the years:

Diabetes Technology Review: New Do-It-Yourself Omnipod Loop (May 2019)

An Artificial Pancreas Leader, on Her Life and Career with Type 1 Diabetes (April 2019)

EoPancreas: A New Patch Pump Closed Loop System (March 2019)

Diabeloop 'Artificial Pancreas' Approved in Europe (November 2018)

Tidepool to Build an Official Artificial Pancreas Loop App! (October 2018)

How Do-It-Yourself Diabetes Looping Works (April 2018)

RileyLink: Homegrown Diabetes Closed Loop Technology (January 2017)

FDA Approves First Pre-Artificial Pancreas in the Medtronic Minimed 670G (September 2016)

Meet Beta Bionics: New Business Structure for iLet Bionic Pancreas (April 2016)

“My Time with iLet Bionic Pancreas” – First Human Trials! (March 2016)

#WeAreNotWaiting Update - Slideset from the 2015 DiabetesMine Innovation Summit (November 2015)

TypeZero Tech: More High Hopes for Closed Loop Commercialization (June 2015)

Meet the Bigfoot Family and Their Homemade Closed Loop System (March 2015)

With This Ring, I Close The Loop and #OpenAPS (March 2015)

Life on a Homemade Artificial Pancreas (December 2015)