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 tech, now officially known as AID (Automated Insulin Delivery) systems, is already changing the game for people whose lives depend on insulin.
To date, the Food and Drug Administration (FDA) has approved four commercial AID systems:
- MiniMed 670G from Medtronic Diabetes in 2016
- Control-IQ from Tandem Diabetes Care in 2020
- Minimed 770G from Medtronic Diabetes in 2020
- Omnipod 5 from Insulet Corp., just approved in late January 2022
Other advanced iterations are also in the works and may be coming soon.
Meanwhile, a vibrant diabetes patient do-it-yourself (DIY) community has been developing their own homemade versions that are now widely used across the country and even internationally.
Although it 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 connect various diabetes devices using a combination of cables and wireless technology and creating a system that can mimic what a healthy pancreas does — monitor glucose levels and deliver insulin as needed.
Currently, an AID system is essentially an insulin pump connected to a continuous glucose monitor (CGM). The monitor is controlled via a receiver (a separate handheld device or eventually a smartphone mobile app) using sophisticated software algorithms to make the whole thing work.
The idea is to automate blood glucose (BG) control as much as possible, so the wearer no longer has to take fingerstick blood sugar readings and then calculate how much insulin to dose or reduce based on 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 to those “hacked” by tech-savvy DIYers who don’t want to wait for FDA-approved products. Incredible strides are being made, and new groups and companies seem to be emerging to work on this exciting advancement in diabetes technology.
Components included in current AID systems:
- Insulin pump provides a continuous flow of insulin into the body via an “infusion site” or small cannula inserted in the skin.
- CGM 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 United States, made by Dexcom and Medtronic, that offer high and low alerts continuously as part of the device functionality.
- Controller can be either the insulin pump itself, a separate handheld controller, or a smartphone mobile app that includes the display screen where users can see glucose data.
- Algorithm software is the “brain” of the system that crunches the numbers to predict where glucose levels are headed and then tells the pump what to do.
“Artificial Pancreas” (or AID) Lingo
Here’s the skinny on some of the key terminology involved:
Algorithms. An algorithm is a set of step-by-step mathematical instructions that solve a recurrent problem. In the AID world, there are a bunch of different approaches to this, which is a shame 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. A closed loop is an automatic control system in which an operation, process, or mechanism is regulated by feedback. In the diabetes world, an “artificial pancreas” or AID system is a closed loop system in which insulin delivery is regulated by feedback from an algorithm based on CGM data. It works to “close the loop” automatically on the glucose management process.
Dual Hormone. This is an AID system that contains both insulin and glucagon. As of early 2022, none of these systems have yet moved out of the development phase.
UI (user interface). UI is a technology term that refers to everything designed into a device with which a human being may interact, such as the display screen, colors, buttons, lights, icon characters, help messages, etc. Researchers have come to realize that a poorly designed UI could prevent patients from using an AID system. Therefore, a great deal of effort is currently going into the design of the UI.
Low-Glucose Suspend (LGS) or Threshold Suspend. This feature allows a system to automatically shut down insulin delivery in case a low blood sugar threshold is reached. This capability is key to creating an AID that can truly control glucose levels.
There is no single inventor to thank but rather a whole host of companies working on developing market-ready systems. They include:
Medtronic Diabetes is the insulin pump market leader and the only company that manufactures 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 AID software Glucositter in its future systems.
On September 28, 2016, Medtronic’s MiniMed 670G “hybrid closed loop” system became the first-ever FDA-approved system to automatically dose insulin based on CGM readings. It was therefore the first “early AP” 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. In 2018, the FDA gave it a “pediatric indication” approval for use in kids as young as age 7.
Medtronic is now working on an even more advanced model, the 780G, that will be more fully automated and personalized with automatic bolusing and a lower target of 100 mg/dL. It will also be connected to the company’s next-generation CGM sensor, known as Zeus.
Tandem Diabetes Care
Tandem Diabetes Care, makers of the innovative t:slim touchscreen insulin pump, launched the second-ever FDA-cleared closed loop system, called Control-IQ, in January 2020.
When launched, it leap-frogged the Medtronic Diabetes first-to-market MiniMed 670G Hybrid Closed Loop that only adjusts background basal rates but doesn’t support automatic food or correction boluses. It was also the first Dexcom CGM-compatible system since the Medtronic system works solely with that company’s own continuous sensor. User feedback has been highly positive.
Omnipod 5 from Insulet Corp
Insulet Corp., the Boston-based manufacturer of the tubeless Omnipod insulin pump, announced integration with the Dexcom CGM in 2014, and later struck a deal with AID software firm Mode AGC (Automated Glucose Control LLC) to develop and incorporate their advanced AID algorithm.
Based on all that, Insulet developed the Omnipod 5 system, formerly known as Omnipod Horizon. This is the first-ever closed loop system to use an insulin pump without tubing. It received FDA clearance in January 2022. It will take some months for the company to ramp up launch to make this system available to patients around the country.
The full retail price for the Medtronic 670G system is between $7,000 and $8,000. But with insurance coverage, most patients pay just over $1,000 to initially get on the system, and then they must pay for pump and CGM supplies separately on an ongoing basis. The annual cost of the CGM transmitter is $699, and sensors run from $50 to $75, depending on the number purchased. Medtronic offers financial assistance to patients in need.
The Tandem Control-IQ system is being offered as a free software update for in-warranty t:slim X2 pump users in the U.S. who purchased the pump before December 31, 2020. Existing users can access the upgrade through the Tandem Device Updater, which is simply plugged into a computer with a micro-USB cable.
Outside of that offer, the cost of the Tandem t:slim X2 pump with Control-IQ is $4,000, but Tandem says health insurance typically covers 80 percent of that cost.
But again, you still need to purchase all the Dexcom G6 CGM supplies separately. While insurance coverage may vary, the retail price would be $237 for a single G6 transmitter that lasts 3 months and $349 for a box of three 10-day sensors.
Official pricing for the newly FDA-approved Omnipod 5 system has not yet been announced. But the manufacturer Insulet has stated that they plan to offer the new system “at parity” with their DASH product.
A box of five Omnipod DASH Pods currently ranges from $270 to $369 at retail pharmacies. Prices may be as low as $118 on Amazon.
Insulet says its own internal research shows the monthly average copay for Omnipod DASH for people using 10 Pods per month was $39 plus a 20 percent coinsurance payment. That same data also indicated that Pods bought at the pharmacy save most of their customers an average of 27 percent in monthly copays, compared to going through traditional insurance. Of course, coverage by private insurers varies, so you’ll need to check your own plan.
Again, these prices do not include the necessary Dexcom CGM supplies that must also be purchased separately.
The hope is that with new AID systems hitting the market in 2022 and beyond, these systems will become more and more affordable.
Research shows that these systems are generally safe and effective. However, just like 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 safely and successfully, with positive health outcomes.
As noted, there are a whole host of companies working on new AID systems that could materialize in upcoming years.
This Northern California startup grew directly out of the do-it-yourself #WeAreNotWaiting movement formed in late 2014 by former JDRF CEO Jeffrey Brewer and a group of other technology-savvy D-Dads. The company’s origin story is pretty inspiring.
Bigfoot hired some of the most prominent AID entrepreneurs and purchased the intellectual property from defunct insulin pump company Asante Solutions and teamed up with Abbott Diabetes Care to use a next-generation FreeStyle Libre Flash monitoring system with their system. Bigfoot later acquired Timesulin to create a smartpen version of their system, alongside the pump version.
The company received FDA clearance for its “Bigfoot Unity” pen version with the FDA in May 2021. While the young company describes this as an early AID system, others point out that it’s more like a bolus dose calculator connecting a CGM and insulin pen. Learn more about Bigfoot Unity here.
Born out of the Boston University iLet Bionic Pancreas Project, Beta Bionics has been led by Dr. Ed Damiano and team for more than a decade. Animal trials took place in 2005, human trials began in 2008, and continue to evolve today.
In 2016, the “Go Bionic” team formed a commercial public benefit corporation to develop and bring their iLet system to market. This dual-chambered device with a sophisticated user interface will include prefilled cartridges of both insulin and glucagon to eliminate the need for manual filling by the user. A first-generation version including insulin only may be available in 2023, depending on clinical trials and regulatory clearance. The full dual hormone iLet version may not be available until at least 2024.
Diabeloop is a European pump company and French research consortium developing and testing new AID systems in the United Kingdom and France. It was using the Kaleido hybrid patch-tubed pump in its first developed version, but since that device has been discontinued, Diabeloop has been working to integrate other pump technology — such as the Roche Accu-Chek system.
Dose Safety is a Seattle-based startup developing a sophisticated controller for use in AID systems.
DreaMed Diabetes is an Israel-based startup established in 2014 as a spinoff of the DREAM International Consortium to commercialize the technology behind its Glucositter software. In 2015, Medtronic signed an agreement to use Glucositter in its future closed loop technology. It uses an algorithm based on a “fuzzy logic” theory, a learning algorithm meant to minimize the risks of hypo/hyper events.
EoFlow is a South Korean company developing an AID 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 Omnipod DASH tubeless insulin pump. The control algorithm will be one previously licensed by TypeZero Technologies. EoFlow received the FDA’s “breakthrough device designation” in March 2019 and remains under study.
Lilly Diabetes, the Indianapolis-based pharma-giant insulin maker, began working on its own AID system in roughly 2014, before announcing it publicly in 2017. But in 2020, Lilly scrapped that project to instead commercialize the European-made YpsoPump in the U.S. to only use Lilly’s brands of insulin.
That technology remains in development and likely won’t be seen before 2024 at least. Lilly is also working on its own connected insulin pen system, collaborating with Dexcom on the CGM side, and that pen-connected system is expected in 2022.
Pancreum is a visionary startup established by a former Insulet engineer who aims to create a three-part modular design to make the AID system more flexible and useful for patients. This has been in the works for the better part of a decade, but there’s no timeline on any real development progress as of early 2022.
In 2018, the nonprofit diabetes data platform startup Tidepool announced that it had obtained funding to start work on an “official” version of the DIY Loop called Tidepool Loop that will be paired with the Omnipod tubeless insulin pump. This will take the DIY community version and build it into a product that can go through the official regulatory process for commercial availability. The organization filed Tidepool Loop with the FDA in early 2021, and the community is very anxious to see it materialize.
TypeZero Technologies began as a Charlottesville, Virginia-based startup that spun off from years of closed loop research and development of a system at the University of Virginia (UVA). Work focused on commercializing what the UVA originally called DiAs (Diabetes Assistant systems) and was first 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 systems.
Many in the D-Community have been turning to DIY tech to create their own AID systems and data-sharing tools. This tech-savvy movement is purely open-source, meaning the community is constantly co-developing the tools collectively by gathering on Facebook and at the developer site GitHub. The technology can be revised as needed based on the work others are doing and how the apps are found to function in the real world.
DIY Diabetes Tech Terms to Know
#WeAreNotWaiting. This hashtag has become a rallying 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 AID development.
#OpenAPS. This DIY AID system was 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. Largely the same as the above-mentioned OpenAPS, but based in Europe, this technology is 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. These are apps that work with an insulin pump, RileyLink device (below), and iPhone. Read this overview of these systems.
RileyLink. A small device 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.
OrangeLink Pro. The newest version of the RileyLink device is a compact, lightweight model that fits in many AirPods protective cases and accessories. It is also powered by AAA batteries, doing away with the need for a special charging cord.
LoopDocs. This is an incredibly comprehensive online instruction guide on Looping, created by D-Mom Katie DiSimone who supports her daughter using this DIY technology and keeps up on the latest developments. This resource also offers a range of other information, including links to Facebook groups and other online tools to learn more and get involved.
Here are some important facts about AID development.
FDA and the advocacy org JDRF are pushing for progress
Actually, these two organizations have been pushing on this for more than a decade. Here’s a timeline:
Path to the AP. Back in 2006, JDRF established the Artificial Pancreas Project Consortium (APPC), a multiyear, multimillion-dollar initiative to accelerate development. This got a big boost when that same year, FDA also named
Guidance. 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 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
Fast-tracked designations. In spring 2019, the FDA granted its “breakthrough device designations” to four different closed loop technologies by Medtronic, Bigfoot Biomedical, and EoFlow. This designation was designed to help speed up the regulatory review process of innovative devices that the agency deems worthy.
Name change. Roughly 4 to 5 years ago, the research and patient communities began referring to Automated Insulin Delivery (AID) systems instead of using the term “Artificial Pancreas,” which was deemed less accurate and confusing, especially to people less familiar with diabetes.
Clinical trials abound
As it stands today, there are several hundred sites around the country and around the world conducting clinical trials on AID systems, many of them in “outpatient” settings. This means study participants are not confined to a hospital or clinic. You can review many of the current studies online at ClinicalTrials.gov.
‘Noninvasive’ diabetes technology does not exist yet
Lots of folks unfamiliar with diabetes are surprised to hear that all this equipment still pierces our skin because they keep hearing about breakthrough “noninvasive” diabetes technology.
While it is true that inhalable insulin is now available (MannKind’s Afrezza), so far that mealtime-only insulin has not been sufficient for use in an AID system. Current systems use a pump that delivers insulin through a small “subcutaneous” (under the skin) cannula.
It has 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 blood glucose through the skin itself, through sweat, and even through the eyes have not been successful.
The good news is that at least 50 companies around the globe are working feverishly to bring a noninvasive glucose sensor to market.