“My diabetes management was significantly improved with my smart alarm system (#DIYPS), but having a closed loop system took it to the next level and significantly reduced the amount of effort required to achieve those outcomes.”Dana Lewis, Digital Health Analyst – Diabetes Patient
If you pay attention to diabetes news at all, you’ve undoubtedly 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. In the last 3-5 years and as a response from the active diabetes patient community and their #wearenotwaiting movement propagating the DIY artificial pancreas, major companies have recognized the potential in connected health devices. While they started the quest for the artificial pancreas and tried to keep pace with the emergence of disruptive innovations, dozens of digital health start-ups also appeared, offering smartphone apps, digital patches, and many other connected solutions – constantly challenging the status quo. This futuristic tech, now officially known as AID (Automated Insulin Delivery) systems, is already changing the game for people whose lives depend on insulin.
First, some basics: What is an artificial pancreas (or AID)? Although it sounds like a single appliance that you would plug into your body, the fact is, we are not there yet. 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.
Forms of the technology are already available for adults and kids with type 1 diabetes. Type 1 diabetes is far less common than type 2 diabetes, which typically strikes in adulthood and is often associated with obesity. The type 1 form is caused by a misguided immune system attack on the body’s insulin-producing cells. Insulin is a hormone that regulates blood sugar, and people with type 1 diabetes need to take synthetic insulin daily. Having a child with type 1 diabetes can be a challenging health condition for parents to manage. They still have to calculate how much insulin the pump should deliver and make frequent changes, both day and night. These systems have improved blood sugar control and made life easier for people with the disease.
What’s currently FDA-cleared? – To date, the Food and Drug Administration (FDA) has approved four commercial AID systems:
- Medtronic: Its MiniMed 670G (2016) and 770G (2020) systems, the first hybrid closed-loop system, continuously monitors blood sugar levels and automatically delivers insulin, but users still have to input the bolus insulin dose (the insulin type usually taken during meals) based on what you eat. 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 its next-generation CGM sensor, known as Zeus. The current cost is approximately $8,000. But with insurance coverage, most patients pay just over $1,000 to get on the system initially, 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.
- Tandem Diabetes Care: Tandem Diabetes Care, makers of the innovative t:slim touchscreen insulin pump, launched the second-ever FDA-cleared closed-loop system, Control-IQ, in January 2020. 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.
- Insulet Corporation: 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 the launch to make this system available to patients around the country. Insulet says its internal research shows the average monthly copay for Omnipod DASH for people using 10 Pods per month was $39 plus a 20 percent coinsurance payment.
- A vibrant diabetes patient do-it-yourself (DIY) community has been developing its own homemade versions that are now widely used across the country and even internationally.
What’s in development? – As noted earlier, several companies are developing next-generation AID technologies that we might see in the next couple of years. Some excellent research reported in Healthline by Mike Hoskins and Amy Tenderich and fact-checked by Maria Gifford identified some notable examples, which include:
- Bigfoot Biomedical: This 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 received FDA clearance for its “Bigfoot Unity” pen version with the FDA in May 2021. Unlike other early “Artificial Pancreas” technologies that connect a continuous glucose monitor (CGM) and an insulin pump to automate dosing, the Unity system is designed for individuals on multiple daily injection therapy, known as MDI.
- Diabeloop: 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. Still, since that device has been discontinued, Diabeloop has been working to integrate other pump technology — such as the Roche Accu-Chek system.
- DreaMed Diabetes: 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.
- Lilly Diabetes: A subsidiary of the Indianapolis-based pharma-giant insulin maker, began working on its AID system in roughly 2014 before announcing it publicly in 2017. But in 2020, Lilly scrapped that project to commercialize the European-made YpsoPump in the U.S., instead only using Lilly’s brands of insulin.
- Tidepool Loop: 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: Work focused on commercializing what the University of Virginia 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 to other players developing these systems.
What does the research show? – As it stands today, there are several hundred sites around the country and 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. Until recently, most research on artificial pancreas systems has focused on adults or older children, though one system is approved in the United States for children aged 2 to 6. A new study, published Jan. 20 in the New England Journal of Medicine, adds to evidence that the technology is safe for toddlers and preschoolers — and may better control their disease. The new trial included 74 children aged 2 to 7. Each spent 16 weeks using a traditional glucose monitor and insulin pump and 16 weeks using an artificial pancreas system developed by the Cambridge researchers. On average, the study found, the children spent about 72% of the day within the normal blood sugar range when they were using the artificial pancreas — just over two hours more than the standard treatment. The system also reduced instances of very high blood sugar without increasing potentially dangerous blood sugar lows.
Currently, nearly 900 patients with type 1 diabetes in England are testing an artificial pancreas. To date, 875 patients have joined the pilot, which will enroll up to 1,000 people. The data collected from the pilot, along with other evidence, will be considered by the National Institute for Health and Care Excellence (NICE) as part of a technology assessment. NICE will make a recommendation about broader adoption within the NHS following a review of the evidence.
What does the future hold? – Researchers at MIT have developed a device that can keep pancreatic islets alive after being implanted into the body. In addition, collaborators from Cornell University, Novo Nordisk, and the University of Michigan Medical School developed their implants containing living pancreatic cells. These experiments may bring an organic replacement of failing organs in the future – either with gene therapies or new organs developed from stem cells. Glucose-responsive insulin that could be taken once a week could react to variation in the blood glucose levels and not require CGM or a pump. And then, there are several gene therapies that could potentially provide a cure for diabetes.
Over 460 million people in the world are currently dealing with diabetes. It is estimated that the number of people affected by diabetes will rise to 700 million by 2045, according to the World Health Organization. And, after older people and nursing home residents, perhaps no group has been harder hit by the COVID-19 pandemic than people with diabetes. Several studies suggest that 30 to 40 percent of all coronavirus deaths in the United States have occurred among people with diabetes. The costs associated with diabetes care are unsustainable, providing the impetus for companies and researchers to find solutions to manage (and potentially cure) this disease effectively.
Researchers are already speculating about microchips that can diagnose type 1 diabetes before the symptoms appear, nanorobots traveling in the bloodstream while measuring glucose and delivering insulin, or silica particles that can slow down the digestion of food to prevent diabetes and obesity.
Don’t expect a slowdown in development any time soon. Patients are demanding solutions, and whatever the future brings, it will undoubtedly make a massive difference in the lives of millions of people worldwide.
Thanks to my friend and colleague Christopher J Farr for suggesting this topic.