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Automated Insulin Delivery

(Artificial Pancreas, Closed Loop)

The development of automated insulin delivery has many names – artificial pancreas, hybrid closed loop, Bionic Pancreas, predictive low glucose suspend – but all share the same goal: using continuous glucose monitors (CGMs) and smart algorithms that automatically adjust insulin delivery via pump. The goal of these products is to reduce/eliminate hypoglycemia, improve time-in-range, and reduce hyperglycemia – especially overnight.

See below for an overview of the automated insulin delivery field, focused on companies working to get products approved. Do-it-yourself automated insulin delivery systems like OpenAPS and Loop are not included here, though they are currently available and used by a growing number of motivated, curious users.

We’ve also included helpful links to articles on specific product and research updates, as well as some key questions.

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 most recently announced public timelines for pivotal studies, FDA submissions, and commercial launches. The organizations are ordered from shortest to longest time to a pivotal study, though these are subject to change and not always directly comparable. This list excludes those without a commercial path to market (e.g., academic groups). The first table focuses on the US, with European-only systems listed in the second table.

Updated: May 31, 2018

US Products

Company/Organization Product Latest Timing in the US

Medtronic

MiniMed 670G/Guardian Sensor 3 – hybrid closed loop that automates basal insulin delivery (still requires meal boluses)

FDA-approved and available in the US, with over 100,000 systems shipped as of May 2018. 

7-13-year-old data was submitted to the FDA as of February 2018; no news yet of approval. 

2-6-year-old study wrapping up soon. 

Tandem

Basal-IQ: t:slim X2 pump with built-in predictive low glucose suspend (PLGS) algorithm; Dexcom G5 CGM

Control-IQ: t:slim X2 pump with built-in hybrid closed loop algorithm and Dexcom G6 CGM. Algorithm includes automatic correction boluses for high blood sugars. 

Currently under FDA review, with launch expected in summer 2018. Current t:slim X2 users will get a free software update. Dexcom G6 to be added by the end of 2018. 

Launch expected in the first half of 2019. Pivotal trial to begin by the end of June 2018.  

Bigfoot Biomedical 

Smartphone app, insulin pump (acquired from Asante), and a next-gen version of Abbott's FreeStyle Libre CGM sensor with continuous communication. 

The smartphone is expected to serve as the only user interface (no pump screen). 

Launch expected in 2020; pivotal trial beginning in early 2019. 

Insulet

OmniPod Horizon: pod with built-in Bluetooth and embedded hybrid closed loop algorithm, Dash touchscreen handheld, and Dexcom G6 CGM

User will remain in closed loop even when Dash handheld is out of range

Launch in “probably 2020 timeframe.” Five-day hotel study completed in pediatrics down to age two years, with data to be shared in June. Insulet will do at least one more study before a pivotal trial.

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

Will launch as an insulin-only system first, with glucagon to be optionally added later. 

Currently using Zealand’s pumpable glucagon analog

Insulin-only: Launch expected in 2020. First home study with iLet device can now begin recruiting. Pivotal trial to start around April 2019.

Insulin+glucagon (bihormonal): Launch timing depends on stable glucagon approval, among other things. Pivotal trial expected to start around June 2019, though this could change.

Lilly

Pump with infusion set, wireless control from a handheld and/or app (no on-pump screen), Dexcom G6 CGM, Class AP hybrid closed loop algorithm

Launch expected in late 2019 or 2020. First study completed.

WaveForm (AgaMatrix)

Plans to develop a closed-loop system with its own CGM, pump, and algorithm.

Development to begin in 2018, pump plans unannounced

European Products

Company/Organization Product Latest Timing in Europe

Medtronic

MiniMed 640G/Enlite Enhanced – predictive low glucose management

MiniMed 670G/Guardian Sensor 3 – hybrid closed loop that automates basal insulin delivery (still requires meal boluses)

Currently available in Europe

European approval (CE Mark) process currently underway, with a launch to follow in select countries.

Diabeloop

Diabeloop algorithm running on a wireless handheld, Cellnovo or Kaleido patch pump, Dexcom G5 CGM

Launch expected in 2018 in France, the Netherlands, and Sweden. Two-arm CE Mark trial ongoing.

Roche, Senseonics, TypeZero

Will use Senseonics’ 180-day CGM sensor, Roche pump, and TypeZero hybrid closed loop algorithm

Pivotal trial expected to begin in Europe in the second half of 2018

Joined JDRF Open Protocol Initiative in early 2018

Cellnovo, TypeZero

Cellnovo patch pump with integrated TypeZero algorithm; presumably a Dexcom CGM

First in-human, three-day trial to begin in June 2018

EOFlow

Tubeless patch pump and TypeZero algorithm, no CGM partner announced. JDRF is offering funding support

Development to begin in 2018, with approval expected in early 2019 and expected launch in Asia

Ypsomed

Closed loop system with YpsoPump (tubed pump), CGM (company not named), and myLife Control smartphone app (allows remote blousing)

CGM integration expected within the next year. Currently in discussions with algorithm developers

Helpful Links

Medtronic: MiniMed 670G

Tandem

Insulet

Bigfoot

Beta Bionics

Test Drives:

test drive - Kelly and Adam's experience with the Dexcom G6; head-to-head comparisons with the G5 reveal what's working great and what could be better. 

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.

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. Our research trial experience with automated insulin delivery 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. 

What fraction of patients will be willing to wear some type of automated insulin delivery system? Right now, many estimate that ~30% of US type 1's wear a pump, and about 20% wear CGM. There are a lot of reasons why that may be the case, including cost, hassle, no perceived benefit, no desire to switch from current therapy, wearing a device on the body, alarm fatigue, etc. Will automated insulin delivery address enough of these challenges to expand the market?

Will healthcare providers embrace automated insulin delivery? Today, healthcare providers lose money when they prescribe pumps and CGM – they are very time consuming to train, prescribe, and obtain reimbursement for. We need to make sure that automated insulin delivery 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 for a wide population of patients. We are optimistic that reimbursement will be there, especially if systems can simultaneously lower A1c, reduce hypoglycemia, and improve time-in-range.

What’s the right balance between automation and human manual input? The holy grail is a fully-automated, reactive closed loop that requires no meal or exercise input. But insulin needs to get faster to make that a reality. For now, daytime systems need to deal with balancing human input with automation, and there’s an associated patient learning curve. How much should automated insulin delivery 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?

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. An insulin+glucagon system could be helpful for those with hypoglycemia unawareness, and if such a system makes it to the market, some patients will certainly 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. An insulin+glucagon system certainly brings multiple cost elements to consider – a second hormone, 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 to insulin-only systems.