Great diaTribe review: 2016: A Pivotal Year for Closed Loop/Automated Insulin Delivery

Adam Brown and Brian Levine over at diaTribe.org have written a great retrospective and summary of 2016 and the hybrid closed loop technology.

It just came out a few days ago and it comprehensively examines all the various enterprises now focusing on artificial pancreas systems. It’s well worth the time to read. It gives a nice chronological coverage of all the players:

This year also included pivotal updates from at least five other players planning to launch systems in the next few years, including Tandem (launches expected in late 2017 and in 2018), Bigfoot Biomedical (pivotal study in mid-2017), Beta Bionics (insulin-only pivotal study in the second half of 2017), Animas (expected launch in late 2018/early 2019), and Insulet (expected launch in late 2019). We dive into all these systems below in more detail, in order of time to market.

They even give a nod to the do-it-yourself, “we are not waiting movement” who have already adopted technology that may take the commercial efforts years to catch-up:

In the meantime, an estimated 100+ people with diabetes globally are not waiting for industry and have built their own do-it-yourself (DIY) automated insulin delivery systems, logging an estimated several hundred thousand real-world “loop hours.” There are now multiple DIY systems in the open-source community, including OpenAPS, Loop, and AndroidAPS. We’ll have a test drive on Loop – which Adam has found very helpful overnight – in early 2017.

Can’t wait for Insulet’s closed loop system!

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This article illustrates exactly why I am hoping my severely cracked, fading Ping lasts until at least one of these new semi-automated pumps comes to Canada. I almost got a Vibe, but I just couldn’t do it. The Vibe already feels outdated to me, and I backed out when I couldn’t stand the idea of getting a Vibe and then having a semi-automated system come along a year or two later. Since the Medtronic pump is likely going to be the first to make it (the 630G is coming to Canada within months, and I’m hoping the 670G would follow shortly), this may mean that I end up giving up the Dexcom and switch to that system. But I don’t care—I think the semi-automated systems, even the first ones, will be a huge step forward in diabetes management for many of us.

@Jen, I wish I could join you in your excitement. I want to wake up in the morning at 100 mg/dL or below. And I already do. Having a fancy system that forces my BG to 120 mg/dL is a threat. Unless I am able to set the target to a healthy level (= 85mg/dL), I am not interested.

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I understand that there are some people who can do a better job than the automated systems. I am not one of those people. Waking up at 120 mg/dl every single morning would be an improvement over my current level of control. That is true of the majority of people living with Type 1, I think.

These are just the first generation semi-automated systems, so things will get better and more sophisticated with time. I understand wanting to wait if they won’t likely offer you any benefit. I don’t think anyone will be forced to use them. I’ll be curious to see whether the semi-automation can be turned on or off depending on different circumstances.

My understanding is that the 120 mg/dl limit was an FDA requirement rather than any kind of limitation of the pump itself. The FDA has no jurisdiction outside of the USA, so it will be interested whether Health Canada requires a similar limitation.

I fully agree with Jen. Sure it will be nice to have an all-in-one solution, so that I don’t need a phone + a “modem” between the phone and the pump BUT I consider 120mg/dl to be on the border of high reading and prefer to wake up in the 80-100 range as well. My biggest fear now is that my old pump will die on me which means no more looping.

Last night consisted of me waking up three times to my Dexcom high alert and issuing corrections only to finally wake up for good this morning at 138 mg/dl. If a semi-closed loop system can do that for me automatically and get better results (120 mg/dl), then yes, please!!! Being able to sleep through the night alone will be worth it.

Does anyone know the algorithm that Medtronic 670G will be using? Specifically, how much they will give for corrections based on your CGM reading, and whether that number is tied to a % of your current basal, or if it is based on a correction rate you have entered?

I am wondering if it will be a one-size-fits-all type of algorithm, or if the user will have some control over it.

Some things I learned about the 630G algorithm struck me as being kind of lame.

It appears that there are several different AP systems in the pipeline. I hope that most or all are viable to make it to market. More choices will serve us well.

Jen, you made a good call on the Vibe. I remember I wanted on at one point in time, too. But when It delayed for so long before it appeared in the US and capped Dexcom integration to the G4 technology, I decided against pursuing it also.

You make a valid point here. If you can confidently go to sleep without any highs or lows to wake you and then rise consistently with a BG of 120 mg/dL (6.7 mmol/L), that’s a definite improvement for many. I would feel better about the 670G if it’s firmware were able to be updated to permit a user selected target BG at some point in the future. That feature alone could possibly span the interest of both you and @Helmut.

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I don’t think those details are available, yet. The article does state that the 670G will adjust basal insulin based on blood sugar levels. I’ve now lived with a basal adjusting AP (Loop) for about a month and I continue to be impressed with how potent that tactic is. I’m also surprised that the Loop can make these calls far sooner than I would as a human watching the trends.

I wonder if ultimately - if the Medtronic algorithm doesn’t allow users to control it much themselves - the end result will be people fooling the CGM into a different value. For example, if they won’t let you target a number lower than 120, then people may just make the CGM “think” their 100 is 120. But then you have to keep track of how your CGM number is off by 20 points.

A lot to be said for being able to do it yourself, instead of relying on an algorithm you can’t change…

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I think people need to keep in mind these are first-generation systems… Just becuase there’s a set value now doesn’t mean that will always be the case. In this first system, it would not surprise me if the automated part is an option that you can turn on or off. (And, remember, it’s only the basal that’s automated, so the user can still deliver a bolus whenever they want.) Maybe have it on at night or on diffiuclt days and off on days when you feel you can do a better job than the computer. By the time these systems have been around for five or ten years, I’m sure they will be sophisticated enough that a user will be able to set their own target value.

I agree, I wouldn’t want the sw to decide my target BG. It’s like having a doctor decide one’s target BG and many still do or try to!:frowning: