Medtronic gets FDA Breakthrough approval for closed loop system

Diabetes Technology
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New system is not a hybrid but a true closed loop system not requiring Bolus for food or corrections.

FEBRUARY 19, 2019 BY SARAH FAULKNER

Medtronic logo updatedMedtronic (NYSE:MDT) said today that it won breakthrough status from the FDA for its investigational personalized closed-loop insulin pump system.

The company touted its technology as enabling automated insulin delivery in a real-time, adaptable and personalized fashion.

Medtronic’s November acquisition of nutrition data science company Nutrino Health will play a role in the development of its closed-loop insulin pump system, according to the medtech titan.

“We are very excited to receive the Breakthrough Device designation from the FDA as it will help us deliver this broadly anticipated innovation to patients much sooner than expected,” Alejandro Galindo, president of the advanced insulin management division within Medtronic’s diabetes business, said in prepared remarks.

“We believe the personalized closed loop system will be transformational for diabetes management, and the personalized nature of the algorithm clears the path to a true closed loop system. We have a long history of partnership with the FDA and look forward to another successful collaboration with the agency to bring this important innovation to patients,” Galindo added.

“It is incredibly rewarding as an endocrinologist to see this novel closed loop innovation in development as it holds significant promise for simplifying diabetes management and taking on much more of the work on behalf of the patient,” Dr. Kevin Kaiserman, a pediatric endocrinologist at SoCal Diabetes, said.

Medtronic was the first to win FDA approval for a hybrid closed-loop insulin delivery system. The FDA approved Medtronic’s MiniMed 670G system in September of 2016.

A hybrid closed-loop system, as the name suggests, is not fully automated – it still requires users to manually enter food data and correct insulin boluses.

In June last year, the FDA expanded its approval for Medtronic’s MiniMed 670G system to include people ages 7 to 13 with Type I diabetes.

Medtronic is also working with IBM Watson on a feature for its Sugar.IQ personal diabetes assistant app that can predict the likelihood of a low glucose event within a four-hour window.

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That sounds great, but I would be a little bit nervous or skeptical due to some of the problems I have had with the current CGM. Although reasonably good, it does occasionally have inaccuracies.

I would think this would always be true, or at least the food data part. A CGM that is 100% perfect may be able to calculate insulin amount for your current BG, but it cannot tell the future, and because insulin does not have an instantaneous action, telling it how much food you will be eating is the only way to do a bolus beforehand, otherwise you will always end up high. For those of you that are currently using the 670G, one thing that I am sure most of you would like that can easily be done is raise the amount used in the microboluses (to avoid the Max Delivery when it is actually doing an appropriate amount), or to do a better accommodation for underestimated carbs. So there are features that can be better, and new technologies that may be able to be used, but no device will ever be able to predict the future, so we will always need to provide some input.

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As FYI, the breakthrough designation is not on current products, it is for products under development. I do not believe Medtronic has provided any firm timeline but rather rough guesses as to when such development may be available as an approved product.

In terms of cgm predicting the future, Medtronic already has that with their current cgm and Watson where they are advertising they can now predict Hypos up to 4 hours in advance.

Certainly I find that amazing but I am sure it is an accurate claim or the FDA would never have allowed them to market such.

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They should work on correctly predicting the “present” before they start working on predicting the future.

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I think you misunderstood what I meant when referring to the future. I was referring to how many carbs someone plans on eating. For example, does somebody plan on eating 8 or 80 carbs? Without knowing this, the CGM may be able to attempt to avoid hypos & hypers based on current & previous numbers & patterns and what speed numbers are changing, but what if I go to a party and have more carbs than usual? What if I end up eating off schedule? Once the insulin is in you, it cannot be taken out, so if you have an unusual day, or if you have an inconsistent schedule, there is a limit as to how much should be injected without confirmation. Correction boluses & microboluses, on the other hand, should be completely automated, since they are based 100% on data provided by the CGM.

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No. There was no misunderstanding on my part.

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The article claims that no Bolus is needed for eating or corrections. I assume the new system will be sensitive to rising BGs and will increase the micro boluses to compensate for the rising BGs. Currently, the 670G system maxes out at a determined level and actually exits auto mode when maximum micro boluses continue for two hours or so.

This is going to be the tricky part and will need a lot of testing before final approval.

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IMO, that means the system would be “chasing” a rising bg–something I’ve never found to be a suitable method for dealing with carb intake, and I’ve been at this diabetes thing for over 40 years. Not once, has a belated meal bolus been a smart, or useful thing, for me to do, EVER. If my bg’s are stable prior to a meal and I bolus say 10-15 minutes prior to eating something with carbs, my bg’s will end up at a far more decent level, than if I eat first, bolus later. No. That is not the way to use insulins currently on the market such as Novolog and Humalog.

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Maybe it would work good for Pizza?

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I dunno Tim. I switched from doing extended boluses for pizza (back when I used to eat TOO MUCH pizza in one sitting), to bolusing when I start eating (2-1/2 pieces of a large pizza) and it works out pretty well. I wouldn’t want to “chase” bg’s even when eating pizza. I think there is a big difference between eating a reasonable amount of pizza and eating a “fun”, filling amount of pizza, as regards to how to best dole out the bolus. I know that I sure do it differently now that I don’t eat such huge portions.

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I agree that one slice of pizza might not work with a belated meal bolus.

But I think 3 slices of pizza might work well with a belated meal bolus.

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I’m sorta on a diet right now…you are killing me!! :slight_smile:

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If I Bolus 25 carbs per slice of pizza 15 minutes prior to eating, I usually end up with a slight high e.g. 165 - 175 about 30 minutes later. However, if I wait until I start eating or later, 200 plus is a guarantee and will take several hours and additional corrections to get back to my normal range.

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That would be approximately the predicament I’d be in also, Don.

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I’m just gonna say it. This seems like another wildly inflated claim, by Medtronic, about what their device can do. Their history of wild exaggeration regarding device performance is enough for me to predict disaster for diabetics. This sounds like the most dangerous system ever invented. I fear it. I fear for our community.

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For me there’s a weird regressive aspect to this stuff that I first experienced with the 670G. I wasn’t really expecting it, and it took me a while to recognize what it was. But basically it was this: In the old days I was shackled to a regimen, R/N, that forced you to arrange your life to fit your medication, but ever since then every major advance I’ve experienced over 35 years, from R/N to MDI with analogs to using a pump & CGM, has been in the direction of giving me more control over my dosing, putting more tools into my hands But the 670G for me felt like a step in the opposite direction. It was supposed to make it so you didn’t have to do anything, and in the abstract that sounded good. But where the promise was “We’ll take all the worry and fuss out of managing your BG—you’ll hardly have to do a thing,” the reality was “Let’s just take your grubby little fingers off the controls dear boy, we’ll lock those away so you can’t hurt yourself, and you just trust us to handle it from now on.” To me it felt like the manacles that had been thrown off when I got off R/N were in some sense being put back on again, because when things went wrong I couldn’t do anything about it. It was so unexpected that it took me a while to recognize that what I was sensing was basically a species of that same It’s gonna do what it wants and I don’t have a say! feeling that I had back in the bad old R/N Eat Now or DIE days. The promise was that it would be more freeing, but in practice I ended up spending vastly too much of my time serving my pump’s needs rather than it serving mine.

All of which is a long lead up to saying this new thing looks like they’re launching themselves even further down that road without having learned anything from the failures of the 670G—and by the comments and complaints you see on all the forums and FB groups, those failures have been many. I understand how the “hands off, we’ll do it all!” promise might sound like a godsend, especially for parents, who end up stuck in the impossible position of making those decisions for someone else. But the rest of us don’t need to be treated like kids who aren’t competent to make parameter adjustments to tailor the thing to our peculiar metabolisms and needs. We need more tools put back under our own control, not fewer. You’d think the user feedback would have brought that to their attention, but apparently they believe the holy grail is eliminating all patient input or control from the system, and that carries over into eliminating it from their development process as well. There’s no end of testimony online that they have fallen short of proving the necessary level of competence with their existing pump, whose goals are more modest, and I think that’s basically because the complexities of the problem are just greater than they’re allowing themselves to recognize. I think there are approaches to this that will ultimately work, but I suspect they’re going to emerge from the efforts of the open-source DIY looping community, not this lockdown mentality that Medtronic is committing itself to.

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This is similar to what OpenAPS and AndroidAPS do. They have a feature called “unannounced meals” (UAMs) that handle stuff like that. The authors themselves state that relying on UAMs alone makes a somewhat okay BG control possible, but pre-bolusing and/or preferring food that doesn’t spike your BG helps the system a ton.

I too think that these claims are inflated. From what I gather, what AndroidAPS/OpenAPS users do is to guesstimate the carbs (with a pre-bolus) and then let the closed loop take care of any unexpected BG rises/falls. This means that the pre-meal bolus is administered as usual, and the loop merely does corrective work. This is much more doable, and I suppose this is where Medtronic is actually headed. Perhaps they even simplify the bolus announcement that you only specify something like “few carbs” / “lots of carbs”.

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That would make sense. But if the Medt. system is going to do it, they’re going to have to let it be a lot more aggressive about catch-up/correction dosing than the 670 is.

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What Medtronic is trying to do is to move towards the creation of a true artificial pancreas. The “breakthrough” closed loop system is moving closer to this goal. Unfortunately, we have to endure their trial and error process before reaching their final goal.

I for one applaud their efforts and am will to live with the short comings which I feel are more than off-set by the improved benefits of each successive generation.

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I’m with Eddie2. Can’t accurately measure the present, no starting point for the future. Useless to me.

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