Omnipod Closed-Loop Study Results at ATTD in Paris

As of right now, I don’t think any commercial systems have this planned. I think the FDA will always make this difficult for the pump makers to achieve, and I find that extremely short-sighted and frustrating.

I gave the example of the new Medtronic 670G using 120 or 150 targets (that’s just from what Medtronic told me, I don’t have one and have never tried one). They will have a thing where it automatically adjusts basal insulin, but how much control do users have over that? How much adjustment does it make, and can we alter it for ourselves based on our own needs?

Medtronic has been extremely tight-lipped about their algorithm, but I suspect everything is percentage based. So maybe as your BG starts to drop, it cuts it by X%, and X increases the closer you get to your low target. But the ideal X% isn’t the same for everyone. And it also isn’t the same depending on time-of-day, or how recently you bolused and ate.

Here is another example of FDA mandated silliness. In Medtronic’s current version (630G) , it suspends basal insulin for a low, but after 2 hours it resumes it, EVEN IF YOU ARE STILL BELOW YOUR LOW TARGET!! Crazy, right? I asked Medtronic why they would resume if you are still below target, and they said the FDA made them because of fears of DKA.
(Medtronic users, please correct me if that is wrong).

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It’s been a while, but as I recall, this is the same reason that OmniPod does not allow for a programmed basal of zero. Being able to program a zero basal would have precluded my need to get up and set a temp basal to “off” in the middle of the night when Caleb was little. I don’t see how the FDA can’t see that there are equal risks. Using an insulin pump is inherently risky. While I understand the risk of DKA, this rule completely ignores the risk of hypoglycemia.

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That’s funny, because what I heard is that Omnipod does that to prevent occlusion! When the cannula is totally inactive for extended periods of time, it is more likely to become blocked. By spitting out 0.05 units of insulin once per hour, they feel that it will help prevent the occlusion.

I had the same debate with their corporate, and explained that I can create a temp basal of ZERO for 12 hours, so it makes no sense that I can’t have a ZERO basal that is programmed. And I got no valid answer to that. And whenever you get no valid answer, that usually means…FDA!!

Ultimately the sticking point for me is that while I may not know the most about the disease, I certainly know more about how to treat myself than anyone else. And the same for you. The best Endos in the world still don’t know as much about Caleb’s requirements as you do. Certainly we each know our own circumstances better than a one-size-fits all algorithm. That’s why I am a bit skeptical with the initial stuff. Perhaps eventually it will get there?

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I’ve heard this, but from doctors, not Insulet. I think this is a more valid reason than avoiding DKA.

We can hope! I’ll always want things more immediately, but in just the 10 years that Caleb’s been dealing with this, there have been remarkable advances in technology and I’m optimistic it will only get better, even if not at the pace I’d like. :wink:

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I can’t verify this, even though I am using the Medtronic 630G system, because I’ve never been in the situation where I won’t react to an insulin suspend event and wait for two hours sitting at below target level. I don’t think anyone will. But even in the highly hypothetical situation you describe, if the insulin is indeed activated again in 2 hours, yet the sensor is still registering lower than target BG values, all that will happen is that a new suspend event will kick in within 5 minutes. So I really can’t take this as strong evidence of “FDA mandated silliness.”

The FDA, as well as all commercial DME producers have a tight rope to walk of approving / providing technology that minimizes the chance of killing their customers (whether via hypo or DKA). I try to keep that in mind for some perspective. They are by design risk averse, so when any new technology comes out, my personal question is not “does this manage to reproduce ideally the function of my (read “everybody’s” since I am not going to be the sole user) compromised pancreas” but “does this provide marginal improvement on what I am currently doing, either by providing better control or by taking some of the effort away”. I think it’s hard not to get excited about closed-loop advances when viewed in this light.

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I understand your point. And certainly it could take some of the effort away.

But currently I have limited reason to think it would make my control better. When they are able to give me 4.9 A1C’s like I’ve done with injections, then I’d be all aboard.

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Looking forward to it! :slight_smile:

Or an uncle who can help us… LOL!

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As an OpenAPS user, I’d say that the issue for the FDA and by association, the manufacturers, is that most people aren’t diabetes ninjas and don’t manage in a way that many in this topic do.

If you’re the FDA, you’re mandating for those guys and not the top 20th percentile, which means you make it as foolproof as possible.

What would be much better is for there to be a pump maker providing an accessible pump that allows access to those who want the ability to tweak, while anyone else can buy something off the shelf that just works, and saves them effort in managing themselves.

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Probably the best explanation I’ve heard so far. “We live in a world of idiots”.

It’s been almost 1 year since these results. Does anyone have any updates on this topic? Are there any known case studies going on at Insulet regarding their new Horizon system?

Thanks.

@anon85331563
The Dexcom CEO made this comment during his last earnings call on Nov 1, 2017:
Probably not exactly what you are looking for but if nothing else, it is encouraging.

Insulet has shown tremendous dedication to our partnership and our teams are working hard to bring our connected systems to market. Once launched, we see a number of differentiating features in our combined systems including an attractive form factor and opportunities for a smartphone connectivity. In the meantime, we have embarked on a few commercial activities together and will continue to work with Insulet to deliver attractive options for our shared patients.

Thanks @Tim35. This study from last Feb was only on 24 patients and only for 36 hours. All pumpers can agree that this is a very short time frame to gauge efficacy of their algorithm.

I would like to see some longer time studies being published soon. As @Annabella keenly pointed out in this thread, how will it behave with absorption issues and incorrect sensor reading… etc.

Thanks.

The new PDM will be out this year but won’t include the loop yet. The Horizon loop is expected in 2019.

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