Omni Loop, A1C Below 7, Finally!

I started looping on the Omnipod last June. Previously, my A1Cs were always about 7.3-7.7, depending on the month and stress, etc, for about 10 years. Never could break 7.

I got my latest A1C results, and I’m at 6.7! Loop has made all the difference. I really think the biggest change is the nighttime control, where Loop keeps my sugars in check, Low and High. I find if I go low at night, I don’t function well the next day (tired!), and my sugars suffer.

Just wanted to share as getting my A1C under 7 has been a long, long term goal for me, and no one I know in my personal life really understands! :slight_smile:

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That’s awesome, and you might even be lower next time, I find the more I fine tune and keep in range, the better my a1c is.

I’ve been able to get very low but I’ve settled in the high 5 range and it’s maintainable. I was reaching for the 4s but I was having lows too often.

Like you my average a1c was around 7 before I started looping

I understand. Thanks for sharing. My doc is talking to me about looping

How do you loop with the OmniPod? I thought you had to have the Horizon system for that, and they are not out with that yet. How are you able to use the OmniPod and loop?

@SherryAnn, I started looping with Eros OmniPod in July 2019. DIY Loop allows much tighter control than OmniPod 5 (new name for Horizon). But it is also more involved to get started. I will stay with DIY Loop even when OmniPod 5 becomes available because I am a fan of tight control.
The following link should answer your questions better than I can:
https://loopkit.github.io/loopdocs/faqs/omnipod-faqs/

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Thanks for the link, Helmut!

Helmut, were you part of the Omnipod 5 trial? What is the basis for your claim of “much tighter control”? Any idea when Loop will be compatible with Omnipod Dash pods?

@Jim2, I was not part of the OmniPod 5 trial. I only have publicly available information about OmniPod 5. From what I read so far, the lowest BG target for OmniPod 5 will be 110 mg/dL. Thus under ideal circumstances this is what your BG will average when using OmniPod 5. DIY Loop has no such restriction. I run my DIY Loop with BG target 80 mg/dL and end up with an average BG of 94 mg/dL. I would not be happy with an average above 100 mg/dL. Loop will be compatible with OmniPod Dash. However, I don’t think the encryption can be hacked and therefore the Loop offered by TidePool will be FDA approved and most likely as constrained as the algo that is built into OmniPod 5. To me it is not obvious that TidePool will have any advantage.

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Thanks, Helmut. I appreciate the explanation. I suppose the FDA is not comfortable with sub-100 target ranges. I wonder if the other closed-loop systems are also restricted in this way?

@Jim2, you are correct. The restriction is FDA imposed and I therefore expect that it will be the same for all pumps. I know that for Tandem it is the same. I always get angry about overregulation. It seems inconsistent that I am allowed to buy a gun but not allowed to set my BG target.

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Just got an email from Insulet telling me that OmniPod Dash is now covered for me with pharmacy benefit. The difference is $40 per 3 months instead of $200. Am I tempted to run my BG 30 mg/dL higher for $160? No.

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I share your emphasis on an ambitious BG target; mine is 83 mg/dL. I also use DIY Loop. I get the FDA’s commitment to safety for the average person wearing an automated insulin dosing system. I believe that normal-target systems (70-90 mg/dL) are only safe when glucose variability is low enough. I’ve found that low glucose variability enables targeting normal sugar levels without increasing risk of severe hypoglycemia.

Perhaps algorithm writers could enable lower (normal) glucose targets only when variability as measured by standard deviation (SD) and coefficient of variation (CV, SD/mean) is below a certain threshold. I’m thinking a 25 mg/dL (1.4 mmol/L) SD and lower might be a good level to start experimenting.

This might not only meet the safety needs of regulators like the FDA but also programmatically educate users that if lower averages (lower A1c) are desired, the way to safely do that is through lower glucose variability. I don’t see this issue talked about much.

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@Terry4, tying BG target to SD is a fantastic idea. It makes too much sense to be adopted by the FDA. T1s with low SD that strive for A1C in the low 5s are so rare that in the eyes of the FDA they might not exist. A lot of them seem to be hanging out here. This might give a false sense of prevalence.

I’d be curious to know if there have been any definitive studies regarding the benefits of an average 85 blood-glucose level as opposed to an average of 110. It seems that I have read that diabetes-related side effects are not significantly improved beyond a certain level of control, but I may be completely wrong about that. Is there evidence to the contrary? Of course, the FDA is much more worried about low episodes, which can be fatal, than squeezing out that extra 20 points of control. Even my doctor feels the same about that.

Here is an 3 March 2021 interview of Tidepool CEO Howard Look by podcaster Stacey Simms. The transcribed section below starts at 26:19.

Stacey Simms: So let’s go back to a bunch of questions about the targets because one of the things that people love so much about DIY, is that they can really set these target ranges for how they want and other things. Um, can you speak to that? What kind of flexibility as compared to what people understand with DIY Loop? May they experience the Tidepool Loop?

Howard Look: Yeah, it’s a super question. The first thing I will say is, we totally understand how the community loves having the flexibility of choosing their own target range set points. And we believe in that as well. That is definitely something that type schoolers [Tidepoolers] who use DIY lube [Loop], understand the value in that my daughter uses DIY Loop . I’ve been very public about that. We did in our submission to the agency proposed flexible set points. We are in review right now, that is something new, and most companies before us have submitted would fix set points or a limited set of set points. That is something that we are discussing with the agency, we’re not yet cleared. So I can’t tell you how that discussion will go. What I can tell you is the agency has been great. They have been so good. During this review. I know a lot of people like to dump on the FDA. I will not do that. Because my experience with the agency has been these are hard working really dedicated public servants that really want the best, safest and most effective solutions for the community. And the questions they have asked us about our clinical study day about how we built the product about cyber security is all completely reasonable. And so I know they are seriously considering it. And we’re hoping we will know the answer to how [emphasis added, I added my corrections to obvious transcription errors]

It looks like to me that Tidepool is doing its best to allow as much DIY Loop flexibility into Tidepool Loop as possible. I am curious, of course, as to what, exactly is meant by flexible set-points. I would be pleasantly surprised if these flexible set-points are made contingent on minimum variability thresholds.

I’m hoping that Tidepool’s unique perspective and good relationship with the FDA will lead to some breakthrough regulatory decisions. I think Howard Look, as a parent of a T1D child who uses DIY Loop, is well-positioned to thread this needle.

We shall see.

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Human evolution, over millions of years, chose to place a high premium on keeping glucose in a very tight range at a relatively low level, 70-90 mg/dL.

While diabetes doctors like to tell us that a 110 average is essentially as good as 85, I am skeptical. Human evolution does not lie and I don’t think we can assign it the human characteristic of obsession. Evolution would not have rewarded tight glucose control in the lower range if there were not some measurable benefit.

I know that it’s extremely difficult for us to manage glucose at an 85 (4.7) average but difficulty should not matter as to what glycemia is best.

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Correct me if I am wrong, but I thought I heard that new omnipod people can’t order the old Eros pods any more. Anyone have any word on how much longer EXISTING customes can order the old pods direct from the company? I have a stockpile, but will stockpile more if there is any danger of not getting them. I pay a 20% copay after my annual dedctable under DME. Not covered yet under my prescription drug side.

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I hadn’t heard that. I hope that is not the case since I use Eros pods for Loop!

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My formulary changed, so I am no longer able to get the old Eros pods. But that is “formulary” not availability.

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Lets hope they keep making them for some time to come. Just in case, just ordered 9 more boxes. Kind of weird. Ever since they forced me to change to Novolog from Humalog I seem to be using a lot less insulin and my pods are going further. I used to have to change them every 24-36 hours. Now I’m closer to the 48 hour mark or later.