Awesome!!! Finally!!!
Estimated Enrollment: 90
Anticipated Study Start Date: August 2017
Estimated Study Completion Date: November 2017
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Good news indeed! Hopefully they can keep up the momentum and regain some of the glory before the UHC deal went down.
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I am not a fan of UHC. They are too big to be in the business of picking the winners and the losers. Deals like the UHC/Medtronic are horrible for free market competition and innovation.
It would be great to have 10 different pump manufactures all competing for business and striving for the best technology and potentially catering to different groups of users. The last thing we need is a single monolithic device company supported by a gargantuan insurance company which no longer has any reason for research and innovation.
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Can’t agree with you more. We need innovation, not stagnation. Plus big blue’s customer support isn’t even in the same zip code as Tandems. I would hate to be beholden to that companies pumps.
When insurance companies cut deals that limit choice, bad things are afoot.
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I hope they use better logic with their algorithm than what I heard about for the Medtronic 640G and 670G pumps…
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You mean like non-adjustable target of 120? Because everybody is the same and everybody wants the same target at all times?
Yeah - I hope so…
BTW - We applied for the trial (some time back). Waiting to hear back if we can get in.
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Can’t speak to the logic question, but likely first generation systems will all suffer from similar issues, since the regulatory pathway shapes almost every decision. Once more than one algorithm is out in the market, then the real innovation will occur since each company will be bashing the others brains in with marketing materials, and then someone will come up with the smart idea to further innovate, and voila, the customer wins.
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I have heard the 670G gives you a target choice of 120 or 150. I find that funny, since the high alert on my Dexcom is set at 140 at night.
The problem is when the first generation becomes the standard, and everyone thinks they need to do the same thing so they don’t have to fight the FDA. The FDA begins to think the 120 or 150 targets are the standard, and anything outside of that standard requires a fight, which the pump companies don’t want to engage in…
Sorry, I don’t want to hijack this thread!
Awesome news for the Tandem users.
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That does appear correct.
670g manual:
“The standard Auto Mode target is 120 mg/dL. You can temporarily change your Auto Mode target to 150 mg/dL for exercise, or other times you would like the Auto Mode target raised.”
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True to a point. Honestly, the reason they choose the numbers they choose, is the FDA agreed with the methodology that Medtronic presented.
Having the FDA bless setting the target of 100 or 90 is going to require a study since the FDA physician advisors would say that these settings will increase the amount of hypoglycemic events. The good news is once the algorithm is out, these types are studies are pretty easy to do.
Now whether the companies will decide the advantage is worth paying for. who knows. I hope so…
Other ways to get what you want is to have the open source folks crack the existing system and over-ride it.
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It seems like it would be a bigger fight with the FDA to get 90 approved instead of 120, right? So the only reason a company would invest in a bigger fight is if it’s worth it to them. When people say “no” to 120, and the companies have to push the envelope a bit to get users to switch.
Is that how you see it?
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But when UHC steps in and removes the choice for a massive amount of people then the entire equation changes.
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That is exactly how I see it. But the open question, is how many users are there that want to push the envelope compared to the total pump population at a company. If it is large, then great, if not, then it will be slow going.
Also, some times companies get lucky and put in functionality and the reviewer at FDA doesn’t completely understand the significance, and they let it slide through. We can hope for either way.
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I don’t have a lot of confidence it will happen. The companies usually choose the easier route.
I have never qualified for a clinical study because they always say my A1C is too low. It is much easier for them to take a higher number and prove they can bring it down, than it is to take a lower number and prove they can maintain it.
So the people they take in for the clinical studies, with the higher A1C’s, will embrace the 120 or 150 target. And the rest of us will just be left on the outside looking in.
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Having the FDA bless setting the target of 100 or 90 is going to require a study since the FDA physician advisors would say that these settings will increase the amount of hypoglycemic events.
My guess is that with the average person with diabetes, lowering the target to 100 or 90 WILL result in more hypoglycemic events, at least in a clniical trial. I mean I haven’t crunched the numbers but my impression is that the underlying parameters (insulin DIA, time to peak, plus people’s unique combination of ISF, carbF, etc. etc.) dictate how much wiggle around the target you can contain. With our son, his overnight target is 115 I believe… he routinely drops down into the mid-70s and goes up into the 160s. I’m sure it’s harder because his parameter set is that of a toddler, but I can’t imagine that most people with diabetes don’t at least a +/- 20 mg/DL wiggle around a set point during sleep.
That’s not to say a lower target can’t be safer for PWD, but many probably don’t know about things like how soon to treat with carbs to preempt a low, and if you’re in pure auto-mode, you can’t use your own instinctive knowledge to, say, set a zero temp basal earlier than you might otherwise, etc.
Then again, the Medtronic algorithm seems to be using some kind of machine learning whereas what we use is pretty “dumb” in the sense that there’s no adaptive learning. So maybe they actually could get tighter targets if they were less scared.
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While I (we) like to embrace change, the majority of folks don’t adopt so readily. I suspect that your read on the functionality is correct. At least the technology will help some folks. We could live if they would allow a target of 100, but 120 isn’t that helpful, except maybe at night where it could keep some highs in check.
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That’s exactly where I am with it. 120 at night would be acceptable for me. Not ideal, but I could tolerate it. But not during the day.
Eric, You would be great for their R&D division. I bet they would seriously LOVE working with you.
Clinical trials for FDA? lol. Probably not so much.
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I looked at the Tandem seriously. I wanted to set it up as a watch, and have the tube connect to my forearm. That would have been super easy to use. CGM and insulin in one place, and wearing it like a watch would be somewhat like tubeless, in that I wouldn’t need to worry about disconnecting for showers or changing pants or going to the bathroom or activities. It would just be like leaving a watch on all the time. Like when I wear a watch for running.
Anyway, that was one route I considered.
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Wow, this sounds very Doc from “Back to the Future”!
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