Oh, so what we've seen inside the as I discussed, what we've seen in all of our pre pivotal studies that we revealed across over time is usually a indicate glucose. This is often about about fifteen. Meg's per deciliter decrease than what we noticed with the eyelet pivotal demo, which might correspond to a couple of half a percent decreased a one particular C one particular.
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that's an awesome notion. Also, I don't want to receive off matter before we get on topic. But how come you're an engineer and so personable?
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Yeah. And that's It is all about scalability. So I am going to depart you with this. This Idea, if you consider what the diabetic issues Management issues trial did amongst 1983 and 1993, was to test the speculation, ideal? This was a landmark study, several scientific sites across the region took 1500 people and randomized about 50 % of them into regular therapy, they named it which was not various pictures every day, or insulin pump therapy was just a few pictures on a daily basis. And that and or intensive therapy where they were checking their blood sugar seven times every day, but importantly, they were being providing a number of photographs many times a day or using a pump. And what they located was they could drastically lessen me necessarily mean glucose and HPA when see from the intense therapy group and sustain that for the period of you know, six and also a 50 % years on normal for Every person at a massive hard work around the Portion of the people who randomized to intensive therapy, along with the physicians that supported them, the clinicians that supported them. And they have been testing the speculation back again then it was not recognized that superior glycemic Management was necessary to stave off very long term complications of diabetes. That was that was a contested issue back from the early 80s. And until eventually we had the HBA when C test, and insulin pump therapy and fingerstick meters, we couldn't really examination the speculation.
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And Therefore the FDA proposed that we use that because the predicate system. And we went ahead with that, that submission with that in mind.
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I imply, there's a lot of history, ideal. And we will converse for a complete podcast within the history check here of the. Yeah, obviously. Though the very long plus the wanting it really is we eventually progressed our considering by knowledge that we experienced to develop this factor ourselves from the ground up and soup to nuts.
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Yeah, yeah. So It is really humorous mainly because if you think about the evolution on the of my terminology, I'm going with the nerdiest of terms that you could envision like a geeky engineer. And when you evaluate my slide decks from 2008 910 11, my, my terminology will get worse and even worse. And I hit an all time very low in 2011. So originally, I known as it a closed loop blood glucose Manage program, which just rolls appropriate off your tongue, ideal? And after that I noticed that that's just not, you realize, It truly is an incredibly academic, you realize, issue engineer specifically would say things like that. Then I made an effort to occur up with superior terms. And that i by no means favored artificial pancreas, simply because artificial practice lets you know what it is not. It's not a real pancreas. And we know it's actually not a true pancreas. Can we have anything that's much more descriptive? So my ward, my lowest moment was Once i identified as it a prosthetic pancreas.
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