Now, many people who do that and do well with that are heading in order to utilize the eyelet successfully and easily, there may be an adjustment that they need to make and become accustomed to handing the steering wheel off to some autonomous procedure. But they might sometimes make the adjustment. You can find Other people who won't be capable to, It's going to provoke a lot of panic, and they just would not get as a result of it. And the truth is, you don't know what form of particular person that you are until eventually you try it. So residing with the eyelid is the sole method to find out if you can Allow go the wheel as he likes to say Yeah, and so We'll give a ninety working day return coverage with the island. So we want to make certain we really want to make sure that the correct persons find this unit. But we also want to make certain that those that just find that the system is just not ideal for them. Find a way to a tool that is really a loop system or more of the guide technique where you obtain in, you understand, you normally takes a lot more duty for insulin dosing.
issues we did? Great question. So we experienced we had focus groups at the conclusion of the demo. So we worked with Joe Weisberg, ventral she's up in Chicago, and he or she works in the Lurie Children's Medical center. And so she's an expert in psychosocial and behavioral results when it comes to studying diabetic issues systems. So she created, validated, behavioral psychosocial checks questionnaires that we gave through the entire study. And also ran the focus teams at the tip for men and women since they arrived off the unit. So that was qualitative. So we have these quantitative questionnaires. Then We now have these qualitative focus groups at the top. So we did get to find out, you realize, how people today felt about things such as diabetic issues, distress, worry of hyperglycemia, but in addition just sort of qualitative actions of how how people experience concerning the eyelet. And that i do Imagine you might be ideal relating to this providing up of carbohydrate counting this diabetes without numbers is really important to individuals because we're endeavoring to say that we really hope this unit is agnostic to levels of literacy and numeracy to levels of to complex acumen to socioeconomic position, race, ethnicity, and so we did lots of work.
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okay, but when I pop I just get someone to write me a script For additional and so It really is I have hardly ever ideal, I am gonna I'm gonna seem odd to get a second.
I think you are going to be finding your way to the clinic in that scenario. But what we did see within our, within our pre pivotal studies is that you happen to be, you understand, right away, where you're finding just Basal insulin right away, so you are not aquiring a ton of insulin, which helps keep glycogen. And you are not taking in in the least, and you've been fasted for an incredibly lengthy time. So you bought no carbohydrates for seven or 8 or 10 or 12 hours, correct? Because you went to school, because you had your supper went to snooze. After they received up for the morning in the morning at 7am. And they start becoming Lively and there, they there could start off heading low, you would see these minimal pictures of glucagon, small tiny micro doses at 6am and 7am.
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Just before 510 K clearance, which we only obtained, you are aware of, just fewer about four months, little below four months back, when we bought 510 K clearance, we can This website easily start moving into into a agreement with CMS. And that takes anywhere between, you recognize, two and three months. So any person on Medicare Medicaid Services, needs to be aware of that we will not get it out to them right away Because there was no way we could have teed that up
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