#1266 Dr. Tom Blevins on Inhaled Insulin

July 30, 2024Scott Benner

Dr. Blevins is back to talk about the inhaled insulin called Afrezza.

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Scott Benner 0:00
Hello friends and welcome to episode 1266 of the Juicebox Podcast.

Hey Dr. Blevins is back today to speak about Frezza the inhaled insulin. You know, I love Dr. Blevins on the GLP episode so I thought, I wonder what else this guy knows about today we're gonna find out. He actually runs a lot of studies out of his Austin practice. So if you're interested in some type one studies, you should reach out to him he tells you how towards the end. Please don't forget that nothing you hear on the Juicebox Podcast should be considered advice, medical or otherwise, always consult a physician before making any changes to your healthcare plan or becoming bold with insulin. Don't forget, if you use my link drink ag one.com/juice box you'll get a free year supply of vitamin D and five free travel packs with your first order. And if you go to cozy earth.com and use the offer code juice box at checkout, you're gonna save 30% off of your entire order. Kids don't forget he won the exchange.org/juice box if you're a type one, or the caregiver of a type one and a US resident I need one and would love if you would go over there join the registry complete the survey takes about 10 minutes you're going to be helping type one diabetes research while you're supporting yourself and me.

This episode of The Juicebox Podcast is sponsored by the only implantable sensor rated for long term wear up to six months. The ever since CGM ever since cgm.com/juicebox. This episode of The Juicebox Podcast is sponsored by us med us med.com/juice box or call 888-721-1514 Get your supplies the same way we do from us med this show is sponsored today by the glucagon that my daughter carries. G voc hypo Penn. Find out more at G voc glucagon.com. Forward slash juicebox. Everyone Dr. Blevins is back, you might know him from some of the GLP conversations we've had recently. But today he's here to talk about a Frezza which is of course, the inhaled insulin. Dr. Blevins Welcome back,

Dr. Blevins 2:24
Scott Good to be here. I do want to point out to the audience that I participated in one of the studies with a Frezza are actually a couple of studies. And I'm actually one of their advisors. So keep that in mind. And it's great to be here. I think this is a this is a type of insulin that everyone wants or needs to know about. Why do you think? Well, I think it's because, number one, it is unique, and is quite unique. And it's kind of less known about and people need to know about it as an option. And it's, it's unique in that it gets in so quickly. First of all, it's inhale that's unique. And it gets in very quickly and out very quickly. And I'm going to talk more about that. Right.

Scott Benner 3:08
So how long has a President been in the marketplace? You

Dr. Blevins 3:13
know, I think if you ask people how long they would say, oh, it's brand new. And the answer is just not at all. It was approved by the FDA in 2014. And it started off being licensed to Sanofi. And then it returned to the company called mankind where it which is where it exists right now, the company mankind in 2016. Some people may remember that in, in the past, a very, very impressive person named Al Mann actually developed the the insulin, he saw this potential of dry powder. And he knew that if it was inhaled, it would get into blood very quickly. And he put a lot of his own money into it. And you might also remember that he was the guy that helped develop the mini med Medtronic insulin pump. No kidding.

Scott Benner 4:03
Yeah, about that. Listen, when people are passionate about things, that's how you get different and change, you know, because it's easy to get behind the thing that exists. But if you have this kind of, because it's not so much well, not that it's not difficult to make something work. But once you make it work, it's the selling it part. And I don't mean the financial part. I mean that explaining it to people and letting them know what it is and getting them to try. Like, that's where a lot of the really difficult work is because yeah, so that's what I don't want. Like, I don't want to be a barrier for people listening, because I was presented with the idea of letting art and use inhaled insulin. I mean, forever ago, and I said, I don't know enough about it. And, you know, just hearing what I'm hearing. I'm like, I don't know how thrilled I am about my daughter just inhaling something. And she was young, so we didn't really look back at it again. So I'm interested to hear what you think of it and what this study showed. Yeah,

Dr. Blevins 4:57
well, you know, many people remember this First inhaled insulin was, came in a ball really literally what we would call a ball. And I'm looking at what across my room, I kept it up in my history of diabetes shelf there. And it was a big mess, you had to put the little medicine and a little, sort of a bong, and it, modified it a little bit and aerated it a little bit. And then you took the big Bong up to your mouth. And this this, now, the Frezza comes in a very little small inhaler, very simple, and very portable, and very discreet. And I think that's one of its advantages.

Scott Benner 5:35
And so, I've had it described to you before, but what's the process of inhaling it and it's a powder, is that right?

Dr. Blevins 5:42
Here's what happens, it comes in three doses, which we'll talk about more in a minute. And of small amount of powder, if you look at the cartridge, and the cartridge is then just inserted into a simple little inhaler that measures about I wish you could see it, but it's about two and a half inches or something like that. In length, the end it's about though maybe a half to three quarters in width, and depth, and says clip it in, put the inhaler up to the mouth and aim. So it goes into the into the airway and not in palate or to the tongue. And then take an inhale inhalation, and then that's it. And and take a deep inhalation. And that is the dose. Okay, so, you know, I was gonna mention this later, too, but it's very discreet. A person could give me in a restaurant, just reach in with the cartridges in, flip it in. No, no injection, no pin needles, no pins, that kind of thing. And those are pretty discreet too, I think. But don't get me wrong. But many people run into the restroom to give their insulin injections in a restaurant, or when they're out in public. And they don't have to. But the inhalation is very, very straightforward. And I've had quite a few patients who sit in a board meeting and they're taking their their medicine, it doesn't interrupt them or anything else, no

Scott Benner 6:56
one knows. It reminds me of a whistle. When I look at it, like that kind of size, you know what I mean? Not not large. And then that's disposable when when you're done right?

Dr. Blevins 7:06
Well, the inhaler lasts for about two weeks at a time, the little cartridges measure may be three quarters by half an inch or something. And they are disposable. They can be carried in person's pocket. They can be carried in a purse or bag and they're very portable. And they are disposable after they're used.

Scott Benner 7:23
Okay, so inhaler that a cartridge goes into, I inhale that the cartridge is disposable. But I can use the inhaler for a bit. That

Dr. Blevins 7:31
is exactly right, usually two weeks at a time, as was recommended. And I'll say something to Scott, when people inhale, I've seen kind of models, there's a kind of a mock up over at the MannKind manufacturing facility, and the Frezza manufacturing facility. And when people inhale that this powder gets into the lung very quickly. And you know, the advantage here is that it gets across the alveoli very quickly. And some people ask, well, you know, what is the surface area for absorption of the lung, it's about the size of a tennis court. I mean, those lungs are there. They're absorptive machines. So getting something across that rapidly is very doable. You put it on a carrier, there's something called a technosphere micro particle that the insulin is is attached to adsorb to and then once they inhaled inhalation occurs that gets out to the alveoli, it gets across into the circulation immediately. And and you know, I can I can say something about the rate of absorption and compare it to other insolence too, so

Scott Benner 8:35
people don't get confused, I think I understand but like your lungs are just a great pathway to get the insulin to your bloodstream. If you take insulin or sulfonylureas you are at risk for your blood sugar going too low. You need a safety net when it matters most. Be ready with G voc hypo pen. My daughter carries G voc hypo pen everywhere she goes because it's a ready to use rescue pen for treating very low blood sugar and people with diabetes ages two and above that I trust. Low blood sugar emergencies can happen unexpectedly and they demand quick action. Luckily, G vo Capo pen can be administered in two simple steps even by yourself in certain situations. Show those around you where you store G vo Capo pen and how to use it. They need to know how to use G vo Capo pen before an emergency situation happens. Learn more about YG vo Capo pen is in Ardens diabetes toolkit at G voc glucagon.com/juicebox. G voc shouldn't be used if you have a tumor in the gland on the top of your kidneys called a pheochromocytoma. Or if you have a tumor in your pancreas called an insulinoma. Visit GE voc glucagon.com/risk For safety information. I used to hate ordering my daughter's diabetes supplies and never had a good experience And it was frustrating. But it hasn't been that way for a while, actually for about three years now, because that's how long we've been using us med. Us med.com/juice box or call 888721151 for us med is the number one distributor for FreeStyle Libre systems nationwide. They are the number one specialty distributor for Omni pod dash. The number one fastest growing tandem distributor nationwide, the number one rated distributor index com customer satisfaction surveys. They have served over 1 million people with diabetes since 1996. And they always provide 90 days worth of supplies and fast and free shipping. US med carries everything from insulin pumps, and diabetes testing supplies to the latest CGM like the libre three and Dexcom g7. They accept Medicare nationwide, and over 800 private insurers find out why us med has an A plus rating with the Better Business Bureau at us med.com/juice box, so just call them at 888-721-1514 get started right now. And you'll be getting your supplies the same way we do.

Dr. Blevins 11:18
It is okay our as it turns out, of course your lungs get oxygen across immediately quickly. And they they also deliver carbon dioxide back out. The lungs are sitting there they're delivering oxygen removing toxins, you might say are metabolic products in a way. And also people take like inhalers for their lungs to dilate the lungs, if they have asthma. They take inhalers for all kinds of things. But also it's a great absorption, Oregon, and things can get across into the circulation very, very promptly if they're delivered properly, and inhaled insulin gets gets that that insulin out there to the alveoli to be absorbed.

Scott Benner 11:58
Why don't we see more medications delivered this way? You know, I

Dr. Blevins 12:02
think I think there's been a big focus on medicines that treat like asthma, and and emphysema, things that are aimed at the lung itself. And a few medicines can go across the lungs, not every medicine, you have to have a small, relatively small particle. That's that gets across the alveoli. So I think you'll see more meds that are delivered that way. And and certainly inhaled insulin is here now. And you know, it's been out again, it's been out since 2014. And we look at it as something new because many times it hasn't been talked about really hasn't been used as much as it should be. And I think part of that was the initial I mentioned a while ago, the thing about the bond, the bond was a real inhibitor to use. And and then along came pins that made giving rapid and some more, more feasible and more doable. So the the excitement about inhaled insulin sort of faded. And now many times practitioners and people with diabetes, just don't think about it. I mean, I have people, unfortunately, I'm probably I'm a culprit too. When it comes to not talking to people unnecessarily about every single option, I make myself do it as much as I can. And now I talk to people about inhaled all the time, because it works so well. And we have now a very good data that shows that inhaled inhaled insulin can be very effective, versus injectable, versus injectable. And, and I could, I can say a few words about injectable. Of course, I mentioned earlier we did a study with the Frezza here at my clinic here in Austin, Texas, Texas, diabetes and Endocrinology, we do quite a bit of phase two and phase three clinical research. And so we did a study We've done studies with other insolence to and with the newer, more rapid acting injected insulins like and I'll say the name brand because people understand them. When you when you talk about namebrand T acid, which is fast acting as part, which is a fast acting Novolog. We did studies here with blue Jeff, which is fast acting LIS Pro, they're called fast acting, they're called Ultra rapid, but they really don't come close to the rapidity of absorption of of the F Frezza. And I can let me go through if it's okay. Let me just give you a few numbers. Yeah, please. Okay. So, there are three measures that are kind of interesting to look at when it comes to absorption of rapid acting insulin. One is time to first measurable effect. The other is, so the first effect it has lowering the sugar. You know, once you give a dose, it takes some time for it to have an effect. And when it comes to injected insulin, what delays the effect is the fact that it's given in the sub q, subcutaneous space and it has to break down into a single molecule of insulin before it can get absorbed. It's given typically and in in cluster of six like it's called hexamer. So when you give insulin, typical insulin sub q, the rate of absorption has everything to do with how rapid it becomes a single molecule, that single molecule can be absorbed a single molecule is called a monomer. So, you know, you want to go mono Marik as quickly as you can if you give sub q, because that's what allows it to get absorbed. That takes some time, even even the most rapid sub q insulins take time to get absorbed longer than a Frezza Frezza. Inhaled, it's into the system right away. It is mono Merrick to begin with, by the way, it doesn't have to break down, there's no subcutaneous tissue for it to break down into, it gets in right away. And that leads to another very important characteristic. And that is, it gets it also gets out quickly. It doesn't linger. And I'll tell you more about that. So time to first effect time to peak effect and time for the insolence return to baseline. The limit, let me give you some comparisons. Yeah. And if interrupt me if I'm not clear, and and you in the audience, you just make notes in your mind or on paper, if you want. And I'm going to, I'm going to go through those measures for a Frezza be asked and also loom Jeff, okay. And those are the best competitors, because those are the most fair competitors that have the most rapid li absorbed sub q insolence. So, time to first a measure of measurable effect of the middle dose of a Frezza is kind of a middle dose is 12 minutes. So it gets some pretty quick, the first measurable effect time to first a measurable effect of the ASP 17 minutes. So it's not as fast as a Frezza. But it's this relatively quick, first measurable and the same as for limb, Jeff 17 minutes. So that's that's interesting. Time to peak effect. So once it starts getting in, you wanted to get in quickly, right? Most people diabetes tell you I don't want I want my sugar to be affected right away. And I have to wait and wait. Well, time to peak effect is about 45 minutes for Frezza. At the the middle dose it was studied. So that's about 45 minutes. And you might say What do you mean 45 minutes? Well, what do you think's gonna happen with fiasco time, the first time to peak effect is 122 minutes. And loom Jeff has 138 This is right out of the product insert? I'm not. Right. This is right out of what is published, for people to see. So that's the peak effect is much faster with the present. So if you take it, you're gonna get an effect, more rapidly peak effect. What about duration? And let me let me just say, you may ask, why is duration important? Well, duration is really important because when you dose insulin, you really want it to act quickly. You don't want it to hang around because you can you can have hypoglycemia if there's a long tail on the rapid acting insulin. Does that make sense?

Scott Benner 18:10
Yeah, it also makes sense to me that if I needed to reduce again, I'd like to be able to feel relatively comfortable that what I did first is gone. This episode of The Juicebox Podcast is sponsored by the ever since CGM. Ever since cgm.com/juicebox. The ever since CGM is the only long term CGM with six months of real time glucose readings giving you more convenience, confidence and flexibility. And you didn't hear me wrong. I didn't say 14 days. I said six months. So if you're tired of changing your CGM sensor every week, you're tired of it falling off or the adhesive not lasting as long as it showed or the sensor failing before the time is up. If you're tired of all that, you really owe it to yourself to try the ever since CGM. Ever since cgm.com/juicebox, I'm here to tell you that if the hassle of changing your sensors multiple times a month is just more than you want to deal with. If you're tired of things falling off and not sticking or sticking too much or having to carry around a whole bunch of extra supplies in case something does fall off. Then taking a few minutes to check out ever since cgm.com/juice box might be the right thing for you. When you use my link. You're supporting the production of the podcast and helping to keep it free and plentiful ever since cgm.com/juicebox.

Dr. Blevins 19:42
Exactly. And that what you're talking about you don't want to stack because once a once the shirt goes up and you're disturbed by it, you want to you you're tempted to reduce it, right hit it again, that might bring it down more quickly but unfortunately that insulin can hang around. And the detail of the first dose, the tail of the second dose can cause you to become hypoglycemic. And that is stalking. So the duration is a big deal that leads into what is the time for the effect to return to baseline of a Frezza. It's about anywhere from 90 to 180 minutes. And let's compare that to the other two. Remember, they're the fast ones. The fiasco time to return is five to six hours. Right? It is, yeah. And the time for limb Jeff, which is a great, it's a fine answer. And we use a lot of it, of course, but the time to return to baseline is 4.6 to 6.2 hours, we're not talking, you know, remember, a phrase is 90 to 180 minutes. So what you said is exactly right. You want the insulin in but you want it out. And if you want to reduce it, you want to be comfortable that that first, or the prior dose is not going to be hanging around to cause you to get low later on. Right?

Scott Benner 21:02
Especially if you know if you if you underdose a meal, for example, or it's fatty and you don't go after correctly, and then you do have to hit it harder. But then eventually that logjam inside breaks and the food passes through and it's no longer impacting your blood sugar. All the leftover insulin is just going to It's like a It's a lead weight than it is. I know, it's not part of what you want to talk about. But if I asked you to go over like Novolog, or or a pager, would they be significantly different than loom? Jeff and fiasco?

Dr. Blevins 21:29
Yeah, they're slower in and they're going to be slower out. Okay.

Scott Benner 21:33
They don't. Six hours still, though? Do they? know they do?

Dr. Blevins 21:36
They go six, seven hours really ration? Okay. Yeah, they do. And they peak later. Most people, if you ask someone who has diabetes, or even practitioners are right down the peak time of various of these insulin, they would they think it peaks sooner. And it doesn't the pay people with diabetes know, they take a dose and they know it takes a while for it to kick in. And they just were patient, and many times very impatient, though. And they'd like something that acts faster. And the fastest pencil on the planet is a Frezza. It gets in quick. And one of its big advantages is also and I'll just say it again. It gets in quick. It gets out quick. Yeah,

Scott Benner 22:17
no, it's a big deal. And let me stop here for a second to highlight what I think might be some people's can, like concern. Yes. What if anything about it, like is dangerous or concerning? Like it's the idea of inhale, I'm still listening to you and thinking like, Yeah, but inhaling something. And I don't know if that's based in just like, a nonsensical fear or if that's a real thing I should be worried about? Well,

Dr. Blevins 22:41
I mean, there are things that are cautions that people need to know about when they use it inhaled insulin. One is there are side effects potential cough can occur in a significant number of people, it tends to get better over time, I tell my patients when I when I start to monitor for, as I say, you may cough, and you may see some powder come out, it's okay. It doesn't mean anything. And nothing has gotten absorbed, I can tell them. That's the what, but the studies show clearly enough has gotten absorbed, if you cough, somehow, a cough can occur sometimes sore throat, which tends to be transient, I had one person who developed a very sore throat initially, and we thought we were going to have to stop the medicine, she kept taking it, it went away. And, and so there are certain people also who shouldn't simply shouldn't be taken it. And those are people who have some kind of any type of chronic lung disease like chronic recurrent pulmonary disease, that would be asthma or COPD. We don't we don't prescribe it for Frezza for people who have those conditions. And there are some people who are hypersensitive to human regular insulin too, of course, they have trouble with any insulin. And we also know that when people take a Frezza there is some reduction in a measure of lung volume called f e v one. And it can reduce a small amount, usually about 1% 30 or 40 cc's of lung volume reduction reduction when on the Frezza. Now, interestingly, when people go off the phrase, it comes right back, so it's not a permanent thing. But let me also put that into context, what 40 cc's of reduction? Well, what is the typical male female lung volume total, that's about anywhere from males have greater lung volume than female, but it ranges anywhere from 3.5 to 4.5 liters. And I would just say make it easy as four liters. And you know, that 40 cc's of 4000 CC's is it's it's tiny amount on percent. So, that is important to know people see that that the lung FEV one can reduce but it's it's really a tiny amount of what we do and it's important for everyone to know we do. Typically we do a measure of lung function at baseline, or at least when we decide to continue the Frezza that's called the FEV. One, it's a simple little test we do in the office, and there's a little machine I can hold in my hand that will allow me to get an FEV. One a person breathes into it. So we do it at baseline, after six months, and then about once a year, that's the current recommendation. And if there's a decline of over 20%, then we would discontinue the medication. So the safety is good that we know we know what kind of changes we might see. And we measure for them. Those are the primary sort of concerns there's people sometimes have, in the past have said, What about lung cancer with inhaled insulin? And let me just make a long story short and say that there were some there were some cases reported, one of them occurred very soon after person started. So it couldn't be related. And, and they're just really tiny numbers. And there's no sign or signal here that I can detect.

Scott Benner 25:56
Yeah. So stuff like this, am I right to say exists with almost every medication you take? So I mean, like, there's some people who are just not going to work well, for some people are going to have an adverse event that you have to discontinue because of, but is it any more or less so than other things? I mean, or I know, with injectable insulin, you can't just stop if you have type one diabetes, because I've interviewed people who have like significant insulin allergies. And it's very infrequent, thank God, but it's it's horrifying. And they had to just keep doing it. Actually, those people end around their problem by using a Frezza. In some situations, generally mean like, my question is, is this something that's more concerning than any other general situation? I put myself in with the medication?

Dr. Blevins 26:46
And Scott, my answer is, I think not. I think that there's been a lot of caution. Fortunately, as there should be. And careful evaluation of data as there should be. The route of administration is unique. To me, the greatest side effect or, or adverse reaction related to insulin is hypoglycemia. If I have an insulin that is associated with less hyperglycemia, then I'm going to be really happy. And I will say that not every bit some of the studies but the Frezza have have suggested lower risk of hypoglycemia, because it doesn't hang around so long. So to me, the greatest risk of insulin is hypoglycemia, be it inhaled or injected. And so finding a quick and quick out insulin for mealtime, or rapid acting, or for intervening when the glucose is high, is is an advantage. I still

Scott Benner 27:40
need a Basal insulin if I'm using a third crack, so I'm going to inject a basil. You do okay. And so this is this is for meals or affecting high blood sugars, or for somebody who's using a pump to bring out high blood sugar down. Are those the use cases that you say?

Dr. Blevins 27:55
Yeah, I'm gonna say yes to all of those. I will point out that the approval currently is adult for adults, it's not approved for children yet, there's a big study that's been conducted that that is looking at that possibility and don't have results yet. And, and I'm optimistic but I don't know yet. It's approved for adults with type one and also type two. So certainly the adults with type one have to have basil. Most of the people with type two will have to have basil too. But there's some people will talk to you that might not need it. But you're also exactly right on this is for mealtime to get in quickly and cover the meals quickly. You know, your when a person doesn't have diabetes, the pancreas doesn't wait. It doesn't pick the insulin at at an hour, it peaks it quickly. And this gets about as close to that as possible. So mealtime is is number one. Number two, yeah, if you're a person's low two hours after a meal, because of the short duration, they can reduce it. And we had people do that in the study, and people on pomps if they have a high reading, and they want rapid reduction they could use it to. And I'll point out in a bit that in the study that we conducted, we had people who went off the pump to go on the study, and they went on to a Basal plus a Frezza. And many of them afterwards decided that they would want to stay on the injected insulin with the A Frezza. And we had a couple people who are on on pumps that decided to use the pump the automated pump as a background and use it Frezzer for the mealtime because of the rapid

Scott Benner 29:29
effect. Is that a thing that insurance is covering our

Dr. Blevins 29:33
results when it comes to getting things covered recently, this has been better and better. Good.

Scott Benner 29:37
Yes. Do you see? I might feel like it's off base for a second but I've now interviewed three people who probably have Lada who started a GLP and now are almost completely off of insulin are completely off of it for that for the time being I imagined but they still see excursions that their meals and they get like some of them are afraid to use insulin When at the excursion because like you said, the the insulin lasts so long would this be a better fit for that? Do you think?

Dr. Blevins 30:05
I have to admit I haven't used it in that way. But I will tell you that your thinking is exactly right. It's quick and quick out. And when a person has beta cell failure near failure, or you know, impending failure, the first thing to go is the postprandial. And the sales just can't keep up with the need. And so yes, the present would be a reasonable option in that in that case, and so I think you have to You're doing the right thing, Scott, you're thinking through, and then that would be one, wrap it in wrap it out, that would be a good potential. For person has a high sugar at bedtime? Frezza gets in gets out doesn't hang around overnight, make different times? Yeah,

Scott Benner 30:50
everything I think about insulin is about timing and amount, like meeting need with with impact. That's just kind of how that's the the entirety of the way I think about managing diabetes. So yeah, it's interesting. Approved for type ones and type twos. Yes.

Unknown Speaker 31:06
Okay. It is.

Scott Benner 31:07
But adults, what is that 18? And over? Or what's the cutoff at the moment,

Dr. Blevins 31:11
it is adults 18. And over, all right, and we're hoping for an approval, it goes down to much, much younger, and it would seem to be a very usable treatment for the pediatric population, because it's, again, it's discrete, it's quick, and you get rapid response to hyperglycemia. And that that just really fits the PD population, but a study has to be done. And then approval has to be obtained.

Scott Benner 31:37
Are there smaller instances of low blood sugars with a Frezza versus injectable?

Dr. Blevins 31:42
You know, there have been a number of studies that have looked at that. And I could go through them by name. But you know, One study in adults with type one showed that Frezza as rapid acting insulin, reduce the frequency or kept maintained it or reduce it just as well as in that in that study, they were using actually insulin as part which is Novolog. And also shown also in people with type two, and there are a couple of the studies have shown a reduction in hypoglycemia as well, because of the shorter duration of action.

Scott Benner 32:12
Okay, what's interesting, am I missing anything before I ask you to move on to the to the study?

Dr. Blevins 32:18
Well, I can I can say that. There are a couple things I might talk about the dosing?

Scott Benner 32:23
Yeah. Oh, please. You know what? Yeah, how did that slipped my mind? That is the most confounding part of this. And even when I asked people, listen, I asked the CEO of mankind, I was like, explain the dosing. And the explanation feels a lot like art, and not a lot like science. And I get that insulin is that in general, but I guess in a world where people are used to hearing my insulin to carb ratio, is this my insulin sensitivity is that that means if I do this, then this is how much insulin I use. This seems vague, I guess. So how does it fundamentally get used in a real world situation?

Dr. Blevins 32:57
Well, let me explain some of the dosing when I go to talk about that study, because I think that study helps to find the right way to dose. And that's why okay, but let me also point out that a Frezza, comes in three doses. One is called a four unit one and I say is called, and I'll explain that in a minute. One is called a four unit, one's called an eight unit, what's called a 12. Unit, the FDA requires mankind to assign the number to the cartridge of relating to the amount of insulin in each cartridge. Okay, that makes sense. But in fact, when you inhale, insulin, some of it gets caught in the inhaler a little bit, a little bit, get caught, gets caught in the oropharynx. And a little bit get constantly gets caught in the upper airway, so it's not going to get absorbed. And so what I tell patients is their three doses, four, eight, and 12. And you can't imagine how many people tell me Oh, four is way too much for me. And I say, Well, it turns out that for as to, when it comes to the amount that gets into the absorptive area of the lung, I'm going to also tell you, that is an estimation, but it works for is to eight is 412 is six. So if you are on four units pre meal, and you're going to change over to a Frezza, do you dose the four you're going to cartridge, and you might do the carb count this, I'm just gonna say if you're on four units, most time before meal, you use the four unit cartridge. And the answer is you can but your sugars not going to do as well because there's really only two units. So we tell people to use that conversion for us too. And by the way, this seems a little confusing, but I've given this conversion to so many people now. And the next visit, you know what they do? They come back and say remember for us to hate us for that. They understand it very well. And it's very straightforward for us to eight is for 12 is six and now that may have to be adjusted. That ratio may not be true for everybody but that works. So you can get people who are very, very sensitive on a four unit cartridge, and they're really just getting about two units. And that works. And then people who have to take more than, like, if they need, like eight units, in reality, the eight units of their usual insulin, then they would have to take a 12. And then nothing would have to take a four to get up to eight, because 12 is six and four is two. And they can do that they can take one Hila inhalation, then go out, cartridge switch really quickly. And inhale again, it's very fast it works.

Scott Benner 35:33
Do you think? I mean, you've spoken to a number of people, obviously, who reuse it? So what's the response? You get back from people using a Frezza? Is it? Do they find it easier? Do they find it more difficult, but worthwhile? Like, what's the what's the user experience? Without,

Dr. Blevins 35:50
we learned that the study, quite a few people who actually had been on the pump before actually decided they wanted to stay on it forever, either with or without the pump, either with with the pump or with Basal insulin. So So Pete, some people really, really like it, not everyone, it's not for everyone, it's an option. And, and the the critical thing here is that we need to be talking to people, we practitioners, we people, other people, people who have diabetes, need to be talking to people about about this, it is an option. And people should, should be exposed to all of the options available. I know that's one of my jobs in medicine period to say, Hey, these are things we can do. And and I give people samples, I let them try it. And if they like it, we move on. Lots of people want to get the prescription after they try the sample. I tell them about it. So a lot of people really do want this type of insulin activity. Some of the responses I've gotten have been, I want to continue it. One, the response I got from a somewhat elderly gentleman, there's no age limit on the upper end. In the end, he told me which which he said no one told me that an option like this existed, and I felt very badly because I'm his doctor. And that was my thing. He was he was sort of a little bit indignant, and I realized that I'm going to change the subject here. But he's doing really well on it. And I've had a few people say, is this insulin new? Because they like it. And they're why haven't we done this before? And another person just said, simply this kind of same thing. Why didn't we start this before? This was a personal study, not a person I was taking care of, as it turns out, in my own personal practice, but when she she volunteered for the study, and she says, wow, this stuff has this effect. Why didn't this get started before? So I Yeah. And some people say, you know, it's not for me, I'm coughing, they have the side effect. It's not for everybody. And some people say, Well, I like the way it works. But I really want to get back onto my pump. And that too, so that we had quite a few people. I could give you some stats on that here in a bit. Yeah, I

Scott Benner 37:56
imagine that that's just going to be the case with everything. But I think to hear that if I begin to take it and I get the call off, and I don't like the call off or it doesn't dissipate, eventually, stopping puts me right back to where I started again. Is

Dr. Blevins 38:09
that correct? That's right. Yeah, that's That's exactly right. So nobody's

Scott Benner 38:13
going to experience permanent damage. As far as the studies have shown or your experience.

Dr. Blevins 38:19
That's exactly what the studies show, when it comes to the FEV. One, that lung volume thing, and the cough will go away. As soon as a person stops, the med sore throat tends to go away. And so that would go away to You're right. You're exactly right. Yeah.

Scott Benner 38:31
For me, personally, I can tell you that, if I didn't have a lot of good information, when I started using a GLP medication, I can see that there would have been times where I would have stopped. I would just said like maybe the juice isn't worth the squeeze here. But I do know now that sticking with it was really was important. And you know, any of the kind of earlier side effects that I had really are gone. I'm doing 12 milligrams of zap bound right now. And I don't have any nausea at all. Well, like nothing. So yeah, that's great. Yeah, it's, it's sometimes you just your body's got to get accustomed to what's happening. Am I right about that, too, to equate those two ideas? I

Dr. Blevins 39:13
think so every medicine has potential side effects, and effects. And sometimes the side effects are not tolerable, and then that that dictates what happens. But many times the side effects are known, tolerable and go away. And, and you get the effect. So it's important. Every medicine has a benefit and a risk. So it's important that you look at medicines, just the way you're talking about these outbound. Look at medicines that way.

Scott Benner 39:40
So when you presented at Ada, is that where you presented the information about the inhale study? Yes,

Dr. Blevins 39:46
I along with a number of other excellent presenters. We had about an hour and a half session at ATA a few weeks ago. Seven presenters got 10 minutes each, and amazingly stayed on time. That doesn't mean Are we presented the inhale three study? What have you

Scott Benner 40:03
not said so far? In our recording the from the study that you think people would be interested to know about Skogafoss Okay,

Dr. Blevins 40:09
let me walk through the study and a real general kind of way. Yeah, yeah. Because the study is in people that are we take care of in practice and and people who agreed to go on a study and some of them took a bit of a leap. Because automated insulin delivery on the pilot with a pump, and these people, you wouldn't expect to go on a study like this. And then the people took a leap as well, some some of them had never heard of inhaled insulin. And one or two had been ordered before and they'd gotten off so they could still participate in study because it was it was they got back on it. It really is very typical patient types in the practice. And these were people with type one diabetes. This was a study that was done around the country, by the way, 19 sites from Jocelyn I won't name everyone, but I'll just say Jocelyn northeast Mount Sinai up in the Northeast University and University of North Carolina, Atlanta, and also Texas, diabetes and Endocrinology right here at Austin, a group in San Antonio diabetes and glandular UT Southwestern Barbara Davis did it Las Vegas, endocrinology Sansom, diabetes, Loma, Linda University of Washington, all over the country, Mayo to Northwestern, and all over all over the country, 19 sites, and the the entry criteria was people had to have type one diabetes, and they had to be adults, they could be on automated insulin delivery, they could be on just a regular pump without automated, they could be on multiple daily injection, they if they had asthma. And just to emphasize this, if they had asthma, or history of lung cancer, they could not be on the study, it turned out that about 48% Were on automated insulin delivery to start the study. Now, the way the study goes is that people are going to be placed on degla Deck, which is true SIBO plus a Frezza. Or they're going to be left on their usual care. It's going to be about, you know, half and half. So that's nearly 50% of people on pumps. Now, what does that tell you? I think that tells you that though, we love pumps, and I love pumps. Not everyone who pump is just totally enamored to the point that they want to go on forever. And they wanted to explore something maybe a little different. And that's kind of interesting. And we should be open to that possibility. And sometimes I think we're not. So most of the pumpers it turns out, we're on the tandem or the Omni pod. It turned out there about 123 people that were randomized 62 that means of course, they're put into one treatment group or the other about half into again, degla deck plus Frezza. And we call it in the in the presentation technosphere insulin because we're not supposed to use brand names in front of a group like a continuing medical education group that the ADA, our usual care. Now usual care was I stayed on what they were on. And it was a 17 week study, we did try to titrate the doses and the way we calculate the dose of the Frezza was that we would multiply the usual dose by two and then we would round down to the closest dose of a Frezza. So bottom line, we were doing exactly what I mentioned earlier, we were doubling the dose of a Frezza recognizing that only about 50% in each cartridge gets absorbed. And we did a what's called a meal tolerance test at the first of the study. And the people on the Frezza took a Frezza beforehand. And the people unusual care gave the insole however they normally gave it afterwards and I'll tell you about that in a minute. The baseline anyone see when people entered the study was about 7.6 With of course some variability but that's kind of the general part. I can tell you with the the baseline meal challenge that we did, again, the reference versus the usual the glucoses were clearly lower out to about 9120 minutes for the people who got it for so I could go into a lot more detail but it's the present gets in quickly. stops

Scott Benner 44:07
a spike. Yes, that's it. Yeah, it gets ahead of a spike right by the end without having to Pre-Bolus at all.

Dr. Blevins 44:14
Yeah, that's right. Okay. That's right. They didn't have to they gave the insulin right when they started to eat thank you for pointing that out.

Scott Benner 44:21
And yeah, I mean it's a big deal because it takes away from that having to like remember 1520 minutes depending on what my blood sugar is etc and so on. So a lot that's right. Yeah, yeah,

Dr. Blevins 44:32
yeah, that's exactly right. One of the people who I know pretty well who was on the study would be in a various meetings and he could just kind of whip out his little inhaler and dose himself right before a snack or eating and and he didn't pre Pre-Bolus did not do that. Is

Scott Benner 44:49
the to ever too much. The two unit cartridge does it is it ever too much where people are like, Oh, I have two more than I want to because I can't go lower.

Dr. Blevins 44:58
You know it it'd be but I have to admit, I haven't seen that happen. It's the four the four unit is the two is what you're talking about. Yeah. And that's a such a small amount. I have people who are very sensitive, I saw someone early this morning is on a Basal of like point two, or like actually reduced it a little bit. So, you know, plenty of people with type one are very insulin sensitive and many are, are really almost type two ish in their in their insulin resistance. So a lot of variability.

Scott Benner 45:27
Okay. All right. Interesting. God, I'm sorry. I didn't mean to cut you off?

Dr. Blevins 45:30
No, that's a great question. And now in terms of so that's the meal test. That's one one outcome, the other was a one C. So let me let me just pose the question to you and and the people who listened to this? And do you think that inhaled insulin with Basal insulin given one time a day placebo degla deck as a background could compete when it comes to a one C with an automated insulin top?

Scott Benner 45:52
I would think that anything that stops a meal spike, and can quickly defeat a stock high blood sugar without causing a low that would cause me maybe to treat and rebound high would have a better chance. Right? Yeah, that's my expectation.

Dr. Blevins 46:11
Yeah, well, you're you're you're right on, I think there were hopes that the ANC would be lower with the president because there was reason to think it could be competing against not everyone who was on automated insulin delivery, that we are the automated insulin pump on and the control group. But many were, it turns out at the end of the day, he was he was the same in both groups, really. So it was an A Frezza was not inferior, that, that I think that's quite an achievement. And there's more to it, though, when you delve and kind of dig into the actual data. And bear with me here, I'll try to make this as clear as I can. The proportion of people in the study, who achieved a one C levels below 7% 30%, with the Frezza 17% with usual care, which of course included the automatic pump, and 21% of those on a Frezza had a go and see improvements of point 5% or greater 21% versus just 5% with usual care. Now you're thinking, Well, how did the one seed turned out to be the same that? Well, it turns out that some people actually got worse. So 26% of people had about a point 5% worsening with the Frezza compared to just 3% of usual care. And and the bottom line here is that not everyone does better with a Frezza. Or as well. And you really have to be someone who is willing to actually dose sometimes between meals when you have a high and and be ready to do that. And is that

Scott Benner 47:48
what you saw that people would just kind of stare at high blood sugars and not do anything about them?

Dr. Blevins 47:53
Yes, yeah. Sometimes, we did instruct people to study if their sugar after a meal. And after the previous dose was over 140, then they could dose again, at one or two hours after, because for two reasons. One, we're aiming for very good control. Two, we know it doesn't hang around, they're not going to stack their chances stack is much lower, put it like that. Many people did that. And we're watching their numbers, and we set their alarms and just do it. And some people just just didn't want to do that. And that's pretty typical what we see in practice in general. I mean, we do see that,

Scott Benner 48:29
Tom, that's almost an argument for automated insulin delivery, because at the very least, if you go to a 224, your algorithm is going to keep pushing when the person maybe who's either unmotivated or distracted or whatever, is not going to do something again. Yeah, yeah.

Dr. Blevins 48:46
Let me say something about that. And that makes logical sense to me, too. It turns out and I'm, you know, asked me in a minute, that quite a few people who had been on the automated pump, who were on the in the Frezza treatment group actually stayed on the Frezza afterwards, so it's like anything else? This is an option. Sure. It's really not designed to compete with the pump. But this was a this was a brave study in a way to actually allow it to compete against automated insulin delivery. Actually, quite well. Yeah. And quite a few people decided that it was in their interest to continue on it would

Scott Benner 49:24
occur to me that there's probably like three outcomes here right? Either I listened to the direction and you know, either stayed where I was, or or did better, and I don't have to wear a pump anymore. So great. Or I did the minimum I needed to do and even my you know, my one C went up a little bit but I love not wearing a pump. So I'm you know, I'm down for this if that's yeah, or I guess the other option is somebody who's super motivated and really paying attention could probably terminate one seeing the fives with this if they were if they were paying attention and then on top of it, sure, yeah. Oh,

Dr. Blevins 49:59
I think you're I think you're right. And this idea of pumps are great automate is great. I love them. We've done studies with them, we use them in clinical practice, we use every one. They're wonderful. I mean, it is so nice, yet, many people really don't want to have the apparatus on their person. Yeah. And many people would just as soon have been, I learned a new term, a pump Keishon, you know, and, and sometimes they want it to be pretty long. So if there's an alternative for them, and gives them the ability to interact, they may take it. So it's, I would never have thought a person with a pump was a candidate for a Frezza. But I know better at this point based on the study. But your point is a good one. I mean, some people really do better do just very well, overall with the automated insulin pump right

Scott Benner 50:49
now. I mean, listen, I It's my expectation. I mean, I've been making this podcast for a decade now. And it would have been easy for me in the beginning to get lost in the idea that like, Oh, everybody wears a pump, or everybody tries really hard all the time. But that just seems to be the people that the podcast attracts either people who are desirous of living that life or wanting to get to it right. But I don't know the numbers. But I wonder if you do, the percentage of type ones wearing pumps is not as high as I would think it is. Is that correct?

Dr. Blevins 51:20
It's pretty high. It depends. It depends can depend a lot on various regions, practices, things like that. But I don't know the exact percent but it's got it's at least two thirds at this point. That's fascinating. Yeah, it is fascinating. Leaves a high percentage of people that are really that aren't on you would think that the technology would kind of bowl people over. But there are reasons not to wear a pop. I mean, one is, it's something you have to wear. The other is the catheter one way or the other is in constantly, and life situations like going swimming, and some things are just come more complicated things getting pulled off falling off and things like that, like catheters and that too. And this gets back to the idea of option. We should be giving people all of the choices and letting them experience and let them decide and not just say, Hey, you are a pumper, son. Let's do it.

Scott Benner 52:16
No, I'm gonna propose that yeah, of that. Yeah, yeah. Yeah. Yeah. There's a lot of different ways to hack your health situation. And at the very least, you deserve to know what they are. That's right. Yeah. No, I agree with that. Totally. Totally. What are we missing here? Anything.

Dr. Blevins 52:33
One thing that was really interesting about the study is that it's a short acting insulin. I've said this before. And we found that when people dosed at bedtime, they did better than theirs. People are so cautious, and had been so cautioned against dosing. Couple hours later stalking, and people have have been Tolo, don't take that insulin Bolus, don't take much at bedtime, you'll get low overnight, because the current sub q insulins hang around even the fastest, as I pointed out, and I talked about the fastest while ago, they hang around. And if you dose at bedtime, you could get in trouble. This one, you really need to guide the insulin at bedtime. And it's a big deal. And this one, inhale gets in and gets out as not going to hang around. And so we did learn that that dosing a bedtime was really important when it came to improving control. Now,

Scott Benner 53:27
I mean, I preach all the time to people, first of all, you can steal a onesie overnight, it's the easiest time because there's no carbs usually. And you know, making a thoughtful Bolus at a meal definitely stops you from having to, to address it again later, which is very likely going to lead to a low if you're not really adept at it. So yeah, but in for those people who are missing, and coming up on bedtime, they're very willing to go to bed with a 200 blood sugar or greater to avoid the risk of even getting low overnight, and then they'll start their next day high. And then then it's just a perpetual circle they can't get out of which is I think, you know, a lot of the ways where we start to accept Oh, my a one C seven. Oh, it's a it's okay. You don't I mean, there's nothing I can do about it like that minds. The mindset around insulin is and, you know, lack of tools and understanding are pretty much the drivers and in poor outcomes, I think, at least Yeah, yeah. I see the value 1,000% of being able to just say look, I have a 200 blood sugar here. I can pump this in real quickly. And, you know, an hour from now 90, would you say 90 minutes, maybe maybe three hours from now at the at the at the greatest? This? This impacts go on for me now. Sure. Yeah.

Dr. Blevins 54:49
Can we get it's gone. You could reduce it in one or two hours. That's what we found that was safe and it worked. And if you've got handy to guide your sugar down, you could guide it down with the quick hit And that devastated after meals that between meals bedtime, and then people learn to be comfortable with that because they've learned to not be comfortable. Like I dare you to take another dose of sub q insulin two hours after you eat and not get low or I dare you to take it a bedtime, we always have people take a bit of time to guide their sugar was sub q2, but it's a little, it's just a little different, you have to be cautious because the insulin does hang around, you don't want to leave the glucose high. With either type of insulin.

Scott Benner 55:29
I have a specific way I talk about snacking, because I genuinely believe both things. First of all, it's not stalking if you need it, it's bolusing. But that infers great settings and a great understanding of timing on your part. And then you know, otherwise stalking is 1,000,000% going to lead to a low blood sugar later, that is probably going to take more carbs than you imagine to stop. And yeah, and so there's you have to keep until you know what you're doing. The idea of bolusing inside of the window where the previous Bolus is still active is, you know, it's an issue because you're you very likely may do it wrong. Once you know what you're doing. I just think it's bolusing. At that point, if I know I need it, then then you use it right? And that doesn't lead to a low, which people also have trouble. Like, when I talk to people, you can see them processing and they're like, Well, I ate and I ate again an hour later. I'm like, wait, we'll be sure Bolus again. And they're like, Well, I get low. And I was like, why don't you get high if you don't? And they're like, yes, that's a person who knows their settings work. You don't I mean, Sakhalin, another person who doesn't just I talking to somebody the other day that said that they're on a pump, they see people on pumps who see doctors and still have a one season double digits. And I think How is that even possible? They don't have a good lead into this, the you know, they their settings are way off, or their understanding of insulin is significantly off. Right. So do you think that a Frezza is more of a ninja level? Or do you think that everybody could use it successfully?

Dr. Blevins 57:00
I think a Frezza. But let me let me let me go. Let me back up. I like that analogy. I think a Frozen is a one of the borders the Greenbelt. Okay. That's that's a starter, I think a presidency we talked about a green belt, and it may make a person a black belt. If if the if they use it the way it can be used? I think it goes all the way up, I think is something we should be talking about from the get go. Let people have the option of it. I don't think wait till any particular time. So now you're a Frezza person, I hope I interpreted your question. Some way did somewhat closely. Okay. I think it's something we need to talk to people about right off the bat, if it makes, if it fits their personality, their life, their thinking, their approach, then they need to know about now. And and frankly, you know, they really need to try it. We try everything along the way. Anybody on a pump has been on probably every insulin basil, you can imagine every bowl as you can imagine, but mostly, most likely they haven't been on present. That is something we need to grapple with. As people who prescribe and talk about options, people should have the options and should should be allowed to try them

Scott Benner 58:15
you find the doctors if they don't understand it well, and the whole force to this is that, like might stop them from understanding it. Like, are you fearful, I guess that this won't get the foothold it deserves. And the community

Dr. Blevins 58:28
and the in all societies already has had that happen. I do think that this inhale three, study. And I'll tell you more about the kind of what we learned here. Finally, as I close out talking about it, I think it really gives us a foundation better than ever. We already have foundations. This is not like the first study, there have been a lot of studies. This is a really good one, though, that tells us about the here. And now. What about against automated insulin delivery? How do you use it? What are the proper concepts that we learned from ourselves and from our patients mainly? And you know, how do you use it? And so I think I think you're right, I think that people don't understand how to use it, therefore they shy away from it. That's one thing. Second thing I think we've made these assumptions that people on pumps want to stay on panels forever. We could keep talking about other insolence for them. Thirdly, there have been a reimbursement issues that people have sometimes knock their head against a brick wall when it comes to reimbursement that's getting a lot better in our experience. And frankly, if we think an option is good for a patient, I'll say we need to go and go to bat for it and we do we do after the what I'll call the GLP one wars when it comes to getting things reimbursed and paid for I think we're pretty good at going to bat when it comes to getting things covered. So I think that whole reimbursement things better now to to there are a few kind of little blocks that have occurred along the way. Yeah, knowledge and reimbursement that that are better now. And I think This study has taught us so much. And our next job is to get all that information out to everyone in the in the people that prescribe insulin world.

Scott Benner 1:00:08
Yeah, I agree with you. I'll tell you, I took my daughter's endocrinologist the better part of two months to talk our insurance company to covering her GLP medication. Right. Yeah. And it was it was more about being on the phone talking, like sending the sending what they asked for worked at first, but then of course, a month later, they were like, we'll do it again. And you know, Mike, I'm like, are we doing this every three and a half weeks, we're gonna have to reevaluate like, what, what's happening here? So she finally got them on the phone and walk them through it. And they said, What did they give her? They gave her a three year window for GLP. Really, yeah, they're gonna reassess or they're gonna reassess her again, in three years.

Dr. Blevins 1:00:48
That doctor is very convincing, I must say, very persistent. And I, I admire that we do the same, we tried to do the same thing here. And, and with GLP, ones for people type one, or Frezza. And it's just the world we live in. I mean, growth hormone. We're, I'm an endocrinologist. And I prescribed things outside of diabetes, of course, and, and cholesterol meds that are hard to get. We're just used to it. And unfortunately, we really have I mean, fortunately, we know how to do it. But unfortunately, we have to go to bat repeatedly. And we just we do that. She's

Scott Benner 1:01:21
interesting, because she's not she wasn't born here. So she has a more less American idea of how things should be. But she's been here long enough that she understands how things work. And so I think I think not growing up in the system allows her to fight against it easier, if that makes sense. Yeah, but anyway, it does.

Dr. Blevins 1:01:42
Yeah. That's impressive. My hat is off to her. All right, good. Finding

Scott Benner 1:01:46
her was one of the luckiest things that ever happened to my family, actually, Dr. elevens, I really do appreciate this. I needed somebody who could talk about this. And I learned from the GLP conversations with you, you are the exact right person to talk about things like this with so I hope to have you back again on other topics. Thank you.

Dr. Blevins 1:02:02
Do we have a few more minutes? Oh, my gosh, if

Scott Benner 1:02:05
you do, I was over your time I was trying to let you go.

Dr. Blevins 1:02:07
Let me let me close out with a few comments, some of which are redundant, truly. But and then I'm then yeah, it's great. This has been fun. This is a whole talking to you is a lot of fun. I tell

Scott Benner 1:02:19
you, Tom, you and I seem to get along very well, I would I expect you're going to be on this podcast for years. So thank you,

Dr. Blevins 1:02:25
I'd be happy to I may have to put off the screening one a little bit. I've just got so much going on right now. But anyway, back to inhale. You know, some things we learned in the inhale three study. And this is a little bit of redundant. But these are a big deal. And I hope to get this information out as soon as possible to people who prescribe insulin, people who are first of all very involved in their own self management, they're perfect for Frezza. And if they want to reduce hyperglycemia, this is a good way to guide the glucose down. And people who would like to try something other than a pump. This study showed this was a very, very, very good alternative. And this thing about rapid in rapid out that is just golden. I mean, we could read those people, one, two hours after a meal, and we didn't see an increase in hypoglycemia at all. And we had actually people you'd be some people roll their eyes here, but we had people set their alarm at 140 and dose over 140. And I'll tell you not everyone did that. But the ones who did did well. And and so the people are gonna have to be, I think, okay, with multiple or extra dosing. Yeah, but this is something they've wanted to do for a long time. I think

Scott Benner 1:03:33
if people you're talking to on this podcast, my daughter's high alarm is at 120. So you're not scared? You're not scared. And then with 140 Don't worry, I'm

Dr. Blevins 1:03:41
so well, thank you for saying that. Yeah, because I felt I was imposing on people on the study, I'd say set your alarm at 140 and kind of look at him. Like, are you going to throw something at me? But no, I'm glad to hear that. That's so good. Because it works. So well.

Scott Benner 1:03:53
Yeah, I'd rather use a little bit now than a lot later. That's just the way I think about it. So go ahead

Dr. Blevins 1:03:59
and the other party or is that people who completed the extension phase, there was a second 17 weeks that I don't have information on yet but afterwards we asked them Do you want to continue or Frezza and I can just tell you if they were on multiple daily injection and before the study, and they were they were we said hey, you can go back to whatever you want 60% wanted to stay on Frezza if they were on pre study automated insulin delivery the fabulous automated pumps water No, I'd love to ask people what they what percent of people they thought would want to stay on a Frezza it was 43% and and then if they were on just regular old pump without the automated features 60% wanted to stay on a Frezza now maybe they selected themselves out to try something different. Okay, maybe so but that was amazing to me. Yeah. And and so why would you use in conclusion, why would you use a Frezza patients choice is number one, and number two, we talked about it in and out. It's discreet and inconvenient. There was a day when I've said the people that are the best candidate are people who are needle phobic, and people who had lipo hypertrophy, you know that fatty buildup that occurs when people give injections in the same place. But really, those are the bottom, they're not low. There are good reasons but they're at the bottom of the list patients choices number one, and and then we talked about the conversion thing. And, you know, in the study, we allowed people to Lex the insulin, we learned that if they're going to have a big meal, that could take an extra four, if they're gonna have a small meal, they could subtract from their Frezza dose, and then they can adjust their dose just the way they do with other types of insulin. And we did have people correct 60 to 90 minutes after they, they ate. And we had them sometimes interact with their rate of fall that they're seeing when they dose rate of rise too. So maybe a little less if it's falling, when there does seem a little more if this rising. And and I'll just also comment that in our, our site here, we had, I think eight or nine people on the study here in Austin, and we had about four of those who wanted to stay on. Oh, that's right, we had we had quite a we had more than 50% Who are to say on a Frezza. At the end of the study, whether they were on MDI, the automated insulin palm, people liked it for quite a few different reasons. And so it's easy for travel exercise, quick and quick out. And you could talk about scenarios quite a bit. So you

Scott Benner 1:06:29
don't have to refrigerate it when you carry it. Is that right? Does it have to be refrigerated when I carry it? Once

Dr. Blevins 1:06:35
you take it out of the blister pack it can say room temperature for about three days. Okay, now you would want to you don't want to keep your your stores refrigerated. But the supply that you're going to use the next few days can be at room temperature. Yeah,

Scott Benner 1:06:50
yeah. And thanks to the people who do the studies, by the way. And, Tom, if people want to jump on a study, can they contact you, I know you, you seem to have some running almost all the time.

Dr. Blevins 1:06:59
You know, the present study is over. And I don't have another phrase instead of yelling away, we are doing some studies and people type one diabetes who are on, especially on multiple daily injection of medicines that are kind of like ozempic, the GLP ones, and we're trying to get a drug approved for type one, that'd be great with GLP. One. And you know, as you said, your daughter's practitioner had to, you know, really go to bat to get it approved. And hopefully that could be a thing of the past in the future if we get something approved. So we're doing studies and people with GLP ones, we're doing a study with a medicine that might help reduce hypoglycemia, and people with type one as well. So if if anyone in the Austin region is interested in talking to us about studies, we'll be happy to talk to them. They could call the Texas diabetes and Endocrinology and ask for the clinical research department.

Scott Benner 1:07:48
Nice. That's excellent. Thank you. I really did I let you get everything out. You did. Great. Would you hold one second for me? I just want to ask you something when we're not recording. Yes. Great. Great. Thank you so much for doing this again. I really appreciate you Scott. It's a pleasure what.

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