Interview with Justin Lake

3:13PM May 16, 2019

Speakers:

Ed Kless

Ron Baker

Ron Baker

Justin Lake

Keywords:

device

application

fda

batteries

manufacturers

blood sugar levels

diabetics

people

justin

technology

decisions

son

days

piece

mechanisms

community

diabetes

apple

meal

dexcom

Alright, well we've got a special bonus episode of The Soul of Enterprise. This time when we are first for the first time ever joined by one of our I guess its listeners would be call you a listener. Justin is that probably the best way to describe you?

I'm definitely a listener. It may not be the best way to describe me, but I'm definitely a listener.

But even more interesting what he what he's doing when he's listening Ed.

Yes, he was just talking about yard work.

Yeah, we're telling you guys, it's a compliment. I know. It doesn't sound like it. But it's really a compliment.

I'll take it. I'll take it. And you should know that Justin and I live about five miles apart. So any kind of yard work in Texas? Yes, you need something to distract you from the blistering heat usually. Although it's been pretty good this spring.

Anyway, the reason why we're having Justin on is he and I are having a conversation. over lunch, we get together every so often. Probably about once a month, would you say Justin or we made I'd like to think it's once a month, maybe it's less than that. But

And when you're not around, I tell people it's my Ed MBA. There you go.

And Justin was was was sharing with me a story of some of the stuff that he's doing with his son who was diagnosed with diabetes, what 18 months ago?

Actually in 2016, believe it or not.

Oh my gosh, wow, it's flying by. Holy cow, three years. And Justin, and listen to some of the shows where we talk about the FDA and approval mechanisms for different technologies. And Justin, I wouldn't mind if you would just reshare the story and then talk about this like community that you found a people who are technologists who are, I guess, improving the lives of their, their loved ones, by working their way around the FDA?

Yeah, it's, it's really a fascinating story.

So for those that aren't familiar, a type one diabetic has to continuously track their blood glucose levels, so that they can manage the amount of insulin that they are taking. So most type one diabetics have to take a basel injection, which is a long acting insulin that they take once or twice per day. And that stays in the system for roughly 24 hours. And then they have to bolus take a bolus injection, prior to eating any meals that have really any carbohydrates, and even some protein and things like that.

So it's, it's a constant balancing effort. For a type one diabetic, every time they think about having a meal, they've got some fairly complex decisions to make about how they're going to prepare their body for that meal. So for years, up until really, within the last decade, this was done really with very little accuracy. Because to test your blood, you had to literally take, you know, Lancet and prick your finger and use a small machine to test your blood sugar levels, and kind of figure out what the carbs are going to be and then kind of hope for the best.

And a lot of the complications that we all know of related to type one diabetes are not actually about the diabetes, and the fact that you're not producing the insulin, it's about having severely high or severely low blood sugar levels that are caused by people not really doing, you know, a scientific job of the math. And I'll tell you, you know, we came into this as a family that was pretty aware of nutrition, we were pretty aware of, you know, macronutrients and carbs and proteins and fat. So I think we actually had an upper hand, and I can tell you right now, my blood, my son's blood sugar levels are three times what they should be right now, at this minute, I'm showing that even when you know what to do, it's, it's still proves to be, you know, pretty difficult to kind of keep that in check.

Fortunately, there have been some technologies that have been rolled out over the last few years that are trying to help with this. And so the two categories are a continuous glucose monitoring system, which is device that you wear on your body, and it's constantly tracking your blood sugar levels in virtual real time. And then the other side of the equation is actually having an insulin pump, so that you can kind of dole out the insulin injections. Rather than having to give yourself an injection at each time, you can attach this pump to your body, and the pump will actually push the insulin into your body as needed. So these two technologies are independent of one another. But and you can use them, you can use one without the other or you can use both. But for all intensive purposes today, they don't work together as a seamless system. So and I don't know if you want me to continue going down that path or if you want to stop and ask any questions about what I've talked about thus far.

No, that makes great sense to me, Justin, Ron did you have anything for him?

No no, yeah keep, I'd like to hear about those two technologies and how they don't work together.

Okay, so the the, the one piece that we have adopted in our family is the continuous glucose monitor. And, and actually, I just realized I said something that might might sound strange when we talk about adopting these things, as a family. Many in the Type One Diabetes community, we think of ourselves as a pancreas family, because it's that the pancreas is the organ in your body that when you're a type one diabetic is no longer functioning properly. And so for those families that manage this disease successfully, we all find that the the family has to kind of chip in and become a family unit to make up for the lack of a pancreas.

And so we made the decision together, obviously, my son had a lot of input in this, but he wears this gadget on his arm. And it is it has an injection point where there's a thin wire that goes under his skin. And it has a Bluetooth radio in it, that transmits the current status of his blood sugar levels to a proprietary receiving device. Or in his case, it connects via Bluetooth to his iPhone, where he has an application on a screen. And it shows what his current blood sugar level is at all times.

My son for now has chosen not to go down the path of a pump. He doesn't really mind the injections. And I think, you know, it's still a fairly new diabetic only three years into this, I think he felt that having just one device to have to manage was enough for him. And since he doesn't really mind taking the shots, he decided to use the blood sugar, the continuous glucose monitor as it as an accessory. But we've the pumping piece out of the next for now. So I'm a little bit more familiar with the continuous glucose monitor. But Ed This is what you and I were talking about with

Yeah, it started about a battery. Right? That's where it started.

Yeah, so this is what's really fascinating. So when when you first get into this, you find Dexcom is the unit that we use, there are a few different manufacturers. But Dexcom, is the manufacturer that we chose to go with. I don't remember the exact decision, but it probably had something to do with which one our insurance company would, you know, pay for it the time. And this unit has a planned life cycle of 90 days. And when we first did this, so you get a new transmitter. And this is a completely sealed device made of injection molded plastic of some sort, it's got a couple of contacts on the bottom. And so every two weeks or so you have to change the sensor that's applied to your skin. And then you flip the transmitter from that sensor to the replacement sensor. And so you kind of go through this cycle every week to two weeks, or in the case of my son, you know when he knocks into something and knocks the sensor off.

But the frustration that I was sharing with you was that what we were learning is that the application on his iPhone would not let that device work past I believe it was 100 days. And as we started doing a little bit of research on this, we realized that the battery life is often will go on Far, far longer than 90 days. But we had like a built in planned obsolescence that the the software that ran the device just would not read after I think it was exactly 100 days. So 90 days was the kind of prescribed duration, they gave you 10 days of buffer in case you hadn't received your new shipment yet. But after that this thing was just not going to work, it was forced to stop working.

So we went through this cycle a few times and in mind you even with insurance, we were still paying hundreds of dollars. In fact, I think it was around $500 per quarter that we were spending per quarter meaning every three months to have to replace this piece of technology. And what was frustrating about that is that the more researched it the more I realized that there really wasn't a need to turn it off yet, it's just that the application simply wouldn't let it work. So as I went into this, and you see some of the folks on Facebook and people that have contacted the manufacturer, and the feedback from the manufacturer was always like, well, it's it's an FDA requirement, we're not allowed to let it go for more than 90 days. And that didn't really make sense to me. Because I knew that, you know, the manufacturers are playing a part in how their products it's you know, it's not like the FDA just made a mandate that all medical devices can only last for 90 days. Somehow these two organizations, this manufacturer and the FDA came into some agreement that 90 days would be the limit.

What we then found, thanks to YouTube University, as I call it, there were ways that you can change the batteries yourself. So this is a completely sealed, injection molded plastic that was not designed to have replaceable batteries. But with a few videos on YouTube and $2 worth batteries literally $2 because there's two batteries, and they cost $1 apiece, I was able to basically extend the life of this device indefinitely.

The piece that was missing was that the software would stop working after the hundred days. So it really didn't matter if I had to think plugged into a wall outlet at this point, if the software wasn't going to receive the signal, then you know, it was it wasn't any value to have working battery. What we found at that point was that there's an entire community of people that have written replacement apps for both Android and iOS and the one that we uses an iOS version of this app that allows for basically indefinite use of these devices. So they have taken the situation they have basically reversed engineered the communication, the Bluetooth communication between the continuous glucose monitor, and the iPhone or the Android devices that they're communicating with, and figured out how that communication happens. So that they could basically bypass the need for the manufacturers application and replace it instead with this third party app.

So what that allows us to do is two things, if you had a brand new device that went through its 90 days, and then you had your 10 days of buffer, you could use these applications just to even harness the additional battery life that was early left and the device and some people were finding that their devices were lasting up to 150 or 180 days, just with the original batteries that came from the manufacturer. So that was really one of the big frustrations is to say, well wait a second, why are they forcing this thing to shut down in 90 days, if in the very real world, were able to get five or six months out of some of these devices. So I'd say the first group of users chose to use these third party applications, just to bypass the kind of false time constraints that were put into the software.

The next group of us then took that to the next level and said, Well, if I can replace the batteries, I sure like to, I'd rather spend, you know, two bucks instead of 500 bucks to replace this transmitter. So we learned how to do that. And I don't know if I shared this part with you. But we literally have a 3d printer, where we created we printed replacement tops for the device. So you grind down the plastic, replace the two batteries, put some silicone on it because my kids swims every day in the pool and has to take showers obviously, so you needed to be waterproof. So we put a dab a silicone on there, we seal the device back up with a 3d printed cover that we made. And, and we get virtually unlimited timeline from that. So with the replacement batteries, we actually use bigger batteries and what came from a manufacturer. So we can actually make that thing last for seven, eight, or even nine months right now, using the larger batteries and using the third party applications. So let let me stop there, because I know that was, that was quite a bit of a story there.

But Justin is a couple questions is, is this device FDA approved? It must be.

Prior modifications. It is FDA approved.

So so it is and and so their application, the manufacturers application is on the App Store, as a, you know, certified medical device in America, and I'm sure other countries as well. And so their devices available that way. Interestingly, these third party applications, because they've not gone through those approvals, Apple steers clear of wanting to approve any of those applications on the App Store, they just want to stay out of, you know, trouble with the feds, which I understand. And so there's been a whole effort to try to distribute these applications, through skirting mechanisms to try to get around the Apple App Store. You know, despite them having pretty good control on it.

You anticipated my next question, because I was going to ask you are the manufacturing manufacturers suing the you know, the replacement app developers? And then is are those replacement apps available on other platforms besides Apple?

Yeah, so the the one that we use is not available on platforms other than Apple, because the developer that kick this thing off, who by the way, is a type one diabetic, who happens to know how to build applications and iOS decided to take matters into his own hands, he used some open source code that was available from some others who had been down this path to varying degrees. And he actually made an even better version of what had been done, and decided to share that there are other folks who have done the same thing in the Android ecosystem. And they have a little bit of an easier time distributing the apps because the Android ecosystem isn't locked down as much as as iOS has been a fascinating cat and mouse game that's been going on over the last few months. And you guys have actually talked about some of this completely unrelated to this effort. But as it relates to iOS, and how they're locking down the App Store, and trying to protect the privacy with companies like Facebook and others who have really abused some of the permissions that they had on our devices. So what's what's happened is, the developers of these applications have used some of the same deployment mechanisms that Facebook would use, for example, to deploy an application to their employees. So Apple allows for you to have non public distribution of applications if they are for internal use by your company. And that's a pretty typical use case, right? If Sage as an example has an internal application for I was gonna say time tracking that would be very funny to have said that.

Maybe they didn't know that. Maybe they do.

Every day, I'm a closet timekeeper.

They probably do have this application that will save that for another podcast. That if they only wanted to deploy that application to Sage employees, for example, there are mechanisms in place to do that without having to go to the app App Store. But the commitment that you're making, as the distributor of that application is that you're only sharing it with actual employees or direct subcontractors in the company for purposes of business, right. So the developers have used that same mechanism to distribute these apps, and eventually started having their certificates revoked from Apple, not because they were targeting, and this is kind of a misnomer in the diabetes community, a lot of people thought, because we're in this community that Apple was just targeting the diabetics of the world and was trying to, you know, prevent diabetics from having access to better technology. And that really couldn't be further from the truth. This was a gnat, I'm sure that they were just trying to swat in the grand scheme of things. They were trying to revoke certificates on a far broader basis for all organizations, including the Facebook's and Google's of the world, who are misusing this capability to distribute apps, therefore, leaving people vulnerable to privacy concerns and things like that. The unfortunate challenge for those people in this community is that they've had to continually look for other workarounds. Right.

So this is kind of the moral dilemma. Is it okay for the system to be cheated when it's for a good purpose? And who gets to decide what the good purposes, right? So there are a lot of people in the community that don't even understand why this has been such a dilemma. They truly believe that Apple is out to get the diabetics, people have insinuated that they were kind of stopping this thing out, because Apple must be coming out with a blood glucose, you know, monitoring system themselves, which I believe might be the case. But I don't believe that that's why they were clamping this down, because we see the same thing happening with a lot of other companies. But it really has been a very challenging thing for I'm reasonably tech savvy. And I happen to have a software company where we build mobile software. So I've been able to get through some of these challenges. And, you know, kind of figure this stuff out on my own. But guys, there are just in this one app that we're using. There are over 10 thousand users globally, that are doing what I'm describing today. And many of them didn't have the technical challenges or the technical competencies to overcome the challenges of kind of figuring out this bypassed process process. And so many of them are are struggling now, because of Apple being a little bit more strict on the certificate revocations that some of these workarounds are beyond the capabilities of some of the individual users

Justin, I'm trying to figure out the manufacturing response to this. I mean, why don't they just, you know, if that device can last seven to nine months, rather than just 100 days? And if it's not an FDA requirement? Why don't they just retool it, and maybe up the price or whatever. But it just seems like the what's the manufacturers doing in this process?

Yeah, that's a great question. So one of the things are a couple things about that. And I happen to meet a guy recently, that runs a company that actually does medical equipment, testing and approvals through the FDA, it was just completely serendipity that I met this individual. And I immediately started, of course, talking to him about this. It's a very interesting thing, he actually sent me some links that I'd be happy to share with you guys. But I'm going to read something that he said to you.

"There's actually a huge regulatory burden on the manufacturers to do what is called post market surveillance, and also separately, to prevent foreseeable misuse of their product."

And he sent me a bunch of links to FDA links and things like that, that I'll get I'll share with you guys. So what was interesting is that if there's any chance in the world that those batteries could die after nine year hundred days, they are under such constraints from the FDA to never let that problem exist, that they probably have calculated that Yeah, on average, they probably last 150 days. So what we're going to commit to is that we can make sure that they work for 90, right. And I'm sure that there are legitimate suppliers issues, right? If they sit in a supply chain for, you know, three, four or five months, even though they're not being used, I'm sure those batteries are draining to some extent. So they've got to find a, you know, a number of days a life of this device, that they can commit to on a very high percentage of time, knowing that some of the users will, you know, if they don't get their 90 days, of course, if you don't get 90 days out of it, they'll they'll replace it from a warranty standpoint, but the user expectation is that they're going to get 90 days out of it. And people are making medical decisions based on the output from that device.

Right? Life and death, almost I mean,

It is literally life and death.

I want to jump in and get a question in on on this, and I want to make sure you understand this. So there's the device, and then there's the battery. Right? And and it's the battery that has the commitment for 90 days. Is that correct? Or is it the device itself? According to the FDA,

Well, remember that the batteries are not replaceable? So the the device in the battery are one.

What in the arcade? That's what I'm saying in the minds of the FDA, that it's what it's one piece of equipment? So that then then is is that I mean that the simple solution? Is manufacturer come out with a version that has replaceable battery so that you just pop the batteries in and out and be done with it. Right?

No question. And that's where my skepticism comes in. from, you know, the the profit motors and you know, I'm a free market guy, right? I listened to your podcast. So I'm all in favor of companies looking for a way to kind of maximize their, you know, maximize their profit, what they've essentially done is created a subscription model out of hardware.

But unnecessarily because, and my guess is this, and this is pure speculation on my part, then that this is an example of what's called regulatory capture. It's the FDA and these companies have gotten together and said, Well, you know, here, here's what the regulation should be this what you know, as per our company, and the FDA says, Yeah, that sounds about right. Okay, great, right. And that's the motivation for the company to say, let's go change this, because they they're getting, you know, replacements every 90 days when the reality is, is they could be not only getting replacement once every several years, because I imagine the device itself, without the battery probably has years of life.

Well, we're proving that in our household because the device that my son has on his arm right now was probably purchased by us in early 2017. And we're probably on our third or fourth set of replaced batteries. And what you reminded me of another thing, somebody else went and figured out how to actually create a rechargeable version of this thing. I mean, you guys just wouldn't believe the ingenuity of some of the, you know, I'll call them hackers. And it sounds like a negative term. But these are just guys that have just figured this stuff out. So they actually put rechargeable batteries in, they put a USB port on the app, so that just like our phones and other accessories, you can just plug it into a USB thing, charge it up and go on about your day. I don't think those batteries last quite as long, but they're rechargeable. So it basically lasts indefinitely. And they even made that device waterproof. Because, you know, Christopher keeps this thing on his body for two weeks at a time and obviously has to swim and, you know, take showers and stuff. So they've, I haven't gone to the point of taking advantage of the rechargeable one yet, just because I've gotten pretty efficient about changing the batteries. And they last for so long that it hasn't been worth it. But yes, all of these things are certainly possible. And I do believe it's a you know, a bit of a convergence here of intentional regulatory constraints around with the you know, preserving maximum profit on the part of the company, despite making the customer experience a little bit more palatable.

Any competition to this device, Justin?

Yeah. So there are there are other competing products. And this is. So there, there are a few manufacturers that basically have the same type of thing as a DexCom, and they've all approached it very similarly, we ended up going with DexCom, because they were one of the first ones that would allow us to bypass their proprietary device and go straight to an iPhone. And the advantage of that is that it broadcasts from the iPhone up to the cloud so that my wife and I can then see his blood sugar levels remotely. Those other devices, were not supporting that. So even on my Mac, as I speak to you guys on zoom right now, at the top of the screen, I can see exactly what my son's blood sugar levels are, because we're monitoring that from afar. So we went down that path for that reason, but other companies have similar versions. Some now offer the remote visibility, and some do not. But there are a few other competitors in the space.

What another topic that I know is near and dear to you guys on this is the problem is is that the consumer, the patient in this case doesn't get a complete, this is not a free market decision for us as a family. Right. So this is when the insurance companies really come into play. So they're all hashing out deals, as the ultimate payers of some of this tech, we're not really the ultimate payers, I shouldn't say that, but as the immediate payers, to these manufacturers, and they are selecting what devices they choose to provide in which they don't. And so this is just like so many other areas that you know, you guys have talked about in your show, where the nature of regulation and the way that the healthcare business has really evolved now is that the insurers are essentially making healthcare decisions on behalf of diabetics and limiting our choices in terms of which ones we can go with.

And if I had to guess and this is just a random guess but there are certain insurance companies that approved one device certain companies ensure improve another another device and not bad other one so it's it's it's just like like we had with with cable, right? The cable companies wink wink nod nod dividing up, you know, neighborhoods and saying we're going to we're going to only lay down cable here for the next five years, you're going to take that neighborhood and we'll we'll compete at some point down the road. But as long as we don't have to why bother? Because the regulators will let us get away with it.

You are 100% correct.

And Justin, you said it was about $500 out of pocket. I mean, that's after the insurance subsidy.

Yes.

And that's what most people pay. So I mean, that is kind of a hit. Even

We had we had subpar insurance, I would say at the time, we were you know, I I'm self employed. And at the time, we were actually buying health care off of the marketplace. And so I would say it was you know, subpar coverage. So we may have been paying a greater out of pocket than others. And you know, on the Facebook groups in the diabetes community, you see people telling horror stories and other people telling, you know, good stories that you know, they, they've been able to find it less expensively. Interestingly, some organizations like Costco, Costco is a huge pharmacy system, you don't really think about them as a pharmacy, but they do have a pretty big operation, they have apparently started opening up some, I'm not really sure how the economics work on this, but they are essentially providing reduced costs DexCom equipment, for folks who have no insurance coverage for that product at all.

What's interesting is that the insurance companies have seemed to come up with a way to say that they'll provide just enough support. So I think that to exaggerate my, my explanation, if the insurance company will even pay $1 than the Costco deals off the table. Right? Because they are only serving this option to those who have no coverage for it whatsoever. So I we haven't pursued this because frankly, I have now kind of gotten us to a point where we're working in the roads, you know, and environment. And I don't want to pay anything other than my $2 and batteries that I buy off of Amazon every couple months.

Wow, wow. Is the manufacturer sueing these app developers?

So that part, and I, I am fascinated that I have not seen more of that. That is something that's still blowing my mind. And I don't know if it's because the relative number in the grand scheme of things is so relatively small. I don't know if there are some PR incentives for them to not pursue this, right? Because I think you know, this community, if any of these companies really came after this community pretty aggressively, which frankly, they probably have every legal right to do. I could see it being just another PR nightmare for them or Sure. And so my my only guess is that, you know, most people aren't going to go through the trouble that my family and I have gone through right? Even though the number is big, right? I said earlier that there's 10,000 people using this application that's globally, they've translate this application has been translated into like 30 different languages, or 25 different languages or something crazy. So it's being used all over the world. So 10,000 people is a lot, but that's 1010, 10,000 people out of almost 7 billion across the earth, it may just be too small for them to go attack this.

Sure. Sure. It's like an orphan drug. Yeah, I really is. Wow,

Except it's really not when you can, you know, sort of the number of people with diabetes that could this could affect it. Just and I want to get get get to something that you picked up. We talked a little bit about earlier. And you said you haven't taken advantage of but I think we started down this conversation when you and I got together and got sidetracked on to something else. But one of the things you mentioned is is this also potentially would enable a continuous loop process to take place, right? So the monitor and then the pump, getting together to effectively create an artificial pancreas. Yes, outside the body. And are there people in the community who actually take it to that level?

Absolutely 100%. And this is really one of the exciting things. And just because of our conversation that we had a few weeks ago, I started spending a little bit more time getting updated on this, because because my son had decided not to wear a pump for right now, this really wasn't in play. But just to explain in a little bit more detail what you're describing. For those who may not be familiar with it. The idea of creating an artificial pancreas is if the things that your body, all of our bodies here that are not type one diabetics that is doing is your body is constantly monitoring your intake of carbohydrates, and then it is doling out an appropriate amount of insulin automatically. So it's pretty amazing process that our bodies do without us even knowing it. So the idea of putting these two parts together is that the continuous glucose monitor can be reading your current blood sugar levels, making predictions about kind of what direction you're headed, what is the trend going up or as a trend going down. And then you can tell a piece of software, what you're going to be eating. And this system can then dole out the appropriate amount of insulin automatically. So that's the idea of creating essentially an artificial pancreas. So it would still be made up of two separate pieces of technology that the glucose monitor and the pump that they'd be working together just like your body does today.

There are passive systems. So one of the manufacturers has now gotten through being able to connect these two systems. But interestingly, as I understand it, today, the technology is not allowed to make decisions for you. It is giving you data about your current status, and then you have to make the decision. So I think it's making recommendations based on the trends that have seen. But we haven't gotten to a point yet where we're comfortable. And I we I mean, the FDA and the manufacturers are current making the actual medical decision about what amount of insulin you should take based on those numbers. So you still have to have human intervention. So that's what's approved today. And what's happening today in the ecosystem. What's happening outside the approved ecosystem, is a hacker community around the world that works under a hashtag. And it's kind of fascinating, they call it #WeAreNotWaiting.

I think I get a just it sounds corny guys. But I get a funny feeling even just saying that, to think about the the power of this community around the world, who has taken their knowledge of technology and has put all of these parts and pieces together working at their desks and in their garages and maybe spend a little extra time at the office if they have the appropriate facilities there to kind of figure out how to do this until they've assembled parts and pieces from all the tools that we talked about today. And they've created applications and the biggest one is called loop. And basically what it is, is it's a an application that's reading data from the continuous glucose monitor, and then helping you make decisions about what should be pumped through the insulin pump, and creating a full loop system.

There's a new company that I just learned about in the last couple of weeks. And I'm very excited about I have their their homepage up on my screen right now. It's called tide pool. And tide pool. Their headline statement says tide pool intends to deliver loop as a supported FDA regulated mobile app in the App Store. So this is an organization that is essentially trying to create or help foster an ecosystem where there can be some universal standards around all of these component pieces. So that they can create an ecosystem of interoperability, where each of the individual components can be approved by the FDA, the communication mechanisms, and that interaction ability can be approved. But we can all make decisions independently about which glucose monitor we want, which phone we want to use, and then which pumps we want to use, you know, for the users of this stuff. I don't know that they'll make it happen. But I do know that that's their their mission. And they've actually recruited some of the top contributors to this, you know, we are not waiting community around the world, to bring them into Thai cool to kind of help foster this ecosystem. So we're obviously very excited to see some of that progress. I do believe Apple may have some interest in playing a part in this, of course, they're just not going to tell us until you know, the September product announcement. But you see some of the things that are happening on the watch, there are some there's been some testing previously about how to read blood sugar levels through kind of the similar light mechanism that they're using for heart rate tracking them. And they can get to a non intrusive optical scanner for blood sugar levels that is accurate enough for this mechanism. I think that would be you know, just another significant, you know, contribution here to the ecosystem. But in the meantime, tide pool is trying to pull together the parts and pieces that they have and get through those regulatory hurdles.

Justin, how one thing that we haven't talked about yet is how effective is this? I mean, is it helping your son's glucose level and keeping it in check? I mean, does it work? I guess, is what I'm asking.

Yeah, it's a great question it you know, by itself, it's, it's just data. And we and he really need to be making decisions about how he uses that data. You know, I do have a number staring in front of me right now is numbers of 285, which is three times what it should be. Right? And what's what's interesting is that today, he had a non typical meal, they had a special breakfast event at school. And then he has an AP history test today. Is that is causing a lot of stress?

Sure, sure.

And so like, there couldn't be a better moment for me to talk about this, from this point, it doesn't matter how much data he has. You know, it's like anything else, right? It's what you do with that data, that's going to make the difference. So I would say we've noticed, at you know, typical teenage, we've got hormones, we've got the stress of school, we've got the stress of being on the swim team, we've got all these other things that you know, we're dealing with, as parents have a 16 year old And oh, by the way, you know, all of this has this, you know, constant undertone of, you know, when your blood sugar levels, and what are you eating at each meal. It is what I will say is that his doctor tells him every time that he is one of the best patients that she sees in his office, in terms of his the A1C, which for those that aren't familiar is your three month average of your blood sugar levels. So it shows up on your blood test. His A1Cs are some of the lowest of all of the patients that she has in her entire practice. And I attribute that to two things, I think first of it is we do maintain a fairly low carb diet in our house. And and I've talked about this stuff before, we did that before his diagnosis. And we've continued to get more aggressive with that post diagnosis as well. But it's also about having access to the data and being able to see, you know how each different type of meal when he eats the meal, that the time difference between when he takes his insulin injection. And when he actually begins to consume that meal actually impacts what happens with his blood sugar. So you know, essentially having a dashboard just like anything else, you know, you can't manage what you you can't measure. And in this case, we're able to measure this with some pretty accurate data and then look at some of the trending over time and use that to make decisions.

I do think the next part of this for us is going to be I sense that he's getting a little frustrated, maybe because he's a teenager, maybe just as you can all imagine just wishes that he just didn't have to deal with this stuff all the time. I think the loop solution is starting to look a little bit more interesting, because I think for him, the decision to take on one additional gadget that he's got to find somewhere in his body that he can adhere it to might be the lesser of two evils, than having to deal with the constant decision making and going out with friends or going to a breakfast event like he did this morning and being worried about not knowing how many carbs are in this meal because it wasn't prepared in our house. And how is he going to measure for that and stuff, having a loop system will make that a little bit easier for him to deal with. And I'm beginning to think that he may end up going down that path to improves on care.

You think about I'm thinking about a 16 year old having to deal with this. And it just kind of shows you how adaptable we really are as as a species, he's adapted, it's a pain and all that. But he's, he's adapted to it, it sounds like.

It's one of the things I'm honestly this a little bit off the talking points, but I'm most proud of my son for being able to do, which is to, you know, kind of stare into the eyes of a lifelong diagnosis. And just kind of take it in stride. So of course, this just pisses him off, and he's frustrated. Sure, I know that social events probably create the most stress for him, I think this morning was a good example of that, where he was going into have breakfast with a bunch of other 16 year olds, you know, high school kids, and they're all just diving into breakfast burritos, and whatever they may be having. And he has to take a step back and really think about that meal to a level that's beyond what what most even adults would have to think about.

So I think it would be stressful, I know, it would be stressful for an adult, certainly stressful for a 16 year old going into that situation. But he's handled it pretty well. I think as a as a person who has basically spent my career looking for ways to bring technology to, to contribute to solving challenges that that humans have. My normal application of that is, you know, with enterprise customers trying to solve problems for asset management and work order management and stuff like that. But when I look at this solution, I say, you know, this is great, where technology is advancing at a pace, where hopefully in the next 10 years, you know, we could combine a continuous glucose monitor and a pump into something that's so small that it's incredibly inconspicuous. And you know, the iPhones are going to be that much more powerful in 10 years, or maybe they'll be a new disruptive technology in that time.

So it is, I do still hold out a lot of optimism, that once we kind of get out of the way of innovation. And by we I mean, the FDA, and probably the insurance companies and things like that, I think if those entities could get out of the way and just let things innovate at the same pace they would outside of these heavily regulated environments, then I think we'd probably have solutions a lot faster and a lot better. So that's the thing that we have to overcome. And I know, you know, this is near and dear to our heart. And a lot of the other things that you guys talked about, I was gonna say we talked about on your podcast, but I'm not normally on it. But that you talked about on your podcast, you know, sometimes the best thing we can do is get out of the way of innovation. And I think that's really what's probably most needed right here. So that those people who have just amazing capabilities to evolve technology and solve problems can be left to do what they do best. And then, you know, let let the customers in my case, my son experienced the benefits of that.

Well, while you've documented just here, some of that innovation just be these app developers and you printing, you know, on your 3d printer, the new top and rechargeable battery story. I mean, this is all incredible human creativity and ingenuity.

It really is. I wish there were away. And Ed you and I did not talk about this. But I've thought about it a lot. Since we spoke on this topic a few weeks ago that I wish there were a way I could just sign a release. And have you know, just say to the FDA, I promise I won't Sue anybody. And I promise I'm not going to hold the feds accountable. But I'd really like to just have a, you know, access to these technologies. And I'll accept the risks. Right? I know that's

Right to try.

Yeah, it's one of the one of the ideas for reform is you could buy drugs that are FDA approved or non FDA approved. Yes, you Yeah.

And I think, you know, there's a responsibility back on us. And, and I would accept that responsibility willingly. Um, you know, we've got to educate ourselves, and we've got to be advocates for ourselves, we've got to, you know, monitor the results, and in some of these cases, will, they'll probably be an obligation for us to provide feedback so that the products can be, you know, improved based on that real world feedback. But we would sign up for that in in a moment. Because we are very actively managing his care as a family. And, you know, if we could just get access to the right, the right innovations, I think that, you know, it would just really make the community advance that much faster.

Yep. Hey, Justin, before we let you go. This is obviously the use case here for diabetes through the community. Have you experienced any, any other communities like this like for other other diseases, other other challenges that people have? Have you heard about that? Anything like that?

That's a really great question. And Ed No, I'm the answer. No. And as I'm thinking about why the answer's no, I'm sure it's not because they don't exist. I'm sure. It's just because...

This one's really important to you?

Well, it Yes. But what I mean is that it's it's very specific, right? So these are not the forums that I'm a part of on Facebook and elsewhere are not medical devices to help with diseases forums, right. They are forums specifically focused on type one diabetes. And so we're pre selecting the audience and the things that we hear about in each of those groups that were a part of, so I'm certain that they exist, I'm just not aware of them.

Fascinating. Ron, you have anything else? This has been great.

No, but thank you so much, Justin, what a great What a great story, great example of all these things that we talked about regulation, permission, permissionless. Innovation, right to try all these things why? Great, great job, and your son Great job. This, I know how difficult that is, my brother had type two diabetes. And, and you know, he managed it really close. And it's just wow, it's, that's, that's, that's great for a 16 year old to be able to, you know, just get through it and just adapt.

It really is. And, and I think it's equally fascinating to see some of the folks that have taken their skills. You know, this this guy, Miguel, from Brazil, somewhere in Brazil, that wrote this application that we we use, you know, the the engineering work that he's done on the software, because his version of this application is actually better than what the manufacturer has rolled out. When he rolls out enhancements, he can roll them out in days. So the innovation, the pace of innovation, not only is he getting better results, but he's improving the pace, because he's not constrained by some of the other things. And that's the part that is just mind boggling to me, is really when when left just to the technical constraints, we actually see that we can knock those hurdles down pretty freakin fast. And that's the part that gives me some optimism that hopefully, you know my son's care of his disease will be that much easier in five years or 10 years if we can get out of the way.

Well, Justin, thanks. Thanks for being a guest today. Really appreciate it.

Thank you guys for having me. I appreciate it was good to talk to you and we'll talk soon.

Thanks, Justin. Bye now.