Bigfoot Biomedical's Unity Gets FDA Approval - CEO Jeffrey Brewer

Big news for Bigfoot Biomedical as the US FDA approves their insulin pen cap system called Unity – which also includes a CGM and an app. CEO Jeffrey Brewer explains what Unity is all about, gives us an update on Bigfoot’s pump system and opens up about his family’s story – his son was diagnosed almost 20 years ago.

Plus, in Stacey's first in-person diabetes meetup since COVID, she observed something very interesting about the newer families.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

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Episode Transcription below: 

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Stacey Simms  0:00

Diabetes Connections is brought to you by Dario health. Manage your blood glucose levels increase your possibilities by Gvoke Hypopen, the first premixed auto injector for very low blood sugar and by Dexcom help make knowledge your superpower with the Dexcom G6 continuous glucose monitoring system.

 

Announcer  0:24

This is Diabetes Connections with Stacey Simms.

 

Stacey Simms  0:29

This week, big news from Bigfoot - FDA approval for their insulin pen cap system called Unity, which also includes a CGM and an app. CEO Jeffrey Brewer says their bundle approach is a bit like Apple’s

 

Jeffrey Brewer  0:42

Apple takes a bunch of different pieces, some of which they licensed and some of which they make and integrates them into the most usable package that actually is going to be accessible to the most people. That's the way we think about it as well.

 

Stacey Simms  0:56

Brewer shares what Unity is all about gives us an update on Bigfoot’s pump system and opens up about his family story. His son was diagnosed almost 20 years ago,

plus my first in person diabetes meetup since COVID, where I got good news beyond just seeing my people. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Welcome to another week of the show. I am always so glad to have you here. You know, we aim to educate and inspire about diabetes with a focus on people who use insulin. And when I started Diabetes Connections in the summer of 2015 this week's guest Jeffrey Brewer was my second guest, it is hard to describe what the diabetes technology situation was six years ago. If you were around then you probably remember especially this podcast audience, you know, I tried to talk about it, as I mentioned in the teaser, had a meetup last week with some local parents, which was fantastic. And I'll tell you more about that later. And a mom of a child diagnosed in January of this year asked me what DIY was all about. she'd heard about loop he heard about do it yourself. She wasn't quite sure what it was all about. So that was a long and winding conversation.

If you are brand new, and you want to learn more, I recommend searching out the we are not waiting episodes of this podcast. And you can easily search those up at Diabetes connections.com. There's a search box on the upper right. It's a very robust search of our almost 400 episodes now. And you can search we are not waiting as all one word. I've put that in all of those kind of DIY open APS CGM in the cloud. You know all of those types of episodes.

I know that six years ago, this pen cap system is not the Bigfoot FDA approval many of us thought would come through First, if you've been following this story for a while Bigfoot was founded in 2014. It was under a different name. It got the Bigfoot name in 2015. But it was founded by a small group of dads of children with type 1 diabetes, including Bryan Mazlish, who got that nickname Bigfoot via reporter looking for the elusive person Bryan who had developed a do it yourself closed loop which his wife and son with type one were using, and the initial headlines for Bigfoot, were all about bringing that closed loop system to market you can go back and see their initial funding press releases, which say things like you know, “the funding will support final development activities for Bigfoot’s Smart loop, automated insulin delivery service, the world's first Internet of Things medical device system delivered as a monthly service.”

Bigfoot Unity, which is what we're talking about today is going to launch as that monthly service. It's such a great idea to cut down on the complexity, it's going to help so many people on multiple daily injections, but I know that this podcast audience leans very much into the pump closed loop give me all the tech news group. And I think it's important to acknowledge that that said, My guest is Bigfoot CEO Jeffrey Brewer. His son was diagnosed with type one in 2002 and as the former CEO of JDRF. Brewer led the artificial pancreas project there. In life before diabetes, Brewer founded and led early.com startups including city search and goto.com.

We will find out all about Bigfoot Unity in just a moment but first Diabetes Connections is brought to you by Gvoke Hypopen  and you know low blood sugar feels horrible. You can get shaky and sweaty or even feel like you're going to pass out there are a lot of symptoms and they can be different for everyone. I'm so glad we have a different option to treat very low blood sugar. Gvoke Hypopen is the first auto injector to treat very low blood sugar fever. Gvoke Hypopen  is pre mixed and ready to go with no visible needle. before Gvoke, people needed to go through a lot of steps to get glucagon treatments ready to be used. This made emergency situations even more challenging and stressful. This is so much better. I'm grateful we have it on hand. Find out more go to Diabetes connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma visit Gvoke Glucagon dot com slash risk.

Jeffrey, thank you so much for joining me, I really appreciate it.

 

Jeffrey Brewer  5:05

Thanks for having me. Glad to be here.

 

Stacey Simms  5:07

So I looked back at my notes, you were my second guest on Diabetes Connections back in the summer of 2015, talking about the big plans for Bigfoot and holistic systems, and then lots of things that you said at the time you couldn't really talk too much about. And now here we are. So first of all, thanks for being my guest way back when when, you know, probably have three people listening, I really appreciate that.

 

Jeffrey Brewer  5:29

Well, thank you, and thanks for sticking with us maybe took us a little bit longer than I had hoped. But we're finally here to be able to offer something to people with diabetes, that we hope it's going to improve life and make it a little easier.

 

Stacey Simms  5:43

Definitely. Well, let's talk about that. So we're talking about Bigfoot Unity, would you mind kind of going through who it's for what it does, this is a system that is going to help people who are on multiple daily injections. So what is big for Unity?

 

Jeffrey Brewer  5:57

Yeah, so as you know, had Bigfoot developing a range of solutions to help people whose lives are dependent upon insulin to live safely and, and hopefully better lives. We are in this journey, focusing first on multiple daily injections, basically, intensive insulin therapy, once a day, have a basal insulin, and then given shots at mealtimes, or for corrections of rapid acting insulin, that particular therapy, which about 3 million people in the United States today do on a daily basis, about half people with type two diabetes, about half people with type one diabetes, but it's really the same therapy, we have developed a system that we believe solves a lot of the problems that therapy has, when it comes to the ability of people to determine the right dose for themselves on an ongoing basis, and also for health care providers to support them in doing so over a long period of time. I

 

Stacey Simms  6:53

totally understand because years ago, my son wanted to take an insulin pump break, he has used an insulin pump, since he was two, really six months after diagnosis, we got him on a pump. And we were so frustrated. Because not only did we have to do all the math manually that the insulin pump had done, there wasn't. And this was really before, there were lots of apps and things, there was no way to do all the stuff that the pump does in terms of insulin on board, and that kind of thing. So I assume that those are just a few of the features that Unity will provide

 

Jeffrey Brewer  7:23

some of the things that a pump does BigfootUnity will help to support your right that for people taking shots, it's mostly a glucometer, a piece of paper with some instructions and a couple of insulin pens. There isn't a lot of technology involved in those people's lives right now. And what we've done is develop a package of technologies that includes some devices, and some software that is knitted together for ease of use, to make life convenient for the person to first of all, be prescribed the therapy to be trained how to use the therapy easily and safely, and then to over time be supported by a healthcare provider who has the responsibility of supporting many of these patients, we are bringing technology to a population of people who I think have been largely overlooked, because most of the innovations have been focused on pumps. And that's really been focused on type one and also focused on very highly engaged people with diabetes that frankly, had to do a lot more in order to support the therapy and seen by doctors who are very excited about the technology. But not everybody sees a clinician like that. And not everybody wants to put everything into their insulin therapy that maybe a pump would require.

 

Stacey Simms  8:42

So take me through a little bit of it if you could, when I looked at it, I was kind of making notes that I wrote white cap black cap. So the white cap is for the fast acting and that gives you a dose, like a pump would say here's the suggested dose.

 

Jeffrey Brewer  8:56

Sure Bigfoot Unity is a bunch of different things together at the centerpiece of the system is these taps that are going to be for the particular insulin that a person is prescribed, whether it is an insulin made by Novo Nordisk or Sanofi or Eli Lilly, we have caps that fit all the different disposable insulin pens for both the basal insulin and the rapid acting insulin. First of all, you get these caps that fit the insulin that you've been prescribed. You also get a couple freestyle Li braise, you get a blood glucose meter that talks to the caps as well. You get in this first time experience kit, everything down to the pen needles and the alcohol swabs that are going to be used for parasite before you put on a sensor, literally everything that you need in order to initiate multiple daily injection therapy with the exception of the Insulet itself. It's all in this box. So this box comes to a person with diabetes in their home. We train them to use the system through a digital interface that we've developed support. onboarding to our system but also for people who are cgmp may never have bought a CGM before will literally through a zoom interface, walk them through the first experience with CGM, and then train them on the whole system. And the centerpiece of the system, as I said, as these caps, which basically do a simple thing they keep track of when you last gave yourself insulin. And they do calculations that are necessary in order to recommend how much to take based on your doctor's direction, very simply on the blackcap, which is focused on the basal insulin, you have one button, and you can only press the button and cycle through screens.

So you press the button. first screen says this is when you last took the dose. So it could have been say 23 hours ago, and it's time to take another dose, you press the button again, and it's going to tell you how much you should take. And that's what you were prescribed by your healthcare provider. And what can be updated in the cloud, by your healthcare provider. Rapid acting cap, the white cap is got some additional functionality, but still works the same way. It's got a screen on it, and then you press the button, the first screen is going to have when you last gave a shot, which is particularly important for stacking insulin as you refer to insulin on board. This is one of the big challenges that people who are on shots have is that they don't have a record of when they last took the shot. And so actually making sure that they don't treat the same high glucose reading too quickly, and then end up with too much insulin and end up low. This is something that we help with by actually keeping a person from stacking insulin. So you press this button, it's going to tell you when the last took a dose, if within three hours, you had taken a dose previously, it's going to lock out a correction. And therefore you're not going to make that mistake. This cap also interfaces directly with the freestyle library to or a blood glucose meter, and basically takes that data and directly translates it into a correction dose if you are taking your correction based on again what your healthcare provider had prescribed. So whether it's a correction factor or a sliding scale that was written down on a piece of paper, you don't have to remember or do any calculations, it basically just takes the number from the libri and turns it into here's how much insulin I should take. And if I had previously taken insulin that keeps me from over insulinizing and stacking insulin

 

Stacey Simms  12:16

over insulinizing? Is that an actual word?

 

Jeffrey Brewer  12:22

Yeah, I think I heard that from one of the researchers one time, so

 

Stacey Simms  12:25

we're claiming it if it's not, it's a rage bolus or it’s over-insulinizing

 

Unknown Speaker  12:29

There you go.

 

Stacey Simms  12:30

I didn't mean to interrupt you, sorry.

 

Jeffrey Brewer  12:32

No, no worries, the next step, after you take a correction, maybe you're going to have a meal. And having recommendation for how to dose from mealtime. It actually turns out that small, medium and large is a format that a lot of people are able to understand and work with in terms of how to take carbohydrate content and actually correlate that with an insulin dose. It's actually the minority of people, even in type one, but certainly with type two that carb counts. And so thinking about this in a different way, and a simpler way, where you have maybe small medium and large buckets, and a corresponding number of units for insulin that shows up right on the pen cap. If you want to add the two together, you are going to click the button again. And then it's going to basically add a correction to whatever the meal bolus would be, you're going to pick that value that you're choosing as a patient, because we're not deciding for you, we're just telling you, here's what your doctor would recommend based on all the calculations that you usually would do, if you had to do them. If your doctor were sitting there with you, this is what he or she would recommend you do. But if you know more, because for instance, you know, you're going to be exercising vigorously later, and you want to protect against hyperglycemia a person might decide to take a year or two less. But basically we're going to get them all the information that we can take it and make it actionable for them take as many steps out as we can to just get them to the answer they want. Because I don't actually think people want to know what their blood sugar is. They want to know, what do I What should I do? How much insulin Should I take. And so every step we can remove, and every thing we can take out of this equation to make it easier for people to stay healthy and take the right amount of insulin and then forget about diabetes for another four hours until another meal. That's what we're trying to do. And we're trying to do that for people who take shots, which is most of the world in terms of multiple daily injection therapy is the preponderant therapy for intensive insulin usage.

 

Stacey Simms  14:28

I appreciate you going through so granularly, I have learned that my listeners really like the deep dive anytime there is something new. So thanks for walking us through that. And you've mentioned the CGM. Let's talk about this. This is all integrated with the Libra when people use the Libra does it alert?

Right back to Jeffrey answering my question but first Diabetes Connections is brought to you by Dario health and one of the things that makes diabetes management difficult for us that really annoys me and Benny isn't actually the big picture stuff. It's all the little tasks adding up. Are you sick of running out of strips? Do you need some direction or encouragement going forward with your diabetes management with visibility into your trends help you on your wellness journey? The Dario diabetes success plan offers all of that and more No more waiting in line at the pharmacy no more searching online for answers. No more wondering about how you're doing with your blood sugar levels, find out more go to my dario.com forward slash diabetes dash connections. Now back to Jeffrey Brewer answering my question about using the abbot libre here, does it alert an alarm?

 

Jeffrey Brewer  15:40

Very good question. So the way the library works is it gives data in two different manners. One is you take the pen cap and you swipe it over the library. And it gives you an on demand reading for what your glucose is at that particular moment. And that's the value that is used in order to calculate any corrections. But there's another way that libri is communicating, which is directly through Bluetooth to the smartphone. Because we have an app on the smartphone. And that's monitoring. For instance, for hypoglycemia, you have a couple different ways the library is working in order to support a person with diabetes, it's either directly on demand to make the calculation on the pen cap or go into the phone for monitoring for hyperglycemia. These are particular capabilities of the library to

 

Stacey Simms  16:27

his delivery that is in big for Unity. Are there any different features? Or is it the same one that people can buy separately?

 

Jeffrey Brewer  16:34

Well, it's the same libri puck. So the sensor itself, the part that you wear on your body, it's the exact same one that gets prescribed and fulfilled at the pharmacy or wherever else a person gets their lead rays. The difference is that we're not using the reader that avid makes, or the app that avid will have on the phone, the libri in our context is talking directly to our pen caps and to the app on the phone. So it's fully integrated into the system. This is an amazing thing that avid has given us, which is the ability to make it very, very simple for the end user such that you don't have to apps you have to worry about all the training is comprehensively designed such that I learned to use the library and the context Bigfoot system, one training one app, one company that's gonna support the whole system, Bigfoot, and then all the data that gets captured, whether we're talking about insulin data or glucose data, and then made available to clinicians in a unified interface to support them in adjusting the therapy over time.

 

Stacey Simms  17:38

Well, this may be a really dumb question. I know that the Libra you scan with the phone, when it's separate from Bigfoot in Bigfoot Unity, do you scan with the pen? Or is it just automatic,

 

Jeffrey Brewer  17:48

it's with the pen, you scan. That's actually the only way you can get right now what's my glucose reading from the CGM is through that NFC interface on the library puck. And one of the key design elements that we felt very strongly about is that you don't have to open up an app on a phone, in order to give yourself a shot. Literally, you're just carrying that pen which you would have with you for meals during the day, it already has the pen cap on it. So you don't carry another device and you're wearing the Libra on the back of your arm, all you have to do is wear the Libra Ray, and then scan that Libra with the pen cap, then it tells you what to do. And no opening an app on the phone, no unlocking the phone, selecting an app opening and navigating through pages, that adds too many steps. And it's frankly, peep something people don't want to do. So we tried to make it as close to what they're doing today, which is you've already got a pen that you're carrying around, we're not adding another device, you don't have to add any additional steps, all you got to do is wear the LIBOR rate and we take that data and then make advice as to what to do.

 

Stacey Simms  18:54

You know, one of the issues with pens is that they'll switch you insulin brands. So you know the insurance when your will cover human log the next year it wants you to take novolog and the pens aren't the pens different the caps fit and the different pens geoffry.

 

Jeffrey Brewer  19:08

The pens are different between the different manufacturers. And then some cases from the same manufacturer, you have different designs, different diameters and geometries and clearance for the needles. What we've done is besides designing different pen caps for all the different insulins, we have basically supported this as a service offering. So when you're using Bigfoot, if you didn't buy a pen cap, you are a customer for the entire offering. And if you get switched by your insurance company from humulus, novolog or back, we're just going to send you the new pen cap that fits the insulin that you're currently prescribed, which is we think one of the big challenges that people have and we've heard and we wanted to make sure that that was an easy transition for people.

 

Stacey Simms  19:54

That's great. And you've already mentioned the way it's packaged, but I'd like to just talk about that. Little bit more I remember. And it was either when we first talked in 2015, or you know, some point very early on that you all were adamant that this was not going to be piecemeal. And you were also going to make it easier for people to purchase things all together. So this is, this is a terrible way to describe it every in my head, I sort of think of those boxes, the subscription boxes, people get right with my kids, it was like, you'd get little fun comic book stuff in them, right, or you'd get a subscription box of exciting bath luxury items. This is obviously not that this is a box with everything in it, right, everything comes together.

 

Jeffrey Brewer  20:34

That's right, when you first initiate therapy, you don't have to go and get a prescription filled, really braise a prescription field for a blood glucose monitor for test strips for lancets. For pen needles, basically, it's all there in the box. And it's trained and set up in a unified fashion. That frankly, just makes it easier to learn. And it makes it more convenient. And we thought that's an important part of the customer experience. There's a lot of blaming, that takes place of the patient in the world that says, Well, people just aren't working hard enough. They're not doing the things that their clinician told them to do. If they were everything would be better, and diabetes wouldn't be a problem. And frankly, we just don't agree with that. We think that it's too complicated, it's too hard. And that it should be easier. So one of the things that needs to be easier is all the different supplies and getting those and making sure you have the right supply. Having access to the tools is something that needs to take place in order for you to be able to successfully use the therapy, we figure if we make that easier if we make it easier to remember things or you don't even have to remember things because we remind you or we descend them to you without you having to remember all that kind of stuff, I think really adds up to a better experience easier and more convenient use of the system, we firmly believe it's going to end up in better results. Because it's just people are going to do things that are more convenient and easier for them to do. So we make it as easy as possible.

 

Stacey Simms  22:03

any issues getting insurance and Medicare coverage when it's all bundled like this. I mean, I'm asking is did Bigfoot have any issues getting it? And is it covered for people now?

 

Jeffrey Brewer  22:13

Why Yeah, there's a lot of innovation that we're having to undertake in order to be able to deliver this to people. One of the aspects of innovation is that we're working through clinics, or endocrinology practices. And this is how we deliver the solution, the clinician will prescribe and then bill for not only the system, but the services of the clinician to use the system and support the system for the person with diabetes. And then when bill comes in, it comes from the clinician. So in order to make this simple, so that there aren't all these different prescriptions. And there aren't all these different places where you have to get all the different pieces, we're working through the clinician. And in this case, there are already codes that are available called remote physiologic monitoring codes that support the treatment of chronic disease and tools in order to support better treatment in chronic disease. And so we're providing these tools to the clinician, and then the clinician basically delivers them through to the patient. And the billing relationship is between the patient and the clinician. All of it gets simplified and makes everybody's life easier. What we're doing is covered by Medicare and private payers more broadly, because we didn't go and get a code for Bigfoot, what we did get is a plan to go and use codes that are already there that clinicians can access in order to reimburse both for what we're providing, and for the services that they have in order to support the effective usage of the system

 

Stacey Simms  23:46

looking forward, because of course, we can never just let something come out, we always have to see what's next. You know, we talked a lot about interoperability is Unity, going to integrate with different cgms or different systems down the road is that in the plans,

 

Jeffrey Brewer  24:00

not in the immediate plan, what we did is we said, we're going to pick what we think is the best CGM for what we're trying to do, which is simple, easy, cost effective and very scalable across a large population. And the library has some very unique capabilities that that we feel very much support what we're trying to accomplish. And so we did a deep partnership with avid, as I said, they've given us the ability to integrate their sensor into our system in a way that other systems are not integrated closed loop systems. Today, you have a company that sells you a sensor, you have a company that sells you a pump, they have different apps on the phone that are going to govern, you know their respective products, they're going to be uploaded to clouds that sometimes require clinicians to look into different places to see the full picture for data. We're doing something much simpler. Describe what we're doing is more like what Apple does. Apple takes a bunch of different pieces, some of which they licensed and some of which they may integrates them into the most usable package that actually is going to be accessible to the most people. That's the way we think about it as well. There are other sensors out there and great options for other sensors. We're not trying to say you have to switch to us if you're happy with your other solution. We're trying to go after a population of people who literally don't have any solutions today and are feeling pretty ill served. We think that with all the people out there that are still to use CGM are still to benefit from CGM and the kind of tools we put around CGM. We don't see ourselves as competing with others. We're just trying to get the goodness that we believe we've created out to people who who need it,

 

Stacey Simms  25:39

I got a question from a listener I meant to ask we were talking about scanning depends. And that was, if a person can still use the the libri, to reader and the librelink app to scan the sensor. Or once you do this, if it is only linked with Bigfoot system?

 

Jeffrey Brewer  25:53

Well, in order to get the benefit of the system, you need to use the pen caps, because that's where the data is captured. That's where the recommendations get made. And it works best in the context of the Bigfoot system.

 

Stacey Simms  26:05

So you can't you can't link it to two different things. In other words, you couldn't use the reader and the pen.

 

Jeffrey Brewer  26:10

Not at the same time, you could use the library separately with a library reader and a librelink. app, but not at the same time.

 

Stacey Simms  26:20

I'd love to get an update Jeffrey, if you could on what I believe is called Bigfoot autonomy, which was the pump system that we did first talk about all those years ago? Can I ask you what the plan is for that, or what you could share with us about it, it is called Bigfoot autonomy, right?

 

Jeffrey Brewer  26:35

That is the name that we have picked for it. Yes, autonomy and Unity Unity use for the shots and autonomy is for the pumps, we have, as you know, a pump ourselves, we have developed and done clinical work for algorithms that we have utilized for closed loop insulin delivery. And we've also developed the full package around how to deliver it as a single thing, using a libri. In a very parallel fashion to what we've done with a foot Unity, we had to focus on one product in order to launch the company and to establish ourselves. So we picked this path because we think it gives us the opportUnity to reach the most people most quickly that frankly, don't have other options available to them. And we think we're going to be able to establish a reputation in the marketplace. In the future Bigfoot autonomy is going to complement Bigfoot Unity and present another option for how people can have insulin therapy. That is something we're committed to down the road.

 

Stacey Simms  27:34

So the people that were very enthusiastic, there's this this whole commUnity that was you know, the DIY commUnity and the we are not waiting commUnity, they should not look at Unity and say, well, Bigfoot has stopped with the pump, right? They shouldn't think that this is not going to go forward. It's not still in the plan.

 

Jeffrey Brewer  27:51

Well, the plan is always and will remain that we're offering choice and selection of different opportunities for people that have different needs. Just as Medtronic today, in acquiring the companion in pen now realizes it's not about pumps or pen, it's about both, we've been saying the same thing for quite a while, we're just starting with the pens, and then expanding to the pumps, versus everybody else is now interested in pens and started in pumps, it's really the same thing. It's a different way of serving a particular part of the population that has different needs, pumps are great. And they can deliver a lot of value and a lot of quality of life. However, they're not going to be right for everybody. And there's going to be a lot larger population of people who will still take shots for the foreseeable future, especially globally. And so it's not a matter of either or it's both in our minds,

 

Stacey Simms  28:43

if your son is living with type one for almost 20 years now. And of course, I think most people got familiar with your name when you were at jdrf really pushing the artificial pancreas program. I wonder if you could just take a second to give us some perspective, because I don't know about you. But my son was diagnosed in 2006. And it almost seemed like for the first eight years, maybe even 10 years, there just didn't seem to be that innovation on the commercial side of things. And now, I feel like I know it's it's not there's no cure. I know it's we're not there yet. But I do feel like the technology is finally working hard. You know, we're doing things for my son. And it's not just pump technology, as you said it's pen technology. And I feel like at least he can do a little less work.

 

Jeffrey Brewer  29:25

I feel the same way. There's been a tremendous amount of progress from 2002 when my son was diagnosed in 2012. There wasn't much of any progress. It has been accelerating in recent years. And I give a lot of credit to jdrf and the work that the volunteers supporting jdrf did to advocate to the executive branch to the legislative branch and then directly to the FDA, we were able to establish a very strong platform for collaboration and the way the FDA has prioritized the innovation in diabetes. enabled it with some clear rules of the road. I believe that's what made it all possible. There has been development of technologies that weren't mature before. But if they didn't have a path through to the marketplace, through the FDA process that worked, we wouldn't benefit from all these things. So it has been a journey. And I think it's been, you know, development of technology. It's been developed in the regulatory practices. It's been greater familiarity and openness amongst clinicians, and also the payers who see value and these tools for patients. So a lot of things that had to change, healthcare is much more complicated and difficult to work in than what I previously did in my high tech career. But it's much more rewarding, because I think it's now having a big benefit and a lot of people and we're happy to join the party, as Bigfootbiomedical.

 

Unknown Speaker  30:47

Do you mind if I ask how your son's doing?

 

Jeffrey Brewer  30:48

Yeah, he's actually doing very well with his diabetes, I will tell you that between the ages of like 15 and 22, it was kind of rough. It was a very similar story that I heard from many parents when I was a CEO of jdrf. It's a really challenging condition to live with adolescents and young adults. But he sort of found his way through that, and now has refocused on taking care of himself. And the tools are better now, to enable him to do that. So I think that it's gone hand in hand, his maturation and the development of these tools. And you know, I think he's in a good place. And hopefully, we can make it better over time. You know, it's

 

Stacey Simms  31:27

funny, I'm not quite sure this is gonna come out appropriately. So I'll try to be careful. But it's kind of nice to free in a way to know that even the head of jdrf. And even the guy at Bigfoot has a kid who was a teen, and struggled. And I know that sounds weird. I don't wish anybody to struggle. Like I wish all the kids went through this, and we're fine. And everybody was the poster child. But I appreciate you sharing that.

 

Jeffrey Brewer  31:50

It's important because I don't think that people talk about it enough. How hard it is for families, how hard it is for the kids, and how young adults, their brains are just not meant to cope with a responsibility like this. It's just not right. It's not something that they're ready for. And, you know, so nobody should be surprised that it's very hard. And it certainly journey. I think it'd be better if people understood that from the beginning, you know, because some people yeah, you're right, they think it's just my kid that's having this trouble. But it's not, it's that this is really, really hard for any family. And it frankly, is the rare family, where you have just a completely well adjusted and easygoing kid with type 1 diabetes. That's the rarity, not the norm. We're a company that stems from the patient experience, you know, my knee through my son, obviously, it's not the same thing as having it. But you know, having a child that grew up with it, a lot of people at Bigfoot have insulin requiring diabetes and know what it's like to live with this drug. I think it's given us a really great perspective on some of the softer aspects of the experience have been missed by some of the medical device companies, things about making it easier and less stressful and just more convenient. Because when you got to do something every day, multiple times a day for the rest of your life, it's just a different kind of thing. And even small benefits to simplicity can have a huge impact and adding up to much less burden, emotionally or intellectually. And I think that all adds up to better lives. We can't point to any one thing about Bigfoot Unity and say, this is the thing that really makes the difference. It's really a bunch of different things that are really holistically designed to as a system, the sustainable and usable on a daily basis. And I think that's really the future of chronic disease and, and we're glad to be able to help tell that story.

 

Stacey Simms  33:45

Well, thanks for spending so much time with me. I really appreciate you going through it. And I'm sure we will talk again soon. Jeffrey, thanks so much for being with me.

 

Unknown Speaker  33:57

You're listening to Diabetes Connections with Stacey Simms.

 

Stacey Simms  34:03

Lots more information about Bigfoot. I will link it up in the show notes at Diabetes connections.com. I have been hearing some weird things about Apple podcasts player recently and some of the other apps that feed off of apple. If you're having any trouble getting links, or even listening to the show. Everything you need is a Diabetes connections.com transcripts of every show. And always please get in touch with me I can usually help you find what you need. Because these are pretty information, dense episodes. And if you prefer to read, I want to make sure you get the info. And if the app isn't helping you then we can help you in a moment.

Something really amazing about my recent diabetes, parenting meetup, I met some new families and it was really unusual their experience and what they're doing for the rest of us. It's complicated, but I'll tell you in just a minute. First Diabetes Connections is brought to you by Dexcom. And when we first started with Dexcom back in December of 2013, the share and follow ups weren't not an option. They hadn't come out with Technology yet. So trust me when I say using the share and follow apps makes a big difference. I think it's really important to talk to the person you're following or sharing with. Even if you're following your young child, I'm telling you, these are great conversations to have, you know, at what number will you text? How long will you wait to call that sort of thing. That way the whole system give everyone real peace of mind, I'll tell you what I absolutely love about Dexcom share. And that is helping Benny with any blood sugar issues using the data from the whole day and night. And not just one moment, internet connectivity is required to access separate Dexcom follow up to learn more, go to Diabetes connections.com and click on the Dexcom logo.

 

Okay, it was jumping out of my skin last week, because I had my first diabetes parent meetup since COVID. I think the last one might have been January or February of 2020. Many of you know I run a very large Facebook group for parents of children with type one in the Charlotte area, I think we have almost 1000 people now when we were starting to pull from all over the state because I have come to find out it's a pretty unique group. If you have a local group that you run, or you're part of what makes it unique is mine is based on meeting in person, I try to really stress and set up you know nothing official, I'm not with any organization, I just say hey, let's meet for coffee here, I stress the idea of let's get together in person, let's get the kids to meet let's get the parents to meet. And it can be kind of hard because not everybody I have found is as I don't know if enthusiastic is the right way to put it or pushy or not shy, maybe it's just I'm not afraid of rejection. If I set up a coffee and I invite you know, the whole 1000 people group, and five people show up or one person shows up, I'm still really happy. And I've come to find out that not everyone feels that way. So don't be shy. Just put your stuff out there, get people to come and meet up with you. It will change your life. It really helps me 14 years into it, I think more than anybody else who comes to these things.

So I set one up, we only had two people come I'm telling you these things are still amazing. But they were both newer diagnosed families. One had a nine year old daughter diagnosed January of 2021, just this past year, and the other had a 16 year old boy who was diagnosed last summer. And it turns out and I knew this before we met we the kids have some mutual friends. And they're both wrestlers. So Benny knew this other kid as well. But what was amazing to me is that both of these families were already enrolled in clinical trials. And they had been presented with this option. So early on. Now we do not live in an area where clinical trials are present. I mean, I've talked about this on the show before it's we've never been able to get in one. We live in Charlotte, North Carolina, most of North Carolina trials and tests and things are in the Raleigh area over by the Research Triangle, or they're in Virginia, at UVA, or Florida. And that's really the closest to us. So that's where these two families both went for separate trials, both at University of Florida health both I believe at trial net, I may have the exact place but both with Dr. Michael Haller, who we've talked to several times before on this show, one of the kids that the 16 year old is in the Teplizumab trial, the other is in the ATG trial. I'm not going to go into detail on both of these, we've actually talked to Dr. Haller about both of them on the show before. So I will link that up in the show notes as well.

But I'll tell you what the ATG trials you've just started. So it's a little too early to tell anything. And of course, this is just with one person. So we should be careful about drawing conclusions. But the 16 year old wrestler, holy cow, so he was diagnosed last year, it's almost a year I believe in In fact, when this episode comes out, it might just be a year. And this is a 16 year old kid. So a teenager who uses probably a lot of insulin, right big kid healthy kid. And I want to say the dad told me that his daily basil is four units. And they're struggling using a pump because he gets such low doses of insulin. They're trying to figure out what to do. Now, who knows, because as I said, it's early on, but it seems to be the thinking that the diploma has really helped make this first year of diabetes, very different than what most 15 or 16 year old kids go through in their first year of diabetes. I'm going to talk to the family. I'll probably circle back around with Dr. Haller again. Because I think that their experience and honestly, it has not been an easy experience. This isn't you know, you go down to Florida, you take a pill you come home, it's a very intense, but brief experience, but they do go I believe, every six months. So I'll tell you more about that as we get there.

But I really wanted to bring up with how amazing that these newer families are helping in this way. Obviously they want to help their own children, but they also understand that this is helping the greater commUnity. These are opportunities that did not exist. 14 years ago, when Benny was diagnosed that did not exist possibly, you know, 10 years ago, we have to pull him up in front of the FDA right now. This is really interesting to me, and I know it is to us. You're listening if you're listening this far into the show, certainly, but man and I know I also live in a more affluent area people have more access to health care and to doctors who know about this stuff. But Wow, I was surprised so happily, so To hear that and and to see that their entry into the diabetes community was also an entry into studies that will help everybody you know whether this stuff works or not, it all helps. So I really appreciate it.

 

 

Okay, before I let you go update on events, my next event is not in person, we're still on zoom for a lot of us but getting in person for more, which is so exciting. On June 5, I'll be speaking at Camp Nejeda. They have a great event for adults with type one, I will link this up in the show notes. And in the Diabetes Connections Facebook group, I'm talking about telling your story and advocacy. So this is more about how to get the media to listen when you want to talk and also maybe just about blogging and speaking Yeah, blogging still Sure why not in podcasting, and tik tok and Instagram, but talking about your story, and advocacy. That's what I'm going to be talking about there. If you're listening in the Charlotte area, we are doing another D parent meetup. That's This Week. If you're listening as the episode first goes live, it'll be Thursday evening. So drop me an email or hit me up on social and I'll give you all the details. And of course, every Wednesday, Diabetes Connections in the news, join me 4:30pm Eastern Time live on Facebook for a very brief five, six minute newscast about what's going on in the diabetes world, all types of diabetes, and that's replayed on social through the rest of the week. And the response to that has been great. So I am going to keep doing it. I'm having a lot of fun with it. All right. Thank you as always to my editor John Bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. I'll see you back here next week. Until then, be kind to yourself.

 

Benny  41:40

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