"The System is Designed to Learn" - An iLet Update from Beta Bionics

We are very excited to catch up with the folks from Beta Bionics! Their fully automated bionic pancreas is called the iLet. They are getting closer to submitting to the US FDA and were able to give us an update on some of the most anticipated features.

Kate Farnsworth is a consultant for Beta Bionics currently acting as Digital Marketing and Communications Manager. She walks us through what makes the iLet a very different insulin pump, including: a system that only needs the user's weight (no basal rates or carb ratios), software that will learn from the user and make adjustments, how the system charges, waterproof status and much more. All dependent on FDA approval.

Kate's daughter was diagnosed at age 8 and we first spoke in July of 2015 about Nightscout. 

Past episode with Beta Bionics:

Ed Damiano in April 2016

Ed Damiano in May 2017

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

 

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 take control of your diabetes and live life to the fullest with Dexcom.

This is Diabetes Connections with Stacey Simms.

This week, catching up with Beta Bionics . Their fully automated bionic pancreas, called the iLet has some new features not available in existing devices. And that's helped to ease the burden of diabetes in new ways.

Kate Farnsworth  0:33

Working for companies like Beta Bionics  give us the opportunity to reach a much wider group of people and really gives us the opportunity because we are a public benefit company to try and engage those people that aren't being engaged currently with the tools that are available.

 

Stacey Simms  1:02

That's Kate Farnsworth a well known name from the DIY community. Now with Beta Bionics . She'll give us the latest news on the iLet’s development and share some personal stories of her family's journey with type one.

Also this week, a big anniversary for the show, as well as for some of our listeners. 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, always so glad to have you on, we aim to educate and inspire about diabetes with a focus on people who use insulin, guys, it has been six years of Diabetes Connections this month, work six years I started in June of 2015. It kind of snuck up on me to be honest with you. I had started the show in May of 2015, actually, but it was just audio that I put on my blog. We didn't get accepted into Apple podcasts and all the rest until June. So that's where I'm marking it from. I had been working on it for months and months. And I kind of wish I had started earlier. But hey, I'm thrilled with how it's gone. Almost 400 episodes now, so many of you wonderful listeners who I hear from all the time. Thank you so much for sticking with me. And if you could just do me a favor, the best thing you could do, I'm not doing much to celebrate this anniversary, I'm not doing a big thing on social or anything like that. But if you could do me a favor, just share the show, share this episode, share whatever episode you like, or just share a link to Diabetes connections.com on your social media, you can put it on your own timeline. Better yet share it in the diabetes Facebook group. It really does help get the word out. You can leave a review that's always fun, but sharing the show itself or telling somebody about showing them even to this day, how to listen to a podcast really goes a long way. So will we be here for another six years? I don't know, man. I hope so. I'm not slowing down. I'm really excited about where we're going. And I love talking to people like my guest this week.

Alright, let's get into it. My guest is Kate Farnsworth. She's a consultant for Beta Bionics currently acting as Digital Marketing and Communications Manager. Many of you know Kate from the DIY community. Her daughter was diagnosed at age eight, and we actually first spoke she was on the podcast in July of 2015. Just after we got started, we talk then about Nightscout she helped so many people get watchfaces set up back in the day among so many other things that she did. Now she helps run the Facebook loop to group with 10s of 1000s of members. Now the iLet, as many of you know has been one of the most heavily watched and anticipated devices in the diabetes space. First human testing was done in 2008. At Damiano the company founder has kept everybody up to speed over the years he has been very public showing the progress in presentations at conferences, and he's been on the show a couple of times himself, I will pick up those older episodes. for newer listeners. The iLet is meant to be a dual chambered pump. That means it will hold and infuse insulin and glucagon to help achieve better time in range.

Just so we're all clear. Putting glucagon into your body isn't like eating sugar or infusing quick acting sugar like glucose or dextrose. Very simply put, injecting glucagon or infusing glucagon stimulates the liver to convert its stored glycogen into glucose which it can then release into the body. The eyelid is being designed with two cartridges and two infusion sets one each for the insulin and glucagon. But the plan right now is to move forward with just the insulin so just one chamber like a quote regular insulin pump for now. I know that was a lot but after Kate and I finished the interview, we realized that a quick description like that and some information about glucagon because I still explain it I still have a lot of people who are newer in the community who don't quite understand. So I really hope that that helped.

Okay, a lot more in just a moment but first diabetes These connections is brought to you by Dario health. And we first noticed Dario a couple of years ago at a conference, and Benny thought being able to turn your smartphone into a meter was pretty amazing. I'm excited to tell you that Dario offers even more now, the Dario diabetes success plan gives you all the supplies and support you need to succeed, you'll get a glucometer that fits in your pocket unlimited test strips and lancets delivered to your door and a mobile app with a complete view of your data. The plan is tailored for you with coaching when and how you need it. And personalized reports based on your activity. Find out more, go to my dario.com forward slash Diabetes Connections.

Kate, thanks, thank you so much for joining me, Boy, am I excited to talk to you.

 

I'm so happy to be here. Before we jump in, my listeners know that I promised this year that in 2021, I was gonna be very heavy on technology. There's so much in front of the FDA, there's so much going into pivotal trials and heading to the FDA that I thought it would be so easy to do all of these interviews. But I realized as we got further along that the very timing of all of this makes it very difficult for the companies to actually come on and share a lot of information because you are limited in what you can say and understandably so. So before we even get started. I know you have a disclaimer that you're probably going to bring out a couple of times during the interview. But why don't you go ahead and say that now.

 

Kate Farnsworth  6:21

Thanks, Stacey. So the iLet bionic pancreas is an investigational device and it's limited by federal or United States law to investigational use is not available for sale

 

Stacey Simms  6:34

as we go forward. And as you listen, I should also let you know that I've given Kate the opportunity as I did when I talked to Howard look from tide pool or you know anybody else who is in this phase of their device or technology, the opportunity to kind of let me know when I've crossed the line. So I may ask a question that you can't answer, Kate. But um, I think we all we kind of understand where we are. So I appreciate that. All right. Having said that, give us the lay of the land, if you can, where is the iLet? In terms of development, let's go high level as far as we can right now.

 

Kate Farnsworth  7:07

Okay, so Beta Bionics  is the company behind the iLet. And we're really different company because we're a certified B Corporation and the public benefit corporation. And that means our company is measured by an independent resource based on how our company's operations and business model impacts our workers, our community, our environment and our customers from our supply chain and input materials to our charitable giving an employee benefits. B Corp certification proves our business meet the highest standards of verified performance. For Beta Bionics . That means the people with diabetes and their loved ones have a seat at the table in our decision making. In that context that we're working to bring the commercial version of the iLet to market. There is currently a pivotal clinical trial testing the eyelid and people living with type 1 diabetes ages six enough. This trial is large and involves 17 different clinical trials sites across the United States. results from this clinical trial will potentially support our application to the FDA for regulatory clearance of the insulin configuration of the device in that population. Once the FDA application is filed, FDA review of 510 k market applications typically take about six months, which includes 90 days of FDA review time and time for response to questions that may come up during the review.

 

Stacey Simms  8:39

My understanding is that the iLet is a device it's we're talking about an insulin pump here. And I guess what I would call an artificial pancreas or hybrid closed loop system, where it communicates with a CGM to help you stay in a certain range. But the island has always been talked about as needing minimal input. In other words, last time I talked to Ed he was talking about you put your weight in. And that's really the only information it needs from the user to get started. Is all of that still the case? Is that what's in these pivotal trials?

 

Kate Farnsworth  9:09

Yeah, so that was designed to be initialized by weight alone. It doesn't require users to set curry shows or basal rates for instance, insulin sensitivity factors, the system uses your weight as a starting point and then learns quickly what your unique responses are based on CGM values that receives every five minutes. So with that in mind, we hope that once the FDA clears it, the iLet can be an automated insulin delivery device that requires very few inputs from healthcare providers and people with diabetes or caregivers. For us this solution isn't just about the feature is it's about the benefit that it could potentially give people reduced cognitive and emotional burden. You might recall Adam Brown has talked about the 42 factors that impact blood glucose at Ada conference and in his book bright spots and landmine, those of us in the community can definitely relate based on our own experiences. There are a number of diverse factors that pay people with diabetes on a whim, combine that juggling act with up to 180 diabetes related decisions that people with diabetes or their caregivers make each day. And we really do have a cognitive and emotional workload that those living without diabetes don't face. So our hope is that the iLet is cleared may reduce that burden, since it's offering a solution to type 1 diabetes management without the same numerical input as traditional employment therapy.

 

Stacey Simms  10:43

Can you speak to the idea of just entering weight and like announcing meals, I mean, I think for those of us my son's used an insulin pump since he was two. So we're coming up on, we're coming up on almost 15 years of using an insulin pump. And the idea of interacting with it less is a little bit mind boggling. You're a mom of a person with type one, you have a child with Type One Diabetes, can you just speak to that idea? You've already talked about the burden being lifted a little bit, but is it difficult for people to kind of wrap their brains around and the reaction of when it does work as well as

 

Kate Farnsworth  11:16

we assume I can't speak about the clinical trial right now or the results that we're getting. But what I can tell you as a mom of a child with diabetes, is that the cognitive and emotional burden that she feels just having to constantly worry about her diabetes is immense. And I think that we even as parents don't fully understand, you know, how much our kids have to think about diabetes, how much it impacts every moment of every day, and interacting with friends or going out or making decisions on whether or not they're going to sleep over at a friend's. And if there was a device that could potentially relieve some of that burden to me, you know, that's huge, that would be amazing for my daughter. So with the eyelid, when you're entering a meal, you would select whether the meal is the usual amount of carbs for you more or less, it's designed not to require you to count the actual number of cartons over time, the system's designed to learn what that means to you personally. So for my daughter, for example, might have a totally different usual meal than your son. So the system is designed to learn and adapt to each individual user. While there's, you know, that's the practical application. There are other considerations for wide the eyelid has been designed that way. There are 1000s of Americans who don't have access to an endocrinologist, we want him to engage them, we want to meet them where they are and help them get closer to their diabetes goals. I feel passionately about improving the lives of people living with diabetes and easing the burden they live with every day. And research has documented racial and ethnic disparities in diabetes treatments and outcomes. Technology uptake, for example, is much higher for white youth than black or Hispanic youth. As a public benefit corporation. Our goal is to get our solutions to as many people as possible. So we're actively exploring how we can reach the underserved populations and hope to be able to provide all people with diabetes, the same level of care,

 

Stacey Simms  13:33

I want to make a note and come back to that because there's been such a wonderful, I don't know how to say it, I want to make a note and come back to that. Because years ago, we talked about the DIY community, how it was reaching so few people, it was such a great benefit, but really not for a lot of people. And so many of you are passionate and wanted to bring this commercial product out. And now it's being done. So I'm gonna I want to follow up on that in just a little bit if I could, but let's continue to kind of talk about where we are, thank you. But the idea of no carb counting, to me, would be such a relief, because one of the shocking things that happened in my brain was within the first year of Benny being diagnosed, I think he was too he wasn't eating as much food as he does now at 16. But we realized that carb counting was so inexact and such guesswork, because you could try to be as exact as possible at home. But then you would go to a restaurant, and you really had no idea. And as you listen, my husband owned and operated a restaurant for many years. So you can tell somebody, this dish has this many carbs in it. But first of all, restaurants put so much more butter and fat, and seasonings and things in your food because that's what makes it taste so delicious at the restaurant, which affects how it breaks down in your body. But also, one person can make it to the next day even at a fast food restaurant, it's not going to be exactly the same. So what was the thinking behind it? Is it really just to make it easier on people or did the researchers and the founders here also kind of think that carb counting really isn't that exact

 

Right back to Kate answering that question, 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 gonna pass out. There are lots of symptoms and they can't be different for everyone. I'm so glad we have a different option to treat very low blood sugar Gvoke Hypopen. It's the first auto injector to treat very low blood sugar. 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 am 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.com slash risk. Now back to Kate answering my question about the inexact science of counting carbs.

 

Kate Farnsworth  16:03

Yeah, carb counting is not very accurate. People are notoriously bad at carb counting, my daughter might be looking at her meal and see 15 carbs, another person with diabetes might count those curves completely differently, it's really helpful to be able to look at your plate and say, you know, this is usual for me, or this is more for me, this breakfast is way more than I would typically eat. So I'm gonna let the system know about that. Rather than counting the exact numbers in that restaurant meal.

 

Stacey Simms  16:43

I could talk about that for an hour. That to me is so revolutionary Benny the other day, we got these big cookies, which is you know, a real tree. We don't eat a ton of junk food, but we don't eat super low carb either. But there were these giant chocolate chip cookies. And he was higher than usual later. And I just asked him, I'm like, Hey, I'm just curious, because I don't look at everything he eats or talked about every bolus anymore. So what did you think those cookies were? And he said, Oh, I think it was I think I put in 35. I was like, dude, those were like, 65. Easy, right? And he was what I did. He's had diabetes for 14 years. Right? It doesn't mean he's a bad person. He just didn't. He just took a guess.

 

Kate Farnsworth  17:19

Yeah, exactly. Exactly. We have the same with my daughter. I don't manage her diabetes, you know, as actively as I used to when she was little, but occasionally I'll ask her, you know, how many carbs Did you think were in that, and then we'll compare it to the package. One really big example that we have, we have those flat pretzels, and they're in a big container. And she'll just pour herself a bowl. And, you know, she guesses on how many carbs are in that bowl. But one time we actually put it on the scale and calculated and she was 45 carbs consistently, because she had been doing this for some time. And I know the same thing happens with cereal, for example, once we move past that carrying a scale with us phase, our eyeballs are the judges and they're not very good. So yeah,

 

Stacey Simms  18:10

I think some people listening might be saying, Well, why don't you carry scales with you anymore? What kind of parents are you, but I got to say I'm not into adding any more diabetes burden, then we need to so I'm thrilled with letting technology replaced my brain on this, you know, control IQ has done a wonderful job for us and really helping and you know, what you're talking about is only going to help as well. So the big question with the iLet has always been about the dual chambered pump. This was a pump that years ago was talked about and I know you're still working toward a dual chambered pump with insulin and with glucagon in it, but my understanding is that what we're talking about today, what the pivotal trials are all about is insulin only. Can you talk a little bit, just kind of give the listeners an update on what we're talking about in terms of the one chambered pump and what you're working toward, with the dual chamber pump.

 

Kate Farnsworth  19:00

So the iLet’s designed with two chambers, one for an insulin cartridge and the other for our glucagon cartridge. Her initial device after an FDA clearance will have the insulin chamber available to users while the glucagon chamber will not be usable. Once the dual hormone configuration has been also cleared through the FDA through a subsequent 510 k application. The glucagon chamber will also be made available to users. Our hope is that it would be the same device just the second chamber would then become available.

 

Stacey Simms  19:34

I understand you may not be able to answer this. But if and when it becomes dual chamber pump. The hardware as you say would be the same. Is it just a question of software updates or is that looking too far in the future?

 

Kate Farnsworth  19:47

It is my understanding that it will be a software update. But we definitely are getting ahead of ourselves there. We have to go through the whole FDA and 510 k application for that company.

 

Stacey Simms  20:00

Got it. Okay. I'll be I'll tread lightly on Be careful on that. Of course, a couple of weeks ago, I talked to the folks at ziggo log, which I'm still not sure I'm saying correctly, which is the glucagon that I believe you all are working with.

 

Unknown Speaker  20:19

Is that still the case?

 

Kate Farnsworth  20:20

Yes. Yes. So we are working with Zealand to provide the glucagon that will be used in the clinical trial for the by hormonal device. And they recently got approval for adaptive glucagon for the treatment of severe hypoglycemia. And they're marketing it under the brand name Tagalog. I hope I am saying that.

 

Unknown Speaker  20:42

I think we're good.

 

Stacey Simms  20:43

I guess my only question on that, because I know it's a separate company. But it was so many years that we were waiting not just for the eyelid, but we were waiting for that shelf stable glucagon, so we didn't have to emergencies or for low treatment, reconstitute or kind of open that red box or that orange emergency box. So it was a big relief in many ways when the different types of shelf stable glue gun were approved. I mean, there's three options. Now, I know you can't speak in detail about a lot of this. But I got a question from a listener about how this would work. And the question wasn't so much about the mechanisms or the software. I know that's proprietary. But the question was, you know, it's always risky to use glucagon too much, right? It's also why we don't want to have too many lows in a row that your liver has to help out with because you can deplete the glucagon supply. And I'm curious, this listener wants to know, is there any danger of depleting the body's own sources if you're always giving it from an external glucagon, injection or infusion?

 

Kate Farnsworth  21:49

So we're deeply aware of the risks of severe hypoglycemia until we know more from a pivotal trial, it would be best at that question to an MD with expertise in glucagon storage and depletion. But what I can tell you is that we're partnering with seeland to provide the glucagon that will be used in the clinical trial for our bio hormonal device. As you know, they recently got approval for his ecolog. And we plan to use that same shelf stable ready to use quizzes on with the island in our bio hormonal pivotal trials. It's really important to note though, that the amount of glucagon that will be dispensed in the iLet will be substantially lower than the amount dispensed in the cycle of injection or prefilled pen. That's because the ladders for severe or hypo rescue and the amount the iLet would dispense is intended to be hypoglycemia prevention. So that iLet is designed to micro dose very small amounts of glucagon as needed based on the person with diabetes CGM readings and the speed of their glucose decline. So it's really important for people to know that they wouldn't be getting a rescue dose of glucagon in that scenario. Of course, the use of Desa glucagon with the iLet will need additional FDA approval for Depo glucagon. And the iLet will also need FDA clearance for dispensing deathly glucagon.

 

Stacey Simms  23:12

I mentioned earlier that the system and you mentioned this as well, is working with a CGM. And my understanding is that this is Dexcom g six.

 

Kate Farnsworth  23:21

That's correct. The eyelid is designed to work with the Dexcom CGM, but we're open to working with other CGM manufacturers in the future. Because we understand that choice is really important to people living with diabetes.

 

Stacey Simms  23:36

That's great. Dexcom g seven is moving forward. I assume that as that moves forward, this iLet will move forward with it.

 

Kate Farnsworth  23:45

I would think that's a fairly safe assumption. Okay, good answer. Can you tell me

 

Stacey Simms  23:50

any details? Again? I feel like I'm fishing here. But can I can you tell me any details about the pump itself? You know, we've got Omni pod, which has the remote PDM that is used with it. We have Tandem, which has buttons on the pump, and they're hoping to get bolus by phone pretty soon. Is the eyelid buttons on the pump? Is it a phone control? Anything you can tell me about that?

 

Kate Farnsworth  24:13

Yeah, so everything currently is designed to be done from the iLet itself. It has a touchscreen interface. And the infusion says at launch will be similar to the inside. So people are familiar with john caustic and our team are working on some of the potential mobile solutions for the iLet’s. And we hope to have more information about those as we get closer to launch.

 

Stacey Simms  24:38

I know that you have had a lot of input from the community because I've seen the the posts that you will have put out there asking for help from the community in terms of I guess what is called human factors and things like that. Can you share a little bit about anything that you've learned just anecdotally about what people like and don't like about using an insulin pump, or what you could any kind of feedback that you got along The way that might be of interest.

 

Kate Farnsworth  25:01

Unfortunately, I can't share that information. I'm sorry. Yeah, I can talk a little bit about the fact that we have a lot of preclinical data that's available on our website. So if anybody is interested in looking at bat, it's Beta Bionics  calm, and I can't comment on the results of our pivotal trial as it's still in progress. We do hope to have those results later this year and look forward to sharing them. Our goal backed by appropriate research, and continuously advancing technology is to create a solution that people with diabetes don't have to spend so much time micromanaging decisions that impact their condition, and that they can spend more time focusing on other things in their lives.

 

Stacey Simms  25:51

This is another question from a listener. And this is about changing the reservoirs out and I this would be when it is dual chambered. So do you have to change them together? Or can you change out the one that is empty? And I'll add to that, again, knowing I don't know if you can answer that, you know, right now, we are all told to change out an insulin cartridge within three days, do you have to change the glucagon in a period of time as well.

 

Kate Farnsworth  26:16

So as designed the insulin cartridge use that the iLet can be changed actually independently of the infusion set. So you can change your insulin cartridge, but not your infusion set. And we intend to have prefilled cartridges and user filled cartridges available if FDA clear, as for the glucagon, that's one of the things we hope to uncover during the by hormonal pivotal trial is the duration that people can leave the Deathly the carton cartridge in the device, and how often it needs to be changed.

 

Stacey Simms  26:52

You I didn't ask about infusion sets, and I'm not a big fan of any of them on the market. I think that's the weak link of pumping. I'm not alone in that assessment. Two questions there. So when it is dual chamber, do you anticipate two infusion lines and two infusion sets? I assume you're not mixing these two together? Right?

 

Kate Farnsworth  27:13

Yes, we anticipate using two inpatients.

 

Stacey Simms  27:16

And then the other question is, can you share what you're using is? Is there a new one coming from Beta Bionics  or are you planning to use one that's already on the market?

 

Kate Farnsworth  27:24

For our pivotal trials, we're using ones that are very similar to in test that are currently available for no medical. And that is what we plan to use that launch.

 

Stacey Simms  27:38

Couple other just kind of life style questions, I guess about the pump? How is it charged? Is it a battery is it is an external? How do you charge the pump.

 

Kate Farnsworth  27:48

So the iLets designed for inductive charging like modern mobile phones, so no cords or cables are required to charge it. The batteries designed to typically last about five days on a single charge and a full charge takes about two hours.

 

Stacey Simms  28:04

So wait, I think that went by too quickly for my brain. Okay, you mean like lay it on a charger? You don't plug it in? Correct? Do I have to get a special charger? Or can you use anything? Like you said a cell phone charger? I mean, no, I don't use one of those, which is why you're hear me stammering around I'm thinking like, do I get one on Amazon? Do you buy that this is easy. These are easily available for regular people.

 

Kate Farnsworth  28:25

Our hope is to ship you a charger with the device, but that it would also work with another charger of similar design that you might have around your house. Okay,

 

Stacey Simms  28:38

and is I'm probably said it's so old fashioned to everybody listening. But you know, what are you gonna do? And talk a little bit about the pump? Is it waterproof? Can it get wet? It is designed to be waterproof. Yes. So wait, now I have to ask. So like I can you can swim with it. It's not just waterproof to a certain amount.

 

Kate Farnsworth  28:57

So you remember those animals bubbling water displays that they used to have when they had their pumps floating in the water. So their devices were certified the same level that the iLet, we hope that the iLet will be certified to as well.

 

Stacey Simms  29:15

Very cool. Anybody have those old animist displays? You guys could grab those. I think I was at a display once they had fish swimming in the water once.

 

Kate Farnsworth  29:22

Yeah, exactly. I that's how it was explained to me by one of our engineers was the old venomous, complex the same way and they had the bubbler with the fish in it.

 

Stacey Simms  29:34

I think I have a photo because you know, I used to work with animals. And I'm pretty sure I spoke at an event where they had these centerpieces at a table and it was a fish tank and the pumps were ended. I'll have to search that up. And that's great. Let me ask you. I'm sure that my listeners will have many more questions about the eyelet. And hopefully we can speak again we'll get more information as it moves forward. But you and I have known each other for a long time in the community as fellow diabetes parents. Do you mind As a couple of questions about how you're doing and your daughter was diagnosed when she was what, eight, nine years old?

 

Kate Farnsworth  30:05

That's a incident. He was diagnosed when she was eight. And she just turned 18. Wow, she is now an adult. Oh, my

 

Stacey Simms  30:13

gosh, how is she doing? I mean, we've already talked about her a little bit, but it sounds like me, you have backed off quite a bit of the diabetes parenting, although we never really back

 

Kate Farnsworth  30:24

off. Yeah, so she's doing great. She's finishing high school, and she has been accepted to university in September, and she will be living in residence. So we are preparing for her moving out of the house in late August. Wow. Oh, my goodness.

 

Stacey Simms  30:42

I'm curious. Now, I don't want to get too far off the topic here. But I'm curious, did you all as a family do anything special in terms of college prep, I have a plan in mind. I don't know if I'll do it where like Benny's, second half of his senior year of high school, I really just want to leave him alone, completely, like, stop following him, you

 

Kate Farnsworth  31:01

know, be here if he really needs me. But I don't know, did you do anything like that. So we have been slowly transitioning and backing off as sort of naturally as the year has progressed. So she takes care of all of her diabetes management side changes all of those things without being reminded by me, which is fantastic. I have started transitioning to her ordering supplies. So I've taught her how to, you know, it's just a login to a website, and you click what you need. And they check our insurance is not very complicated. But I have walked her through how to do that, so that she has a bit more comfort with it, we are really worried about overnight, because she currently does not wake up for low blood sugars. So we've been sort of thinking through how we can do that. And over the summer, we will be backing off that and having her finding ways to get her to wake up to her low blood sugar alarms and try and manage those overnight. Because that is my biggest concern about her moving away.

 

Stacey Simms  32:11

When you and I first spoke, it was the summer of 2015 was the first year of this podcast. And we were talking about nightscout I can probably dig up the pictures, I had this giant setup that I slept to friends for life that I don't use on the road anymore. When we're back on the road, I'm really excited to see people again, but we talked at the time about the nightscout project and about your help to so many people in designing the Pebble watch face, you know helping people set that up. I'm curious as you look back, I mean, a lot of people from the Do It Yourself community, you already mentioned john kostik, and many others are now working in the commercial space to bring we mentioned this towards the beginning to bring what was better technology, better care. That was really only a very, very small percentage of people to the larger community. Could you speak to that for a minute, it's amazing to me to see how far everything has come.

 

Kate Farnsworth  33:09

I started out with a real passion for helping people living with diabetes and trying to get you know all of the technology to them. And the problem is that we reach a certain wall with the people that we can reach online, we're sort of in this echo chamber of the same people all the time. And what we've discovered is that technology uptake is much higher in certain populations. You know, I recently did a study and we're finding that people who are Caucasian or higher income are much more likely to be using these tools than the people of color and their counterparts. So working for companies like Beta Bionics  give us the opportunity to reach a much wider group of people and really gives us the opportunity because we are a public benefit company to try and engage those people that aren't being engaged currently with the tools that are available.

 

Stacey Simms  34:13

When you look back at your time in the DIY community. You know what stands out to you. It was such a buzzy busy time between 2013 and 2016, or even 2017. But as commercial offerings have, frankly, gotten better, you know, I know a lot of people still use the DIY stuff, but it seems like there was an energy and there was a really, you know, a time not too long ago were folks like you were I gotta imagine your phone was buzzing all the time with people asking for help. You know, what was

 

Kate Farnsworth  34:45

all that? Like? Yeah, it was a crazy time. And, you know, to a certain extent, those communities are still really active. The Loop community, which I run has 27,000 people in it, you know, so there's still A lot of activity surrounding these things. But I think as the commercial solutions come around, we're able to provide solutions for so many more people that that sort of aggressive need dies down from a little bit from the DIY community, because a greater number of people without maybe the same technical expertise are able to find solutions with the commercial offering. So I always said, I would keep doing that volunteer job until a commercial offering was able to put me out of business. because ideally, you know, I hope that commercial solutions like that iLet will be able to serve the diabetes community, so that we don't have to look to DIY solutions anymore.

 

Stacey Simms  35:49

I always hate asking this question, because I know there's probably not going to be an answer at the end of it. But what is the hoped for timeline here? Can you tell us anything about the submission or or things like that?

 

Kate Farnsworth  36:08

I love the silence. That's okay. I have to ask. Yeah. So as I said, once the clinical trial is completed, then we will submit for FDA regulatory clearance of the insulin only configuration. Once the FDA application is filed, there will be an FDA review of the 510 k market applications, those typically take six months. And then we will have a launch date. Once that has all been completed. This

 

Stacey Simms  36:38

might be an odd question. But as we start to wrap it up here, when we go to conferences, like friends for life over the last several years, and Ed Damiano speaks about the the product and the process and everything. Anything that has to do with Beta Bionics  and the iLet is so closely watched, it has just become, I guess the way to say this, you guys have a lot of fans out there in the community. I mean, it might be a small portion of the entire diabetes world. But this is a really passionate group of people kind of waiting for this. Do you as you talk to each other? Like, do you feel the pressure of that? Is that exciting to you? I just would imagine and I can't answer this for you. But going to work, there must be amazing every day to know that people are so excited about the product

 

Kate Farnsworth  37:25

is absolutely amazing. We definitely feel the community spirit and presence and pressure to deliver you know, every day, we talked about the fact that, you know, we want to help the people living with diabetes who have been waiting for us. And we don't want to make them wait any longer than they have to. And you know, the process has taken longer than we hoped it would. So we're definitely committed to the people with diabetes that we're trying to help. And we have the most passionate team working on this, everybody is so committed. And we have so many people who are touched by type 1 diabetes, either living with Type One Diabetes, or parents of children with Type One Diabetes, or children of parents with Type One Diabetes. You know, we're part of the community. We really feel passionately about this. So we cannot wait to have this device ready for those people.

 

Stacey Simms  38:27

Okay, thank you so much for joining me and for being patient with my questions. I know as I said, you're limited in what you can say. But I cannot tell you how much I appreciate Beta Bionics  making you accessible and coming in to share this. So and thanks for all your hard work. I cannot wait to learn more. I know you can't wait to tell us more. So thanks so much for being here.

 

Kate Farnsworth  38:46

Thank you so much for having me. I'm really grateful for this opportunity. And I look forward to talking to you again in the future.

 

Unknown Speaker  38:58

You're listening to Diabetes Connections with Stacey Simms.

 

Stacey Simms  39:04

More information at Diabetes connections.com. Or, of course in the show notes. You can always go to the homepage though, to get the full notes and the transcription of every episode. And there's a lot there. as Kate alluded to, there are some other studies, there's some more information, and it's all at Beta Bionics . So I will link that up in addition to the interviews we've done in the past with Ed Damiano, and I'm gonna link up the first interview I did with Kate back in 2015. Because looking back, that made me laugh and this has nothing to do with Beta Bionics  or the pumper or technology or it's my technology. So I use very light technology.

This is just a little bit of inside baseball now on the podcast when I travel and I'm going to be traveling again to conventions this year, which is so exciting. I have a small kind of a studio in your pocket. It's a zoom h5 recorder and I use a couple of ATR 2100s if you're into that kind of microphone technology. Light stuff. I don't even need to plug it into a computer. The h5 is its own little studio. But when I interviewed Kate and I interviewed a bunch of people at that first friend for life that I went to as a podcaster, I brought my Yeti. The Yeti microphone is a brick. It's not that great a microphone actually that don't get me started. But it's a brick. And it's so, so heavy. And I brought like a mini studio, I had this paneling setup. Oh my gosh, I had so many things to check when I got on the airplane. And then I was schlepping it around the hotel at friends for life, which is not the most compact hotel. It's a lot of walking. So I'll see if I can dig up some pictures. But Kate was very patient with me as was everybody I talked to that day. Just funny how things do change over six years.

All right, we've got some Tell me something good coming up with some fantastic anniversaries, not about the podcast, some listeners who are celebrating very long time diversities and are doing great. But first Diabetes Connections is brought to you by Dexcom. And one of the most common questions I get is how to help kids become more independent. You know, those transitional times are pretty tricky. elementary to middle middle to high school. You know what I mean? Using the Dexcom makes a big difference for us. It's not all about share and follow that's helpful. Think about how much easier it is for a middle schooler to just look at their Dexcom rather than do four to five finger sticks at school or for a second grader to just show their care team their number before Jim at one point Benny was up to 10 finger sticks a day and not having to do that makes his management a lot easier for him. It's also a lot easier to spot the trends and use the technology to keep your kids more independence. Find out more at Diabetes connections.com and click on the Dexcom logo.

 

And tell me something good this week big time big diversities. Terry Lopes is celebrating 50 years of type 1 diabetes. She was diagnosed at the age of nine. And she made a really nice Facebook post where she talks about being grateful to the people in her life who helped her and looked out for her early on parents, siblings, friends, teachers, camp counselors, nurses, doctors, she says and thankful for those who still look out for me and for the technology that helps me have better control and live much more freely. And also makes it so that no one needs to be told they may only live to the age of 40 when diagnosed as a young child. Terry, thank you so much for sharing this. She also posted that her dad turned 90 recently as well. So Happy Birthday to him, my goodness. But it really is hard to imagine. And I know I'm so grateful to know many people who have lived with type one for 40,50, even 60,70 years. I mean, it's amazing that you know, I don't know them personally, but we've been connected online. And they were all told as children as children, that they would not live a long and healthy life. Our kids are not told that anymore. And I'm so grateful for that. Terry, I'm thrilled that you're in the group and thank you so much for sharing that.

Yerachamil Altman shared a different kind of diaverary, he posted that he has been using an insulin pump for 40 years. 4-0! he has got to be one of the first people to use an insulin pump. And we've had him on the show. I know he helped design insulin pumps. I mean, my goodness, what a life. And he always posts we're so thankful for this the old technology. So if you're in the Facebook group, Diabetes Connections, the group I'll make sure to repost this. But I mean, the first insulin pump was basically like a syringe taped to what looks like a big pager, and it just stabbed you with the needle and gave you the Insulet I don't know it just it doesn't look like something that would work. It looks like something Benny would have slapped together from spear diabetes parts when he was in second grade. God bless the people who use this and tested everything and made it so like I just said so that our kids and adults diagnosed today can live long and healthy lives. 40 years with an insulin pump, you're off a meal. Thank you for sharing that. And you know, I love sharing the good news. If you've got something Tell me about it. Stacey at Diabetes connections.com or post in the Facebook group. I love to hear it.

Before I let you go quick reminder about in the news, my new feature every Wednesday 4:30pm Eastern live on Facebook. I hope you can join me for that I'm working on some different texts. And to see if I can make it look a little bit more TV newsy. That's been really fun. I got a green screen and oh my gosh, I started out in television. And then I went to radio and then I went to podcasting. And now it's like back in TV reporting. It's bonkers. But I'm also as you know, if you're a regular podcast listener, and putting out those in the news episodes every Friday as well so if you miss it live, or you just want to hear the audio, I definitely want you to have options and like doing this a lot. It's been really fun. I'm trying to keep them short. So if you like it or you don't you've got any constructive criticism, any kind of criticism I can take but come on be nice. Please, please please let me know. I also announced on social media that I have taken a new position I am working with the fabulous folks at she podcasts. I'm Selling sponsorships for she podcasts live, which is coming up in October of this year. I'm going to do friends for life in New York in the beginning of October, and then I'm going to shoot podcasts live in the middle of October in Scottsdale, Arizona. It's going to be a busy month. I also have a big birthday in that month. So we're going to be we're looking forward to October, it's going to be great. But if you are at all involved in podcasting, and you're a woman, please check out she podcasts, I'll put a link if you are interested in reaching 1000s of women who podcast You don't have to be a technology company. But if you want to reach women who are movers and shakers, let me know because I can hook you up. That's my new gig. I'm still gonna be doing the podcast of course, and all my other projects. This is perfect because I get to meet some new people and do some fun stuff. But I don't have to give up anything but maybe some sleep. I don't know. I'm gonna get this done.

Alright, thank you, as always to my editor John Bukeas from audio editing solutions. Thank you so much for listening six years. Oh my gosh. I'm Stacey Simms. I'll see you back here in just a couple of days. Until then, be kind to yourself.

 

Benny  46:10

Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged

 

Transcribed by https://otter.ai