David Klonoff: 0:03

Welcome to Diabetes Technology Report, co-hosted by endocrinologist David Klonoff from UCSF and David Kerr from Sutter Health. Welcome to Diabetes Technology Report Starts. I'm Dr. David Klonoff. I'm an endocrinologist in San Mateo, California. I'm here with my fellow host, Dr. David Kerr, who will introduce our interviewee today. David.

David Kerr: 0:30

Thanks, David. Hello, everyone. I'm David Kerr. I'm speaking to you from sunny Santa Barbara as usual. And we have another person living in the sunshine. That's John Sjoland from Luna. Welcome, John, to Diabetes Technology Report Starts. It's good to see you.

John Sjolund: 0:47

Great. Dr. Kerr, Dr. Klonoff, thank you for having me. It's nice to see you guys. Sun is shining. So thank you.

David Kerr: 0:53

Excellent. So we'd like to begin this by asking two simple questions. Why are you interested in diabetes? And from your company's perspective, what is the fundamental problem that you're trying to solve?

John Sjolund: 1:07

So my interest in diabetes is very personal in that I've had diabetes for nearly type 1 diabetes for nearly 40 years myself. I was diagnosed shortly before my fourth birthday and have been living and managing and doing my best to take care of it. But only later in life, and not my it wasn't my first career to start developing products, but I did start developing products for people like us with diabetes because I felt that technology was not reaching the masses. And I saw it as an obligation to take my skills and what I'd learned in life to try to bring really, really helpful and useful products to more people. And in terms of what we're doing, so Luna is a product that we created, which is about bringing the incredible and awesome benefits of automated insulin delivery to pen users. And we've always felt for decades that people have been asked to make a decision whether to stay tethered and be attached to a pump or to be exposed to nighttime hypoglycemia, hyperglycemia at night. And there's been this all or nothing standard where the majority of people who use pens for one reason or another, all users that use pens, which is the majority of instant delivery, aren't benefiting from technology. And we wanted to solve that. And that's what we've done at Luna.

David Kerr: 2:34

So the aim is to do what? To prevent hypoglycemia or maintain a certain level of control? Or what's how what's success look like if you start using Luna?

John Sjolund: 2:48

So here's the thing, Dr. Kerr. Over 65% of type ones in the US use pens. And in Sweden, where I'm from, it's much higher. The other key important learning that this the secret of automated insulin delivery, whether it's tandem or Medtronic or other products or insulate, is that they work really well at nighttime. Over 80% of the glucose improvement that happens over 24 hours happens at night. And so when you're using pens, you're just you're going to bed and hoping for the best. On average, people spend 40% of the night at hyperglycemia. They're waking up, they're sweaty, they're low. So what we do is when you wear a CGM and you wear our product, which is the world's smallest patch pump, we're automatically giving you insulin if you need it to get you to wake up at target. And we're helping with your basal insulin dose if you need it to avoid hypoglycemia. So we're, we're, we're, we're going at it from both ends. And we really about optimizing your night so you wake up at target.

David Klonoff: 3:54

John, what type of studies have you done to demonstrate that your product is effective?

John Sjolund: 3:58

Yeah, so the product is not yet cleared. We're not on the market yet because we're still in the midst of studies. But we've run both safety studies where you take a small group, small groups of people with type one and bring them to a clinic where they're monitored by safety staff. They're checking. Because of course, if your algorithm goes haywire, it could be very, very dangerous. Um, that's all gotten a green light. And we've also put it out into the field where people bring it home for 90 days. They go about their normal life. And uh yeah, we have you know nearly 2,000 nights of people using it. And we've learned a lot. We've improved our product. We're about to start a new round of studies and a big pivotal study later this year for both type 1 and type 2 diabetes.

David Klonoff: 4:42

What type of algorithm are you using? Where did it come from? And uh what makes it effective? Does it have any particular features that other algorithms don't have?

John Sjolund: 4:53

It's most powerful featured is that it doesn't have any features. So it this is something that we've developed here. We have an incredibly incredible data science and algorithm team. And what we're trying to do is bring automation to people that already have their basal insulin on board, whether it's Lantis or Togeo or whatever it is. And that's a really hard automation problem. Our team and Lane Desbrough, who we all know, you know, when we started this with Lane, we thought this was going to be an easy thing. If high, give insulin. It wasn't, and it hasn't been because people are over-basalized or under-basalized, their basal needs change week to week, night to night. So our algorithm is about letting people do whatever they need to manage their diabetes by themselves during the day. And then at nighttime, the automation takes over. And in the morning, you take it off and you go back to pens and do your normal day-to-day routine. But this, the ability to transition people onto automation each night and off in the morning, and doing that in a way where we're not asking them when they last took their bolus, what they eat, how many proteins, we ask zero questions. You just put it on and you take it off. That's the that's the magic of our algorithm. And that's where, going back to where I started, not having any features. There's no carb ratios, there's no basal rates, there's no uh insulin sensitivity factors. All you do is is tell it one thing when you start, you do it once, and then it learns about you and and does some really powerful stuff.

David Kerr: 6:29

John, this is really intriguing. So let me understand this. So do you take it off every day and put it back on, or or do you wear it and switch it off? Is my first question. And my second question is I mean, glucose is really interesting, but what about sleep is a I mean, we spend a third of our life with sleep. Have you got any insights as to whether the quality and the quantity of sleep is better when you're using your device and when glucose is maintained? So sorry about that. It's two questions.

John Sjolund: 7:02

That is a great question. And I'm gonna start with your second question because I got so excited that you asked me that I partially forgot what the first question was. So let me start with the second question. You are correct. In in diabetes studies to date, it's all about A1C. It's all about A1C improvements. And even time and range is a such a new metric. And our our pivotal study, which got approved by the FDA, was the first diabetes study approved for time and range that we're aware of, to the best of our knowledge. Maybe somebody will correct in the comments. But that's increasingly becoming table stakes. People know that automation works. We know that a Medtronic pump or NSLET or beta bionics works. That's table stakes. But wow, if we can prove and show that you sleep an hour longer, or if we can prove that you have 20% more REM sleep, or we can prove that you're not having to get up to go to the bathroom, or because your CGM is going, that's really powerful. So we certainly have some tricks up our sleeve for what we're doing there. And that's part of our what we're gonna be going forward with.

David Kerr: 8:11

Yeah, my my first question was that just the practicalities of this, what time do you put it on? And do you have to take it off every night, or do you switch it off and leave it, you know, on your skin for 10 days or 14 days? I'm just wondering about the practicalities for our audience.

John Sjolund: 8:29

Thank you for reminding me. But we've made the world's smallest patch pump. It's about the size of a CGM sensor or solo, or at least of a G6, and it's composed of a reusable part that lasts for a long time, and a single use disposable part that you change, you put on before you go to bed and you take it off in the morning. So, why is this important? The things that are expensive, the motor, the processor, the memory, that's all reusable. So you're not throwing away batteries, you're not throwing away processors, those things get amortized over a long time. And then the disposable is super simple. And the reason for this is we want to make this accessible to way more people. Cost is a real thing for a lot of people, of course. And by doing it in this way, we can drastically change the cost of automation. Secondly, and importantly, because you have basal insulin on board that you've taken from your pen, if you forget to put on Luna, you don't want to wear it one night. It's it's periodic in nature. So for a lot of people, they they get the benefit and they should be wearing it seven days a week. But if you got things in control, you ate dinner at 6 p.m., it was low carb, you're testing your glucose, you might not need it that night. And so you get the choice. And that's what a lot of people like about what we're doing is we're we're we're giving you the choice to, you know, not consume your identity by always being tethered to something all the time.

David Klonoff: 10:02

How do you feel that your pump will work if someone is using one of these new weekly insulins that are being developed?

John Sjolund: 10:09

A good question. I guess. How do we feel about weekly insulins to begin with and how people's lives will be working? If you're if you're taking taking too little weekly insulin and you need 20% more basal insulin and you can't take another injection, this is perfect for you because this will be able to pick, you know, pull up the, give you that extra insulin that you need, and it will put your diabetes on autopilot when you're sleeping. So it's perfect for that. If you took a little bit too much of it and you're getting lows all the time, we're not going to give you any insulin, but we also can't suck it out, we can't suspend it, we can't do anything about it. So you're gonna have the same problem as you as you did with or without us.

David Klonoff: 10:48

Because people are changing their pump every day, how do you see the amount of waste that is accumulating with your product compared to other types of insulin pumps? Great question.

John Sjolund: 11:00

So there is a lot less insulin wasted with our device because you use all the insulin. So that's one. The second thing is no batteries, no motors, no PCBAs. You're not throwing any of those things away. Is it correct that there is a disposable? Yes, there is. That is as small as we done, we use environmentally sound packaging. It is part of what we do because we we've all seen the pictures of people and their diabetes supplies and their CGM applicators, and boy, does that add up after a couple months or a year. So we we can't eliminate it. Everything that we do, we think about how do we reduce this? How do we how do we use how do we reduce our impact in the design of the product?

David Kerr: 11:42

John, I'm getting very excited listening to this. It opens up all sorts of possibilities. The first thing is, is this this should be a good product if you're traveling across time zones, wouldn't it? When you have your sleep disrupted and all that good stuff. And secondly, the fact that you're controlling overnight hepatic glucose production, essentially, does that mean that in the type 2 space we might find this could be a major paradigm shift to overnight insulin and borals or GLP1s or something during the day? I mean, is that a direction of travel that you guys are interested in, or is it far too early for that?

John Sjolund: 12:24

It's not far too early, and I I'm glad you asked that question, Dr. Kerr. The we often when we start talking about what we're doing and we start saying we're making a new diabetes therapy, we need people to just stop for a moment and say, we're not another omnipod, we're not another patch pump, we're not there are pumps around and there are good ones. And if you want to be tethered to a pump all day, there are good options for you. We are something different and you got to think about it differently. So, does it work for travel? Of course. If you're using Lantis and you're you're not quite taking it every 24 hours because you're going across time zones, this is a great way to pick up that delta in between. But the the second question is I'm type one, I've had it my whole life, I've been making products in type one for a long time. As I'm starting to learn more about type two, and we have clinicians working with us, they are telling us, guys, if you're taking only basal insulin in type two, or if you're on a GLP one before you introduce rapid-acting insulin, this might be a very powerful way to solve the needs that people have that are different from type one. And so that's why we've decided to pull in our type two program now, and we're doing it in parallel with type one, because we think we can help a lot of people. And remember, you set this device up with one thing. What is your total daily basal dose? It's just not possible for primary care doctors to support other insulin pumps with carb ratios and insulin sensitivity factors. It's not possible for me to figure it out. And this is what I do all day, every day. So we think that we can really simplify the onboarding. You get trained at home at your own pace. It's really simple. So that's our goal. Our goal is to make insulin automation accessible.

David Klonoff: 14:12

John, this sounds like a really nice product. There's a need for it. Is there anything else that you haven't told us that's important about Luna?

John Sjolund: 14:20

There's a lot of things I haven't told you about Luna because that's our secret sauce in here, right? But I think, Dr. Klonoff, the key here is that diabetes is different from many other conditions and diseases, as we know, because there's a person that is dealing with this every day at home. They don't have a doctor in their pocket, they don't have a nurse in their pocket. We are about bringing life back to people with diabetes. We're about giving their identity back because so much of diabetes is consuming our identities with the amount of time we're spending on it, the remembering, the occlusions. So we are a company that are about simplifying things and making it easier and reducing friction. If you want the Lamborghini of diabetes devices out there, they exist. And there are people that want that. They want all the knobs, all the dials. They're out there, and you're going to get a couple more points of time and range. But for the masses that just want to focus on their kids and their lives and their schoolwork and want diabetes to go to the background, we are for you. And that's how we've designed our product to make it simple.

David Klonoff: 15:36

John, it sounds like you have a nice product. I do have one more question. I I didn't think I had any more. But what do you see as the role of basal insulin treatment in people using your product? Will will people, if they're using uh a standard basil, will they take it in the morning or the evening? Will they use any at all?

John Sjolund: 15:56

This is not replacing basal insulin. This is complementing basal insulin. And so you you'll take it, you'll you will continue to take your basal insulin exactly like you did before. Let's say you're using Luna every day, and then you take a break for a day, you take your basil next day, you take your basil. But what we'll do is we will help you to titrate your basil as well as can possibly be done. There are no tools for for for at least for type one. There are no tools right now to help you titrate your basil and use all this data that we get from our CGM to do so. So we will help you to get your basil right. So you're doing great during the day, you're avoiding hypo at night, and we're letting automation to take over when you need a little bit more support. So no change, no change to basil.

David Klonoff: 16:44

Well, thank you. Thank you for explaining Luna. This looks like a really nice product. It's unique, and it looks like it's going to fill a unique niche. So I hope uh all your future studies go well and that you have a lot of success and that uh you get a product on the market. We're now ending this session of Diabetes Technology Report Starts. I want to thank Dr. David Kerr for co-hosting and thank you, John, for speaking. This episode of Diabetes Technology Report Starts will be available on the Diabetes Technology Society website at Spotify and at other sites. And until our next session, we say goodbye now and good luck in the future. Bye bye. Thank you for having me. Thank you.