David Klonoff: 0:14

Welcome to Diabetes Technology Report. I'm David Klonoff. I'm an endocrinologist at Mills Peninsula Medical Center. I'm here with Dr David Kerr and we have a very special inventor in the field of diabetes to interview today. David, please introduce yourself and our speaker.

David Kerr: 0:31

Thanks, David, and hello to everyone. I'm David Kerr. As usual, I'm speaking to you from Santa Barbara, California. Today, the topic is going to be a specific area that's rapidly developing diabetes, and it's a great pleasure to introduce Paul Good from Glucotrack. Welcome, Paul.

Paul Goode: 0:48

Thank you, david and Dr Klonoff, I really appreciate it.

David Kerr: 0:51

So we always begin these podcasts by asking people how on earth did you end up in diabetes? What was the spark for your enthusiasm in this space?

Paul Goode: 1:02

It was actually serendipitous. I was at a cardiac pacemaker company many years ago and got bought out and shut down by a competitor, and so there was a lot of recruitment going on and the good Al Mann God rest his soul had his folks from Minimet come out and pick from the talent and I got hired to go to Minimet, and that's when my passion for diabetes started.

David Kerr: 1:29

So just tell the audience briefly what is Gluquitrac up to now? What's the vision here?

Paul Goode: 1:37

What we're trying to accomplish is, you know, first of all CGM. We're doing an implantable CGM and we want to just out of the gate. Cgm is phenomenal technology. Many of us have worked on at least one generation of CGM that's out there or has been out there. Wonderful technology, but not everybody can benefit from it for one reason or another, and so we want to offer patients a choice. And when you do the market research, you see the largest challenge is primarily one form or another. It boils down to the wearability aspect. So we decided well, we can solve that by going implantable and give patients choice for those who need something different.

David Klonoff: 2:15

Paul, do you have experience with implantable devices, and what are features of the product you're working on that give you optimism?

Paul Goode: 2:25

Yes, sir, what are features of the product you're working on that give you optimism? Yes, sir, actually you know, my career, with the exception of MiniMed, has been exclusively in the implantable device space, so 25 years, even when Dexcom was still implantable in the early days, and I've done other implantables, so I've got a lot of experience there. And what we've done at Gloopertrack is actually, you know, we're leveraging, you know, all the known and tried and true aspects of cardiology devices to you know. So it's known, it's safe, both technically, regulatory-wise, clinically, and so there's a lot of knowledge there and that's what we're leveraging.

David Kerr: 3:01

So when is it going to appear? I mean, what's your sort of given FDA and all that usual stuff? When is this going to appear?

Paul Goode: 3:10

Sure, Well, we're going to be starting, you know, this summer at least the clinical trials. Right, we're starting our first long-term clinical trial in Australia and with the DTRG and Baker Institute. But in terms of commercial aspects, our target is late 28. Didn't rhyme on purpose. And that's of course if we hit all of our intro milestones and our success with that circle.

David Kerr: 3:37

And just looking at the picture, who is this going to be for? Is it a typical person with diabetes or is it a range of people with diabetes? Who's it for?

Paul Goode: 3:47

It's interesting. Probably you know the regulatory pathway is going to drive that and we're going, you know, first trying to address the type 1, patient with type 1 diabetes and the patient with type 2 diabetes that are on insulin intensive therapy. You know we have a lot of different people calling us oh, this is perfect for your type 2s who are not on insulin, and so forth, and it may very well be, but we think we're going to go with that market to start with, just to give them that choice.

David Kerr: 4:14

And just so that the audience can get a picture where do you implant it? Which part of the body is it? Is it under the skin? Is it in the blood vessel? I mean, where do you put it and how big is it?

Paul Goode: 4:27

Yeah, so it's about. So there's two parts to it. There's what we call a catheter or a lead that's a little over one millimeter in diameter and that goes into a blood vessel and that's connected to electronics which is placed under the skin. And that is about. I should have these dimensions by memory but roughly about two inches long, about a quarter of it. Let's do centimeters. I think it's like six centimeters long and less than a centimeter wide, less than a centimeter thick, and so the device goes in, the catheter or the lead goes in, just like a cardiac pacemaker would, again driving through technology, but the same tools and techniques and location. But instead of snaking it all the way down and anchoring it to the heart, it just goes in five centimeters, two inches, into the vessel and just floats there, and how long does it work for?

David Kerr: 5:21

How often does it have to be replaced?

Paul Goode: 5:24

Yes, so our target lifetime that we're confident we can hit is three years. And what limits? That is, of course, the chemistry. The enzyme Remember CGM started at three days, eventually worked their way to 15 days. The chemistry has been the issue and we've made it in this scenario the last three years. There is a way to replace it. We've designed it in this scenario the last three years there is a way to replace it.

Paul Goode: 5:46

We've designed it for replaceability and you can replace it and use the same body real estate so you don't have to migrate from one location to the other. So to speak, it goes in the same spots.

David Kerr: 5:57

And do you have to calibrate it or anything like that?

Paul Goode: 6:01

Yeah, we do expect that there'll be some minimal calibration. A lot of it will be informed. We have our ideas up front, but I don't want to get ahead of my skis. We want human data to drive that, but we expect it to be very minimal compared to what's been on the market today and in the past.

David Klonoff: 6:19

Paul, if you have an intravascular blood glucose monitor, how will that handle rapid fluctuations in glucose?

Paul Goode: 6:33

Do you expect to see a lag? No, actually good question. We actually expect and what we see from preclinical data? There is no lag. So blood glucose is blood glucose and CGMs are very accurate. They do a phenomenal job, but they're measuring glucose in the interstitial fluid as opposed to the blood. It's biology. It's not a sensory problem, it's a biology problem. There's a delay from the blood to the interstitial fluid because it's got to get pushed down to the capillaries into that fluid. So most of the time that's not a problem. For patients with diabetes that delay is immaterial. The time when it is a bit of a challenge is I mean, you're the physician but the time is when you know, after rapid rates of change meals, exercise, stress, illness that allows the patients to respond sooner by not having that lag.

David Klonoff: 7:17

When it comes to placing a sensor into a blood vessel. Many doctors don't have the training or they used to know how and they're no longer able to. Who's going to do this? What kind of a doctor is going to be placing this sensor into a vein?

Paul Goode: 7:37

Yeah, we actually were very particular about that, since we designed it around cardiovascular, in particular, pacemaker technologies to de-risk so many different things. We want that specialist to do that. That specialist can do this very easily. They're trained, it's their experience and they had a very good one. There's no complications rates, right, so not complications. There are very low complication rates with those procedures and we expect there to be even lower with the ARS, because it's simpler and well, just look into the future.

David Kerr: 8:13

Now I've just come back from the american diabetes association where there was enthusiasm about measuring other things. So you know, and if your device gets to the market and it works, it measures glucose and everyone's happy. What's the next analyte for you, or will it only be for glucose? That's's a good question.

Paul Goode: 8:34

We obviously we can measure other things right. It's just like you know, others are showing that they can add analytes to the same platform. We can do the same thing as well. There is, you know, we have to be selective about what we can do because you know we're not lasting for 15 days but we want to last for three years, and so some analytes for example, lactate is a great thing to measure, but the enzyme stability there is less than glucose oxidase and so that may not be a candidate for long-term. So right now we're hyper-focused on glucose.

David Kerr: 9:08

And then my final question is is this for adults only, or is this going to also be for children with diabetes?

Paul Goode: 9:16

So the initial labeling will be for adults only. We are trying to. You know, we have a site on an even smaller version that we hope to be able to do, which could address the pediatric patient. I mean, this is small enough but we'd like to go even smaller. But it will be later. Initially it will only be adults, adults and eventually follow on with pediatric.

David Klonoff: 9:38

Paul, I have one question for you. Your device is going to generate a lot of data for a long period of time. Doctors and health care organizations are being flooded with data so much data and it may be difficult to do the right thing with the data. It requires interpretation and responses. Do you feel that you're going to be providing too much data? Do you think the system can handle all the data that a device like yours is going to generate?

Paul Goode: 10:15

going to generate. Wow, that's a very, very good down the road question. I mean, it's kind of present here now too. But yeah, we don't plan to flood. We want to leverage a lot of these new technologies, particularly in AI analytics with diabetes signals is to try to give the doc condensed data and we feel like, because we're measuring 24-7, 365 times, there's no breaks, no sensor fall off, there's no wonky first day performance, so we feel like we'll be able to even give them better insights from those types of tools.

David Klonoff: 10:47

Paul, thank you very much for letting us interview you. I think what you're developing is really unique, really important. I hope that everything goes successfully with you and David. Thank you for being a co-interviewer and to the audience, thank you for being an audience. This completes our session today of Diabetes Technology Report. We're available at the Apple Store and on Spotify and, until our next interview, we'll catch you later.

David Kerr: 11:15

Goodbye, that was great, thank you. Thank you.