Introduction to Diabetes Technology Report

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

Paul Good's Journey into Diabetes

David Kerr 0:47

. 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

Implantable CGM Vision and Timeline

David Kerr 1:34

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 ?

Device Placement and Technical Details

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 ?

Clinical Applications and Future Directions

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 ?

Closing Remarks and Sign-Off

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 .