Paul Goode on Implantable CGM

An interview on implantable CGM with Paul V. Goode, PhD, President and CEO of Glucotrack.

Episode Transcript

David Klonoff (00:14):
Welcome to Diabetes Technology Report.
I'm David Klonoff.
I'm an endocrinologist at MillsPeninsula Medical Center.
I'm here with Dr David Kerr andwe have a very special inventor
in the field of diabetes tointerview today.
David, please introduceyourself and our speaker.

David Kerr (00:31):
Thanks, David, and hello to everyone.
I'm David Kerr.
As usual, I'm speaking to youfrom Santa Barbara, California.
Today, the topic is going to bea specific area that's rapidly
developing diabetes, and it's agreat pleasure to introduce Paul
Good from Glucotrack.
Welcome, Paul.

Paul Goode (00:48):
Thank you, david and Dr Klonoff, I really appreciate
it.

David Kerr (00:51):
So we always begin these podcasts by asking people
how on earth did you end up indiabetes?
What was the spark for yourenthusiasm in this space?

Paul Goode (01:02):
It was actually serendipitous.
I was at a cardiac pacemakercompany many years ago and got
bought out and shut down by acompetitor, and so there was a
lot of recruitment going on andthe good Al Mann God rest his
soul had his folks from Minimetcome out and pick from the
talent and I got hired to go toMinimet, and that's when my

(01:26):
passion for diabetes started.

David Kerr (01:29):
So just tell the audience briefly what is
Gluquitrac up to now?
What's the vision here?

Paul Goode (01:37):
What we're trying to accomplish is, you know, first
of all CGM.
We're doing an implantable CGMand we want to just out of the
gate.
Cgm is phenomenal technology.
Many of us have worked on atleast one generation of CGM
that's out there or has been outthere.
Wonderful technology, but noteverybody can benefit from it
for one reason or another, andso we want to offer patients a

(01:58):
choice.
And when you do the marketresearch, you see the largest
challenge is primarily one formor another.
It boils down to thewearability aspect.
So we decided well, we cansolve that by going implantable
and give patients choice forthose who need something
different.

David Klonoff (02:15):
Paul, do you have experience with implantable
devices, and what are featuresof the product you're working on
that give you optimism?

Paul Goode (02:25):
Yes, sir, what are features of the product you're
working on that give youoptimism?
Yes, sir, actually you know, mycareer, with the exception of
MiniMed, has been exclusively inthe implantable device space,
so 25 years, even when Dexcomwas still implantable in the
early days, and I've done otherimplantables, so I've got a lot
of experience there.
And what we've done atGloopertrack is actually, you
know, we're leveraging, you know, all the known and tried and

(02:53):
true aspects of cardiologydevices to you know.
So it's known, it's safe, bothtechnically, regulatory-wise,
clinically, and so there's a lotof knowledge there and that's
what we're leveraging.

David Kerr (03:01):
So when is it going to appear?
I mean, what's your sort ofgiven FDA and all that usual
stuff?
When is this going to appear?

Paul Goode (03:10):
Sure, Well, we're going to be starting, you know,
this summer at least theclinical trials.
Right, we're starting our firstlong-term clinical trial in
Australia and with the DTRG andBaker Institute.
But in terms of commercialaspects, our target is late 28.
Didn't rhyme on purpose.
And that's of course if we hitall of our intro milestones and

(03:35):
our success with that circle.

David Kerr (03:37):
And just looking at the picture, who is this going
to be for?
Is it a typical person withdiabetes or is it a range of
people with diabetes?
Who's it for?

Paul Goode (03:47):
It's interesting.
Probably you know theregulatory pathway is going to
drive that and we're going, youknow, first trying to address
the type 1, patient with type 1diabetes and the patient with
type 2 diabetes that are oninsulin intensive therapy.
You know we have a lot ofdifferent people calling us oh,
this is perfect for your type 2swho are not on insulin, and so
forth, and it may very well be,but we think we're going to go

(04:09):
with that market to start with,just to give them that choice.

David Kerr (04:14):
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 andhow big is it?

Paul Goode (04:27):
Yeah, so it's about.
So there's two parts to it.
There's what we call a catheteror a lead that's a little over
one millimeter in diameter andthat goes into a blood vessel
and that's connected toelectronics which is placed
under the skin.
And that is about.
I should have these dimensionsby memory but roughly about two

(04:48):
inches long, about a quarter ofit.
Let's do centimeters.
I think it's like sixcentimeters long and less than a
centimeter wide, less than acentimeter thick, and so the
device goes in, the catheter orthe lead goes in, just like a
cardiac pacemaker would, againdriving through technology, but
the same tools and techniquesand location.

(05:09):
But instead of snaking it allthe way down and anchoring it to
the heart, it just goes in fivecentimeters, two inches, into
the vessel and just floats there, and how long does it work for?

David Kerr (05:21):
How often does it have to be replaced?

Paul Goode (05:24):
Yes, so our target lifetime that we're confident we
can hit is three years.
And what limits?
That is, of course, thechemistry.
The enzyme Remember CGM startedat three days, eventually
worked their way to 15 days.
The chemistry has been theissue and we've made it in this
scenario the last three years.
There is a way to replace it.
We've designed it in thisscenario the last three years

(05:44):
there is a way to replace it.
We've designed it forreplaceability and you can
replace it and use the same bodyreal estate so you don't have
to migrate from one location tothe other.
So to speak, it goes in thesame spots.

David Kerr (05:57):
And do you have to calibrate it or anything like
that?

Paul Goode (06:01):
Yeah, we do expect that there'll be some minimal
calibration.
A lot of it will be informed.
We have our ideas up front, butI don't want to get ahead of my
skis.
We want human data to drivethat, but we expect it to be
very minimal compared to what'sbeen on the market today and in
the past.

David Klonoff (06:19):
Paul, if you have an intravascular blood glucose
monitor, how will that handlerapid fluctuations in glucose?

Paul Goode (06:33):
Do you expect to see a lag?
No, actually good question.
We actually expect and what wesee from preclinical data?
There is no lag.
So blood glucose is bloodglucose and CGMs are very
accurate.
They do a phenomenal job, butthey're measuring glucose in the
interstitial fluid as opposedto the blood.
It's biology.
It's not a sensory problem,it's a biology problem.
There's a delay from the bloodto the interstitial fluid

(06:54):
because it's got to get pusheddown to the capillaries into
that fluid.
So most of the time that's nota problem.
For patients with diabetes thatdelay is immaterial.
The time when it is a bit of achallenge is I mean, you're the
physician but the time is whenyou know, after rapid rates of
change meals, exercise, stress,illness that allows the patients
to respond sooner by not havingthat lag.

David Klonoff (07:17):
When it comes to placing a sensor into a blood
vessel.
Many doctors don't have thetraining or they used to know
how and they're no longer ableto.
Who's going to do this?
What kind of a doctor is goingto be placing this sensor into a
vein?

Paul Goode (07:37):
Yeah, we actually were very particular about that,
since we designed it aroundcardiovascular, in particular,
pacemaker technologies tode-risk so many different things
.
We want that specialist to dothat.
That specialist can do thisvery easily.
They're trained, it's theirexperience and they had a very

(07:59):
good one.
There's no complications rates,right, so not complications.
There are very low complicationrates with those procedures and
we expect there to be evenlower with the ARS, because it's
simpler and well, just lookinto the future.

David Kerr (08:13):
Now I've just come back from the american diabetes
association where there wasenthusiasm about measuring other
things.
So you know, and if your devicegets to the market and it works
, it measures glucose andeveryone's happy.
What's the next analyte for you, or will it only be for glucose
?
That's's a good question.

Paul Goode (08:34):
We obviously we can measure other things right.
It's just like you know, othersare showing that they can add
analytes to the same platform.
We can do the same thing aswell.
There is, you know, we have tobe selective about what we can
do because you know we're notlasting for 15 days but we want
to last for three years, and sosome analytes for example,

(09:01):
lactate is a great thing tomeasure, but the enzyme
stability there is less thanglucose oxidase and so that may
not be a candidate for long-term.
So right now we'rehyper-focused on glucose.

David Kerr (09:08):
And then my final question is is this for adults
only, or is this going to alsobe for children with diabetes?

Paul Goode (09:16):
So the initial labeling will be for adults only
.
We are trying to.
You know, we have a site on aneven smaller version that we
hope to be able to do, whichcould address the pediatric
patient.
I mean, this is small enoughbut we'd like to go even smaller
.
But it will be later.
Initially it will only beadults, adults and eventually
follow on with pediatric.

David Klonoff (09:38):
Paul, I have one question for you.
Your device is going togenerate a lot of data for a
long period of time.
Doctors and health careorganizations are being flooded
with data so much data and itmay be difficult to do the right
thing with the data.
It requires interpretation andresponses.

(09:58):
Do you feel that you're goingto be providing too much data?
Do you think the system canhandle all the data that a
device like yours is going togenerate?

Paul Goode (10:15):
going to generate.
Wow, that's a very, very gooddown the road question.
I mean, it's kind of presenthere now too.
But yeah, we don't plan toflood.
We want to leverage a lot ofthese new technologies,
particularly in AI analyticswith diabetes signals is to try
to give the doc condensed dataand we feel like, because we're
measuring 24-7, 365 times,there's no breaks, no sensor

(10:38):
fall off, there's no wonky firstday performance, so we feel
like we'll be able to even givethem 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 developingis really unique, really
important.
I hope that everything goessuccessfully with you and David.
Thank you for being aco-interviewer and to the
audience, thank you for being anaudience.
This completes our sessiontoday of Diabetes Technology

(11:07):
Report.
We're available at the AppleStore and on Spotify and, until
our next interview, we'll catchyou later.

David Kerr (11:15):
Goodbye, that was great, thank you.
Thank you.