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Dexcom Exec Interview: Sensor Failures, Recalls, and The Future of CGM | Diabetech | YouTubeToText
YouTube Transcript: Dexcom Exec Interview: Sensor Failures, Recalls, and The Future of CGM
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Summary
Core Theme
Dexcom is navigating a period of significant innovation and product development, marked by exciting new features and upcoming devices, while simultaneously addressing critical challenges related to product recalls, FDA scrutiny, and user-reported sensor issues.
There are many exciting things coming
out of Dexcom. A 15-day Dexcom CGM is on
the horizon. The app just launched AI
powered food tracking with image
recognition. And there's a new
integration between Stello and Aura
Ring, bringing glucose data and wellness
biomarkers together in one place. But
not everything has been smooth. Dexcom
received an FDA warning letter in March.
The FDA recently issued a class one
recall for certain receivers that failed
to alert users. And Dexcom is facing
growing frustration over users having
issues with sensor errors. From sensors
not connecting to the app to an issue
known as gooseenecking. I've experienced
both myself and in some cases these are
leaving people with no sensor readings
for days or if they're traveling having
no way of getting new Dexcom CGMs.
Welcome to the show. I'm Justin. I have
type 1 diabetes and on here I talk all
things diabetes tech news and research
with industry leaders, health care
professionals, and people living with
diabetes. Today I'm joined by Dexcom's
president and COO Jake Leachch to talk
through it all, the exciting updates,
the current challenges. We get into how
Dexcom monitors these sensor errors. We
dive into the FDA warning letter and the
recent recall. and Jake gives me a peek
into what the future of CGM technology
looks like. It's very exciting. Keep in
mind that this show is not medical
advice and is for educational purposes
only. Always consult with a physician
before making changes to your
healthcare. Let's get into it. Jake,
how's it going? Thank you for coming on
the show.
>> Yeah, it's great to be here, Justin.
Good to see you again.
>> Of course. Yeah, I want to start with
some of the most recent news uh
regarding Dexcom, which is this recall
over the receivers. So, I know that
there was a recall of about just over
700,000 receivers due to an audio issue
that could result in missed alerts. Can
you just explain to everyone what's
going on here?
>> Sure. Sure. So um through uh
investigation um of a number of uh
complaints we uh basically were able to
figure out that in very rare
circumstances there's a c certain set of
our receivers that um the audio speaker
component can fail. Um we had a it's a
particular supplier issue with that that
component. Um, and so while the chances
are very low, it's like 015%
chance that if you have that component
over time, and this is not like right
out of the box, this is over time that
speaker may fail. And so once we
discovered that, we wanted to uh
basically alert users and provide um a
free replacement if they have one of
those receivers that could potentially
in the future have that issue. Um, and
so what we have is on our website, it's
dexcom.com receiver check. We're we're
um asking users to go there, enter their
serial number, their receiver, and it'll
tell them whether their ser their their
receiver has that component in it or
not. And if it does, then they're
prompted to to call our technical team
uh who will get them out of replacement
to replace that receiver. So, the
chances are really low, but because of
the importance of um uh the audio
alerts, it's one of the most important
things our product does for users to
help keep them safe. It alert them when
their glucose is um out of range. So,
that is basically why we did the recall
is we felt it important to replace those
receivers for those they're impacted. Um
now, uh people who don't use their don't
have a receiver, don't use it. Um it's
not really going to impact anything
there. doesn't impact any of the pump
connections or anybody uses a mobile
app. Um but it but it is um if you had
the one of those receivers, we want want
to get you a replacement. There's even a
speaker test if you've used Justin
receiver. There's a speaker test built
in when you charge it that for this
exact um uh kind of to help mitigate not
knowing that the component was going to
fail, but just wanting to ensure that
people know that their alerts are
working. We actually even have that test
in every one of those receivers. Um as
you plug it in, it makes a beep and does
a speaker test. And that's why that's in
there is because it's so important to
make sure that these these receivers
would that are you know they're around
for many years um for our users and so
we want to make sure that they they're
always working.
>> Gotcha. And I'm sure there's like more
of an older crowd that are using the
receivers. I feel like these people tend
to be or or younger I guess that people
that don't have a phone, right?
>> It's all it's all the different mixes.
I've seen I've seen you know a lot of
our Medicare customers prefer I mean
they have a smartphone but they prefer
to use the receiver. For them it's
simpler. I think um I've seen folks that
use receiver but then you know their
loved ones really want them on the
mobile app so then they use both right
so the mobile app can share so they want
the their loved ones want to be able to
see their glucose so they're using the
receiver and the the mobile app so um I
think it's it's all around like there's
all kinds of different use cases but
yeah anybody who uses a receiver want to
make sure you check it and if if it's
one of those it's part of this group
then we'll we'll get you a new one.
Okay. And and these audio issues, this
wasn't something that was happening, you
know, out of the box, right? It was
something that I guess over time this
could happen.
>> Yeah. Over time that the basically over
time that speaker um component
connection um has the possibility of
failing. Again, like I said, it's a
really low percentage, but um but just
to be safe, uh we want to make sure
everyone um who has that particular
component in the receiver can get a new one.
one.
>> Okay. And what I'll do is I'll put the
link to this page in the show notes so
people listening if they have a receiver
they can go in and and put that number
and that skew. All right. Well, let's
talk about this Dexcom G7 app refresh. I
know there were some changes that came
to it.
>> Um, one of the maybe smaller ones that I
noticed from the instant I opened up the
app was when I was sliding over it,
there was just a change in like the
style of the reading. tell me a little
bit about why I guess this change was
made and what it is.
>> Yeah, so um the um version 2.9 of the G7
app for both Android and iOS, we
launched that globally. It has a whole
bunch of updates in it and some of as
you mentioned around the um uh the way
that we display the readings as you
scroll through. It's really a user
feedback around um you know wanting um
the look and feel of the app to be you
know kind of high design fun to play
with and work with and look at. And so
you know our design teams are always
looking at better ways to work the UI of
the of the mobile app. And so that was
one of the very small tweaks we made. We
also added in um uh photo event logging.
So super fun. You can now take a picture
of your hike or um uh your meal. And
actually on the meal, there's a new
feature um called smart food log where
you can take a picture of your meal and
it does a um uses um AI to identify uh
the meal and put a description um into
the text box. You don't have to type in
what you're eating. It actually does it
for you. Um it's pretty it's pretty
cool. I've been playing with it for
quite a while. Um and it it also puts
that information into clarity. So your
physician um if if you're having
challenges trying to work through you
know insulin delivery and and uh carb
estimation along with meals um you know
physician can see um the description of
of the of the meals and help you out
with the carb counting if if you're
having challenges. So I think it's a
good feature for users and for their
their HCPs um and it's a it's a great
way to log and it it's just kind of the
beginning of it. It's really let's start
getting those meals logged and then we
can start using um AI further uh use
that insight engine to to give more and
more feedback personalized around that
person's glucose and their their meal.
There's a cool you can also select um uh
kind of the meal reflection. It'll show
you the picture of the meal but also
captures your glucose for you can
program it for how many hours you want
it to capture your glucose and attach to
that meal experience. That's one of the
updates. We also um added in seven-day
GMI. So one of the things we're you know
so GMI before um we used a longer time
frame to estimate it and we had users
that wanted to see in their GMI
reflection of all the improvements in
their time and range that they were
making. Um and so we now have a 7-day
GMI um that's that's built in. And then
um one of the other things is the
customizable target ranges which is
helpful. something we've also user
feedback based HCP physicianbased
wanting to be able to set um different
glucose ranges for targets for certain
different individuals. Um pregnancy is
an example um where they wanted tighter
but they wanted a tighter range in there
so we now make it programmable.
>> Yeah. I think one of my favorite things
about using Dexcom G7 is the app really
does seem to get better pretty often and
that you are innovating a lot with it
and it's and sometimes I just it's me
update like noticing my app updated and
and seeing something completely
different before you even say it was
updated and it's just cool to to be
surprised and be like wow I can I can do
these new things. And when it comes to
the smart food logging, using that AI,
right now it it takes that photo, it
can, you know, use the AI to kind of
label it. Do you see this one day also
estimating carb count or even like the
fat content and things like that that
could prove really helpful?
>> There's um there's technologies out
there already that do that. not to the
level they're not validated and and
accurate to the level yet that we would
need to be able to provide these to our
users such as a carb count. Um but we're
going to get there. Um we already have
the systems in the background running on
those and doing those types of
calculations. We're just not displaying
it to users yet because we need to
validate that it's accurate. I think the
key there is um uh portion size is the
part that's the hardest for this. The
system is very good at identifying the
actual food. Uh I've been super
impressed. one of our uh team members um
took some was traveling in India
recently and took a bunch of pictures um
of different foods there and it was even
getting like the spices in the spice
rack in the tray and with the meal
getting those right. So it's like pretty
impressive. Um but uh it's the portion
size that is the the key to estimating
the the the actual amount of macros. So
we're working on it and we and we know
users want that and and we do feel that
that could really help help people in
their journey. are these images that
we're all uploading to this helping
train like your machine learning to
understand the photos that will come in
and yeah you're you're training on it really
really
>> we're training on it um we're the the
technology is based uh we um you know
our partner uh Google uh they've been a
partner with us for a long time um their
Gemini system is what we're using um but
we're certainly training it um with some
of our because you know you can use
their entire model but then you start
getting pictures of what actual our
actual users are are doing with it. And
so you can really start um fine-tuning
things. And so that's really what what
we're after.
>> This episode is sponsored by Omnipod. As
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Now I know Stell your CGM that's for
people who aren't using insulin that has
an integration with the Aura ring. >> Yeah.
>> Yeah.
>> And it's taking all these biometrics and
and implementing Stello glucose readings
into the app. Can you tell us a little
bit about what these new metabolic
features on the Aura Ring app do? The
the meals and the glucose.
>> Sure. Sure. So, um yeah, as you
mentioned, um we have a strategic
partnership with Aura. If you uh acquire
an Aura Ring or an Aura Ring user, um
there's a new feature now that can
connect your your Stella directly, uh to
the Aura apps. You still run the Stell
app in the background, but it basically
is loading all that data um into the
Aura app. Uh and then so B it's it you
can always get your glucose in the Aura
app and you can look at meal reflections
in there. Um and then they're also
starting to link that um to sleep. Um
and the idea is is they're recommending
healthy habits um from you know being
able to see that glucose data. Um it's a
unique partnership. I mean uh Aura is
actually distributing Stella as well.
You can buy you can get Stella on
Stella.com. You can buy it from Amazon
but you can also get it directly from
Aura. Uh and so u we've definitely seen
an increase um in um uh basically or uh
stell users uh through that partnership.
Um and so very excited about the way
that they're they're innovating uh on on
the glucose data combined with their
their sleep um and um you know heart
rate uh respiratory rates all those
things. I think we're still early days
in terms of the guidance that the system
is providing based on the data that's
going into it. that the way that we you
know the way this starts just like you
mentioned around the food logging for
for the G7 app uh is that you start
generating the data sets that you want
to use to then further optimize things
and train machine learning algorithms.
Um also testing out what works for users
and what doesn't. One of the things I
love about Aura is they update their app
like almost every couple of days I can
see that there's an update there. Um and
so it's really been a nice partnership
for us uh to work with Aura and um bring
they're helping um you know some of our
thinking around um how to continue to
evolve um how we approach our users
because all you know some people call
Stella the the consumer product but
really all CGMs that we manufacture for
any person is a consumer product right
um you're using it it needs to fit into
your lifestyle it needs to be you know
it needs to work seamlessly um you know
on your phone and and the experience
that you use when you're on board so all
those things it's helping push us and
and we're learning things through
working with Aura that going to make all
of our products better.
>> Yeah, I was uh using Aura for a bit and
I really liked it. I I will say I don't
like that they charge you monthly to use
it um after paying $400 for the device
that so I actually returned it cuz I was
like I'm not going to pay you $9 a
month. But there are a lot of people who
will do that and and they have a ton of
customers and and one day I probably
will get Aura Ring and probably what's
what's really stopping me right now is
that I would love to see G7 integration
there and I guess that's kind of what I
was wondering is do you see this Aura
Ring collaboration with Stelling
ground for gathering all of that data in
just more of a consumer way people who
aren't making decisions on insulin you
know with this data
Um, do you see this as a way to gather
all this information and do you want to
see all of this like sidebyside
information of glucose with stress,
sleep, activity, etc. with uh on the
Dexcom G7?
>> Yes. Yes. Yeah. We we definitely want to
we we working right now on how to extend
it um into the connection between Aura
and G7. So, it's definitely part of the
the road map. Um I h I often get asked
about um when we're bringing it to G7
and we certainly will.
>> Would you need to get some sort of FDA
clearance for that integration? Like are
there different intricacies to getting
that integration going on G7 than
>> Stello? There can be it depends you it
really depends on what you're actioning
to the user and and how it how it works
what information providing just to do
the connection and the visualization is
is pretty straightforward. you know,
everything we do is is kind of um
purview uh for the FDA. Some things you
have to you have to have cleared before
you can launch, right? And so um but
some of the initial stuff we don't need
that. It's more around what do you do
with the data and how does it, you know,
um impact users. That's really where the
FDA is is interested. So yeah, it it's
coming. We're working through it. Could
you see a future where this biometric data
data
is being used alongside your CGM and
your automated insulin algorithm? I do.
I mean, I think one of the ones that's
um you if people aren't working on this
already, I'm I'm sure some of it may
already be done is just even the concept
of knowing that someone's in motion or
not, right? I mean, that's like the
simplest uh stream, right? You get an
activity, but knowing that someone is is
hasn't moved and they're likely sleeping
when also measuring glucose and having
an automated insulin delivery system.
Totally different than if someone's
highly active that you could that could
influence, you know, obviously the
insulin delivery algorithm. I mean today
a lot of the AID systems right there's
like the exercise button or you know you
can change it. So um I do think you know
just from that's like the most
simplistic way. I think um it's up for
the folks that are developing those
algorithms um to determine the impact
that something like sleep can have on
how you would tune an algorithm. I think
for the absolute best control uh with an
aid system I I do think that you know
sleep and stress and all those things do
factor into glucose um you know how much
insulin you need. So, um, yeah, I I I
think that I could easily see a day
where where that data is is impacting algorithms.
algorithms.
>> Yeah. You know, interestingly, the Kido2
pump from uh that in the from the
Netherlands, they put a gyroscope in
that pump.
>> So, there's no news on whether or not
that will be used with their with
Diaboloop, their aid algorithm. Uh
that's a separate company, but they are
putting it there because they know that
it could one day be used. So they they
created a pump that at least can fit it
in. So yeah, maybe at least if your pump
knows that you're, you know, going up
and down a lot. Yeah, that could be
interesting info. I wanted to get into
some um user feedback that I've been
getting. So, I personally had a sensor I
I've actually had a few sensor issues
when it comes to um applicating it. I
had put on a sensor and then it would
not connect to the G7 app. Then I took
that off and I put on another one and
the same thing happened.
>> It would not connect.
>> I called support. support wasn't able to
fix it, but I did put on a third one and
that one worked. This inspired me to
create a video and put it up on social
media across all of my pages just to be
like, "This happened. Like, is this
happening to anyone else?" Cuz I had
heard things, but I don't know. It it
happened to me and I was like, "Well,
okay, this is this is happening." I
received over 1,500 comments across my
platforms on this of people experiencing
the same the same thing, putting on a
sensor, it not connecting to the app.
So, it's obviously not an isolated
event. Is Dexcom aware of this? And what
is going on here?
>> Basically, um you know, as you
mentioned, there sensors can fail uh
when you put them on. Um certainly this
one sounds like it's not pairing. So,
you're basically getting a not it's not
pairing, right? So, generally when that
happens, um it's based on something
around um you know, the sensor starts up
right when you deploy it. And if there's
any kind of an issue with the battery of
that device, um it can get to the point
where it doesn't start up because we
have a bunch of safety checks in there
to make sure the battery has the energy
it needs to be able to, you know, last
the whole time. So when that happens, um
uh the device doesn't start up and
doesn't pair. Um and so yes, uh it is it
is a failure mode that can happen. Um,
and it's certainly something that we
constantly are working on, you know,
ensuring that, um, the devices always
work out of the box. Um, and I'm hoping
that when you called support that you
got free replacements. Um, you know,
that's something that, you know, it's
also something that, you know, we've
also continued to enhance the way that
our our technical support interacts with
customers and making sure they
understand that there's no cap on sensor
replacements for anything where the
sensor fails on its own like that. Um,
you know, any those are replaced without
any kind of uh restriction. I think
there was a lot of confusion over time
about that and I and you know, we take
responsibility for not communicating
that well to users. So, we want to make
sure it's super clear. Um but yeah that
that is that's something you know we've
seen those rates of that occurring um
you know have gone up and then gone down
um usually based on us you know
detecting the issue and then kind of
trying to determine exactly where it's
coming from. Um it's a small percentage
in terms of the millions and millions of
sensors that get used but um it does
happen and it's something that um yeah
we're definitely aware of it. I know
that's one of the things like are you
guys aware this happening? He's like yes
we see it we're working on it. We we are
making um updates all the time and and
chasing down issues all the time. We
have a whole team that does nothing but
focus on that um because as you scale to
you know um you know hundreds of
millions of sensors around the world um
things happen uh you know in different
places and so we're always working to
improve the systems to make sure that
doesn't happen and if it does the most
important thing is if it does happen you
know you need we need to make sure that
users can get replacements in a timely
manner. You know, one thing that the
reason I was so worried when it happened
to me was I was about to go on a 60-day
trip around Europe. Now, you know, I
already bring a fair amount of backups
just in case of anything, but the the
fact that two in a row failed and I
didn't know if my stash of the eight
that I was going to bring, if if five of
them failed, that means I would only
have 30 days of Dexcom and I'd be in
Europe where I'm unable due to
restrictions on the government and
insurance, whatever it is. And maybe you
can explain that
>> um I would be unable to get Dexcom. What
do you say to people who are about to go
travel for 30 days, 2 weeks, like should
they be bringing
four times as many Dexcoms that they're
you know cuz I' I've had people message
me saying four in a row failed upon
application. So, I guess like that's
where I'm not worried about as much um
replacements, although some people only
get a month's supply at a time, but I'm
worried about the people, especially
during summer that are traveling for for
a long period of time.
>> Yeah, it's it's a really important topic
around making sure you've got enough
sensors. And I would say that, you know,
multiple uh sensor failures in a row, it
can happen, right? It's clearly happened
to you, it's happened to others. Um, and
you know, I think it's it's certainly
less likely to happen now than, you
know, in the past when as we've
continued to improve the product, but it
it can happen and I think it is
important to have extras whether you
know whether it's you know an issue with
the sensor or maybe the sensor falls off
um while you're on your trip. It's
important to have those extras. Um I
wouldn't say you know you need to bring
a huge number. Um, one of the things
though is that we are working on that
the the complexity of replacing sensors
for users that are traveling. It's not
impossible to figure out how to do this
um because you are a US customer and it
is a US product. It's US approved. But
the way the current networks work is
that unless you have a European uh kind
of prescription or a European access, if
you're let's just get say you're
traveling in Europe, it's really hard
for us to like compliantly get you a
sensor with from with from the European
group, right? But there is a potential
opportunity for us to figure out how to
get it to you from a US um entity. And
so we are working on how because we do
understand how important it is. It's
similar to the when we had some of the
um geoloccation work that basically
guaranteed that if you were in a
location your your feature set available
to you if you installed the app was
based on that location right so people
were having issues traveling so we did a
lot of work to to resolve all those
things so that the mobile apps when you
travel or whether you even lose your
phone and have to reload everything
while you're in say you know Germany for
example you still have access to all the
things you need u uh for for your US
version there's still opportunity for us
to to continue to improve
>> all of these sensors. You see it on the
box and the applicator that they have
all of these serial ID numbers, right?
They ask you when you call up which lot
number was this. If Dexcom has all of
this data on applicators on which ones
they are, where they come from, the
specific factory, time of day, whatever
it was produced, is that information not
enough to know ex to know where these
sensors are coming from and then alert
people who have those lot numbers
because people like I'm on I'm a bit on
edge when I'm packing right now cuz I
have other sensors still and I don't
even know which ones cuz they're all
mixed up from that same lot. Like, does
that is that information not available
for you to kind of say, "Hey, anyone
with a Dexcom that has this lot number,
maybe that's not your backup for your
60-day trip across the world."
>> It's it's a we have all that data and we
do analyze it all the time to look for
any kind of trends or anything, but
generally this isn't like an entire
lot's bad or even though the the lot has
a higher failure rate. It's more like
these are generally component-based type
things. It's not like a whole batch of
things are bad. So, it's really more um
by chance you get something that maybe
doesn't that doesn't work. So, it's it
it's it's not really possible for us to
say like that because we wouldn't want
to say that lot's bad because they're
all perfectly good. It's more around um
continuing to get to the root cause of
it and then also making sure when people
do have an issue that they can get get
the replacements they need. I think
that's we attack it both ways. Um, and
um, that's basically what we've been
focused on since since the launch of the
the the first CGM, but you know,
certainly G7 in the scale, it's much
larger. Um, and so, you know, people,
you know, when they do have an issue, we
want to make sure they get that sensor.
>> Yeah. I had a lot of people reach out to
me saying that they they used a magnet
trick that the applicator on the G7, you
know, the magnet detaching from it,
that's what activates it, right? it
starts the warm-up time, which is so
cool about it because you don't even
have to link it to the app. It just
automatically is warming up. So, people,
what they've done, they found that when
their sensor doesn't connect directly to
the app, that if they kind of wave that
applicator over it with that magnet,
that it does allow it to activate that
there was some sort of mechanism that
didn't release it from that or
something. Are you aware of that?
>> Yeah, I am. And it can work. It's
actually quite um, you know, industrious
to the community. That's one of the
things I love about um the diabetes
community is um just kind of like the
creativity uh and and um we are aware of
it. That is something that can work. Um
it doesn't always work. Um and it's
basically just giving that sensor
another opportunity to fire up. Like I
said, we we check the battery to make
sure um it's uh you know adequate to
last the whole sensor duration. Um and
so it's allowing that check to occur.
Again, it shouldn't have to do that,
right? It's not designed to do it that
way, but it is it is a workaround that
people have figured out.
>> You know, a lot of people wouldn't have
heard about this trick unless me and a
few other people said something about
it. No, I don't think Dexcom's said
anything about it. And it is an easy
fix. Why did Why has Dexcom not put out
some sort of release letting people know
that if your sensor fails like this
could work, you know, to save aggravation?
aggravation?
>> It's a really good question. I think
it's because um while that can work um
the system didn't start up for a reason.
So we would really prefer to replace
your sensor than give you that
workaround. Um but you know again people
are absolutely free to do do um as as
they need. Um but yeah for us to
officially say that that we can't really
officially say that's the right way to
solve the issue. The right thing is to
get you a new sensor.
>> Um but yeah that's that's basically why.
>> Okay. Now, one other thing I've
experienced and and other people have
too, and I put this out, people
responded saying it's happened to them,
um, is what we're calling gooseenecking.
So, you put on the sensor and you can
actually see the sensor filament looped
and stuck in like the little hole like
it doesn't actually go into the skin.
What is happening with that?
>> Yeah, it's basically when the sensor
deploys, um, it the sensor doesn't get
deployed under the skin, it gets pulled
back with the needle. Um and so that is
a failure mode that can happen. Um it's
actually a failure mode that um earlier
this year we saw it start to creep up.
Um you know it's it's normally at
extremely low levels and it crept up a
bit and then we went in and we made some
changes in our manufacturing processes
to resolve it. Um and so um but users
were experiencing it. Actually we we got
an indication of that. Um and so it's
basically that's what's happening. The
sensor is not getting deployed properly
and so while it does pair it will
rapidly give you a sensor failure. And
so that's something that again we're
aware of. Um we've we've addressed it in
the in the manufacturing uh plant. Um
you know it was very it was it was small
numbers but the people that obviously
happened to um you know it's highly
impactful when your sensor doesn't work
out of the box. And so it's something
that like is not not acceptable. And so
we really want to make sure obviously
those get replaced. Um but we do feel
like we've we've um addressed that
issue. And while it may still occur to
folks, it certainly um we saw it happen
and we we made some changes to fix it.
>> Yeah. Well, it's great to hear that
you're aware of all this. And I will say
that I've had nothing but great experiences
experiences
um with support and getting
replacements. Whenever I've had issues,
I get that replacement, no questions
asked. And um so, you know, things are
working well over there, at least for my
experience. Um I have a couple more hard
questions and then I have some fun ones. So
So
>> yeah, no problem. I don't mind. I mean,
I think it's important.
>> Yeah. No, I appreciate you, you know,
giving us all this information because I
it's one thing for all of my listeners
and readers to hear from me, but I know
it does mean a lot to hear that Dexcom's
aware and that they'll give replacements
and that this is what they're working
on. And really, just hearing from you
directly is even putting me at ease
because it it does make sense when
you're producing these in the millions.
Like things can happen, right? and
you're seeing them uptick and you're
like, "Okay, let's figure this out." So, like,
like,
>> you know, it makes sense from so many
perspectives as to why you would, you
know, be aware of these and working on
them. But just hearing it from you, um,
it's making me feel more comfortable.
So, I I appreciate it.
>> Um, so earlier this year in March,
Dexcom received an FDA warning letter
due to a change in
um, a mechanism you were using from from
a third party to your own. And the FDA
said that this resulted in less accurate
sensors. Can you explain kind of what
happened here and and how the accuracy
was affected? Yeah. So, um I think what
is important to note is that um there's
no actual claim that the performance of
the sensor isn't acurate as the old one.
What the real issue was is that when we
qualified that new material, the FDA um
wanted to see us do some different
things to be able to qualify it. Um we
we used that material for quite a quite
some time on our G6 product and we used
it for a very short amount of time on
G7. Um and basically the FDA through a
normal inspection process, right, they
come in and inspect us all the time. Um
multiple facilities, factories,
everything. And so during one of the
inspections, they they um started
reviewing this and they said, "Look, um
we would have preferred you do this
differently in terms of the way you
qualified it and also we would have
preferred you tell us about the change
uh ahead of time as like a submission,
right? I talked about that idea of what
gets submitted versus what's um part of
this quality system and of course
reviewable." And so they basically came
back and said, "We'd prefer you do it
differently." And so while we still very
much um felt that what we did was
appropriate, we took their feedback and
said okay we won't make we won't
manufacture sensors with that material
um until we do um you know a redo the
validation in the way you want to see
it. Um but you know ultimately um in the
the product of the field it was not less
accurate by any means. Um it just was
they we did show them all the things
that they would want to see uh to be
able to verify it. So that was that was
basically it. Um, so we agreed and said,
"Okay, we'll next time we'll because we
do actually want to ultimately include
that material too in our sensors." Um,
and so we will um go back through that
that process with them and we're
actually already in the process of doing it.
it.
>> Okay. And none of those sensors that
were involved in that, they're not in
circulation at all, right? Anymore or at
least you're not putting those?
>> Yeah, we're not I mean we're not
manufacturing with it anymore, but
there's no reason there's nothing wrong
with those sensors. Um it was more of a
just that um uh we moving forward uh
we'll do a submission uh to get that
that material in there.
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notes.
>> The G7 is getting a 15-day model.
>> Yeah. Yeah. So, super exciting. 50 50%
more days, uh, less to pack. Can you
tell us a little bit about this upcoming device?
device?
>> Yeah. Yeah, I'm super excited. We're
planning to launch it here, um, later
this year. Um, and it's a G7. It's the
longest lasting uh, sensor. So, it's 15
and a half days, and it's the most
accurate sensor uh, we've ever produced.
So it um comes with a new algorithm
within the device that not only extends
the duration but also improves the
performance of the product. Um and so
you can see you know less outliers um
you know more readings all all the
things that we're always improving.
Similar you know we've done this um this
type of algorithm improvement on each of
our generations of products after
they've been in the field for a while.
So G, we did it with G4. Uh we came up
with a new software release after G4 had
been out for a number of years. Did that
further enhanced the the accuracy of and
the reliability of the product. We did
it with G6 as well. Um after a couple
years, we made an enhancement. So now
G7's been out there for a couple years.
We're making this enhancement into the
15-day uh product. And so it it it
improves accuracy um and also extends
the the duration.
>> Yeah. It's like the iPhone 7, then the
iPhone 7S. This is the Dexcom G7.
announced the Dexcom G7s.
>> That's right. You learn I mean when you
when you have you know you launch a new
product um you know you do your best
when you're developing it. We do lots
and lots of clinical studies but you
know we're we're in the thousands of
people have have used the product before
it launches. But then once you launch it
and you have to have millions of people
using it um you learn about the the you
know infield performance and then you
start to learn okay well how can we make
this better? How can we further improve
it? And as you manufacture them, you
also learn things about how you can
tweak the algorithm to to really push
push the boundary on performance. So
does yeah, the most accurate ICGM ever produced.
produced.
>> Well, so how does the change in an
algorithm make the accuracy better?
>> It's um yeah, it's a really good
question, Justin. So it it's basically,
you know, when you when you're trying to
um produce the most accurate um
estimated glucose value for for a user
um on the on the display device, you
you're taking a signal from a sensor and
you run it through this fairly complex
algorithm that uses all kinds of things
including probabilities um as well as
the the life how long the sensor's been
in use. um as well as you know one of
the things is you're taking you know the
sensors are measuring interstitial
glucose but you're you want to reflect
glucose changes as fast as you can. One
of the things that um you know having
worn sensors for many years, the sensors
of today are much more responsive to
glucose changes than the sensors um of
yesterday, the older sensors. And that's
one of the things we're always working
on too is how do you uh ensure that when
let's say you've got a low and you're
waiting for that glucose to turn around,
you know, how can we ensure that we as
accurately as possible, we don't be, you
know, you don't have to be too noisy,
but you basically want to be able to
capture that that change in glucose or
rapidly changing glucose, right? I think
sensors today have have even less lag
time than previous sensors because
they're keeping up with that. So those
are all things that you do to to get to
a more accurate sensor as well as
outliers, right? We when you know we do
have the occasional sensor that you
start to detect, okay, this one's not
sensing glucose accurately. Um so you
further refine those algorithms too.
>> Interesting. So there's no physical
change, right? This is a software
algorithm change. the the sensors remain
the same
>> primarily the sensors uh you know we
we've continued to enhance the the
sensors themselves but this is primarily
a algorithm uh change uh that that is
and and a new clinical study that
supports it.
>> Okay. And now this sensor the 15-day is
for those 18 years and older. So what is
the thought process behind this age?
>> Yeah. Um two things. Um one was that um
but you know as we look at sensor
duration in in children um sensor
duration is is usually less the sensors
less last less time in the pediatrics
and it's typically things like the you
know patches get torn off um or um you
know the sensor probe um you know kind
of gets to the point where it says okay
I'm not sensing glucose more accurately
and lots of things drive all that but
when we look at our population of users
um we didn't feel that it was
appropriate yet to bring out the uh G7
that so many kids around the world use
to 15 days because we want more of the
sensors to last the full 15 days in
those kids than where we were at. So we
said in the adults we see good
performance 15-day stell's already
15-day we've seen great longevity of
sensors there um in the adult population
we ran our studies we're seeing good
longevity out to 15 days with it but
when you look at the pediatrics it's not
the same and so we felt it's important
um to have the pediatric 10day product
uh G7 10day available for the kids
because we just we want to make sure
everyone has I mean our number one goal
is to make sure you have the sensors you
need and you get you have the glucose
readings um all the time right we don't
want people to go without and so we felt
that if we took pediatrics to 15-day
we'd have more issues with that and so
um we will have a pediatric 15-day
sensor um but you know we we are the
leaders in in sensors for feeds and we
always have been and we always will be
and we felt it was the right thing to
do. So this is expected to launch later
this year in the US. Are there plans to
bring it to other regions that you are
already in? Like kind of what does that
look like?
>> Yeah, we we're looking we're we've in
fact we've been evaluating it. um all
every different region is um got
complexities to how you service um you
know uh CGMs for different uh age groups
and there isn't yet the precedent there
where we could do a you know a 10day for
pediatrics and a 15-day for adults there
isn't in the reimbursement channels and
how all that works there's some
complexity there that we're trying to
navigate into how to do it so that we
can get the 15-day duration um to to
those that that um could can use it. So
we're still looking at it. Um, we're
going to launch in the US first. Um,
there's a clear way for us to do it
here. So, we're going to work through
how we do it within the international
markets. We also have our Dexcom one
product uh internationally too. And so,
we're evaluating the 15-day um survival
there, too.
>> Oh, amazing. So, when it came to the
15-day, there was a press release that
had some fine print that mentioned that
roughly 25% of the sensors won't last
the full time. Is this typical for CGMs?
you know that there will be a percentage
that don't make it the full period.
>> I mean we I think having you you've worn
CGM before some people um their sensors
always last and I think it's it's just a
combination of lifestyle and a little
bit about physiology and so yeah it
can't sensors don't always last and
that's why um we want to make sure that
you know we have a robust process for
replacing your sensors. I think the vast
majority, you know, of users have no
problem getting their sensors to last.
And I think 15 days is going to be a
delighter for many people who wish they
could just keep wearing their sensor and
it when it times out at 10 days. >> Yeah.
>> Yeah.
>> Um and so I think that's that's what
it's for. But if um you know there
things can happen, right? And as you go
out to 15 days from 10 days, there's
more opportunities for something to
happen um you know, an adhesive issue or
or whatever. So I think that's where we
really um feel like as we've looked,
we've studied pretty closely. We studied
with Stella, we studied it a lot of
15-day product in type one and type two
people with type one diabetes, type
people with type two diabetes, lot of
clinical studies to be comfortable that
um we've got this right. Uh and so very
excited to get it out out the door. Um
and um you you should be hearing about
more soon about the actual launch.
>> Yeah, my G7s stay on like would stay on
way past 10 days for sure. I just I'm
like, I got to take this off. Um, so
yeah, I have really good luck with them.
I know everyone's skin type's so
different, but I'm I'm ready for the
15day. Yeah. Yeah. And I know it's gonna
stay on and I don't even always This
isn't label, but I don't put the over
patch on and it still stays on. It could
stay on for for 15 days. So, love that.
For me, a lot of people in the US, their
insurance only allows them to get one
month supply at a time for anything,
which I think is not
not the way it should be, right? Like I
get three month supplies with my
insurance and I have a backup
>> throughout all this time. So, if I have
a sensor that fails, I've got seven more
waiting for me. But what if there's
someone who gets their, let's say it's a
15-day, they have two sensors, they put
one on, works great, they put on the
second one, it falls off after 5 days,
something happens, right? They're out of
luck for the rest of the month until
currently Dexcom sends them a
replacement. Why is it on Dexcom
to do that when there is statistically
25% of sensors won't last the full time?
Why is it on Dexcom to do that and not
insurance companies? Why aren't
insurance companies held accountable for
the percentage 25% more sensors that we
may likely need?
>> So, um, a lot in there. What I would say
is um many people the the the 90day
supply, the three month supply is is you
know is a great way to go if you can do
it. Um and many many people do. Most
people do actually but there are those
like you said they only get two two
days. I think there's a couple things
I'd say. One is there are um you know
I've I've seen cases where folks are
writing prescriptions for more than than
sensors than just the the exact two or
exact you know three today for G7. They
write more than that just so people have
those extras in case they need them.
Some insurance companies cover that.
Right. There is an ongoing discussion
that we're working through with payers
in terms of how do we make sure this is
right. Um the other thing too that we've
launched too that is is helpful is that
we've got this uh voucher program going
and and we've been trying to you know
it's been going out across the states
where um if you do have a sensor issue
you can get a QR code from us and and a
voucher and take it into a pharmacy and
pick up a sensor that day. Um, and so
that's that's a that's been, you know,
we launched it in Canada. It was very
successful. We've launched it um in a
number of states uh in the US. Um, and
it's it's working quite well. We're
still working on getting it around the
entire US. So that gives another
additional option to be able to get a
sensor that day. And so um the other
thing too is for for anyone who's in the
situation where they they literally
don't have any more sensors and their
last one failed, we do expedite shipping
for those folks. So, that's important to
communicate that if you're talking to
one of our tech support reps to be able
to get you get you the sensors because
we we know how important this is and
we're always evolving. And I was
actually talking to some physicians in
Colorado the other day around how to do
this because the same issue came up.
It's like if if I you know can only get
a certain amount of sensors and have an
issue and I'm kind of don't have any
spares. Um what do I do, right? And so
the patients uh often ask for
prescriptions for extras. So I think we
we got it's one of those things we got
to continue to work on. Yeah, that's
great to hear. I actually that I now
remember when I was on the phone with
support recently, they asked if there
was a nearby pharmacy
>> and they were going to say, "Oh, we can,
you know, you can go pick it up." And
because I had my backups of supplies, I
was fine with getting it shipped, but
>> um that's a great option for people,
especially um if they're if they need it
right away. Uh I want to just end with a
little bit of a peak into the future for
Dexcom. Obviously, we're seeing 15 days.
That's fantastic. Uh the future would
could have a 15-day ped uh sensor as
well for you. You know, we're seeing a
lot of implantables. We're seeing ketone
monitoring. We're seeing this longer
wear time. Where do you see the future
of CGM going?
Um, I think the number one thing I see
is that the um, you know, there's still
so many people outside um, uh, of the US
that don't have the same type of access
to CGM that that we do here in the US.
We're very lucky. We still don't have
access for all people with diabetes in
the US. Some insurance companies cover
that, but um you know the data is so
clear uh around um the benefits that
people um can receive when they they
wear a CGM and and the lifestyle changes
that they make and that really helps
them manage. So we're working hard to
secure coverage for all people with
diabetes around the world. And I think
when I think about what's that's what
I'm most excited about is getting this
technology to more people. there's, you
know, we're still between us and and all
the folks that make CGMs in the world,
you know, we're at like a 2% use of CGM
and those that have diabetes, right? And
so it's just unbelievable um the the
people that could benefit that don't
have access. So I think that's one but
to your question around a big part of
making that happen is to continue to
enhance the technology in terms of you
know its affordability uh continuing to
drive uh you know awareness of the
technology u doing the clinical studies
that are required to show just the
outcomes and and some sometimes you got
to do it in certain countries the
economic benefits you know it's not just
a user benefit it's actually there's an
economic benefit to the health care
systems because they're spending less
money when people are managing their
diabetes or able to manage your diabetes
better, like less visits to the
hospital, less utilization of
healthcare, no the emergency room visits
go down. So all of that um requires us
to continue to innovate, right? And
we're committed to innovation across the
whole portfolio. Um you know, G7, Dexcom
1, Stella, we're going to keep pushing
the boundaries on all of it. Um you
know, smaller wearables, uh um you
looking at multi analytes, you mentioned
ketones as one of them. um adding that
into the sensor. I mean glucose is so
powerful, but as you start to add in
some of these other analytes that that
can help further the utilization and I
mean we're seeing in Stella, we're
seeing a lot of people in the
pre-diabetes category start to use the
product. Um and and while we don't, you
know, we don't have a claim for weight
loss, um I was literally in in the gym
this morning and one of the the folks
that was there comes in and says, "Hey,
uh I just lost 8 pounds." And he was
talking to a trainer. He's like, "I just
lost eight pounds over about a month
period." And they're like, "What did you
do?" He's like, "Well, I changed my
diet." And he's like, "How?" He's like,
"I used this Stell thing." And I'm
sitting there.
>> Oh, wow.
>> He doesn't know I work for Dexcom,
right? And I'm just like, uh, I'm like,
"Wow." I mean, that was like right front
and center. Uh, you know, he's like,
"Yeah, I learned that like, you know,
uh, sushi and the rice in the sushi was
wasn't great for me." And, um, some of
the drinks he was having, the the
carbohydrates in them were not working
well with his blood sugar. And he's
like, "Yeah, I just thought." So really
it had him reduce his carbohydrate
intake and he was you know feeling
feeling amazing. And so I I think
there's just so much opportunity for CGM
to make a difference in people's lives.
Um and you know CGM it doesn't really
have any side effects right it's a side
effect is better glucose as one of our
physicians said.
>> So yeah I think there's there's a lot of
lot of uh great stuff coming. And then
of course on the software side, we're
going to continue to innovate with um
the AI technologies is absolutely
incredible when you think about
supporting customers, providing insights
within the the mobile apps, the new data
streams we're starting to bring in um to
the platforms around sleep um activity.
Um you start to combine all that stuff.
I mean, there's just so much innovation
going on. I I haven't seen as much
innovation in wearables in a long time.
I mean, you think about the Aura Ring,
you think about CGM, um you know, you
think about the some of the activity
stuff. It just there's and you've got,
you know, um RFK, um you know, talking
about wearables and CGM for everybody. I
mean, it's really I think there we're
starting to recognize just the the
benefits that could come from from
people more people using these
technologies to better understand their health.
health.
>> Wow. Yeah. I'm excited to see all of the
new things that come with Dexcom,
especially with this AI stuff and all
the biometrics and Aura Ring. I'm really
hopeful that I get to buy another one.
>> Awesome. You will you will have Aura
data connect with G7.
>> Okay. Thank you. Well, Jake, thank you
so much for coming on the show and
answering all these questions and and
just giving some transparency to all my
listeners. I know I know it means a lot.
>> Yeah, happy to. Yeah, really I really
enjoyed the time and appreciate you
having me on.
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