Technology has transformed the way
we do almost everything.
And it's finally
innovating diabetes management.
I know how much carbohydrate there is,
and based on that information, I can
pre-programmed this little machine to give
you the right amount of
insulin. Insulin pumps are
not a new invention.
They've been around since the 1960s.
And with the advancement in
technologies like continuous glucose monitors,
traditional pumps are evolving
into smarter devices.
But companies have been
slow to innovate them.
So slow that a community of
diabetics, including myself, learned how to
hack into old insulin pumps by
using instructions you can find online.
The DIY system, or Loop, as it's
called, works so well that thousands of
diabetics started using it despite the fact
that it wasn't approved by the
FDA and required you to
maintain the system yourself.
I felt like I was
looking at snake oil.
Like, honestly, it looks like one of
those weight loss ads where they say,
take one pill and you'll
lose seventy five pounds.
I said, there's no way this is true.
But I pursued it and it built on
my phone and I nearly fell apart crying.
After two days, it was a joy
because Loop is open source and doesn't
require FDA approval.
It has lots of features diabetics
can't get from the commercial systems.
We've talked to the DIY
community for a long time.
They have very good ideas and there's a
lot of things that we want to
Control-IQ. And that's useful and all that
that comes from them and we
plan to do that. I just
switch from Loop to Tandem's Control-IQ.
And after three months of using it, I
could say it's a real game changer
and that insulin pumps
are finally getting smarter.
Diabetes is becoming more
and more prevalent.
Thirty four point two million Americans
have some form of it.
That's one out of every 10 people,
roughly five percent or one point six
million have type one diabetes.
When you have type one, the
pancreas makes no insulin at all.
Type two can be managed in a
variety of ways, including diet, exercise and
medication. But a large number of the
type two population end up needing
to take insulin too.
Insulin gets injected with a
needle or through a pump.
Without insulin, blood sugar will
rise to unhealthy levels, causing
serious complications or even death.
Insulin pumps are meant to try and
mimic what a normal pancreas would do,
which is keep blood
sugars under tight control.
Right now, the insulin pump users in
the United States alone is between
350,000 - 500,000 people, depending on
where you get the data from.
That doesn't include 40 to 50000
people with type two diabetes .
Insulin pumps have come a long way.
The device was invented in 1963 and was so
big that it had to be worn as a
backpack. Over the past few decades,
they've gotten small enough to fit
into a pocket or stick
directly onto the body.
They hold up to three days of insulin
and use a needle to insert tubing
under the skin. Medtronic and Tandem are
tethered to the body with tubing.
Insulet's Omnipod is tubeless so it can
be placed directly on the skin and
uses a smartphone like
device as the controller.
But traditional pumps don't work
by simply putting them on.
They need information like what your blood
sugar level is and how many
carbohydrates you're eating.
Traditional insulin pumps do allow you
to program a drip of background
insulin all day, but the user needs
to do the rest of the work.
The size of the global insulin market
was just over four billion in 2019
and is projected to grow
over eight billion by 2027.
In the U.S., Medtronic, Tandem Diabetes
and Insulet dominate the market.
All three have been working
on hybrid closed loop systems.
Closed loop systems work like this.
A continuous glucose monitor sends blood
sugar data to the pump.
The pump uses an algorithm to target
a specific blood sugar range and
releases more or less insulin
to keep you on target.
It's hybrid because users still need to
tell it when and how many carbs
they eat. You can't just
set it and forget it.
Currently, only two systems
are commercially available.
Medtronic released the 670G in 2017
and Tandem just released Control-IQ.
I didn't know anybody would type one,
so I didn't have anybody telling me
what a great option it is.
Like, look, I'm giving myself insulin
by pressing these three buttons
instead of drawing up
an injection, okay?
That actually sounds amazing.
Managing diabetes with or without a
pump can be very difficult.
Diabetics need to keep their blood sugar
and as normal range as possible
to stay healthy and
help prevent complications.
The invention of continuous glucose
monitors changed the way people
interpreted and managed blood sugars.
CGM can read blood sugar levels every
one to five minutes, replacing the
need to constantly prick your finger.
The focus of a
system for several decades.
But decisions that really changed
not only diabetes outcomes, diabetes
care just by themselves,
stand alone, CGM.
But certainly as critical complement
to making the systems success.
Now that a continuous stream of blood
sugar data is available, the next
step is to create an
algorithm and close the loop.
Insulin pumps with hybrid closed loop
systems are targeting a specific
blood sugar value and then giving more
or less insulin based on the CGM
data. But allowing a computer to decide
how much insulin to deliver can be
a scary thing. Insulin can be very
dangerous if a diabetic takes too much
or doesn't get enough. The actual math
behind closing the loop is not that
difficult. It's the same math that
powers your thermostat, powers your
cruise control. What becomes interesting is
actually how you put all the
pieces of the system together, how
the pump particular pumps are
delivering insulin, how particular sensors
are measuring glucose, and then
how that algorithm takes all of
those particulars and brings them
together. You're balancing the time and
range and the safety profile.
And so it's that kind of secret sauce
on top of just a simple control
algorithm that you need to go through and
then be able to get the FDA
comfortable with to be able to get
approval for a hybrid sales system.
The journey to get here has
be en long, but very rewarding.
In 2010, 2011, we were doing inpatient
trials and those trials continue to
continue. It until the
final pivotal trial.
This past year, 2019, which gave
us Control-IQ as we know it.
Medtronic and Tandem are the only
commercial FDA approved systems on the
market. They come with less features
than loop, but are covered by
insurance and have the safety
approval of the FDA.
Tandem's Control-IQ is the latest
to win FDA approval.
The company says it has
155,000 using its pump technology.
It uses a touch screen, and when
the system has new features, you simply
update it over Wi-Fi rather than needing
to order a brand new pump.
Tandem stock has risen over 400
percent since June 21st, 2018.
After the FDA approved its
first automated software, Basil-IQ.
So our first
algorithms followed Basel-IQ.
It simply suspended insulin.
If the algorithm predicted that you were
going to go low and get
hypoglycemia. So that was our first
foray into devices that use
algorithms. This algorithms
was more sophisticated.
Both commercial systems can adjust
insulin rates every five minutes.
Control-IQ has taken the automation a
step further with a feature that
gives a bigger dose of insulin if it
sees that blood sugar is getting too
high. The technology is all designed to
reduce the burden of diabetes by
automating a lot of the decisions that
you would have to make yourself.
Medtronic's 670G came to
market in 2017.
It's one of the largest
device companies in the world.
In a report from 2019, many
users complained about technical difficulties
keeping the pump in auto mode,
referring to the hybrid closed looped
automated basal adjustments.
It also had to recall some of
the 670G'S due to incorrect insulin dosing
due to a faulty piece on the pump.
Despite these challenges, the company has
237,000 patients using the 670G
system, and results from a recent study
of its next system are showing
positive results. One suggestion for people
making that switch to the 670G
is to be really patient.
And then for us, auto
mode was never an issue.
Once we turned it on,
it was always on.
But when we heard about the Tandem
is really good from our doctor our
doctor who has type
one recommended it.
So I was still having high blood sugars, as
in the 300's a lot and I still
thought that it was so great.
She was like, let's try
this pump and it's amazing.
Gweneth Stewart has had type
one for 10 years.
She's tried every closed loop system
available, even Loop, and is now
using Tandem's Control-IQ.
The Medtronic sensor works
really well for me.
But the Dexcom was crazy, amazing when
we got back onto G 6.
And it was like even more accurate
than the Medtronic one was, which is
really crazy because the Medtronic one
worked really well for us.
Choosing between the two systems could
come down to the CGM.
Medtronic uses its Guardian sensor 3
and requires calibrations with a
blood glucose monitor.
Tandem uses Dexcom G 6 and
eventually Abbott's Freestyle Libre 2.
Neither of which require
finger stick calibrations.
But both FDA approved systems still
lacks features users want, including
personalized glucose targets and the
ability to remotely give insulin.
Two features that have been
available on Loop for years.
The system uses out of warranty Medtronic
pumps or Omnipod Eros Pods, an
iPhone app you must build yourself,
a riley link to bridge communications
from the pump to a phone and a CGM.
I used Loop for 18 months building the
app and maintaining it was a lot of
work and it lost
connection quite often.
But after two months of using it,
my blood sugar levels dropped down into
prediabetic levels and so it
was worth the inconvenience.
I think that Loop users in general
are people that all the traditional
commercial companies should go after.
We're not people who are
sitting around taking huge risks.
Katie DiSimone created Loop Docs, the
step-by-step instructions on how to
create the DIY Loop
app on your phone.
Her daughter Anna switched from Loop
to Tandem's Control-IQ and has been
comparing the outcomes online.
I think the commercial companies should
actually probably view loop users
as really a demographic that fits comfortably
if they do their job with
good commercial design. And I think
that Tandem's Control-IQ and the pub
that they have is really doing that.
And I do actually see a lot of Loop
users would be really well served by a
Control-IQ. Control IQ has given me really
great results and is less work
than Loop. For whatever reason, if the
pump breaks, I can just call up
Tandem and get a new one
because it's covered under a warranty.
Now, the one issue that I have had
with it is it loses connection with the
CGM sometimes. Tandem told me that
the Bluetooth to signal actually comes
out of the front glass
facing part of the pump.
So, for example, my CGM is on my
right arm on the side of the body.
And if I have the pump on this side
of the body with the glass facing out,
there is a risk that it'll
lose connection with the Dexcom.
The other thing that it's missing is
a mobile app that can control the
pump. Now, this was a feature that
Loop did have and it was really
awesome. Tandem expects to update their
app with this feature later this
year. I've never tried Medtronic 670G, so
I can't compare the two systems.
Before switching the Tandem, I used Medtronic
pumps for 19 years and have
always been happy with them.
Insurance companies cover pumps for four
years, meaning they won't cover
the costs of another system until the
warranty is up on the last one.
Adding a lot of pressure to make sure
you were signing up for the system
that will bring you the most benefit.
I was not provided a pump for the
making of this video and paid for it
using my own health insurance.
Without insurance, the tandem system and
three months of supplies would
have cost me over $8,000.
But with insurance, I paid $453.
Those costs don't include how much
I pay for the Dexcom sensors.
There are a lot of chronic diseases,
but very few that require 24/7
management such as type 1.
That is pretty unforgiving or
even a small disease.
For those of us using these systems,
having computers take over more of the
work doesn't just improve our health, but
it also gives us more time to
focus on normal life.
I think the biggest thing, it's
not really quantifiable, but her mental
piece. You know, she told me, like,
the amount of thought that has been
lifted from her shoulders
because of it.
It's like she didn't even know the
burden because it's just life, you
know, since she was nine.
And while these systems are light years
ahead of insulin pumps of the past,
there is still lots of room
for improvement, better user experiences and
more choices. The future for the
technology in this space is really
exciting. We do believe that it's possible
would get to a full closed loop
from a technology standpoint where, yes,
these devices are there, but then
there's no patient or action record
beyond getting those devices on.
Medtronic and Tandem j ust made
a surprising announcement that the two
companies are entering into a
non-exclusive patent cross license
agreement. Tandems says the agreement
is mutually beneficial and will
allow both companies to innovate more
freely and to make products quicker.
As far as more options, there are
lots of new systems in the works.
Medtronic 780G is expected this fall in
Europe but has yet to be approved
in the U.S. Tandem's t:sport
is due out in 2021.
This pump will be half the size of
its current model and we'll have the
option to be controlled by phone.
Also coming in 2021 is Insulet's Omnipod 5,
which will use a phone as the
controller and we'll be the
first tubeless closed loop system.
Tidepool is working on an
FDA approved version of Loop.
Not to mention a few other private
companies with systems of their own.
It's still a one size fits all of
these products that are coming onto the
market. It has to be adaptable to
personalize the ball to a person and
person's needs. And so there is
significant room to improve the algorithms
much, much further.
I feel so thankful that the pump will
be there helping me like a little
friend in my pocket,
just helping me out.
And like releasing me from some
of the burdens of diabetes.
