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.