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  • 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.

Technology has transformed the way we do almost everything.

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