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**Beta_Bionics-Makers_of_the_Bionic_Pancreas.mp3** (5m 43s)
**11 speakers**
(Ethan, Speaker 2, Speaker 3, Speaker 4, Speaker 5, Speaker 6, Speaker 7,
Speaker 8, Speaker 9, Speaker 10, Speaker 11)

*[0:00:00]* **Ethan**: Hi. My name is Ethan, and I'm living with type 1
diabetes. One time, I was playing a sport, and it just hit me like a rock or
something, and I felt low. It was really hard. My vision started to blur. I
felt so weak. I know I was low, and there was nothing I could do to stop that
from happening. When my blood sugar's low, I feel tired, I'm weak, I have
blurry vision, and it's just a really miserable experience.

*[0:00:06]* **Speaker 2**: To be a type 1 diabetic requires constant care.
You're constantly managing it, worrying about it, and thinking about it.
There's nothing you do without thinking about diabetes.

*[0:00:08]* **Speaker 3**: Right now, the pump that I'm wearing doesn't make
any decisions for me. I check my own blood sugar. I put that into the pump. I
carb count. I put the number of carbs into the pump. The pump is set to
calculate a dosage based on settings that I give it.

*[0:00:12]* **Speaker 2**: The margin for error is very slim. You can even do
the exact same thing today that was very successful for you yesterday, and it
can have bad results today. Your blood sugar can be sky high or drop severely
low, and we don't understand why.

*[0:00:16]* **Speaker 4**: I'd like to introduce the first fully-automated,
stand-alone bionic pancreas, and we're calling it the iLet. This is the bionic
pancreas that we've been all striving to develop all these years. Ultimately,
what we've come down to is a platform, a medical device platform that
automatically controls blood sugar. It's a completely stand-alone device. It
does not depend upon a smartphone technology.

*[0:00:21]* **Speaker 5**: The way it works is it loops every five minutes by
grabbing glucose data from a continuous glucose monitor that the patient wears
on their skin, takes that information, makes a therapeutic decision using the
control algorithm that is embedded in, and computes how much insulin and/or
glucagon to dose, and then infuses those doses through a tubing assembly that
terminates in a needle site, also worn under the skin. That goes on
relentlessly and continuously, once every five minutes.

*[0:00:27]* **Speaker 6**: I've been watching it develop for 14 years now,
starting out in pig studies, and now it's on real children. I just feel so
confident that this thing works. This little bionic pancreas will be available
for everybody's child.

*[0:00:30]* **Speaker 4**: The bionic pancreas allows people to be spontaneous,
to be as physically active whenever and as often as they want, to eat whenever
they want. Basically, to keep diabetes from interfering with their life.

*[0:00:33]* **Speaker 5**: This is not an incremental change. This is really a
fully autonomous system that, in my opinion, takes it to the top level short of
a cure. This is the best you can do because, like I explained, with this
device, the patients not only not need to worry about their insulin doses, they
don't even have to appreciate how much insulin this device is getting.

*[0:00:38]* **Speaker 3**: Well, the first time that I wore the bionic pancreas
... It's an incredible feeling, really. It's knowing that it's possible to have
blood glucose that's what it should be all the time. My control for that one
week, and then the seven weeks that I did last year ... My control was better
than I've ever been able to get on my own in 15 years.

*[0:00:43]* **Speaker 6**: For parents, the iLet is a dream come true, one step
short of a cure, in that it can be there with him, monitoring his blood sugar
and treating it constantly, around the clock, which we can't be.

*[0:00:46]* **Ethan**: When I was on the bionic pancreas trial, I didn't know
that I was on it. It almost seemed like I was a normal person again, without
diabetes. I didn't have any illness or disease in any form. I didn't have to do
any of the work that a diabetic has to do. I was a normal kid again. It was
incredible.

*[0:00:51]* **Speaker 4**: Beta Bionics is a Massachusetts public benefit
corporation. It allows us to put the needs of our community in front of
shareholder interest and allows us to make decisions in a way that's ultimately
best for the patient.

*[0:00:54]* **Speaker 7**: For the first time in over 80 years, the United
States ... You can own a piece of a company that is not publicly traded through
their platform.

*[0:00:56]* **Speaker 8**: I think it's amazing that by simply going to
wefunder.com and find the Beta Bionics profile, you can click "invest" and
literally be part of something that could change the life of millions of kids
with type 1 diabetes.

*[0:00:59]* **Speaker 9**: As parents and loved ones of people living with type
1 diabetes, we often feel hopeless and out of control. This crowd funding
offering gives you a chance to say that you contributed to the cause and you
helped us bring this amazing technology to market.

*[0:01:03]* **Speaker 10**: Beta Bionics is like a perfect example of why I
founded this company. I wanted to support really important things. Venture
capitalists really don't invest in long-term things, but a community of people
who really care about diabetes will invest in it, and that's kind of the impact
I want to have on this world.

*[0:01:07]* **Speaker 11**: To those people who believe in the vision that we
can build a better technology for our loved ones with type 1 diabetes, who want
to help us build a bridge to a biological cure, and these are the investors
we're looking for. These are

*[0:01:10]* **Speaker 11**: the partners we want to move this technology
forward.

*[0:01:11]*






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**NPR Father Devises A 'Bionic Pancreas' To Help Son With Diabetes**

LINDA WERTHEIMER, HOST:

It's MORNING EDITION from NPR News. I'm Linda Wertheimer.

RENEE MONTAGNE, HOST:

And I'm Renee Montagne. Today in Your Health, one man's quest to protect his
son. The New England Journal of Medicine reports that his experimental device,
a bionic pancreas to automatically control blood sugar for people with Type 1
diabetes, appears to be working. NPR's Rob Stein has the story.

ROB STEIN, BYLINE: When I started working on this story, I knew life could be
hard for people with diabetes. But I didn't really get how hard until Ed
Damiano invited me into his home. Ed lives on a quiet cul-de-sac in a pretty
little town outside Boston. It's the middle of the night. I'm camped out in his
living room.  Ed and his family are all asleep upstairs. An alarm goes off on
Ed's nightstand.  He jumps out of bed and I run upstairs. Ed's son, David, is
asleep in the room next door.

STEIN: So what just happened?

ED DAMIANO: So David's alarm went off.

STEIN: David has Type 1 diabetes, so he sleeps hooked up to a monitor that goes
off when his blood sugar gets too low.

E. DAMIANO: It suggests that he's very, very low.

STEIN: Why are you worried about that. What's the danger?

E. DAMIANO: So the danger there is that there's a syndrome called dead-in-bed
syndrome.

STEIN: Dead-in-bed syndrome. Some diabetics go to sleep and just never wake up.
It's rare, but it does happen.

E. DAMIANO: The fear is that there's going to be this little cold limb and I
screwed up. And that's quite a screw-up. You know, I mean, that' - it's all on
me.

STEIN: OK so you're going to go into his room right now?

E. DAMIANO: Yep.

STEIN: OK.

STEIN: We tiptoe into his son's room. David, he's 15. He's sprawled out on the
bed. His father reaches for his hand. David's warm. He's OK. We slip out of the
room. David's still sleeping.

E. DAMIANO: That's the moment of relief, right?

STEIN: Ed Damiano's been doing this night after night, sometimes several times
a night since David was diagnosed 14 years ago.

STEIN: You do this every night?

E. DAMIANO: It became a new routine of my life 14 years ago - my new normal.

STEIN: But Ed knows he can't keep this up forever. In just a few years, David's
going off to college. What then? So Ed, who is a biomedical engineer, decided
to invent something to watch over his son - something he calls a bionic
pancreas.

TOBY DAMIANO: David? Are you awake? You are.

STEIN: The next morning, Ed and his wife, Toby, seem like any other parents
rushing to get their kids, David and his sister Emily, off to school.

T. DAMIANO: Bye, honey.

STEIN: After they're gone, they explain how all this started.

T. DAMIANO: So Davey was 11 months old. He was starting to walk. He was pushing
a push wagon. And then he stopped doing it.

STEIN: He stopped trying to walk, stopped eating, got weaker and weaker. Toby
took her son to the doctor. Turned out, his pancreas didn't make insulin so the
sugar in his blood was poisoning his body. She realized he was facing a long
list of terrible complications later in life - blindness, amputations, heart
attacks. She rushed him to the hospital.

T. DAMIANO: I crawled into that hospital crib with my son and I held him. And
he got stuck and pricked and, you know, I knew how much work we were going to
have to do to keep him safe and I knew the consequences of not doing a good
job.

STEIN: Toby's a pediatrician. She and Ed made themselves into experts about
diabetes. And Ed became a 24/7 walking blood sugar monitor.

E. DAMIANO: It's now 1:20 a.m.

STEIN: Even pricking David's finger in his sleep to test him, giving him
insulin when his blood sugar's too high and getting him to sip juice without
waking up when he's too low.

E. DAMIANO: David is sleeping soundly.

STEIN: But even Ed, watching him so closely, couldn't become a human pancreas.

E. DAMIANO: It's intimidating when you start considering the list of things
that influences blood sugar - I mean, emotions and physical activity, if you're
healthy, if you're under the weather. You can't possibly take into account and
balance all those things. And you sometimes get it right and you often get it
wrong.

STEIN: Ed became convinced there must be a better way and that he could find
it.  So he essentially switched careers from writing esoteric papers about
mathematics to developing a bionic pancreas at Boston University.

E. DAMIANO: A bionic pancreas is a device that automatically takes care of your
blood sugars 24/7. It's a device that basically comes to know you. And it's the
next best thing to a cure.

STEIN: That's a pretty bold statement. But Ed's clearly a confident guy and he
tells me he doesn't let doubts get in his way. There's lots of other people out
there working on something like this, but his gizmo is one of the most
advanced.  At the moment, it's basically a really, really smart app.

E. DAMIANO: The current incarnation of our system runs on an iPhone and that
iPhone is connected to a continuous blood sugar monitor.

STEIN: A monitor that some diabetics already wear taped to their bellies. They
look kind of like a small pager.

E. DAMIANO: And it wirelessly talked to two pumps - one filled with insulin...

STEIN: Which lowers blood sugar.

E. DAMIANO: ...And one filled with glucagon.

STEIN: Glucagon - another hormone which raises blood sugar. For the person
using the app, it constantly crunches the numbers from the monitor to tell the
pumps how much insulin or glucagon to infuse through tiny tubes inserted under
their skin.

E. DAMIANO: It's life-transformative, not having to think about their diabetes
anymore. OK, it's a total game-changer.

STEIN: And it looks like it's working. In the New England Journal of Medicine,
Ed and his colleagues reported his bionic pancreas did great on 52 teens and
adults. And Ed's got the go-ahead to let volunteers use it on their own for the
first time.

STEIN: Ed's clearly psyched when he meets his volunteers at the Massachusetts
General Hospital in downtown Boston.

E. DAMIANO: It's fun to just be in the, you know, in the heat of the moment.
(Laughing).

STEIN: His team's getting ready to hook up the volunteers.

ARIANA KOSTER: I'm Ariana. I am 23 years old.

STEIN: Ariana Koster's been struggling with diabetes since she was 11. She
can't wait.

KOSTER: It's very, very exciting. This thing is going to take the worries about
my blood sugar off my hands for a few days.

STEIN: Ed's team explains how the bionic pancreas works, helps Ariana set it
all up.

KOSTER: All right, insulin is loaded.

STEIN: And starts counting down...

KOSTER: Ten, nine, eight...

STEIN: ...To the moment when they'll switch on her bionic pancreas.

(APPLAUSE)

E. DAMIANO: You guys are bionic.

KOSTER: I'm a bionic woman.

STEIN: Back at Ed's house that night, he's watching his volunteers' sugar in
real time on his iPad mini. He pulls up Ariana's numbers.

E. DAMIANO: There it is.

STEIN: The bionic pancreas is literally making life-and-death decisions for
her.

E. DAMIANO: Oh it's amazing, right? I'm blown away by these numbers. I'm so
reassured by these numbers.

STEIN: But things didn't go as well for his son David that day. He doesn't have
the bionic pancreas yet.

E. DAMIANO: You went to class with your pump, where? In the locker room?

DAVID DAMIANO: In my backpack.

E. DAMIANO: You forgot to connect it?

D. DAMIANO: Yes. You want to record this?

E. DAMIANO: Yes, I definitely want to record that. The teenage brain.

STEIN: They're laughing, but this is just the kind of thing that terrifies Ed
and Toby. It won't be long before David goes off to college and Ed's not there
to make sure he's okay.

E. DAMIANO: I mean, we could just get a phone call from the dean of students
one day.

T. DAMIANO: Your son is dead. He's in his room. We don't know anything. OK? And
I know what happened. He overdosed on insulin by accident. I raised this
precious person for 20 years and he died for some stupid mistake.

STEIN: David knows he has to work harder at taking care of himself, but he's
confident his dad's bionic pancreas will be ready in time.

D. DAMIANO: My whole life I've just known - just had this knowledge that my dad
is going to have this bionic pancreas out when I go to college.

STEIN: Are you kind of figuring he's going to make it?

D. DAMIANO: Yeah I'm confident in him. He works really hard - really hard.

KOSTER: Maybe I'll bring you cookies.

E. DAMIANO: Two-thirty in the morning.

STEIN: By the end of the week, it's time for Ed to check in with Ariana and the
other volunteers.

KOSTER: I can already see how awesome it is.

STEIN: For the first time in forever, Ariana's not obsessing over her blood
sugar. She even snuck a cookie that night.

KOSTER: Oh, it's amazing. It's going to change my life.

STEIN: The next round of testing starts this afternoon. Ariana, and dozens of
other volunteers around the country, including some kids at camp this summer,
are trying it for even longer. Ed hopes that will help prove his bionic
pancreas works just in time for David's first night alone in his dorm room. Rob
Stein, NPR News.

MONTAGNE: And you're listening to MORNING EDITION from NPR News.

Copyright  2014 NPR. All rights reserved. Visit our website terms of use and
permissions pages at www.npr.org for further information.

NPR transcripts are created on a rush deadline by Verb8tm, Inc., an NPR
contractor, and produced using a proprietary transcription process developed
with NPR. This text may not be in its final form and may be updated or revised
in the future. Accuracy and availability may vary. The authoritative record of
NPR's programming is the audio record.



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**Summer_Camp_2013_Helmsley.mp3** (5m 36s)
**5 speakers**
(Announcer, Male, Female, Group of voices, Grandson)

*[0:00:00]* **Announcer**: This is one of the most advanced laboratories in the
world. These are the test subjects and these are the most grueling tests that
we could design. What is happening at these camps is an outpatient trial of an
innovative technology in the early stages of development that could really
change the game for people with type 1 diabetes.

*[0:00:04]* **Male**: Type 1 diabetes is a condition in which the pancreas
stops making insulin which is a hormone that lowers blood sugar and when this
happens, people with type 1 diabetes have to manage their blood sugar manually
so they need to check their blood sugar frequently by pricking their skin and
they need to give themselves doses of insulin either with an insulin pump or a
needle. The challenge is to maintain near normal blood sugar levels, but while
at the same time minimizing the exposure to very low blood sugars which are
acutely dangerous. To have to think about he amount of glucose in your blood
day in and day out, hour after hour after hour is an absurd and impossible
task. It is the only disease that I know of that you're making dosing decisions
with a medicine that can kill you if you get it wrong and you're doing those
decisions 24-7.  We're trying to build a system that as much as possible does
not require the person with diabetes to even know what their blood sugars are.

*[0:00:18]* **Female**: This is my bionic pancreas, but we have a name for it.
It's called the bio pancky to keep it more fun because diabetes can be fun.

*[0:00:20]* **Male**: I call it the fancreas, the fake pancreas. The front of
it is an iPhone that runs the software that they design and the back of it is a
continuous glucose monitor. The bionic pancreas takes a measurement of blood
sugar every five minutes and then makes a decision without involving the person
with diabetes in that decision about how much insulin or glucagon to give,
regulating their blood sugar 24 hours a day. Including at night when they're
sleeping or when they're distracted. The T1D program of the Helmsley Charitable
Trust aims to accelerate the development of tools and devices to ease the
burden of living with T1D. One of the important roles at the trust is to
facilitate collaboration amongst grantees across the T1D landscape and the
bionic pancreas study is a great example of that. It's bringing together an
exciting new technology and development with the great work that's being done
at these camps.

*[0:00:32]* **Female**: This camp, specifically Clara Barton Camp, is for young
woman and the Joslin Camp is for young boys and all together we make up the
Barton Organization for Diabetes Education. We're trying to make people live
well with diabetes. Firsts are a really big deal here so we make a big
announcement in the dining halls, so and so did their shot in their leg for the
first time. So and so did this or that. Kids can just sort of be kids.

*[0:00:38]* **Male**: Okay folks. We're about to start the bionic pancreas on
eight girls. Eight of you are on usual care this week, and the other eight are
on flows with control and you'll be completely controlled by the device for the
next five days. Is everybody ready?

*[0:00:42]* **Group of voices**: Yes. 9-8-7-6-5-4-3-2-1. Go.

*[0:00:43]* **Male**: Okay guys. We've got eight bionic girls here for the next
five days. There's really no better environment to test this device in and
adolescent population than in a diabetes camp setting. They're very, very
physically active so they give lots of challenges to the system that you
wouldn't see in many other settings. Looking at the performance of the device
in the first week has been very encouraging.

*[0:00:48]* **Female**: This system really gets to know your body and my blood
sugars have been great. I think my average for the day I think is 120 which is
really, really good. I love it a lot because my blood sugar's been really good.
Average is 130. If I'm out and playing like at sports I tend to go low, but if
I had like a bio pancreas it would like treat me so I could keep playing. It's
just a dream I guess until they have a cure.

*[0:00:56]* **Grandson **: My daughter was diagnosed March 23, 2007. She was 6
years old. Five months later my grandmother Leona Helmsley died and I became a
trustee of a very large trust. As I did diligence, it became very clear to me
that this was more about everyone living with type 1 and not just my daughter.
We had the wherewithal and the ability to actually have a significant impact on
this disease. Our major goal because we fully recognize the cure's not
happening any time soon, is to ease the burden of managing this disease. This
technology would not only ease the burden it would have an absolutely dramatic
effect on outcomes.

*[0:01:04]* **Male**: I really do firmly believe that we have a lot of good
reason to hope

*[0:01:05]* **Male**: that this technology will provide the bridge that we need
to get to a cure.

*[0:01:06]*



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**Beta_Bionics_-_Ted_Talk.mp3** (18m 5s)
**1 speaker**
(Speaker 1)

*[0:00:04]* **Speaker 1**: Imagine for a moment if you are the parent of a
child with a chronic illness and the medicine that you give that child every
night could kill him if you get the dose wrong, just a little bit . Now imagine
for a moment that the dose that you gave him yesterday that worked doesn't work
today for some reason. Imagine that you have to worry about this every single
day for the rest of your child's life. Finally, imagine that you have to send
that child off to college one day and the full burden of that responsibility
falls on your child's shoulders and the worry of that child being able to get
up and take on a new day was always ever in your mind. If you could imagine all
of that, then you can image what it is to be a parent of a child with Type I
Diabetes. About 15 years ago, my wife Toby who had been a practicing
pediatrician at the time for just a year diagnosed our son David with Type I
Diabetes who's only 11 months old at the time. He nevertheless had this
constant burden that he had to deal with and would have to deal with for as
long as he had Diabetes, which potentially is the rest of his life. I think of
everybody with Type I Diabetes as being either the boy or girl who lived. That
first night when David was diagnosed, I can remember my wife crawled into the
crib. It was really a small hospital bed in the ICU and she curled herself
around his tiny self. While I really didn't know or appreciate what life had in
store for us after that, all I could really remember, the thought that came to
mind was that really the only difference between nightmare and reality is that
reality lasts longer. It was a pretty scary moment. Not too long after that, I
began to think about a way in which I might be able to help build a technology
or at least contribute in some way to building a technology that could
automatically take care of David's blood sugar levels so that he wouldn't have
to. Now, my background was in applied mathematics. I used to study the way
biological systems worked and I used mathematics as a principle tool to do
that. It turns out that while I didn't think I could find a cure for Type I
Diabetes, those weren't my skill sets, I did think I had the skill sets that I
could lend to this problem of building this automated technology. What really
began as essentially a research project ... It was really a hobby at first. It
then grew into a research project.  Ultimately, it turned into an all consuming
determined effort to build an automated glucose control system, a bionic
pancreas that would take care of David by the time he goes off to college in
just 27 months, not that I'm counting. I had no idea really what all of that
would entail when I took this on. I think what we need to do first is just step
back and talk about what is Type I Diabetes. Type I Diabetes is an autoimmune
disorder and it's an autoimmune disorder in which a person's T cells perversely
attack the insulin producing beta cells in the pancreas leaving them deplete of
any insulin. What does that mean? It turns out that insulin itself is extremely
important for glucose regulation. What it does is it shuttles glucose sugar
from the blood into fat and muscle cells where they can use them for energy and
storage. What happens when someone has Diabetes and they don't have insulin
anymore prior to the discovery of insulin, people would be diagnosed with Type
I Diabetes and they would begin to waste away. They would ultimately become
catabolic and very lethal ketones would build up in their blood and they would
ultimately be poisoned and die. It was essentially a death sentence. A
diagnosis of Type I Diabetes was a worse diagnosis than cancer at the time. It
turns out that when this was discovered, people survived a diagnosis of Type I
Diabetes but ultimately they needed to manage their blood sugars in such a way
as to stave off the long term complications. This wasn't known for decades. It
wasn't understood what was happening. People were surviving diagnosis but they
were suffering from long term chronic complications of Diabetes. These include
heart disease, stroke, blindness. It's a very dangerous, long, scary list of
complications. People's lives were plagued with morbidity and their life spans
were shortened dramatically for decades after insulin therapy. It wasn't until
about 70 years later that people started to ... clinical research scientists
began to realize what was going on here. They conducted a trial, a seminal
study called the diabetes control and complications trial in which they looked
at whether or not lowering your blood sugar levels could stave off long term
complications of type I diabetes or at least reduce them. It turns out that's
exactly what they showed. In a 10 year long study, they were able to discover
that if you could lower average blood sugar levels in people with type I, you
could stave off the long term complications and they could live healthier lives
with less morbidity. That was all well and good but it turns out there was a
catch. The catch was that while you could stave off long term complications
with good insulin therapy, the problem was that if you overdosed insulin just a
little bit, you could kill people. You could have what's called hypoglycemia.
Insulin is a very dangerous substance. It's got a very high toxicity index and
a very narrow therapeutic range. What that means really is that a slight
overdose of insulin can be lethal. It turns out while we were trying our best
to bring people's average blood sugars down, we were finding that in those
people that were achieving those goals for therapy, they were suffering from
hypoglycemia, low blood sugar levels. Severe hypoglycemia could be deadly. In
fact, if you had severe hypoglycemia at nighttime, you might in fact never wake
up. It's called dead in bed syndrome and it's one of the scariest concerns of
people with type I diabetes and parents of children with type I diabetes. It
really is literally keeping people up at night. We would check David's blood
sugar levels one, two, three times a night every night, sometimes more,
sometimes less. You have to do this to make sure that your child is safe at
night because if you give him a little bit too much insulin, he may never wake
up. In David's case, we would give him a little bit of insulin if his blood
sugar was high, give him a little bit of juice if his blood sugar was low, and
he would sleep through all of this by the way. He would never wake up to this.
We'd give him a little straw and he'd suck it down sound asleep, after all, he
was only an infant when he was diagnosed. He was nursing at the time, so he
just continues that reflex. The reality is that while that is a blessing, it is
a tremendously scary prospect when he heads off to college because he doesn't
wake up to alarms. He doesn't wake up to hypoglycemia. Whereas some people do,
he doesn't. The worry is what happens when David heads off to college. Whereas
the DCCT, this DCCT trial showed us that we need to maintain as tight a blood
glucose control without hypoglycemia. It also showed us in the 20 years since
them that we don't have the tools to prevent, we really just don't have the
tools necessary to achieve those glycemic levels. What's happening instead is
people are running high blood sugar levels or they're suffering from severe
hypoglycemia. As we'll see in a moment, the standard of care in the US today is
not meeting for therapy. People are running around with high blood sugar
levels, about twice the normal average.  These are leading to all these
complications I was telling you about. The task is clear: maintain your blood
sugar levels as near to the normal range as possible without hypoglycemia but
the tools are not up to the task. What we need is a new tool. Until quite
recently, the tools that we had at our disposal were really anemic. The medical
device industry in diabetes and the insulin, the pharmaceutical industries in
diabetes really were not innovating. Quite recently, they've started to make
tremendous progress and we've leveraged that progress and integrated it with
our bionic pancreas to build a synergistic system that automatically regulates
blood sugar in type I diabetes to levels that are really quite close to the
normal range and that stave off hypoglycemia.  What started with a clumsy
cobbling together of a laptop with glucose sensors and pumps, which we used in
our first studies, turned into a slightly more elegant albeit still somewhat
clumsy iPhone mobile system where all our systems ran on the iPhone and
controlled wirelessly to pumps and also received glucose levels from a censor.
This device allowed us to do outpatient studies. What we've done since then is
to build a much more elegant package. We've built a true medical device that
integrates all of these pieces into one single device.  We call this device the
. The iLet is a single handheld unit that has both insulin and glucagon.
Insulin as I was telling you is a hormone that lowers blood sugar levels.
Glucagon counters that. It's a hormone also secreted by the pancreas that
raises blood sugar. These things act in counter to one another.  The iLet
consists of three components. It's got a continuous glucose sensor which is a
body worn sensor you change roughly once a week and it sends glucose levels
wirelessly to the device. It has in it all these mathematical algorithms that
we developed which make therapeutic decisions to determine how much insulin and
glucagon to deliver every five minutes. Then, it controls two built in pumps,
one to deliver insulin and one to deliver glucagon through tiny tubes that come
out of the bottom of the device and connect through little thin catheters that
are placed under your skin. It has about a week's supply of drug.  This device
you can put in your pocket. It's about the size of an iPhone about twice as
thick. It truly takes over diabetes management. It's a turnkey solution for
type I diabetes. You type in your weight and it automatically begins adapting
to your ever changing insulin needs. With our device, we've studied subjects in
out patient studies over the past two years, the iPhone system, the predecessor
to this one, in people six years old and as old as 76 years old, and people
weighing 47 pounds and as large as 288 pounds. People have had diagnosis for
one year and as much as 45 years. The bionic pancreas doesn't discriminate
against age, it doesn't discriminate against gender, against race, or even how
well or poorly you manage your blood sugar levels on your own. Really to make
this point clear, I'd like to show you an example of how well this device works
in just one of our subjects. This is an anecdotal example but I think it really
gives you a sense of how powerful this tool is in helping people manage their
blood sugars. What you see here is the average daily blood sugar levels of one
subject with type I diabetes. You can see all 11 days wearing her own insulin
pump, taking care of her own diabetes. She's not on the bionic pancreas. You
can see that the goal for therapy, which is this green shaded region, is not
being achieved day or night. She's well away from the goal for therapy every
single day and every single night on her own care. I choose this example
because this is how people take care of themselves out there. This is quite
typical of the national average of type I diabetes in this country. This is not
far off from what people do day in and day out in this country with the tools
we have for them today. Notice also how much variability there is from day to
day. Blood sugar control is totally capricious when it comes to self managed
diabetes care.  Now look what happens when the person wears the bionic pancreas
for 11 days.  Notice how little variability there is. Every day she's in target
range. Every night she's in target range. Notice how little variability there
is from day to day. I would like to emphasize that when she's on her own pump,
when she's taking care of her own diabetes, she's working hard to get this
result. This is not coming easy to her. When she's on the bionic pancreas,
she's not thinking about her diabetes anymore. She's not worrying about her
blood sugar levels. The bionic pancreas takes that over for her. She can be
spontaneous again. She can exercise at will, as much as she wants, as little as
she wants. She can eat whenever and whatever she wants. The bionic pancreas
truly is a game changing technology. I just want to close with a couple of
comments. For one thing, the bionic pancreas is truly an innovative technology
unlike anything we've seen since the discovery and purification of insulin. It
solves four of the leading concerns in type I diabetes management. It brings
average glucose levels down in everyone to levels that would stave off all long
term complications. It controls hypoglycemia and prevents even mild
hypoglycemia and likely completely eradicates severe hypoglycemia in everyone.
It unburdens people of the stress of taking care of diabetes, of the effort and
the relentless need to comply with therapy. After all, the bionic pancreas is
the first technology to comply with the patient rather than the other way
around. Finally, the bionic pancreas unburdens people of the emotional stress,
of the fear of hypoglycemia and the worry and dread of long term, chronic
complications. I'd like to just make the comment about David now. David is a
teenage boy. He just sent me a text yesterday that he's just gotten his permit
and now he is driving or will be soon. I was a teenage boy. I know whereof I
speak. Teenage boys are not human.  Teenage boys are highly complex,
multi-cellular organisms at best. They're a disconnected mass of excitable
cells but they're a danger to themselves as I was many times over again. David
once nearly stabbed himself with a toothbrush.  Imagine that for just a moment.
All of the worries and the fear of type I diabetes and we almost lost him to
stabbing, self stabbing by a toothbrush. This is a blunt instrument. How that
could happen, I'll get into that another time.  The fact is that David
literally pierced the back of his throat by brushing his teeth. Dental hygiene
is extremely dangerous among teenage boys as is diabetes, maybe more so. My
wife rushed him to Boston Children's Hospital where one fellow after another
looked at this perplexing problem, had no idea what to do. They did a CT of the
head and neck and then finally the attending physician comes in and says
there's a 95% chance you didn't lacerate the carotid artery. He shouldn't bleed
out on the way home. David has done fine since then. I would just like to
finish by pointing out that I believe that David is in good hands as long as
he's with us. He's well taken care of. Basically, I feel like he's safe we've
taken care of him to infancy through toddler hood through adolescence, the
whole arc of his young life. I feel like as long as he's with us, he's safe but
the worry is when he leaves home, when he's on his own, when he's in college
and he's got to check those blood sugars at night. Will he wake up at night?
Will he wake up to see another day? We cannot, we must not get that phone call.
If I leave you with anything tonight, it is with this appreciation for the true
risk that is type I diabetes, for this reality, the reality we're trying to
change. The point here is that the bionic pancreas is not a cure.  People with
type I diabetes have been told literally for decades that the cure is but five
years away decade after decade after decade. I can tell you with great sadness
that there is no cure in five years and there's not likely to be one in 10. The
bionic pancreas is no cure but it is a bridge to a cure. The bionic pancreas is
a sturdy bridge to a cure. It is the ever extendable bridge to the ever elusive
cure.

*[0:18:01]* **Speaker 1**: I thank you all very much.

*[0:18:02]*




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**Report_and_update_on_Elise_and_the_Bionic_Pancreas.mp3** (2m 44s)
**6 speakers**
(Speaker 1, Speaker 2, Speaker 3, Speaker 4, Speaker 5, Speaker 6)

*[0:00:00]* **Speaker 1**: It's not a cure for juvenile diabetes but many
parents are calling the bionic pancreas the next best thing, and now a north
Texas 6 year old is helping perfect it. CBS 11's Robbie Owens has the story
from Grapevine.

*[0:00:03]* **Speaker 2**: At 6, Elysse is an adorable, happy little girl, but
keeping her healthy is a 24/7 affair.

*[0:00:05]* **Speaker 3**: At around or midnight, and then we check her again
at 3 A.M., and those are just 2 checks, assuming everything is good, so if
things are not good, there's many more checks throughout the night.

*[0:00:08]* **Speaker 2**: Just days after her first birthday, Elysse was
diagnosed as a type 1 diabetic.

*[0:00:09]* **Speaker 4**: What I knew about diabetes scared me, and she was a
baby, so I was thinking, "How am I going to do this?"

*[0:00:11]* **Speaker 3**: One of us would hold her down while she screamed and
the other one would give her the shots. Luckily she doesn't remember that.

*[0:00:13]* **Speaker 2**: The diagnosis turned the Kunyas into instant
activists, mobilizing teams around the world for fundraising walk.

*[0:00:15]* **Speaker 5**: It's sometimes hard and not fair. I just don't like
diabetes.

*[0:00:16]* **Speaker 2**: So the brave 6 year old will soon take part in
clinical trials for what's being called the next best thing to a cure, the
bionic pancreas.

*[0:00:18]* **Speaker 3**: This is a game changer.

*[0:00:19]* **Speaker 2**: The revolutionary device not only monitors blood
sugar levels but automatically dispenses the correct amount of insulin when
sugar levels are too high, or glucagon when levels are too low.

*[0:00:21]* **Speaker 4**: I got to hold it. I got to see it actually work.

*[0:00:22]* **Speaker 3**: There's all these things that we have to think
about, and then the bionic pancreas basically just does all the thinking for
you.

*[0:00:24]* **Speaker 2**: Elysse will participate in the trial during a 2 week
stay at a camp for diabetic kids, and while mom admits to more than a little
separation anxiety, she's letting her go now in the hope that her burden will
be lighter when she has to let her go for good.

*[0:00:28]* **Speaker 4**: It is all on them to take care of themselves, and it
is exhausting. I mean, it is exhausting, and if we can take some of that away
from her where it's not such a burden, that would mean everything to me.

*[0:00:31]* **Speaker 2**: In Grapevine, Robbie Owens. CBS 11 News.

*[0:00:32]* **Speaker 6**: The family of a 6 year old diabetic girl says she's
doing great in a first of its kind clinical trial. We introduced you to Elysse
Kunya on Friday. Doctors have now fitted her with something they call a bionic
pancreas. Helps control her type 1 diabetes. She is participating in this
clinical trial. Some doctors are already calling this the next best thing to a
cure. It's a bionic pancreas. It will test and

*[0:00:37]* **Speaker 6**: maintain her blood sugar levels without any finger
pricks or any shots whatsoever.

*[0:00:38]*