[Senate Hearing 115-469]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 115-469

                   PROGRESS TOWARD A CURE FOR TYPE I
                       DIABETES: RESEARCH AND THE
                          ARTIFICIAL PANCREAS

=======================================================================

                                HEARING

                               BEFORE THE

                       SPECIAL COMMITTEE ON AGING

                          UNITED STATES SENATE

                     ONE HUNDRED FIFTEENTH CONGRESS


                             FIRST SESSION

                               __________

                             WASHINGTON, DC

                               __________

                             JULY 26, 2017

                               __________

                            Serial No. 115-8

         Printed for the use of the Special Committee on Aging
         
         
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                       SPECIAL COMMITTEE ON AGING

                   SUSAN M. COLLINS, Maine, Chairman

ORRIN G. HATCH, Utah                 ROBERT P. CASEY, JR., Pennsylvania
JEFF FLAKE, Arizona                  BILL NELSON, Florida
TIM SCOTT, South Carolina            SHELDON WHITEHOUSE, Rhode Island
THOM TILLIS, North Carolina          KIRSTEN E. GILLIBRAND, New York
BOB CORKER, Tennessee                RICHARD BLUMENTHAL, Connecticut
RICHARD BURR, North Carolina         JOE DONNELLY, Indiana
MARCO RUBIO, Florida                 ELIZABETH WARREN, Massachusetts
DEB FISCHER, Nebraska                CATHERINE CORTEZ MASTO, Nevada


                              ---------- 
                              
                 Kevin Kelley, Majority Staff Director
                  Kate Mevis, Minority Staff Director
                                
                                
                                CONTENTS

                              ----------                              

                                                                   Page

Opening Statement of Senator Susan M. Collins, Chairman..........     1
Statement of Senator Robert P. Casey, Jr., Ranking Member........     3

                           PANEL OF WITNESSES

Paul Sparks, Actor, New York, New York...........................     5
Griffin P. Rodgers, M.D., M.A.C.P., Director of the National 
  Institute of Diabetes and Digestive and Kidney Diseases, 
  National Institutes of Health, U.S. Department of Health And 
  Human Services.................................................     7
Charlie Albair, JDRF 2017 Children's Congress Delegate, Gray, 
  Maine..........................................................    10
Lorynn Watt, JDRF 2017 Children's Congress Delegate, Stroudsburg, 
  Pennsylvania...................................................    11
Angie Platt, Chair Mom of the JDRF 2017 Children's Congress, 
  accompanied by her son, Jonathan Platt, Encino, California.....    12

                                APPENDIX
                      Prepared Witness Statements

Paul Sparks, Actor, New York, New York...........................    28
Griffin P. Rodgers, M.D., M.A.C.P., Director of the National 
  Institute of Diabetes and Digestive and Kidney Diseases, 
  National Institutes of Health, U.S. Department of Health And 
  Human Services.................................................    29
Charlie Albair, JDRF 2017 Children's Congress Delegate, Gray, 
  Maine..........................................................    42
Lorynn Watt, JDRF 2017 Children's Congress Delegate, Stroudsburg, 
  Pennsylvania...................................................    42
Angie Platt, Chair Mom of the JDRF 2017 Children's Congress, 
  accompanied by her son, Jonathan Platt, Encino, California.....    43

 
                       PROGRESS TOWARD A CURE FOR
                     TYPE I DIABETES: RESEARCH AND
                        THE ARTIFICIAL PANCREAS

                              ----------                              


                             JULY 26, 2017

                                       U.S. Senate,
                                Special Committee on Aging,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 9:30 a.m., in 
room SD-106, Dirksen Senate Office Building, Hon. Susan M. 
Collins (Chairman of the Committee) presiding.
    Present: Senators Collins, Scott, Fischer, Casey, 
Gillibrand, Donnelly, Warren, and Cortez Masto.
    Also present: Senator Shaheen.

    OPENING STATEMENT OF SENATOR SUSAN M. COLLINS, CHAIRMAN

    The Chairman. Good morning. What a wonderful sea of blue I 
see out there. Welcome.
    I am delighted to convene this biennial hearing in 
conjunction with the JDRF 2017 Children's Congress to examine 
how Type 1 diabetes affects Americans of all ages. This is the 
tenth Children's Congress that the JDRF has held in Washington, 
DC, and it is the ninth that I have chaired. It is such a 
privilege to work with JDRF, whose commitment to finding a cure 
is unwavering.
    Let me welcome our distinguished witnesses and the more 
than 160 delegates who have traveled here from every state in 
the Nation and from around the world to this year's Children's 
Congress. We are really glad to have you here.
    [Applause.]
    The Chairman. Thank you for coming to share your personal 
stories and to tell Members of Congress what it is like to live 
with diabetes, just how serious it is, and why it is so 
important that Congress fund the research necessary to discover 
better treatments and, ultimately, a cure.
    I want to give a special shout-out to the two delegates 
from the great State of Maine: Charlie Albair of Gray, who we 
will hear from later, and Brady Chappell of Naples. I am so 
proud that you are here representing our state.
    We also will be joined shortly by our colleague Senator 
Jeanne Shaheen, who joins me as the Co-Chair of the Senate 
Diabetes Caucus. She has been a strong advocate for those 
living with the disease, including her own granddaughter.
    Since founding the Senate Diabetes Caucus 20 years ago, I 
have learned a lot about the difficulties and, at times, 
heartbreak that this disease causes for so many American 
families as we await a cure.
    Diabetes is a lifelong condition. It does not discriminate. 
It affects people of every age, race, and nationality. It also 
takes a major financial toll. The devastating disease costs our 
country an estimated $240 billion a year--a cost that is 
skyrocketing and is projected to reach more than $490 billion 
by the year 2020. Treatment of diabetes accounts for one out of 
three Medicare dollars. In fact, medical costs for Americans 
with diabetes are more than double those incurred by 
individuals without diabetes.
    The statistics are pretty overwhelming. But the burden is 
particularly heavy for individuals with Type 1 diabetes. 
Usually diagnosed in childhood or adolescence, Type 1 diabetes 
is a lifelong disease that, to date, one can never outgrow.
    Thankfully, there is good news for people with diabetes. 
Since I first started the Diabetes Caucus, funding for diabetes 
research has more than tripled. It is now about $1 billion a 
year. As a result, we have seen encouraging developments in the 
management, treatment, and potential cures for Type 1 diabetes.
    One program in particular at the National Institutes of 
Health has led to phenomenal discoveries, and that is the 
Special Diabetes Program. This critical program provides an 
extra $150 million a year for Type 1 diabetes research, and 
that is in addition to the regular NIH appropriation for 
diabetes research.
    Last year, the Special Diabetes Program led to the 
development of the first-ever, FDA-approved artificial 
pancreas, which can control blood glucose levels automatically 
and will revolutionize diabetes care. So the Special Diabetes 
Program is changing the future of diabetes.
    You know, when I first held these hearings, there was not 
even a very usable pump. Now we have a really small pump. How 
many of you wear a pump? Look at that. Wow.
    Now, are any of you involved in the clinical trials for the 
artificial pancreas? All right. That is wonderful. Well, I 
think that that holds such great promise.
    And today you will hear from some of our witnesses about 
how truly life-changing these innovative technologies can be. 
Other advances in technology, like continuous glucose monitors, 
are helping patients better control their blood glucose levels, 
and you know that that is key to preventing diabetes 
complications.
    So what is our task? This year, we must pass legislation to 
extend the Special Diabetes Program because, otherwise, it will 
expire in September. Are you all on board with that?
    [Applause.]
    The Chairman. So the great news is due to the efforts that 
all of you have been making. Seventy-five senators signed a 
letter that I led in September urging that this federal 
investment continue. Seventy-five senators out of 100. You 
hardly get 75 senators to agree on anything nowadays.
    [Applause.]
    The Chairman. So with the continuation of this investment, 
we can see a future in which all the children who are here 
today can look forward to a better and brighter tomorrow.
    It is so inspiring for both Senator Casey and me and for 
all those who will be joining us to look out and see that wave 
of Carolina Blue--each of you personally affected by diabetes. 
But let me just end by taking a moment to remember a personal 
hero--and we have put up her picture on the screen--who worked 
so passionately on behalf of all of you and testified year 
after year at the Children's Congresses in the past.
    Mary Tyler Moore endured the ups and down of Type 1 
diabetes for many years, but she did not complain. She focused 
her energy on finding better treatments and a cure to improve 
the lives of all of you. So we will honor Mary's legacy by 
continuing the work to which she committed so much of her life.
    Again, thank you all for joining us from all over the 
country, and I am now very pleased to turn to our Ranking 
Member, Senator Casey, for his statement. Thank you.
    [Applause.]

  OPENING STATEMENT OF SENATOR ROBERT P. CASEY, JR., RANKING 
                             MEMBER

    Senator Casey. Let us hear it for Senator Collins, our 
Chairman.
    [Applause.]
    Senator Casey. We do not get a chance to do that very 
often. I am grateful you participated in that. We do not do it 
enough, but we do want to thank Chairman Collins for having the 
hearing and also for her years and years of work on these 
issues. And we are grateful that you all are here to help us 
this year.
    We are also pleased that we will have the Co-Chair of the 
Diabetes Caucus, Senator Shaheen, to participate in our hearing 
today. That is unusual, when you are not a member of a 
committee to be part of another committee hearing. So we are 
grateful that she is willing to spend that time and to do that 
work.
    We are also pleased to have so many delegates here of the 
JDRF Children's Congress to help us in the Senate to get this 
message out and to work with us. It is so important that you 
have joined us today because finding a cure for Type 1 diabetes 
requires a combined effort from people of all ages and all 
backgrounds. Thanks to the delegates for advocating for the 
Special Diabetes Program.
    Each of you, each delegate here will be more persuasive 
than I will be in making the case. That is why it is so 
important that you are here today. Please continue to tell 
elected officials, not only here in Washington but around the 
country in your own communities and your own states, why 
research funding matters.
    Investing in research has led to the development of the 
artificial pancreas. Investing in research means a lot of you 
do not have to use needles to track your blood sugar levels. 
Investing in research also means that your diabetes has not 
stopped you from going to camp or playing outside at recess or 
riding a bike or doing so many other things. These are just a 
couple of examples of the success of the Special Diabetes 
Program and what can be accomplished when Congress fully funds 
our promise to fight Type 1 diabetes.
    You are also here during an important debate about health 
care. So, in addition to telling those of us on the Committee 
and in Congress about the importance of this program, it is 
important to explain why health insurance matters, why Medicaid 
and CHIP are so important to you and your families.
    We must ensure that people who have Type 1 diabetes are not 
denied care or asked to pay more for their care. That used to 
happen once in a while around here when people would make those 
arguments, but too often lately those arguments have not been 
made. We want to ensure that when you get older you can access 
care that is affordable as well.
    The Senate health care bill, in my judgment, could lead to 
higher costs for individuals and families in this room.
    I am pleased that our witnesses are here today with us.
    In my case, because I represent the State of Pennsylvania, 
I am grateful to welcome Lorynn to the witness table and 
grateful for her testimony and also grateful that she is 
willing to share not only why research is so important, but why 
affordable care is as well. Max and Ryan--if you can put your 
hands up--are also Pennsylvania delegates. Thank you to Max and 
Ryan for being here as well.
    So we look forward to hearing from Lorynn and the other 
witnesses. We are grateful that each of you is here to provide 
testimony. And I look forward to working with Chairman Collins 
and others to ensure that the Special Diabetes Program 
continues in 2018 and beyond. And I am convinced that together 
we can turn Type 1 into type none.
    Thank you.
    [Applause.]
    The Chairman. Thank you very much, Senator Casey.
    I also want to acknowledge the presence of Senator Fischer 
from Nebraska. Senator Warren and Senator Gillibrand from 
Massachusetts and New York will be back shortly.
    And we now get to hear from the stars of the show, and that 
is our panel of witnesses. And it is appropriate that I use the 
word ``star'' because our first witness is actor Paul Sparks. 
Paul is known for his roles in the HBO series ``Boardwalk 
Empire'' as well as the Netflix series ``House of Cards.'' And 
no--Washington really is not like that.
    [Laughter.]
    Mr. Sparks. I did not think so.
    The Chairman. I want to go on record.
    [Laughter.]
    The Chairman. Paul was diagnosed with Type 1 diabetes at 
the age of 28, and he has since been a powerful advocate for 
JDRF and for those with Type 1. And I think that is the 
starring role that he is probably most proud of.
    Second, we will hear from Dr. Griffin Rodgers, the Director 
of the National Institute of Diabetes and Digestive and Kidney 
Diseases at the National Institutes of Health. Dr. Rodgers has 
testified before us so many times, and I always look forward to 
hearing his update. I know how talented and committed that he 
is.
    And, of course, I take special pleasure in welcoming our 
witness from the great State of Maine, Charlie Albair. Charlie 
is 10 years old and was diagnosed with Type 1 at age 6. 
Nevertheless, be careful because he has a red belt in the 
martial arts. He also plays football, baseball, and basketball. 
He has been active in his community, raising awareness about 
what it is like to live with Type 1 diabetes.
    I am now going to turn to our Ranking Member to introduce 
our witness from Pennsylvania.
    Senator Casey. Thanks very much, Chairman Collins. I was 
mentioning before that one of our witnesses is from 
Pennsylvania: Lorynn Watt. Lorynn is 17. She is a rising senior 
from Stroudsburg, Pennsylvania, up in northeastern Pennsylvania 
near where I live. And despite living with Type 1 diabetes 
since the time she was 9, Lorynn, like all of the delegates 
before us, has not let the disease slow her down or stop her 
from pursuing her goals.
    Along with her regular academic work as a high school 
student, she is very involved in extracurricular activities. 
For example, in the upcoming school year, she will be directing 
the school play, participating in the Community Service Club, 
and serving on the Prom Committee. So that is a pretty busy 
schedule coming up.
    Lorynn, thank you for making the time in your schedule to 
become active in JDRF and advocating here in Washington on 
behalf of your peers. We look forward to your testimony. Thank 
you.
    The Chairman. Finally, we will hear today from Angie Platt. 
Angie serves on the board of the Los Angeles Chapter of JDRF as 
well as JDRF's International Board of Directors. But her 
impressive work does not end there. She is also the mother of 
Jonathan, who accompanies her as a witness today, and we 
welcome you back, Jonathan.
    He was diagnosed with Type 1 at age 6, but that has not 
held him down at all. In fact, I am told you are six-five--is 
there any truth to that?--at age 14. Outside of being an 
advocate, Jonathan is an impressive athlete and was a 
participant in the artificial pancreas trial. So we are really 
looking forward to your testimony.
    And I also want to acknowledge that we have been joined by 
our colleague Senator Donnelly from Indiana, who is here today.
    You will see senators in and out because of their 
schedules, but believe me, they care a lot about this issue.
    So we will now start with Mr. Sparks.

      STATEMENT OF PAUL SPARKS, ACTOR, NEW YORK, NEW YORK

    Mr. Sparks. Thank you, Chairman Collins, and thank you, 
Ranking Member Casey, and the members of the Committee for 
inviting me to testify here today. I am totally nervous, but it 
is a really big honor for me to be here.
    I will just start by saying that I know how important the 
research supported by the Special Diabetes Program is because 
in my own lifetime personally, as a person with Type 1 
diabetes, I have seen and I have benefited from the advances 
discovered in our labs and clinical trials and brought to 
market.
    I was diagnosed with Type 1 diabetes when I was 28 years 
old. I was living in New York, working as an actor--which is 
code for I was living in New York working as a construction 
worker trying to be an actor.
    Over the course of about 7 or 8 months, I lost close to 40 
pounds. I had to go to the bathroom all the time. I had cramps 
constantly. I was thirsty, hungry, starving. I could not see 
very clearly. I mean, my body was completely falling apart.
    Luckily, I went home to Oklahoma to visit my parents, but I 
was so thin, so grim, looked so unhealthy that my mother and 
father almost had a heart attack when they saw me.
    Luckily, my brother was a medical resident at OU, Oklahoma 
University, and over the phone I talked about symptoms. And he 
said, ``Well, get to a doctor because it sounds like you may 
have Type 1 diabetes or diabetes.'' I went the next day, and he 
was right. Thanks, David.
    I spent the next few months or years trying to learn about 
T1D, trying to learn and figure out how to get care for myself, 
learn how to care for myself.
    As the kids in this room and the parents know, this is a 
very anxiety-producing disease. You are the patient, but you 
are also sort of the caregiver. You have to do it yourself. You 
take care of yourself. You listen to yourself. You are 
responsible for keeping yourself healthy in many ways. And you 
have to stay on top of it because if you do not, you will get 
very sick, as you guys know, or worse.
    That is why the research and the advances in care are so 
important. Today, nearly 20 years after my diagnosis, I use an 
inhaled insulin that quickly and safely brings my blood glucose 
back into range. I wear a continuous glucose monitor, which is 
awesome, and it allows me to know at all times what my glucose 
levels are so I do not go too high and I do not go too low. 
These advances have transformed my life.
    I used to have to stash sugar when I would do a play on the 
stage somewhere in case I needed to stabilize my blood glucose. 
I can tell you that it is a pretty strange moment when an 18th 
century period drama character pulls a bottle of Tropicana 
orange juice out of a sofa cushion and starts drinking it mid-
dialog.
    But probably the most demonstrative example that I have 
experienced of how important these advances are: About 3 years 
ago, I turned my CGM off at night before I went to bed so that 
my very pregnant wife at that time, Annie--who is sitting right 
there with that little kid who was inside of her--could sleep 
peacefully through the night. She was struggling to do that 
because she was about 8 months pregnant, because the glucose 
monitor beeps when your blood sugar goes low. Well, because it 
was off, it did not beep when I went low, and I had a really 
severe low. And in the morning, they could not wake me up. And 
when I finally did wake up, I was standing in the presence of a 
very terrified pregnant woman and a crying 4-year-old boy, who 
has green hair right over there, and seven New York City EMTs.
    These technologies, like the CGM, when they are turned on, 
and other research advances literally save my life every day. 
They save the lives of all these delegates. We are on the cusp 
of a new generation of therapies and devices and, hopefully, a 
cure.
    That is why we cannot let up on this research. We need more 
advances. We need to cure and prevent Type 1 diabetes so all of 
us, like Charlie and Lorynn and Jonathan who are sitting here, 
and all these kids, can live a life without thinking about the 
disease all the time.
    We need to keep the momentum going. We need to renew the 
Special Diabetes Program before it expires at the end of 
September.
    I am going to let the other people talk about the science 
and the policies that support it. But let me just say this: 
This research has made a difference in my life. It has made a 
difference in the lives of all these people in this room, and 
millions of people all over the United States.
    So thank you, seriously, thank you, Chairman Collins, for 
your outstanding leadership, and thank you, Ranking Member 
Casey, for your support of T1D research and coverage for 
technologies like the continuous glucose monitor. It is great 
that people on Medicare can get it just like the rest of us.
    Thank you and your colleagues for their bipartisan support 
of the Special Diabetes Program. It is doing great work for 
everybody.
    Thank you.
    [Applause.]
    The Chairman. Thank you so much for your testimony, Mr. 
Sparks, and for your willingness to take the time out of your 
schedule to be with us today.
    You mentioned the continuous glucose monitor, and Senator 
Shaheen, who has joined us and, as I mentioned earlier, is Co-
Chair of the Diabetes Caucus, and I had to push so hard for CMS 
to cover that for people on Medicare. We are still having a 
problem with the Omnipod, but we are not giving up on that 
either.
    Dr. Rodgers, thank you for being here.

 STATEMENT OF GRIFFIN P. RODGERS, M.D., M.A.C.P., DIRECTOR OF 
  THE NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY 
  DISEASES, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF 
                   HEALTH AND HUMAN SERVICES

    Dr. Rodgers. Thanks so much. Chairman Collins, Senator 
Casey, and members of the Committee, thank you for your 
invitation to testify today.
    Type 1 diabetes is a lifelong disease that affects 
Americans of all ages, including seniors. And on behalf of the 
National Institutes of Health, I am pleased to report that our 
research investments continue to improve the lives of people 
with Type 1 diabetes. Through coordinated efforts with research 
partners, such as the JDRF, the ADA, the Helmsley Charitable 
Trust, as well as the support of the special statutory funding 
program for Type 1 diabetes, we are helping the children here 
today and all people with Type 1 diabetes live longer, 
healthier lives.
    Since I last testified before this Committee two years ago, 
significant scientific progress has been made that is putting 
us closer to the goal of preventing, treating, and ultimately 
curing Type 1 diabetes and its complications. These advances 
are really the fruits of the long-term sustained investment of 
the Special Diabetes Program in Type 1 diabetes research and a 
preview of what we hope will come as a result of those efforts.
    First, I would like to just acknowledge the important 
contribution of my fellow witnesses.
    Paul Sparks, you are a tireless advocate not only for a 
future cure but for improving people's lives today.
    Charlie Albair and Lorynn Watt, your commitment to 
educating others and raising awareness about Type 1 diabetes is 
truly outstanding.
    And, Jonathan and Angie Platt, I am happy to be able to 
share the table again with you. Without participation of you 
and others in clinical research, we would not be where we are 
today.
    I would also like to thank those here today representing 
Americans of all ages. This is so important for people with 
Type 1 diabetes.
    I would say that the outlook for people with Type 1 
diabetes is better than ever, and one of the main reasons is 
the evolution of the artificial or bionic pancreas technology. 
This device measures blood sugar levels and automatically 
administers insulin and can help people with Type 1 diabetes 
achieve better blood sugar control and avoid the episodes of 
hypoglycemia, as Mr. Sparks just talked about, or dangerously 
low blood sugar levels.
    As you have heard, a significant milestone was achieved 
last fall when the FDA approved the first commercial hybrid 
artificial pancreas device, and NIDDK supported early research 
that contributed to the development of the approved device and 
continues to vigorously support research at all stages to 
advance this technology.
    The FDA-approved device is a first-generation device for 
people age 14 and older. It partially automates blood sugar 
sensing and insulin administration, but still requires users to 
count and enter mealtime carbohydrates.
    Numerous improvements are on the horizon to more fully 
automate artificial pancreas technology, to make the devices 
simpler and more user friendly, to personalize care, and to 
bring this technology to all.
    For example, the first at-home study of a bihormonal 
pancreas system--one which delivers not only insulin but 
glucagon, without the need for a mealtime carbohydrate 
counting--showed it improved blood sugar control better than 
the conventional insulin pump. And the success of this and 
other studies lay the groundwork for four new Special Diabetes 
Program-supported clinical trials to generate data toward FDA 
approval of other devices. These trials will bring us closer to 
the goal of having multiple artificial pancreas devices that 
are FDA-approved for all ages, allowing people with Type 1 
diabetes, the caregivers, and their health care providers to 
choose the technology that is best suited to their needs.
    And although this technology holds great promise as a near-
term approach to helping people manage Type 1 diabetes, it is 
not a cure. Replacing the destroyed beta cells, which would be 
a biological cure, is another area of vigorous investigation. 
And one way to do this is through islet transplantation, and I 
am happy to report progress in this field. The NIDDK and the 
NIAID co-led the Clinical Islet Transplantation Consortium, 
completed a study of islet transplantation without accompanying 
kidney transplantation in people with difficult-to-control Type 
1 diabetes despite expert care. This study found two years 
after the transplantation that more than 70 percent of the 
participants were free of severe hypoglycemia events and had 
established near-normal control of their blood sugar levels and 
had restored hypoglycemia awareness.
    These findings indicate that islet transplantation is an 
effective treatment for people whose Type 1 diabetes cannot be 
controlled by other means and for whom hypoglycemia events are 
life-threatening. These results will be the basis of an 
application to the FDA for licensure of a pancreatic islet 
product for transplantation.
    Now, a current barrier to islet transplantation is the 
scarcity of donor islet transplants, and so the NIDDK's Human 
Islet Research Network, known as HIRN--everything in government 
has an acronym--is pursuing other strategies for replacing the 
lost beta cells.
    Small molecules can be made into the form of drugs and hold 
promise for inducing beta cell replication in a patient's 
remaining beta cells or regenerating beta cells from related 
cells in the body, and HIRN scientists are pursuing these 
possibilities.
    HIRN has also made exciting progress in identifying 
biomarkers of beta cell loss and developing means to measure 
these markers in people with Type 1 diabetes. These advances 
can lead to an approach to monitor people at risk for the 
disease and to diagnose Type 1 diabetes much earlier, perhaps 
when the beta cells are still present, and, therefore, they can 
be prevented from being completely destroyed.
    I am also pleased to report important strides in combating 
diabetic eye disease. Nearly 35 years after the NIDDK's 
landmark Diabetes Control and Complication Trial, or DCCT, 
began, this study continues to provide critical information and 
insights about reducing the devastating risks of this 
complication. The study recently reported that people who 
intensively controlled their blood sugar early in life are 
nearly 50 percent less likely to need eye surgery. The DCCT 
scientists also determined that people with Type 1 diabetes 
should get eye exams to detect diabetic eye disease based upon 
their risk rather than on an automated schedule. So adjusting 
the frequency of eye examination and screening to a more 
personalized approach will result in fewer eye exams and lower 
costs and quicker diagnosis.
    The Special Diabetes Program also provides significant 
funds to our sister institute, the National Eye Institute, its 
Diabetic Retinopathy Clinical Research Network, which also 
continues to report significant advances in treating diabetic 
eye disease. Building on the network's finding that sanative 
drugs are more effective than laser treatment, they compared 
three of these drugs with widely differing costs for treating 
different people with a certain type of diabetic eye disease. 
The results showed that in people with mild vision loss, all 
three drugs were equally effective after 2 years. These results 
can inform clinical decisions and lead to a more personalized 
treatment for diabetic eye disease, while having significant 
cost implications. Importantly, the drugs were found to improve 
vision, which could be the difference between whether a person 
can drive or not, greatly affecting the person's quality of 
life.
    The network also showed that the sanative is more effective 
than laser treatment for treating patients with a more severe 
diabetic eye disease, so-called proliferate diabetic 
retinopathy. This result gave people with diabetes and their 
providers the first new option for treating this disease since 
the 1970's, four decades. In April, based upon these results, 
the FDA has now approved this drug for all forms of diabetic 
eye disease, extending their previous approval.
    Chairman Collins, Senator Casey, and members of the 
Committee, thank you for this opportunity to testify before you 
today. The NIH is grateful for the continued support of 
Congress, for our public and private research partners, and for 
the unwavering efforts of our clinical study volunteers. With 
the remarkable progress already achieved through the support of 
the Special Diabetes Program and the progress of future 
biomedical research, it is possible to imagine that people will 
lives free of the burden of Type 1 diabetes and its 
complications.
    Thank you for your attention, and I am pleased to answer 
any questions you may have. Thanks so much.
    The Chairman. Thank you very much, Doctor.
    [Applause.]
    The Chairman. Charlie, you are up.

  STATEMENT OF CHARLIE ALBAIR, JDRF 2017 CHILDREN'S CONGRESS 
                     DELEGATE, GRAY, MAINE

    Mr. Albair. Chairman Collins, Ranking Member Casey, 
Senators, thank you for inviting me to speak before you today.
    My name is Charlie Albair from Gray, Maine. I am 10 years 
old, and I will be entering the fifth grade at Gray New 
Gloucester Middle School.
    I am just like a lot of other kids. I love sports, 
especially basketball and baseball. And when I grow up, I hope 
to play in the Major Leagues--for the Boston Red Sox.
    [Applause/laughter.]
    Mr. Albair. The one big difference is that I have Type 1 
diabetes, or T1D. I was diagnosed with T1D way back when I was 
6 years old. I was in the first grade. I started not feeling 
like myself. I kept asking the teacher to go to the bathroom 
because I really, really had to. She got angry at me because 
she thought I just was trying to skip class.
    She felt bad when she found out the real reason.
    At first I was kind of confused when I was diagnosed. I did 
not know what it was; ``diabetes'' was a big word for a first-
grader.
    In the beginning, we treated my diabetes with syringes. And 
a half a year later, I got the Omnipod pump and then a CGM to 
monitor my sugar levels. I love it.
    I do not have to be constantly stabbing myself with a 
needle five or ten times a day.
    What does this mean for me?
    When I first found out I had diabetes, I remember thinking 
that this would change my whole life. I thought that I would 
not realize my dream of being a sports star.
    Now I can realize I can do whatever I want.
    Sometimes my Omnipod or CGM beeps in class, and the other 
kids say, ``Charlie, stop making noise.'' I just tell them that 
that is my natural ``robot'' noise.
    [Laughter.]
    Mr. Albair. The pump and CGM are so much a part of me. But 
I do wish that they did not have to be.
    I want my disease to go away--for me and all the other kids 
who suffer from it. I want us all to be able to live without 
thinking about it.
    That is why I am here.
    We need money for research.
    We need money so scientists can invent new pumps and 
monitors better than what we have now and so they can come up 
with a cure for T1D.
    You have supported kids like me for so many years, and all 
I ask is that you continue to do so. And if you do, I will 
invite you to a game when I am on the Red Sox.
    [Laughter.]
    Thank you.
    The Chairman. Thank you, Charlie.
    [Applause.]
    The Chairman. I cannot wait to see you playing at Fenway 
Park. I will be there.
    Lorynn, welcome.

    STATEMENT OF LORYNN WATT, JDRF 2017 CHILDREN'S CONGRESS 
              DELEGATE, STROUDSBURG, PENNSYLVANIA

    Ms. Watt. Hi. Chairman Collins, Ranking Member Casey, 
Senators, thank you so much for inviting me to talk with you 
today.
    My name is Lorynn Watt, as we have established. I am 17 
years old, and this fall I will be a senior at Evergreen 
Community Charter School in Cresco, Pennsylvania.
    When I was 9, I was diagnosed with Type 1 diabetes. I 
remember sitting on my parents' bed, just about a week before 
Halloween, as my Mom and step-dad told me that I had T1D. That 
day they loaded me into the car and took me to the hospital, 
where I would learn to care for myself.
    At that point, I only knew about diabetes from an episode 
of ``Hannah Montana'' I saw just before I was diagnosed. That 
was it. What I did know was that I was scared and felt awful, 
and all of a sudden I was living a life where I had to inject 
myself with insulin multiple times a day, even though I was 
horrified of needles.
    Then at 14, I got a continuous glucose monitor, or CGM, and 
an insulin pump. It made my life so much easier. Now, all I 
have to do is look at my phone--which kids my age do anyways--
and I can see my blood sugar. It has been life-changing, and I 
hope this, the artificial pancreas, and other advances are 
small steps toward a cure.
    I have heard every year since I was diagnosed that in 5 
years there will be a cure. I have had this disease for almost 
8 years, and you know, I am no mathematician, but I think we 
are behind schedule.
    I believe that with your help we can have a cure. After 
all, we have come so far.
    I know this because my biological father also had T1D. He 
was not in my life much, and he did not have great care--no 
pump or CGM or even the ability to check his blood sugar every 
day.
    So he lost his foot and then his eyesight and then the use 
of his kidneys. He had to get a stent in his heart. And he died 
less than a year after my own T1D diagnosis, at just 38 years 
old.
    I am here today asking you for more support and more 
funding for more research because no one should have to suffer 
and lose their life because of T1D.
    I am here, inspired by his memory, and determined that none 
of the kids here today or sitting in a hospital room--I am 
sorry----
    [Applause.]
    Ms. Watt [continuing]. Or sitting in a hospital room right 
now--scared--as they get their diagnosis, will have the same 
fate as my father.
    With your help, I know we can do it. I know we can find a 
cure.
    Thank you.
    The Chairman. Thank you, Lorynn.
    [Applause.]
    The Chairman. Thank you so much. I know that was really 
hard, but your story really inspires us to work even harder.
    Mrs. Platt, I know you are speaking on behalf of yourself 
and your son. We would love to hear your testimony.

STATEMENT OF ANGIE PLATT, CHAIR MOM OF THE JDRF 2017 CHILDREN'S 
   CONGRESS, ACCOMPANIED BY HER SON, JONATHAN PLATT, ENCINO, 
                           CALIFORNIA

    Ms. Platt. Chairman Collins, Ranking Member Casey, 
Senators, thank you for inviting me to speak with you today.
    I am Angie Platt from Encino, California. My husband, Jon, 
and I have three children, all boys: twin 4-year-olds, and this 
is our oldest son, Jonathan, who is 14 years old.
    It is hard for me to believe that this, like you said, six-
foot-five young man sitting next to me is the same boy who was 
here for JDRF's 2011 Children's Congress. He was only 7 years 
old at the time, just two years into his diagnosis.
    If you watch Jonathan play in his competitive basketball 
tournaments, it would be very hard to believe that he is a 
child living with Type 1 diabetes.
    I am here today to tell you and your colleagues that 
Jonathan is living proof that your leadership and actions have 
made a real difference in the lives of Jonathan and the lives 
of all the people with Type 1 diabetes.
    In 2011, when Jonathan was here, the Type 1 diabetes 
community was asking for your help, and, Senators, you gave it. 
The Special Diabetes Program has provided hundreds of millions 
of dollars of crucial funding for a range of therapies and 
investigations, including the artificial pancreas.
    In April 2016, Jonathan was enrolled in the pediatric trial 
for the Medtronic Hybrid Closed Loop 670G--otherwise known as 
the ``artificial pancreas.'' We felt as if we had won the 
diabetes lottery when Jonathan got a spot on that trial.
    This device has given Jonathan better blood sugar control 
than he has ever had in his diabetic life, and it gives our 
family some desperately needed peace of mind. In the past, we 
would wake up and check Jonathan's blood sugar at minimum three 
times a night, similar to the parents behind me and the parents 
at home caring for children with Type 1 diabetes. Jonathan used 
to have to stop practicing with his team or even sit out in 
games because his blood sugar levels were too erratic. Now he 
gets to play right through crunch time, and we are so thankful 
for that.
    As you know, last fall the FDA approved this artificial 
pancreas system. And, Senators, let me be clear: This would not 
have happened without your help and without the support of the 
Special Diabetes Program.
    Diabetes is relentless. We all work so hard. We are so 
responsible. We are playing by all the rules. Jonathan is on 
the latest and the most advanced technology, and he doing 
everything right.
    But the ugly reality of diabetes is that, as hard as we 
work, our kids are still vulnerable. This past June at 
Jonathan's eye exam, it was discovered that Jonathan has three 
dot hemorrhages. Children with Type 1 diabetes at the age of 14 
should not be diagnosed with diabetes complications. And, quite 
frankly, there are kids who are a lot worse off than Jonathan, 
and those of us who are sitting here are among the lucky ones.
    I know that we have made progress, and my son is wearing 
the very first artificial pancreas system approved in the 
world. But this disease does not stop, and so we cannot stop.
    We need the next generation of devices that can fully 
automate insulin delivery.
    We need to ensure that progress continues in the area of 
diabetes complications.
    We also need to prevent others from ever developing Type 1 
diabetes, including my twin sons, Jonathan's brothers, who are 
at a higher risk of developing Type 1. They are enrolled in 
TrialNet, a Special Diabetes Program-funded prevention program.
    The Special Diabetes Program has done so much, but as you 
said, it will expire on September 30th. The SDP gives me so 
much hope, but it needs a hero. We need you Senators and your 
Senate colleagues to renew it for another three years so 
researchers can continue their great work.
    Senators, I want to thank you for all that you have done to 
make my family's life and the lives of all of us here today, 
and the lives of all of those back at home better. Senator 
Collins, I particularly want to thank you for your steadfast 
commitment and outstanding leadership to advance Type 1 
diabetes research and to help people gain access to new 
technologies. You have been a champion of us for a long time.
    Look at Jonathan. He will not lose to Type 1 diabetes.
    We will fight alongside him. We will fight alongside all 
these kids before you, and we will fight alongside all the kids 
at home.
    I ask that you please continue to fight alongside with us. 
Thank you.
    [Applause.]
    The Chairman. Thank you all for such inspiring testimony. I 
know that it is hard to share your personal stories, and it 
makes such a difference because then it puts a human face on 
the disease, and that is what we need as we advocate for more 
money.
    I want to start with Dr. Rodgers because I know that you 
will remember that 10 years ago, in September 2006, I chaired a 
hearing, the Children's Congress, and the topic was the 
artificial pancreas. And it was like something way in the 
future, but what a difference it would make. And it is so 
exciting when I learned of the FDA's decision last fall to see 
the progress that we have made. So I know that it seems hard 
for those of you, particularly those of you who are newly 
diagnosed, but the amount of progress in the 20 years that I 
have co-chaired the Diabetes Caucus really is encouraging. And 
we are going to keep working on that.
    I also love, Dr. Rodgers, that you called it, instead of 
the artificial pancreas, the ``bionic pancreas.'' I think I 
will adopt that term from now on. But I want to point out that 
the Special Diabetes Program has been critical to achieving 
many of the advances you described and was the program that 
spurred the development of the artificial pancreas technology.
    What additional advancements is the Special Diabetes 
Program supporting that are in the pipeline now? Is the islet 
transplantation part of that?
    Dr. Rodgers. Absolutely, Senator. In fact, I remember 
vividly. That is about 10 years ago, and that was actually the 
first year I was the Director of the Institute, and you really 
challenged us to move forward with this artificial pancreas. 
And it seemed at that time to sort of be a dream, but here we 
are.
    What I can tell you is that we are actually even moving 
much further along in that regard with the bionic artificial 
pancreas. With the current funds that are remaining in the 
Special Diabetes Program, we are actually just launching four 
new clinical trials toward FDA approval of the artificial 
pancreas device, and one of these trials, I have already begun 
recruiting patients. These trials will be testing, for example, 
the combination of insulin and glucagon, as I mentioned, a 
bihormonal therapy led by researchers at Boston University.
    There is a trial that is underway at the University of 
Virginia which is developing an intraoperative system. We 
understand there are going to be advances in the infusion 
technology as well as the sensing technology. This system will 
be a plug and play where it does not matter which of these 
devices really moves forward. This system will test that 
interoperability, and that is at the University of Virginia.
    There is a third, which is the trial that is currently 
recruiting patients. That is led by investigators at the 
University of Cambridge in England, and they will test an 
artificial pancreas specifically in youth. As I said, the 
current device is for kids 14 and older. This is looking at a 
much younger pediatric group to determine its efficacy.
    Then the fourth trial that we are funding is led by an 
international diabetes center in Minneapolis and the Schneider 
Children's Medical Center in Israel, and they will be testing 
the next generation of this currently approved device to 
determine its efficacy in a broader group.
    The HIRN that I mentioned has also been spurred on by the 
Special Diabetes Program, and being able to develop a way to 
take the patient's cells from their skin and to induce them to 
actually become glucose-responsive beta-type cells and to 
expand them for potential transplantation is really going to be 
a great advance. And we are well along the way with that with 
the additional and continuous funding of this Special Diabetes 
Program.
    Having these cells available--and I do not want to go on 
very long, but it will also give us another advantage, because 
one can take these cells and culture them in a dish and put 
them on a chip, and this chip now, with the patient's own 
cells, can actually determine the effectiveness of certain 
drugs, for example. In this way, you can envision making 
therapies even more personalized.
    So those are just a few of the many things that have been 
spurred on and we hope will continue with the Special Diabetes 
Program support. Thank you.
    The Chairman. Thank you.
    Charlie, how does having Type 1 affect you when you are 
playing sports, when you are on the court or in the field?
    Mr. Albair. Well, sometimes if my Dexcom says I am low, I 
have to just run out onto the sidelines, take sugar, and then 
wait however long I need to. And then when I go up, I can go 
back out and play. But the normal blood sugar that my parents 
want it at is 160 to 170 because it is a lot of running around, 
so it could make me go low, and there is a lot of adrenalin, so 
I could go high. And it is just hard because we do not know 
what way I am going to go, down or up.
    The Chairman. That must be hard to constantly monitor it, 
and yet pay attention to the game, too. But it sounds like you 
do a great job doing both.
    My time has expired, so Senator Casey. Thank you, Charlie.
    Senator Casey. Thanks, Chairman Collins.
    I want to thank all the witnesses for being here. Your 
testimony is very compelling, and that is the kind of testimony 
that will help us win some of these legislative battles. So we 
are grateful you are willing to do that, and I extend that to 
all of the delegates. In your own ways, you will all be 
witnesses to bring testimony to individual Members of Congress.
    Lorynn, I am especially grateful that you are here 
representing our state. I do have one brief suggestion. Just a 
thought. You do not have to answer. I know you are busy with 
the Prom Committee and all those other activities, but you are 
going to finish high school with great grades. You are going to 
go to college. My suggestion is become a lawyer, then become a 
sports agent, and get Charlie and Jonathan to play for the 
`76ers. OK?
    [Laughter/applause.]
    Senator Casey. We could use the help.
    [Laughter.]
    Senator Casey. But, Lorynn, thank you for sharing your 
story about your dad and about your own life. It is those 
stories that move the needle on these public debates. All of us 
will continue to make arguments. We will make speeches and all 
of that. If you are Senator Collins, they usually work out 
better than the rest of us. We know we are going to need you.
    I guess the one question I had is: You have got, obviously, 
the benefit, and so many do, of new technology, and that is 
something to be positive about. And I guess part of the benefit 
of that is it has helped you to manage your own condition. But 
tell me a little bit more about how it has made your life 
better both at school and at home. If you can just kind of walk 
us through part of your day or give us a sense of what it is 
like every day.
    Ms. Watt. Well, a major part of it is sleep. I like to 
sleep, and I did not really get to do that a lot before, 
because my Mom would come in three times a night, four times a 
night, depending on how that day is going, and check my blood 
sugar for me, to the point where I would just sleep through it 
because it just became like clockwork.
    But, you know, it is really cool to be in class, and all of 
my teachers know that I have Type 1, and so I am allowed to 
have my phone on the desk. And so I can look at my phone, and, 
you know, if I see that I am high, I can take my insulin with 
my pump without having to run to the nurse and do a shot. I do 
not really need to do a finger stick right away. I have time. 
And if I see I am low or if I am going down, I have the ability 
to treat it before it becomes a real problem for me. And so it 
has been really helpful. I am really grateful.
    Senator Casey. Well, that helps us as well to be able to 
give folks a sense of the challenge that you face every day.
    Another issue that I wanted to raise is part of the debate 
we are having right now about programs like Medicaid. We know 
that living with T1D--and it is nice to have an acronym for 
that, too. I guess as we said, we have lots of acronyms. But 
living with T1D presents lots of challenges. One of the 
challenges, of course, is making sure that the services are 
there. Whether it is insulin or doctors' visits, to technology, 
technology like the continuous glucose monitor, those are 
significant costs. And I know that a lot of families here 
benefit not only from coverage, but I guess, Lorynn, in your 
case, in terms of what your Mom gets from work, that impacts 
you as well. Can you talk about that in terms of the coverage?
    Ms. Watt. I do not know a lot about that, just because I am 
a minor, so I am not allowed to deal with a lot of that.
    Senator Casey. Right.
    Ms. Watt. I do know that the ability to afford the 
technology I have is really great because a lot of people 
cannot afford $14,000 out-of-pocket for an insulin pump and a 
CGM. So the fact that we have the insurance, you know, even 
like a vial of insulin is about $300, and I am using about 
three a month. We do not have $900 a month to put toward 
insulin. So having the ability to know that that is going to be 
there and we are not going to have to worry is really relaxing 
to know.
    Senator Casey. Well, we will have to bring you back here 
when we are debating the budget with regard to NIH research 
dollars. So thanks for your help.
    Ms. Watt. Thank you.
    The Chairman. Thank you.
    Senator Donnelly?
    Senator Donnelly. Thank you, Madam Chair. And I want to 
thank all of you for coming to the Congress today. To my 
Hoosier friends, Becca and Katie and everyone else, we are so 
excited that you are here. It is awesome to see all of you.
    Charlie, my dream in life was to be a Major League baseball 
player, but I could not hit a curve ball, so my recommendation 
to you is spend a lot of time in the cage. And, actually living 
not too far from Chicago, it is difficult to root for the Red 
Sox. However, when you get to Fenway, I will come and watch you 
play, and it will be awesome to see that.
    And to Jonathan, I am a Notre Dame graduate and would be 
happy to put you in touch with the basketball coach.
    [Laughter.]
    Senator Donnelly. It could be a win-win situation, my 
friend.
    Dr. Rodgers, you talked a bit about the successful clinical 
trials on artificial pancreas technology, and we have all been 
very interested in this. Could you tell us about the future and 
how you think this is going to go from clinical to products in 
the market and where we are headed?
    Dr. Rodgers. Sure. Thank you, Senator, and, again, thank 
you for all your support. I think, you know, again, this next 
generation, our goal is really to provide patients and their 
families with options. And while this has really been quite 
successful, getting this first artificial pancreas approved by 
the FDA, as you have heard, it still has limitations. And so 
really the purpose of these four trials that I just outlined a 
moment ago is to provide people with even more options, 
something that is more----
    Senator Donnelly. You are still in effect flooding the 
zone, so to speak, to put as many lines out there as you can.
    Dr. Rodgers. Exactly right. And as I said in my opening 
remarks, you know, even having these available, it is still not 
a cure. And so we really have to make sure that we look at ways 
of replacing those cells that have been damaged. Ideally, 
actually determining the disease so early in people who are 
genetically at risk that we can halt the progression of the 
autoimmune disease and then get their own cells to repopulate 
and regenerate, those islet cells produce cells.
    Senator Donnelly. Now, when you do that, the islet 
transplantation and the work that is being done on that, would 
that be like a patch that would be used? Or how would it be 
delivered? And, you know, the magic thing that Lorynn was 
talking about, we are always told it is five years every year.
    Dr. Rodgers. Right.
    Senator Donnelly. Where are we in terms of that? Because I 
know up in Harvard with Dr. Melton they are doing work, and 
elsewhere they are doing work.
    Dr. Rodgers. That is right. They are supported by the 
Special Diabetes Program, and expanding these cells was really 
a remarkable achievement. I hate to use the word 
``breakthrough,'' but that was truly a breakthrough. Being able 
to take the patient's own cells and expand them in such a 
fashion is totally outstanding.
    Of course, even if you expand those cells and transplant 
them back in through a variety of ways, you still have to 
overcome the autoimmune disease, and so you could either 
encapsulate these or in some way modulate the autoimmune 
disease to make sure that those cells remain healthy and 
survive.
    The one aspect I do want to sort of go back to this 
artificial pancreas is even if we expand this technology and 
really achieve a lot of benefits, it really will not be to 
anyone's benefit if people do not use them. And so we have to 
make sure that these are readily available for a large number 
of people and for whatever barriers that there may be to using 
them that we can overcome that. And one of the major things 
that SDP is doing, we are able to bring people into this field 
of research who had never envisioned going into this--chemical 
engineers, bioinformaticians, computer scientists, people who 
are involved in psychology to try to determine how one might 
effectively influence behaviors in terms of using these 
technologies. So it really does take a large number of people 
that we are just envisioning.
    And then, finally, I just would quickly say that, as you 
heard, even as these technologies emerge, there are still 
people with the disease at risk for developing complications, 
so we have to put efforts into making sure that the eye 
disease, the kidney disease, the foot ulcers, the heart disease 
is appropriately managed. And we have activities underway to--
--
    Senator Donnelly. Well, I can tell you that on the Special 
Diabetes Program you have got--what is the term? ``A steely 
eyed missile commander'' in Susan Collins and Jeanne Shaheen 
and Bob Casey, and everybody is all in to make sure that is 
protected.
    And to all of you young people, one of the folks who 
visited my office today is a fellow named Charlie Kimball. 
Charlie is a young man who is an IndyCar driver. Charlie has 
won IndyCar races. Charlie drives around the track at 230 miles 
an hour. And Charlie has Type 1 diabetes and has driven entire 
races, was ahead in the Indy 500 with about 10 laps to go a few 
years ago. And so any dream you have, anything you are hoping 
for, anything you want to accomplish, I think Dr. Rodgers and 
all of you would say--Dr. Rodgers, there is no reason they 
cannot achieve anything they want, is there?
    Dr. Rodgers. Absolutely.
    Senator Donnelly. Thank you.
    The Chairman. Thank you very much, Senator.
    Senator Scott?
    Senator Scott. Thank you, Chairwoman. And thank you for 
holding such an important hearing this morning. I will always 
remember growing up in South Carolina with my best friend at 
the time, at 13 years old was diagnosed as a child with 
juvenile diabetes. And the good news is that at 51 years old--I 
am dating myself at this point. At 51 years old now, Billy is 
still very healthy. So the longevity and the good health is 
prayerfully in the future of so many kids who have juvenile 
diabetes.
    I do know that we have at least three delegates from South 
Carolina. If you are here, please stand up. Cameron. Is Cameron 
here? Or Julian?
    The Chairman. Right here.
    Senator Scott. A tall youngster. And Riley? All right.
    [Laughter.]
    Senator Scott. Excellent. Are there any other South 
Carolina delegates here? Would you stand up for me, please? 
Excellent. Well, thank you very much for being here. In my 
previous life before Congress, I served on our local Juvenile 
Diabetes Research Foundation for a short period of time, and I 
am so thankful to see this hearing and hear about the progress 
being made.
    I thank the panelists for being here to discuss this very 
important issue as well.
    The Chairman. Thank you very much, Senator.
    I am now very pleased to call upon the Co-Chair of the 
Senate Diabetes Caucus, who has been a wonderful partner and 
leader in the fight against Type 1 diabetes and in helping us 
get research dollars, and that is my neighbor from New 
Hampshire, Senator Jeanne Shaheen.
    Senator Shaheen. Well, thank you very much, Madam Chair, 
and I am honored to serve with you and appreciate the 
leadership that you have provided for so many years in the 
Senate. We would not be here where we are today without your 
leadership, so thank you very much for that.
    I also want to recognize Anna Cook, who is here from New 
Hampshire, and her mother, Amy. Is Anna here in front 
someplace? Thank you, Anna, for being here.
    And I really appreciate all of you being here because you 
do not know yet how much difference you have made and the 
Children's Congress has made in advancing research in diabetes. 
You are the best advocates there could be as you fan out and go 
meet with senators and members of the House to talk about why 
this is so important, and the stories that you have to tell are 
what has moved this debate.
    I have a granddaughter, Elle, who has Type 1 diabetes. She 
was diagnosed a little after her eighth birthday. She is headed 
off to college this fall with her diabetes service dog, Coach, 
who went to high school with her. He graduated with his own cap 
and gown.
    [Laughter.]
    Senator Shaheen. And he is headed off with her, and he has 
made a huge difference for her. But even Coach has not been 
able to address the kind of issue that you all know about and 
that Mr. Sparks spoke to, where she has on occasion--in fact, 
just last week, she also turned off her CGM, and her mother was 
not able to wake her. And, fortunately, she did not have to go 
to the hospital. She was finally able to get her awake after a 
lot of carbohydrates.
    So I appreciate and have seen how important the Special 
Diabetes Fund and the research it promotes is in her life.
    And I hope that as you all go to offices that you will talk 
about this not just in the context of how important it is for 
you individually and what your stories are like, but you will 
also let people know--oh, we have a diabetes service dog in the 
audience. All right. What is the dog's name? Gigi? All right. 
Gigi is great, I bet.
    But that you will let people know that this is also 
important to the policy of this country and to addressing a 
chronic illness that is not going to get any better unless we 
actually do the research.
    Now, Dr. Rodgers, you talked about the importance of better 
understanding and diagnosing people who might have a proclivity 
to diabetes so we can address it before it becomes full-blown. 
Can you talk about the connection between gestational diabetes 
and whether that will then lead to diabetes later in life?
    Dr. Rodgers. Thank you, Senator. Gestational diabetes, 
which is, as the Senator indicated, the type of diabetes that 
occurs during pregnancy, affects some five to seven percent of 
all pregnancies. In certain ethnic groups, it may be as high as 
17 percent. As a result of NIH funding for this research, we 
know that the infant born during that pregnancy has a higher 
risk--not only does the mother have a higher risk of developing 
diabetes, but the infant born of that pregnancy compared to 
their siblings in which the mother did not have gestational 
diabetes has an increased risk of developing obesity and 
diabetes. In this particular case, it is Type 2 diabetes.
    Senator Shaheen. Right. Thank you. So it would behoove us 
to screen for gestational diabetes in every pregnant mother, 
right?
    Dr. Rodgers. Absolutely.
    Senator Shaheen. Mr. Sparks, you talked about inhaled 
insulin. I have never heard of inhaled insulin. Can you talk 
about how long you have had that and how that is different?
    Mr. Sparks. Yes, I can. I have been on inhaled insulin. It 
is called ``Afrezza.'' It has been on the market, I think, for 
a little over 2 years. Aaron Kowalski, who is the chief mission 
officer for JDRF, turned me on to it. He said this is something 
that was going on. I know it is not a lot out there, but it is 
really simple. There are no needles. You just have these little 
pods, and there is a little inhaler device that goes in. I find 
it to be--look, I do not know the science. I am an actor. I do 
not even play a doctor on TV.
    [Laughter.]
    Mr. Sparks. But I know that my experience of it is that it 
is very quick acting. It leaves the body very quickly, maybe an 
hour and a half after you use it. It does not store and then 
sneak up on you like later for some unknown reason. And it has 
been a big change for me. I love it. It does not seem to have 
the same low quality that I have had before when I was using 
vial insulin. So, yes, I love it. I sing its praises whenever I 
talk to anybody.
    Senator Shaheen. Thank you. My time is up. Thank you, Madam 
Chair.
    The Chairman. Thank you.
    Senator Warren?
    Senator Warren. Thank you, Madam Chair. Thank you once 
again for having this hearing, and thank you, Ranking Member 
Casey.
    I am going to meet with some Massachusetts folks this 
afternoon, but I do not know if there are any here today 
already. Well, there they are. OK, good. Good. I thought you 
would be louder than that. All right. It is good to see you. I 
hope I did not wake you up over there. OK, good. Good.
    But I am really glad that all of you are here, and I am 
glad that we are getting a chance to talk about Type 1 diabetes 
and to meet some of the people who are speaking out for the 
one-and-a-quarter million Americans who have Type 1 diabetes.
    I know that researchers all across the country are working 
hard to try to understand Type 1 diabetes and to develop better 
treatments on how to deal with it. There is even some talk of 
cure. And we have made a lot of progress with medicines and 
innovative devices that I think we have been talking about this 
morning, like insulin pumps and an artificial pancreas and 
inhalable insulin. That all happens because of our investments 
in biomedical research. But we know there is a lot more to do.
    So, Dr. Rodgers, I know you have already talked some about 
the artificial pancreas and how it has been a game changer for 
many of the people in this room. And you mentioned that NIH 
funding has been critical for several trials that have been 
able to get you in a position to push the envelope on what the 
artificial pancreas can do, including one led by researchers at 
Boston University and Massachusetts General Hospital. And I 
just wondered if you could just say one more word about the 
work that is being done, there in Massachusetts or anywhere 
else in the country, about how we are pushing out on the edges 
of research for diabetes.
    Dr. Rodgers. Absolutely, Senator. And that work that they 
have done, particularly in Boston--and then I will talk about 
the other places--they really have done some critical pivotal 
trials sort of in the real world. So, for example, they led 
trials looking at the Beacon Hill area and having people in the 
community living as normal an existence as possible as they 
were being monitored. They have had summer camps for young kids 
using these, and a lot of these were precursors to their 
current study that is on the way of this bihormonal pump, which 
includes both insulin as well as glucagon investigators.
    I had mentioned a little bit earlier but it does bear 
repeating that other investigators are looking at ways with the 
existing FDA-approved device to expand this in the pediatric 
population because currently it is only approved for 14 years 
of age. And we know that the better control of your blood sugar 
that you can get early on will lead to better improvements or 
risk reduction in complications later on in life.
    Senator Warren. I appreciate that. I think there are a 
bunch of people here under 14 who are rooting for you to get 
this done as quickly as possible. Are you guys ready for that, 
ready to do a little experimentation?
    [Applause.]
    Senator Warren. Yes, you have got to help here.
    Now, I want to put in a small plug because this research 
has been made possible by the National Institutes of Health, 
and it is vitally important that it continue, important to 
everyone in this room, important to all of your families, and 
important to people all across the country.
    We are grateful for your work, Dr. Rodgers, and grateful 
for the work of other researchers in this area. But we are also 
grateful to our fellow Americans whose tax dollars help make 
that research possible. And it is the reason that many of us 
oppose cuts to the National Institutes of Health. Even if the 
Special Diabetes Program is reauthorized, right now there are 
proposed cuts of over 20 percent in a single year, and that 
would knock out the legs from underneath the kind of innovation 
we are trying to build and the kind of innovation for new 
treatments and even cures for diabetes.
    So I just want to make the point that research takes money, 
and we need to support it in a sustained way. I know it is 
something that Senator Collins has been strong on, Senator 
Casey has been strong on, Senator Shaheen, Senator Donnelly. 
But we are going to need all of you to be out there and help 
support the National Institutes of Health because they support 
the research scientists who are going to make your lives a 
whole lot better. Thank you.
    Thank you, Madam Chair.
    [Applause.]
    The Chairman. Thank you, Senator.
    Before I adjourn the hearing and let all those who are 
sitting on the floor have an opportunity to get up and move 
about, I just wanted to ask Jonathan if he had anything that he 
would like us to know or to tell us about. I do not mean to put 
you on the spot, but since you did not get a chance to talk--I 
know that you are known for having a really positive attitude, 
and maybe you could share that with the other children who are 
here today. How do you keep such a great attitude? Sorry. I 
think I did put you on the spot.
    [Laughter.]
    Ms. Platt. How has your device helped with basketball?
    Mr. Platt. Well, my artificial pancreas has really helped 
with my basketball games because now when I get pulled out of 
basketball games, I do not always have to check my blood sugar 
to make sure it is ready for me to get back in, because before 
this device, when I was on the CGM and the pump, when I came 
out of games, I would always have to check and make sure it was 
right. If I was high, I would stay on the bench for an extended 
amount of time to make sure I get my mind ready to get back in 
the game. And if I was low, I would not be able to get back in 
the game at all until my blood sugar raised up, which since I 
was on the court a long time running up and down, it normally 
took a really long time for my blood sugar to start getting up. 
And I would have to wait until it got to like 150 in order to 
get back out, because if I got back on at like 120, I would 
just go low again in a matter of minutes.
    The Chairman. Thank you. That is really helpful.
    And as I am sure everybody here knows, but maybe not 
everyone watching knows, the artificial pancreas is in the 
midst of a clinical trial for younger children, so that it 
would be more widely available, and I am really looking forward 
to the results of that clinical trial as well. So thank you for 
sharing.
    Senator Shaheen. Madam Chair?
    The Chairman. Yes?
    Senator Shaheen. Could we ask Jonathan to maybe hold up his 
artificial pancreas? I think a lot of people do not know what 
we are talking about when we say that.
    The Chairman. Good idea. Wow, look at how tiny it is. That 
is amazing.
    Senator Shaheen. Can everybody see that? It is really 
small.
    The Chairman. Hold it up high.
    [Applause.]
    The Chairman. There you go. Thank you. And, Jonathan, you 
now just proved that you really are six-five.
    [Laughter.]
    The Chairman. So thank you for sharing your personal story, 
and thank you, Senator Shaheen. That was an excellent idea.
    I would like to thank each of our witnesses for being here 
today. You each added so much to our understanding.
    I want to end this hearing for my part by telling you how I 
got involved in this issue. I do not have any family members or 
close friends or relatives with Type 1 diabetes. I do have some 
friends who have it, but what got me involved was 20 years ago, 
when I was a brand-new Senator, and JDRF arranged for me to 
meet with a family who had a 10-year-old son with diabetes. I 
will never forget his looking up at me and saying that he 
wished that he could just take 1 day off from having diabetes, 
his birthday or Christmas. And that so touched me that when I 
came back to Washington, I said to my assistant at the time, 
``Is there a Diabetes Caucus in the Senate?'' And she said, 
``No. Only in the House.'' And I said, ``Well, guess what? 
There is going to be one now.''
    [Applause.]
    The Chairman. And the reason that I share that story with 
you is I want you to know what a difference you make when you 
come to Washington and meet with your Senators and your Members 
of the House. When you tell them what it is like to live with 
diabetes, it really helps us mobilize support for the research 
dollars that have made the artificial pancreas, continuous 
glucose monitors, and better pumps possible. So you and your 
advocacy make such a difference, and I know that from my 
personal experience. So please keep up the good work. It really 
makes a difference.
    Thank you all for traveling to Washington. Your commitment 
to this cause is truly extraordinary and inspiring.
    I would now like to turn to Senator Casey for any final 
thoughts he might have.
    Senator Casey. Madam Chair, thanks very much. We want to 
thank all of the witnesses, to Lorynn, Charlie, and Jonathan, 
Angie, Dr. Rodgers, Mr. Sparks, so many others who are here.
    Another suggestion I have, you know, we are worried about 
the budget cut to the National Institutes of Health, a big cut 
of billions of dollars. I thought, because Mr. Sparks is 
familiar with the White House, he could somehow get in there 
and get that and just cross it out of the budget document.
    [Laughter.]
    Senator Casey. Just a suggestion.
    But I am serious about the issue. In addition to the work 
we have to do to reauthorize the Special Diabetes Program, we 
have got to fight hard against the cuts to NIH. Fortunately, 
the opposition to those cuts is bipartisan. I think we can do 
that together. But all of our delegates will play a role in all 
of these issues.
    The stories that you tell about your own lives and your own 
challenges are going to be critically important in this debate. 
We are grateful you are with us today, and this is among the 
more enjoyable hearings we will ever have, despite all the 
challenges that you have and the stories that you told. Thank 
you and God bless you.
    The Chairman. Thank you.
    [Applause.]
    The Chairman. Committee members will have until Friday, 
August 11th, to submit questions for the record. Again, my 
thanks to JDRF, to all the delegates who inspire us, to our 
terrific panel of witnesses. Thank you so much for being here.
    This hearing is now adjourned.
    [Applause.]
    [Whereupon, at 10:55 a.m., the Committee was adjourned.]

     
      
=======================================================================


                                APPENDIX
      
      
=======================================================================


               Prepared Witness Statements for the Record

=======================================================================


      Prepared Statement of Paul Sparks, Actor, New York, New York
    Thank you, Chairman Collins, thank you, Ranking Member Casey, and 
the members of the Committee for inviting me to testify today. It's an 
honor for me to be here.
    I'll start by saying, I know how important the research supported 
by the Special Diabetes Program is because in my own lifetime as a 
person with type 1 diabetes, I have seen--and benefited--from the 
advances discovered in our labs, tested in our clinical trials, and 
brought to market.
    I was diagnosed with T1D when I was 27, living in New York, working 
as an actor--which also meant that I was working as a construction 
worker in order to pay my bills.
    Over the course of about seven or eight months, I lost about 45 
pounds. I noticed that I was going to the bathroom a lot. I was having 
muscle cramps all the time. I started not being able to see clearly. I 
was very thirsty--and constantly starving.
    Basically, my body was falling apart. Thankfully, I went home to 
Oklahoma to see my parents for Thanksgiving. I looked so grim, so thin 
and so unhealthy, that my mother almost had a heart attack when she saw 
me.
    Luckily, my brother was a medical resident at the time. Via a phone 
call, he recommended that I see a doctor soon, because it sounded like 
I had diabetes.
    Well, I did see a doctor the next day, and my brother was right.
    I spent the next few months trying to learn about T1D and figure 
out how to get the care I needed.
    As the kids and parents here know, this is an anxiety-producing 
disease. You are the patient but you are also, in many ways, the 
caregiver. You are responsible for keeping yourself healthy. And you 
have to stay on top of it; because if you don't, you will get very 
sick--or worse.
    That's why the research and advances in care are so important.
    Today, nearly 20 years after my diagnosis, I use inhaled insulin 
that quickly and safely brings my blood glucose back in range. And I 
wear a continuous glucose monitor, or CGM, that allows me to know at 
all times whether my glucose is going too high or too low so I can take 
action.
    These advances have transformed the quality of my life.
    I used to have to stash sugar on the set of plays I was in, in case 
I needed to stabilize my blood glucose. And I can tell you it's kind of 
strange when a character in a 18th century period drama pulls a bottle 
of orange juice out of a sofa cushion and starts chugging mid-dialog!
    Probably the most demonstrative example of how important these 
advances are: Three years ago, I turned off my GCM so that my very 
pregnant wife, Annie, could sleep peacefully through the night without 
any beeping, which occurs when my glucose level goes low. Because I'd 
switched it off, it did not alert me, I suffered a severe low blood 
sugar while asleep, and woke up to a frightened pregnant wife, a crying 
4-year old, and seven New York City EMTs standing over me.
    These new technologies, when they are turned on, and other research 
advances literally save my life every day and they save the lives of 
every one of these delegates. And we are at the cusp of a whole new 
generation of therapies, devices, and dare I say, a cure.
    That's why we can't let up on research. We need more advances--so 
we can cure and prevent T1D--so all of us, like Charlie, Lorynn and 
Jonathan who are here on the panel with me, can live life without 
thinking about this disease at all.
    We need to keep the momentum going by renewing the Special Diabetes 
Program before it expires at the end of September.
    I'll let others today go on about the science and the policies that 
support it. But let me just say this: this research has made a 
difference in my life--it has made a difference in the lives of 
everyone in this room--and millions more.
    So thank you, Chairman Collins, for your outstanding leadership, 
and thank you Ranking member Casey for your strong support of T1D 
research and coverage for technologies like the Continuous Glucose 
Monitor. It's great that people on Medicare now have access to CGMs 
just like the rest of us.
    And thank you and your colleagues for the bipartisan support of the 
Special Diabetes Program. It's doing great work for the millions of 
Americans living with this disease--like me.
    Thank you.

[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
  Prepared Statement of Charlie Albair, JDRF 2017 Children's Congress 
                         Delegate, Gray, Maine
    Chairman Collins, Ranking Member Casey, and Senators, thank you for 
inviting me to speak before you today.
    My name is Charlie Albair from Gray, Maine. I am 10-years old, and 
will be entering the 5th grade at Gray New Gloucester Middle School.
    I am just like a lot of other kids. I love sports, especially 
basketball and baseball. And when I grow up, I hope to play in the 
Major Leagues--for the Boston Red Sox.
    The one big difference is that I have type 1 diabetes or T1D.
    I was diagnosed with T1D way back when I was 6-years-old. I was in 
the first grade. I started not feeling like myself. I kept asking the 
teacher to go to the bathroom because I really, really had to. She got 
angry at me because she thought I just was trying to skip class.
    She felt bad when she found out the real reason.
    At first I was kind of confused when I was diagnosed. I didn't know 
what it was; ``diabetes'' was a big word for a first-grader.
    In the beginning, we treated my diabetes with syringes. And a half 
a year later, I got the Omnipod pump and then a CGM to monitor my sugar 
levels.
    I love it.
    I don't have to be constantly stabbing myself with a needle--like 
five or 10 times a day.
    What does this mean for me?
    When I first found out I had diabetes, I remember thinking that 
this would change my whole life. I thought that I wouldn't realize my 
dream of being a sports star.
    Now I can realize I can do whatever I want.
    Sometimes my Omnipod or CGM beeps in class, and the other kids say, 
``Charlie, stop making noise.'' I just tell them that that's my natural 
``robot'' noise.
    The pump and CGM are so much a part of me. But I do wish that they 
didn't have to be.
    I want my disease to go away--for me and all the other kids who 
suffer from it. I want us all to be able to live without thinking about 
it.
    That's why I am here.
    We need money for research.
    We need money so scientists can invent new pumps and monitors 
better than what we have now--and so they can come up with a cure for 
T1D.
    You have supported kids like me for so many years, and all I ask is 
that you continue to do so. And if you do, I will invite you to a game 
when I am on the Red Sox.
    Thank you.
                               __________

   Prepared Statement of Lorynn Watt, JDRF 2017 Children's Congress 
                  Delegate, Stroudsburg, Pennsylvania

    Chairman Collins, Ranking Member Casey, and Senators--thank 
you for inviting me to talk with you today.
    My name is Lorynn Watt, I am 17 years old, and this fall I 
will be a senior at Evergreen Community Charter School in 
Cresco, Pennsylvania.
    When I was nine, I was diagnosed with type 1 diabetes. I 
remember sitting on my parents' bed, just about a week before 
Halloween, as my mom and step-dad told me that I had T1D. That 
day they loaded me into the car and took me to the hospital, 
where I'd learn how to care for myself.
    At that point, I only knew about diabetes from an episode 
of Hannah Montana I saw just before I was diagnosed. That was 
it. What I did know was that I was scared, felt awful, and all 
of a sudden was living a life where I had to inject myself with 
insulin multiple times a day, even though I was horrified of 
needles.
    Then at 14, I got a continuous glucose monitor (or CGM) and 
an insulin pump. It made my life so much easier. Now, all I 
need to do is look at my phone--which most kids my age do all 
the time--and I can see my blood sugar. It has been life-
changing, and I hope this, the artificial pancreas, and other 
advances are small steps toward a cure.
    I've heard every year since I was diagnosed that in 5 years 
there will be a cure. I've had this disease for almost 8 years. 
Now, I'm no mathematician, but you can see that we are a bit 
behind schedule.
    I believe that with your help we can have a cure.
    After all, we already have come so far.
    I know this because my biological father also had T1D. He 
wasn't in my life much. He didn't have great care--no pump or 
CGM or even ability to check his blood sugar every day.
    So, he lost his foot, then his eyesight, and the use of his 
kidneys. He had to get a stent in his heart. And he died less 
than a year after my own T1D diagnosis, at just 38 years old.
    I am here today asking you to support more funding for more 
research because no one should have to suffer and lose their 
life because of T1D.
    I am here, inspired by his memory, and determined that none 
of the kids here today or sitting in a hospital room right 
now--scared--as they get their diagnosis, will have the same 
fate as my father.
    With your help, I know we can do it. I know we can find a 
cure.
    Thank you.
                              ----------                              

  Prepared Statement of Angie Platt, Chair Mom, JDRF 2017 Children's 
  Congress, Accompanied by her Son Jonathan Platt, Encino, California
    Chairman Collins, Ranking Member Casey, and Senators--thank you for 
inviting me to speak with you today.
    I am Angie Platt from Encino, California. My husband Jon and I have 
three children, all boys--twin 4 year olds and meet our oldest son 
Jonathan who is 14 years old.
    It's hard for me to believe that the 6'5'' young man sitting next 
to me is the same boy who was here for JDRF's 2011 Children's Congress. 
He was only 7 years old at the time, just 2 years into his diagnosis.
    If you watch him play in his competitive basketball tournaments, it 
would be very hard to believe that he is a child living with type 1 
diabetes.
    I am here today to tell you and your colleagues that Jonathan is 
living proof that your leadership and actions have made a real 
difference in our lives and the lives of all people with T1D.
    In 2011, the T1D community asked you for help, and Senators, you 
gave it. The Special Diabetes Program has provided hundreds of millions 
of dollars of crucial funding for a range of therapies and 
investigations--including the artificial pancreas.
    In April 2016, Jonathan was enrolled in the pediatric trial for the 
Medtronic Hybrid Closed Loop 670G--otherwise known as the ``artificial 
pancreas.'' We felt as if we won the lottery.
    This device has given Jonathan better blood sugar control than he 
has ever had--and it gives our family some desperately needed peace of 
mind. In the past, we would wake up at minimum 3 times a night to check 
my son's blood sugar. Jonathan used to have to stop practicing with his 
team or even sit out in a game because his blood sugars were too 
erratic. Now, he gets to play right through crunch time.
    As you know, last fall the FDA approved this artificial pancreas 
system.
    Senators, let me be clear: this would not have happened without 
your support of the Special Diabetes Program.
    Diabetes is relentless. We work so hard, we are so responsible, we 
are playing by all the rules. Jonathan is on the latest most advanced 
technology. Jonathan is doing everything right.
    But the ugly reality of diabetes is that as hard as we work, our 
kids are still vulnerable. This past June at Jonathan's eye exam it was 
discovered that Jonathan has three dot hemorrhages. Quite frankly, 
there are kids who are a lot worse off than Jonathan. Those of us here 
are among the lucky ones.
    I know that we have made progress; my son is wearing the first 
artificial pancreas system approved in the world! But this disease 
doesn't stop, so neither can we.
    We need the next generation devices that can fully automate insulin 
delivery.
    We need to ensure that progress continues in the area of diabetes 
complication treatments.
    We also need to prevent others from ever developing T1D--including 
my twin sons, Jonathan's brothers, who are at a higher risk of 
developing it. They are enrolled in TrialNet, an SDP-funded prevention 
program.
    SDP has done so much, but it will expire on September 30th. The SDP 
gives me so much hope, but it needs a hero. We need you and your Senate 
colleagues to renew it for another three years so researchers can 
continue their great work.
    Senators, I want to thank you for all that you have done to make my 
family's life and the lives of all of us here today better. Senator 
Collins, I particularly want to thank you for your steadfast commitment 
and outstanding leadership to advance type 1 diabetes research and to 
help people gain access to new technologies. You have been a champion 
for us for a long time.
    Look at Jonathan--he will not lose to diabetes.
    We will fight alongside Jonathan.
    We will fight for all of these kids.
    I ask you to continue to fight along with us.
    Thank you.
  

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