`[Senate Hearing 118-491]
[From the U.S. Government Publishing Office]




                                                        S. Hrg. 118-491

    ACCELERATING BREAKTHROUGHS: HOW THE SPECIAL DIABETES PROGRAM IS 
          CREATING HOPE FOR THOSE LIVING WITH TYPE 1 DIABETES

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

                                HEARING

                               before the

            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                    ONE HUNDRED EIGHTEENTH CONGRESS

                             FIRST SESSION

                               __________


                            SPECIAL HEARING

                     JULY 11, 2023--WASHINGTON, DC

                               __________



         Printed for the use of the Committee on Appropriations






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        Available via the World Wide Web: http://www.govinfo.gov


                               __________


                 U.S. GOVERNMENT PUBLISHING OFFICE

57-406 PDF                WASHINGTON : 2024









                      COMMITTEE ON APPROPRIATIONS

                    PATTY MURRAY, Washington, Chair

DIANNE FEINSTEIN, California         SUSAN M. COLLINS, Maine, Vice 
RICHARD J. DURBIN, Illinois              Chair
JACK REED, Rhode Island              MITCH McCONNELL, Kentucky
JON TESTER, Montana                  LISA MURKOWSKI, Alaska
JEANNE SHAHEEN, New Hampshire        LINDSEY GRAHAM, South Carolina
JEFF MERKLEY, Oregon                 JERRY MORAN, Kansas
CHRISTOPHER A. COONS, Delaware       JOHN HOEVEN, North Dakota
BRIAN SCHATZ, Hawaii                 JOHN BOOZMAN, Arkansas
TAMMY BALDWIN, Wisconsin             SHELLEY MOORE CAPITO, West 
CHRISTOPHER MURPHY, Connecticut          Virginia
JOE MANCHIN, III, West Virginia      JOHN KENNEDY, Louisiana
CHRIS VAN HOLLEN, Maryland           CINDY HYDE-SMITH, Mississippi
MARTIN HEINRICH, New Mexico          BILL HAGERTY, Tennessee
GARY PETERS, Michigan                KATIE BRITT, Alabama
                                     MARCO RUBIO, Florida
                                     DEB FISCHER, Nebraska

                     Evan D. Schatz, Staff Director
              Elizabeth McDonnell, Minority Staff Director








                            C O N T E N T S

                              ----------                              
                                                                   Page

Opening Statement of Chair Patty Murray..........................     1
Statement of Vice Chair Susan M. Collins.........................     2
Statement of Griffin P. Rodgers, MD, M.A.C.P., Director, National 
  Institute of Diabetes and Digestive and Kidney Diseases, 
  National Institutes of Health..................................     5
    Prepared Statement...........................................     7
Statement of Aaron J. Kowalski, Ph.D., Chief Executive Officer, 
  JDRF...........................................................    13
    Prepared Statement...........................................    14
Statement of James ``Jimmy Jam'' Harris, Award-Winning Music 
  Producer and Philanthropist....................................    18
    Prepared Statement...........................................    19
Statement of Maria Muayad, JDRF 2023 Children's Congress Delegate    20
    Prepared Statement...........................................    21
Statement of Elise Cataldo, JDRF 2023 Children's Congress 
  Delegate.......................................................    22
    Prepared Statement...........................................    23
Conclusion of Hearing............................................    40









 
    ACCELERATING BREAKTHROUGHS: HOW THE SPECIAL DIABETES PROGRAM IS 
          CREATING HOPE FOR THOSE LIVING WITH TYPE 1 DIABETES

                              ----------                              


                         TUESDAY, JULY 11, 2023

                                       U.S. Senate,
                               Committee on Appropriations,
                                                    Washington, DC.
    The committee met at 10:07 a.m. in room SD-106, Dirksen 
Senate Office Building, Hon. Patty Murray (chair) presiding.
    Present: Senators Murray, Tester, Baldwin, Murphy, Manchin, 
Peters, Collins, Murkowski, Moran, Boozman, Capito, Kennedy, 
Hyde-Smith, Britt, and Fischer.


                opening statement of chair patty murray


    Chair Murray. Good morning. This hearing of the Senate 
Appropriations will please come to order.
    We are here for a very important reason, and the first is 
to thank all of the young people who are here today for your 
commitment to coming and fighting for yourself and for many 
others to talk about the Special Diabetes Program (SDP) and its 
critical work that supports life-saving research for millions 
of kids and people across our country and the world who are 
living with type 1 diabetes (T1D). And in particular, we are 
here today to hear from kids living with type 1 diabetes about 
why this program matters.
    So before I get started, I want to welcome all of you to 
Washington, DC, and to Congress. I know many of you have 
traveled from all over the country to be here today. And I want 
you to know that your voices make a huge difference in making 
sure that Congress takes action to treat and eventually cure 
type 1 diabetes. And the Special Diabetes Program plays a 
crucial role in fighting this disease because it supports NIH 
(National Institutes of Health) research into type 1 diabetes 
that has led to breakthroughs in diabetes prevention and 
treatment.
    Given this program does so much good for so many families 
back home, it should be no surprise that it has strong 
bipartisan support here in Congress. I was pleased to work with 
Senator Alexander to reauthorize this program back in 2020 when 
we led the HELP (Health, Education, Labor and Pensions) 
Committee together.
    And Vice Chair Collins is such a tremendous leader in that 
effort and is a tireless champion on this issue as Co-Chair of 
the Diabetes Caucus, along with Senator Shaheen. So I am very 
glad to have Vice Chair Collins who will lead this hearing 
today. I have heard from so many patients fighting this 
disease. It can be really hard. Here in Congress, we need to 
make things easier and give people hope and show we are serious 
about breakthroughs to prevent, treat, and cure diabetes. That 
includes continuing to authorize this crucial program and to 
support it and, hopefully, reauthorize it again this year.
    And we also need to make life-saving insulin affordable for 
everyone, something Senator Collins and Senator Shaheen are 
working tirelessly on.
    I am going to keep pushing to grow the bipartisan momentum 
that we have for fighting this disease with everything we've 
got. And I know with the incredible advocates from this year's 
Children's Congress, we are going to keep making progress. We 
are going to keep investing in life-changing research and, 
eventually, cure type 1 diabetes.
    And on that note, I am very proud to turn it over--the 
gavel--to Vice Chair Collins who will lead this hearing.
    Senator Collins.


                statement of vice chair susan m. collins


    Vice Chair Collins. Well, before Senator Murray has to 
leave, I want to first thank you for your leadership on this 
issue and for allowing me to share the honor of chairing this 
important hearing.
    Good morning, everyone. And welcome to our Nation's 
Capitol. This is our 12th Children's Congress and the first 
since the pandemic. It is wonderful to host you and your 
families at the Senate Appropriations Committee. And again, I 
want to especially thank our Chair for sharing the honor of 
chairing this Children's Congress.
    As the founding Co-Chair of the Senate Diabetes Caucus, I 
have long promoted diabetes research as one of my top 
priorities. Your advocacy for the life-changing research to 
prevent, treat, and one day cure diabetes--type 1 diabetes--
motivates me.
    I think of all the terrific children with type 1, whom I 
have met over the years. Many I have watched grow up. Children 
like Aidan Sweeney, whom I first met at age 4, and he turned 21 
this year; Ruby Whitmore, a young teen who is my summer 
neighbor; Nicole Wiesendanger is a Maine teacher who has lived 
with diabetes for more than 35 years, and she is married to my 
nephew; and so many more including our Maine delegate who will 
be testifying shortly. You inspire me. You inspire all of us.
    More than 160 delegates have traveled to Washington from 
every State in the Union and five foreign countries. In fact, 
this morning, I met someone from the United Kingdom who is here 
as well. You are all here to share your personal stories with 
Members of Congress. You will tell us what it is like to live 
with type 1 diabetes, and why it is critical for Congress to 
fund the research necessary to discover better treatments, more 
effective technology, and one day, a cure. Your personal 
stories really matter. They motivate Senators and 
Representatives to get involved in the cause.
    And I want to tell you my personal story of how I got 
involved. One of the very first meetings I had as a brand-new 
Senator in 1997 was with families who had children with type 1. 
I will never forget this 10-year-old boy looking up at me and 
saying, ``Senator Collins, I wish I could just take one day off 
from having diabetes--Christmas or my birthday.'' And of 
course, he never can. And that is why I started the Bipartisan 
Senate Diabetes Caucus that very year.
    Since then, Federal funding for diabetes research has 
almost quadrupled. The Federal Government now invests more than 
$1.2 billion for diabetes research each year. Funding, as the 
Chair mentioned, for the Special Diabetes Program in 
particular, has contributed to phenomenal discoveries, 
including several advances since we last convened. For example, 
research conducted by the SDP-funded TrialNet Program 
demonstrated for the first time that early preventive treatment 
with a drug targeting the immune system can delay the onset of 
clinical T1D for some at-risk individuals. The FDA (U.S. Food 
and Drug Administration) also approved the first cell therapy 
to treat individuals with type 1. SDP supported clinical trial 
data that contributed to that advancement.
    Technology has also advanced. I remember the very first 
Children's Congress that I chaired. We did not have continuous 
glucose monitors back then, or artificial pancreas systems. 
People had big bulky pumps with them; they were checking their 
blood sugar; they were taking injections. We have come a long 
ways.
    Another important component of the Special Diabetes Program 
supports prevention and treatment services for American Indians 
and Alaska Natives who experience type 2 diabetes at nearly 
three times the national average. Without an extension, both 
programs are at risk of expiring at the end of this fiscal 
year. That is September 30th.
    So, we simply must pass legislation to reauthorize the SDP. 
It has strong bipartisan support. Sixty Senators signed a 
letter, that Senator Shaheen and I authored, to Senate leaders 
advocating for this program. So, please ask your Senators and 
your Representatives to support the extension of this vital 
program.
    And there is encouraging news. Just last month, the Senate 
Health Education Labor and Pensions Committee, on which the 
Chair and I both serve, overwhelmingly approved the SDP 
Reauthorization Act that I introduced with Senator Shaheen. Our 
bill would fund both components of the Special Diabetes Program 
through December 2025. And here is the good news. Our bill 
contains a $20 million annual increase per program, and that 
would be the first increase in 20 years. So let us get that 
done.
    Finally, let me touch on another pressing issue which the 
Chair mentioned. And that is insulin affordability. And I know 
that many of you will be educating Members about this today.
    As some of you have experienced firsthand, the cost of 
insulin has soared in recent years, and this life-saving 
treatment has become unaffordable for far too many individuals 
with diabetes. So, we need comprehensive legislation to reform 
the whole insulin market, and we need to put a monthly cap on 
the cost. And that is what legislation Senator Shaheen and I 
have introduced would do.
    Let me just close by saying, it is so inspiring to look out 
and see that wave of blue in town today. When I was coming in 
to work this morning, I met a whole group of you and it lifted 
my spirits immediately. It is inspiring. Your passion and 
advocacy, your hope for a cure are contagious. Together, I am 
confident that we will continue our progress and achieve that 
goal. Thank you.
    And I now have a brief statement from the Co-Chair of the 
Diabetes Caucus, Jean Shaheen of New Hampshire. She has a 
constituent who is going to be testifying before us today.
    Here is what Senator Shaheen said.
    [The following statement was read by Vice Chair Collins for 
Senator Shaheen:]

            I welcome all the witnesses, and the more than 160 
        advocates that have traveled to Washington, DC, to 
        participate in today's 12th Annual Children's Congress. 
        Your relentless efforts to find a cure for type 1, and 
        for all those living with the disease including my 
        granddaughter, are an inspiration.
            In particular, I want to welcome Elise Cataldo and 
        her family, from New Hampshire, whom I had the pleasure 
        of meeting in our state. Elise is among the very best. 
        There is no better advocate for those living with type 
        1.
            I urge my colleagues to listen to each witness 
        closely, truly hear their stories, and finally act on 
        legislation to improve the lives of those living with 
        type 1. That means increasing investments and research 
        to find a cure, such as the Special Diabetes Program 
        Reauthorization Act authored by Senator Collins and 
        myself, but it also means passing legislation to 
        comprehensively and permanently solve insulin 
        affordability, namely our Bipartisan Insulin Act which 
        Senator Collins and I authored.

    Vice Chair Collins. It is kind of weird to refer to myself 
in third person, but I am reading Senator Shaheen's statement.
    [Laughter.]
    [The statement continues:]

            Until the day comes when we finally have a cure, no 
        patient should be forced to risk their lives rationing 
        their daily insulin. Thank you again for coming today 
        to share your stories. I wish you a productive and 
        memorable Children's Congress, and hope to see you 
        again in DC very soon.

    Vice Chair Collins. Thank you, Senator Shaheen, for that 
statement.
    Well, thank you all for being here. And if there are any of 
our Members who want to make a very brief statement before we 
turn--are we all set? All right, we will introduce our 
witnesses.
    Our first witness today is Dr. Griffin Rodgers, the 
Director of the National Institute of Diabetes and Digestive 
Kidney Diseases (NIDDK) at the National Institutes of Health. 
He is no stranger to our Committee. He is a familiar face to 
the Children's Congress. He assumed his current position in 
2007. He has testified before us at each and every Children's 
Congress. And I admire him so much, and I am delighted to 
welcome him back.
    Next, we will hear from Dr. Aaron Kowalski, the President 
and CEO (Chief Executive Officer) of JDRF. He is the first 
person with type 1 diabetes to lead JDRF. We had the pleasure 
of having Dr. Kowalski testify as part of the 2019 Children's 
Congress, that was the last one we had before the pandemic, and 
I am delighted to welcome him back. Prior to his appointment as 
President, he served as JDRF's Chief Mission Officer. That 
means he oversaw significant advances in diabetes research.
    Now, our next witness comes to us from a very different 
background, R&B (rhythm and blues) songwriting and music 
productions. I am pleased to welcome ``Jimmy Jam'' Harris to 
testify before our Committee. Jimmy Jam is an award-winning 
music producer who has been inducted into the Rock and Roll 
Hall of Fame. His son, Max, was diagnosed with type 1 diabetes 
at 2 years old. Jimmy Jam is here to advocate on behalf of Max, 
who is now a thriving young adult and is sitting right over 
there, and to inspire other kids and teens living with 
diabetes.
    And with due respect to those three wonderful witnesses, we 
are then going to hear from the stars of the show. We are going 
to hear from two delegates. First, Maria Muayad--I practiced 
all this.
    [Laughter.]
    Vice Chair Collins. Maria Muayad--there I did it--from 
Yarmouth, Maine. Maria is 10 years old and was diagnosed with 
type 1 diabetes when she was 7. She is proud to be a type 1 
diabetes advocate and has helped to increase awareness at her 
school.
    We will also then hear from Elise Cataldo from New 
Hampshire. Elise does not remember life without diabetes since 
she was diagnosed at just over a year old. But she has not let 
type 1 diabetes hold her back. She is an extremely active 
teenager. She is an extraordinary athlete playing soccer, 
basketball, and lacrosse. Outside of school and sports, Elise 
is passionate about educating those around her about life with 
T1D.
    Thank you all for joining us. And we will start with Dr. 
Rodgers.
    Thank you Dr. Rodgers.

STATEMENT OF GRIFFIN P. RODGERS, MD, M.A.C.P., 
            DIRECTOR, NATIONAL INSTITUTE OF DIABETES 
            AND DIGESTIVE AND KIDNEY DISEASES, NATIONAL 
            INSTITUTES OF HEALTH
    Dr. Rodgers. Thank you so much. Chair Murray, Vice Chair 
Collins, Senator Shaheen, Members of the Committee, thank you 
for this invitation to testify, and for your support of type 1 
diabetes research. Research supported through the Special 
Diabetes Program, or SDP, has ushered in a new era of type 1 
diabetes management and continues to improve the lives of 
people living with this disease.
    I would like to recognize my fellow witnesses. All of you, 
everyone here today are true champions in advancing diabetes 
research. NIH's clinical research studies would not be possible 
without the participation and support of people like you, and 
those you represent across this country. Thank you.
    This year we celebrate the SDP's silver anniversary. For 25 
years, SDP-supported research has sought ways to prevent, 
treat, and cure type 1 diabetes and its complications. This 
enduring investment has enabled us to take on challenges beyond 
what we could support with NIH's regular appropriations and to 
perform critical trials unlikely to be done by the private 
sector.
    There is much progress to report since I last testified 
here in person 4 years ago. In November of 2022, the FDA 
approved the first early preventive treatment that can delay 
clinical diagnosis of type 1 diabetes for at least 3 years. 
That is 3 years without having to take insulin or you check 
your blood glucose, 3 years toward preventing or delaying 
diabetes complications.
    Key research underlying this landmark approval stem from 
clinical trials conducted by SDP-supported type 1 diabetes 
TrialNet. That trial was made possible by decades of NIH- and 
SDP-supported research by TrialNet and others that built a 
paradigm shift in understanding of how type 1 diabetes 
progresses from normal glucose levels to clinical disease.
    That knowledge also helped identify potential therapies and 
made prevention trials possible. TrialNet continues to test new 
prevention approaches with trials ongoing and others ready to 
launch. There has also been significant progress on ways to 
ease the burden of daily glucose management.
    When I first testified about type 1 diabetes 16 years ago, 
the goal was clear: Get an artificial pancreas device into the 
hands of those who need it. Now, we have six artificial 
pancreas devices on the market. Five of these had SDP support, 
and two of those devices the SDP supported both the development 
and clinical trials underscoring the value of long-term 
research support. Importantly, some of these devices are 
approved for children as young as 2, which can be life-changing 
for them and for their families. Looking into the future, NIDDK 
is supporting the development of the next generation of 
artificial pancreas devices, including fully automated systems. 
Toward this goal of a bionic pancreas which requires minimal 
user input and can automate insulin doses, one was just 
approved just this May. Another research focus is ensuring that 
new devices benefit all including groups that are understudied 
by industry.
    Finally, we continue to search for a biological cure for 
type 1 diabetes, a high priority for people with the disease 
and their families. This includes research to understanding how 
insulin producing beta cells are lost, and how they can be 
protected and replaced. Scientists are gaining new insights 
into how beta cell develop, finding ways to make replacements 
in the lab. And they are also devising ways to protect lab-
grown cells from the body's immune attack.
    You might be interested to know that SDP-funded research 
also provides benefits beyond type 1 diabetes. Blood glucose 
management technologies benefit those with type 2 diabetes, as 
does research on complications that affects organs, like the 
heart and the eyes. These broad benefits will expand as 
cutting-edge technology< such as artificial intelligence and 
machine learning, are applied to the big data that is being 
generated by SDP-supported studies.
    On the silver anniversary of the SDP, we celebrate the 
incredible progress made possible by this program and recognize 
the SDP value as a long-term investment in health. But we must 
continue to build on our remarkable progress. We look forward 
to achieving our ultimate goal: Preventing and curing type 1 
diabetes.
    Thank you. And I will be pleased to answer questions when 
time is available. Thank you.
    [Applause.]
    [The statement follows:]

        Prepared Statement of Griffin P. Rodgers, M.D., M.A.C.P.
    Chair Murray, Vice Chair Collins, and Members of the Committee, as 
Director of the National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK), I thank you for your invitation to testify at this 
hearing on type 1 diabetes. On behalf of NIDDK and the other Institutes 
and Centers of the National Institutes of Health (NIH) within the U.S. 
Department of Health and Human Services (HHS), I am honored to be here 
today to update you on recent scientific advances and future research 
opportunities in type 1 diabetes and its complications, including 
research supported by the Special Statutory Funding Program for Type 1 
Diabetes Research (Special Diabetes Program).
    Diabetes takes an enormous personal and economic toll on our 
country, but we are making great strides in reducing that burden 
through the support of biomedical research. NIH invests over $1 billion 
a year in diabetes research, and NIDDK supports the majority of that 
research, including studies on both prevention and treatment of type 1 
diabetes, type 2 diabetes, gestational diabetes, and diabetes 
complications. This NIH investment includes funding from the Special 
Diabetes Program, which has enabled the agency to expand type 1 
diabetes research beyond what is possible with our regular 
appropriations and to conduct clinical trials that were unlikely to 
have been performed in the private sector. NIH's efforts also have been 
complemented by our research partners--academic institutions; the U.S. 
Food and Drug Administration (FDA); the Centers for Disease Control and 
Prevention (CDC); and charitable, professional, and patient advocacy 
groups such as JDRF, the Endocrine Society, the American Diabetes 
Association (ADA), and the Leona M. and Harry B. Helmsley Charitable 
Trust.
    The important progress I will discuss today has only been possible 
through the invaluable support of Congress, the hard work of our 
researchers, and the dedication of our clinical study participants. 
Together, we are all working toward the goal of helping those with type 
1 diabetes live longer, healthier lives.
           improving the lives of people with type 1 diabetes
    Type 1 diabetes can arise at any age, but it often begins in 
childhood or adolescence. It is an autoimmune disease, where the immune 
system attacks and destroys the insulin-producing beta cells in 
clusters called islets in the pancreas. Since their pancreas cannot 
make enough insulin, people with type 1 diabetes (or their caregivers) 
must monitor their blood glucose (sugar) levels, administering insulin 
as needed depending on their food intake, physical activity levels, and 
other factors. This is an enormous and relentless burden, and despite 
constant vigilance, keeping blood glucose levels in a healthy range day 
in and day out is a challenge. NIDDK-supported studies have shown that 
early, intensive management of blood glucose levels can prevent or 
delay the development of devastating complications such as eye, kidney, 
nerve, and heart disease. Therefore, it is imperative that we continue 
to develop effective ways to prevent and treat type 1 diabetes, and 
that we search for a cure.
    Furthermore, the SEARCH for Diabetes in Youth study, supported by 
CDC and NIDDK, has reported that type 1 diabetes incidence is 
increasing in youth under age 20 in the United States. Also, the rates 
of increase were higher among racial and ethnic minority groups, such 
as non-Hispanic Black and Hispanic youth.\1\ These findings underscore 
a major goal in NIDDK's management of the Special Diabetes Program: to 
identify ways to overcome barriers to using new treatments and 
technologies. New research advances should benefit all people with type 
1 diabetes, regardless of where they live, their socioeconomic status, 
their age, their race or ethnicity, or their medical status. Yet 
individuals from backgrounds traditionally underrepresented in research 
can also have more difficulty managing blood glucose levels and can 
have worse health outcomes and more complications. People with a 
history of high blood glucose levels or with frequent episodes of 
hypoglycemia (low blood glucose) also can be ineligible to participate 
in some clinical research studies, leaving open questions about whether 
a new approach will work for people with complex, ``real-world'' 
experiences and needs.
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    \1\ https://pubmed.ncbi.nlm.nih.gov/36868256
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    NIH is pursuing a multi-pronged approach to type 1 diabetes 
research, focusing on key questions such as: how can we prevent this 
disease, how can we improve treatment, and how can we develop a cure? 
As the Special Diabetes Program celebrates its 25th anniversary this 
year, I am happy to report that Congress' investment in the Program has 
led to life-changing improvements for people with the disease. When I 
testified at the 2015 Children's Congress, there were no artificial 
pancreas devices on the market. Today, there are six, with still more 
under FDA review. Some of these devices are now available to children 
as young as 2 years old, which is a tremendous advance given that it 
can be difficult to manage blood glucose levels in young children. As 
of the last Children's Congress in 2019, there were no therapies on the 
market to slow type 1 diabetes progression. Now, we have an FDA-
approved medication that delays clinical diagnosis of type 1 diabetes. 
These are only two examples of how the Special Diabetes Program has 
helped improve the lives of those with type 1 diabetes. There is much 
more progress to report, and a lot of work still to be done.
         preventing type 1 diabetes initiation and progression
    Preventing type 1 diabetes has been a long-standing goal of NIH-
funded research. I am pleased to report that long-term research 
supported by the NIH and the Special Diabetes Program recently 
culminated in the FDA approval of the first early, preventive treatment 
that can delay clinical diagnosis of type 1 diabetes. In November 2022, 
FDA approved the use of the immune-modulating drug teplizumab to delay 
progression of type 1 diabetes in those 8 years and older who are at 
high risk of developing the disease.\2\
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    \2\ https://www.fda.gov/news-events/press-announcements/fda-
approves-first-drug-can-delay-onset-type-1-diabetes
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    Key research underlying this FDA approval stemmed from a clinical 
trial conducted by the NIDDK--and Special Diabetes Program--supported 
Type 1 Diabetes TrialNet, which is a large, collaborative, 
international consortium designed to perform clinical trials of 
therapies to delay or prevent type 1 diabetes progression. The clinical 
trial found that teplizumab delayed type 1 diabetes onset by over 32 
months.\3\ This important finding has ushered in a new era of type 1 
diabetes clinical management, allowing nearly 3 years without having to 
take insulin and nearly 3 years toward preventing or delaying 
complications. The landmark FDA approval of teplizumab based on these 
clinical trial results underscores the importance of TrialNet, which 
continues to be a unique and critical network for testing novel type 1 
diabetes preventive therapies.
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    \3\ https://pubmed.ncbi.nlm.nih.gov/31180194, https://
pubmed.ncbi.nlm.nih.gov/33658358
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    This clinical trial was made possible by decades of NIH--and 
Special Diabetes Program--supported research on teplizumab, and by 
other research to understand how type 1 diabetes progresses and to 
identify potential therapeutic targets and agents. For example, it 
built on research conducted by the Immune Tolerance Network, led by the 
National Institute of Allergy and Infectious Diseases (NIAID) with 
Special Diabetes Program support, showing that teplizumab delayed the 
loss of insulin production in people with newly diagnosed type 1 
diabetes. Additionally, for many years, NIDDK has invested in research 
looking for ways to reliably identify those at risk for type 1 
diabetes. Data from TrialNet and a long-term clinical research study 
called The Environmental Determinants of Diabetes in the Young (TEDDY) 
have been critical to understanding and identifying markers of the 
early stages of type 1 diabetes. Thanks to these studies and others, we 
now know that there are distinct stages of type 1 diabetes, several of 
which happen before symptoms appear. Being able to identify those in 
these early stages of type 1 diabetes before their disease progresses 
to clinical diagnosis has enabled testing of type 1 diabetes prevention 
therapies, such as teplizumab. To this end, TrialNet has screened over 
200,000 people, identifying those at risk of type 1 diabetes who are 
eligible to enroll in clinical trials testing ways to prevent disease 
onset or slow its progression.
    TrialNet is now testing multiple agents, as well as combination 
therapies, in those at high risk of type 1 diabetes and in the newly 
diagnosed, with new trials ready to launch. Researchers outside 
TrialNet are also testing another promising treatment: the blood 
pressure medication verapamil. A small clinical trial supported by the 
Special Diabetes Program has found that in people newly diagnosed with 
type 1 diabetes, taking oral verapamil can delay disease progression 
and lower insulin requirements for at least 2 years.\4\ Due to these 
and other advances, I am happy to report that the long-term goal of 
preventing type 1 diabetes is now closer than ever, thanks to decades 
of dedicated work from scientists and clinical trial participants.
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    \4\ https://pubmed.ncbi.nlm.nih.gov/35241690
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              understanding the causes of type 1 diabetes
    Understanding the causes of type 1 diabetes could also help 
identify and advance new prevention strategies. We know that a person's 
risk for developing type 1 diabetes is dependent on both genetic and 
environmental factors. We now know over 90 percent of the genetic 
contributions to type 1 diabetes risk in those of European ancestry, 
who have the highest prevalence of the disease. We also continue to 
expand our knowledge of type 1 diabetes in those with other 
backgrounds, and a recent large, ancestrally diverse study identified 
36 new gene regions associated with type 1 diabetes, offering potential 
new drug targets to treat or prevent disease.\5\
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    \5\ https://pubmed.ncbi.nlm.nih.gov/34127860
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    But genetics is only part of the story, and a person's environment 
and environmental exposures also play a role in their risk of 
developing type 1 diabetes. Identifying these environmental influences 
will give us a better understanding of the disease and may point to new 
prevention strategies.
    To identify these environmental components of type 1 diabetes risk, 
NIDDK, through the Special Diabetes Program, supports an ambitious, 
long-term clinical research study called TEDDY. TEDDY has screened over 
425,000 newborns, enrolling 8,000 who were at high genetic risk of type 
1 diabetes. These children are being followed until they are 15 years 
old, and they and their families have donated over 4 million biological 
study samples to date. The youngest TEDDY participant will turn 15 in 
2025, at which point final data analyses can begin. In the meantime, 
the TEDDY study is generating insights made possible by analysis of the 
``big data'' collected by such a large study. TEDDY researchers are 
looking at genes, proteins, and metabolites and are also studying the 
children's microbiomes, viromes, and environmental exposures to 
understand how these evolve during childhood and how they might 
influence disease. Analyses of these factors have yielded new insights 
into how the microbes in a child's gut change as they age, and how 
those changes are affected by breastfeeding.\6\ Various TEDDY findings 
have also allowed researchers to construct a risk score tool that uses 
both genetic and immune factors to predict an individual's risk of type 
1 diabetes. Finally, new research is also illustrating how type 1 
diabetes is not a single disease but a ``heterogeneous'' one that does 
not progress the same for every person. For example, type 1 diabetes 
diagnosed before 6 years of age is more aggressive than that diagnosed 
in older children, and these two different courses of disease are 
associated with specific autoimmune reactions.\7\ These important 
findings could lead to more personalized preventive strategies in the 
future as we move toward the goal of precision medicine.
---------------------------------------------------------------------------
    \6\ https://pubmed.ncbi.nlm.nih.gov/30356183, https://
pubmed.ncbi.nlm.nih.gov/30356187
    \7\ https://pubmed.ncbi.nlm.nih.gov/34291312
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developing approaches to improve glucose management and quality of life
    For people already diagnosed with type 1 diabetes, keeping blood 
glucose levels within a healthy range is a key step to maintaining good 
health. NIDDK-supported research has demonstrated that intensely 
managing blood glucose levels, beginning as soon as possible after a 
type 1 diabetes diagnosis, can prevent or delay the development of 
long-term complications of the eyes, kidneys, nerves, heart, and other 
organs. However, intensive management also brings with it the risk of 
potentially dangerous and distressing episodes of hypoglycemia. New 
tools and approaches to glucose management--and ways to ensure that 
these new technologies meet peoples' real-world requirements--are 
critically needed.
    The Special Diabetes Program has supported pivotal research in this 
area by contributing to the development of glucose management 
technologies, including artificial pancreas systems that automate 
insulin delivery in response to blood glucose levels. This support has 
successfully moved devices out of the lab and into peoples' daily 
lives. In the last 8 years, the number of commercially available, FDA-
approved artificial pancreas devices has increased from zero to six, 
offering people with type 1 diabetes more tools to manage their health.
    I am pleased to report that NIDDK and Special Diabetes Program-
supported research contributed to the development or testing of five of 
the six commercial devices, demonstrating the impact that research has 
had on improving the health and quality of life of people with type 1 
diabetes. For example, the Special Diabetes Program supported 
development of the technology underlying the Control-IQ hybrid 
artificial pancreas system, and then later supported clinical trials 
demonstrating the system's effectiveness at managing blood glucose 
levels in both children and adults. This research helped support FDA 
approval of Control-IQ technology for people with type 1 diabetes who 
are 6 years old and older.\8\ Further Special Diabetes Program-
supported research has since tested the safety and efficacy of this 
device in children as young as 2 years old.\9\
---------------------------------------------------------------------------
    \8\ https://www.fda.gov/news-events/press-announcements/fda-
authorizes-first-interoperable-automated-insulin-dosing-controller-
designed-allow-more-choices
    \9\ https://pubmed.ncbi.nlm.nih.gov/36920756
---------------------------------------------------------------------------
    We are also looking ahead to developing the next generation of 
artificial pancreas systems. As mentioned earlier, the Special Diabetes 
Program plays a unique role in expanding our knowledge of how new 
glucose management technologies can benefit all with type 1 diabetes, 
with the goal of having multiple artificial pancreas technologies 
available to fit people's individual needs. An example of this is 
studying the use of these devices during pregnancy or in populations 
where managing blood glucose levels is particularly challenging, such 
as very young children and people with high hemoglobin A1c (HbA1c) 
levels (a measure of average blood glucose levels).
    A recent Special Diabetes Program-supported clinical trial is a 
successful example of the benefits of studying advanced artificial 
pancreas devices in groups that are representative of the type 1 
diabetes community. This trial demonstrated that the iLet bionic 
pancreas device--which requires minimal user input and handles dosing 
decisions autonomously--improved blood glucose management for a diverse 
group of children and adults, keeping their blood glucose levels in a 
healthy range better than standard care.\10\ This trial specifically 
sought to recruit volunteers from a variety of backgrounds, including 
people with lower income and education levels, those from previously 
underrepresented racial and ethnic groups, and people with high HbA1c 
levels that put them at increased risk for developing long-term 
complications. As a result, this trial found that people from all 
backgrounds benefitted from use of the bionic pancreas, including those 
who had never used an artificial pancreas device previously. 
Additionally, those who had more difficulty managing blood glucose 
levels at the study's start appeared to benefit most from using the 
bionic pancreas, reducing racial and ethnic disparities in average 
HbA1c levels.\11\
---------------------------------------------------------------------------
    \10\ https://pubmed.ncbi.nlm.nih.gov/36170500
    \11\ https://pubmed.ncbi.nlm.nih.gov/37000680
---------------------------------------------------------------------------
    Of note, the artificial pancreas research community is a prime 
example of the power of teamwork, and we look forward to continued 
collaboration with our partners who have advanced this field. Just this 
past May, NIH hosted the 5th Artificial Pancreas Workshop organized 
collaboratively with the Diabetes Technology Society, the Helmsley 
Charitable Trust, JDRF, and FDA to discuss the current and potential 
future challenges in this field.
    NIDDK also continues to support academic and small business 
investigators at all stages to build upon past successes and advance 
research into innovative blood glucose management tools, including 
artificial pancreas systems. This includes supporting development of 
new technologies such as sensors, pumps, and algorithms; clinical 
trials to test safety and efficacy; and research into behavioral, 
psychosocial, and other ``human'' factors that affect peoples' ability 
to use these new technologies. One example of the positive impact this 
support has had on people's lives is the Special Diabetes Program-
supported development of an improved glucagon formulation that does not 
require refrigeration. This research resulted in a ready-to-use rescue 
pen that is now commercially available to treat low blood glucose, a 
daily concern for people with type 1 diabetes.\12\
---------------------------------------------------------------------------
    \12\ https://xerispharma.gcs-web.com/news-releases/news-release-
details/xeris-pharmaceuticals-receives-us-fda-approval-gvoketm-glucagon
---------------------------------------------------------------------------
                      restoring beta cell function
    Technologies for managing type 1 diabetes are important tools for 
alleviating the burden of this disease, but they are not a cure. 
Finding a biological cure for type 1 diabetes--a way to restore the 
body's ability to produce insulin and regulate blood glucose levels--is 
another major, long-term goal of NIDDK- and Special Diabetes Program-
funded research. One approach to a cure is the development of islet 
transplantation strategies. The Clinical Islet Transplantation 
Consortium--co-led by NIDDK and NIAID--demonstrated that 
transplantation of islets into a person with type 1 diabetes can 
eliminate severe hypoglycemic events, with some participants achieving 
near-normal average blood sugar levels and an improved quality of life. 
Though we are excited about this progress, we also recognize that, 
because of current limitations, including the need for lifelong 
immunosuppressive drugs and the low availability of donated islets, 
islet transplantation would only be suitable for a small number of 
people with type 1 diabetes. Therefore, it remains critically important 
to pursue research toward developing cell replacement strategies that 
could benefit more people.
    Advances in islet transplantation have also informed other studies 
of beta cell function. NIDDK's Human Islet Research Network (HIRN) is a 
large, multidisciplinary group of consortia with the goal of 
understanding how beta cells are lost in type 1 diabetes and how they 
can be protected or replaced in people. HIRN investigations into how 
beta cells develop and mature are expanding our understanding of how to 
make new beta cells. For example, HIRN researchers recently found that 
cells from a person's stomach can be coaxed in the lab to form 
pancreatic islet-like mini-organs or ``organoids'' that secrete insulin 
and can manage blood glucose levels in mice.\13\
---------------------------------------------------------------------------
    \13\ https://pubmed.ncbi.nlm.nih.gov/37106062
---------------------------------------------------------------------------
    Information on beta cell biology is also fueling the study of beta 
cell replacement strategies. Special Diabetes Program-supported 
researchers are working on approaches to develop bioartificial cell 
replacement technologies such as building multicomponent ``designer 
islets'' in the lab. Other researchers are developing improved 
techniques and technologies needed to place and maintain these beta 
cell replacements in the body. For example, Special Diabetes Program 
funding has supported work on improved islet transplantation procedures 
and has provided key support for developing the specialized 
encapsulation technologies needed to protect the transplanted cells 
from immune attack. Early investment in the development of these 
technologies through grants to academic labs and small businesses is 
providing the technical know-how required for future advances.
             preventing and treating diabetic complications
    People with type 1 diabetes are living longer than ever thanks to 
new therapies, devices, and other improvements in treatment. Therefore, 
it is critically important to find ways to prevent and treat the 
diabetes complications that can arise throughout the lifespan. To this 
end, NIDDK is collaborating with other NIH Institutes to study these 
potentially life-threatening complications, including through research 
supported by the Special Diabetes Program.
    Cardiovascular disease (CVD) is a leading cause of death for people 
with type 1 diabetes, and CVD risk remains increased even with 
standard-of-care measures to treat underlying risk factors. However, 
many questions remain about how CVD may be different (or may be 
prevented) in people with type 1 diabetes compared to those without 
diabetes or with type 2 diabetes. NIDDK and the National Heart, Lung, 
and Blood Institute (NHLBI) have teamed up to investigate these 
questions by forming the Cardiovascular Biorepository for Type 1 
Diabetes (CaRe-T1D). The CaRe-T1D biorepository is collecting donated 
tissues from human donors with and without type 1 or type 2 diabetes. 
This repository of biological samples will be a critical resource for 
future research into how type 1 diabetes and CVD interact, and how type 
1 and type 2 diabetes affect the heart differently. Such studies could 
lead to potential insights into new therapeutic targets and care 
strategies.
    Another major research opportunity is to investigate drugs already 
protecting the cardiovascular health of people with type 2 diabetes. 
For example, sodium-glucose cotransporter-2 (SGLT2) inhibitor 
medications, which are approved to help manage blood glucose levels in 
type 2 diabetes, have heart-protective effects and may also protect 
against kidney disease. Determining if these treatments are safe and 
effective for people with type 1 diabetes could provide a much-needed 
tool for preventing multiple important complications.
    Another debilitating and often-feared diabetes complication is 
blindness. For two decades, research from the National Eye Institute's 
DRCR Retina Network, with Special Diabetes Program support, has been 
changing how diabetic eye disease is treated. Network studies--
including studies comparing different drugs, which were unlikely to be 
performed by industry--have transformed clinical practice guidelines 
for diabetic eye care. Recently, DRCR Retina Network investigators 
continued to help guide management of diabetic eye disease by showing 
that early treatment of diabetic-related eye disease slowed progression 
to more serious disease but did not improve visual acuity compared with 
treating more severe disease once it developed.\14\ This result 
indicates that monitoring patients with diabetic retinopathy and 
treating eyes only as needed is the best approach.
---------------------------------------------------------------------------
    \14\ https://pubmed.ncbi.nlm.nih.gov/36749332
---------------------------------------------------------------------------
    We are also supporting research to study a potentially serious 
complication called impaired awareness of hypoglycemia. Repeated 
episodes of severe hypoglycemia can diminish a person's ability to 
recognize these episodes, leaving them unaware that they need 
assistance and increasing the risk of injury or even death. Impaired 
awareness of hypoglycemia also can make someone ineligible to 
participate in a type 1 diabetes clinical trial, leaving this serious 
condition understudied. A new international research consortium is 
seeking to shed light on this condition, with the goals of identifying 
the factors that can lead to life-threatening hypoglycemic events and 
developing strategies to mitigate these factors and improve quality of 
life.
    Additionally, NIDDK is supporting important efforts to improve care 
for another serious and understudied complication of type 1 diabetes: 
diabetic foot ulcers. Foot ulcers that become infected or do not heal 
can lead to amputations, but little is known about why some ulcers heal 
while others do not, and few treatments are available. NIDDK's Diabetic 
Foot Consortium is the first consortium of its kind and is laying the 
foundation for a clinical trials network to test new strategies to 
improve diabetic wound healing and prevent amputations. Among other 
successes, Consortium scientists have gained new insights into factors 
that impair wound healing by comparing wound healing response in 
diabetes foot ulcers and normal skin.\15\ This Consortium, with Special 
Diabetes Program support, plans to accelerate advances in foot ulcer 
clinical care, including using machine learning techniques on the 
Consortium's gathered data to identify wound characteristics that 
predict successful healing.
---------------------------------------------------------------------------
    \15\ https://pubmed.ncbi.nlm.nih.gov/32938916
---------------------------------------------------------------------------
           emerging opportunities in type 1 diabetes research
    The scientific achievements that I described today are just a few 
examples of recent progress in understanding and combatting type 1 
diabetes and its complications. The investments we have made in 
infrastructure, technology, bold ideas, research talent, and enduring 
collaborations are bearing fruit, improving the lives of people with 
type 1 diabetes and others. Blood glucose monitoring and management 
technologies are also benefitting those with type 2 diabetes, and 
insights into the immune system's role in type 1 diabetes can shed 
light on other autoimmune diseases. Likewise, the study of type 1 
diabetes complications can also inform research into other diseases and 
conditions of the heart, eyes, kidneys, skin, and other organs. In 
these ways, type 1 diabetes research, including that supported by the 
Special Diabetes Program, continues to reap broad benefits.
    As we celebrate our successes, we recognize that there is still 
much critical work to be done. Our efforts were significantly 
strengthened by the renewal of the Special Diabetes Program through the 
end of Fiscal Year 2023, which enabled NIH to continue many of these 
successful, long-running programs. Sustained long-term funding of the 
Program has allowed NIH to launch new clinical trials and support novel 
research areas, capitalizing on emerging opportunities in type 1 
diabetes. Maximizing the value of the Special Diabetes Program and 
responsibly administering its funds is one of NIDDK's highest 
priorities.
    As mentioned throughout this testimony, further research will help 
us maintain the momentum we have built. Tomorrow's research advances 
are already on the horizon as we continue to build upon past successes 
and advance into emerging areas of interest. ``Big data'' analysis of 
large datasets such as those amassed by TEDDY and the DRCR Retina 
Network are unlocking even more insights from these long-standing 
efforts, and cutting-edge machine learning, artificial intelligence, 
``omics'' technologies, and other emerging methods offer new 
opportunities to inform clinical care approaches. These technologies 
also underscore the importance of NIDDK's long-standing commitment to 
making biosamples and data from completed studies available to the 
broad scientific community. Data sharing is critically important for 
maximizing the return on our research investments, and the NIDDK 
Central Repository continues to share resources from completed studies 
with the scientific research community.
    Significant opportunities also exist to identify existing barriers 
to good health and ways to overcome them. The Special Diabetes Program 
is supporting multiple approaches toward this end. One such effort is 
searching for ways to improve technology adoption, for instance by 
identifying behavioral factors that contribute to successful artificial 
pancreas usage. Other researchers are investigating the use of social 
and medical care interventions to improve diabetes outcomes by 
addressing social barriers to good diabetes management. People with 
type 1 diabetes are also disproportionately affected by mental health 
issues, which can affect their diabetes outcomes. To help understand 
this possible barrier to diabetes care, research is ongoing on how to 
treat the ``diabetes distress'' that can result from the demands of 
living with type 1 diabetes. There is also growing evidence of 
neurocognitive complications of type 1 diabetes, and NIDDK-supported 
studies are seeking to better understand the neurocognitive impact of 
type 1 diabetes in children and adults.
    It is imperative that we foster a talented, diverse biomedical 
workforce to conduct tomorrow's cutting-edge research into type 1 
diabetes and its complications. The NIDDK Diabetes-Docs program strives 
to bolster the pipeline of pediatric endocrinologists and other 
physicians committed to careers in diabetes research. Additionally, the 
New Investigator Gateway Awards in Type 1 Diabetes Research will 
support innovative projects by promising new investigators by embedding 
them in the rich intellectual environment of existing large NIDDK 
collaborative research programs. These and other training and career 
development efforts--as well as consistent funding for type 1 diabetes 
research--will help recruit and support the next generation of type 1 
diabetes researchers.
    Looking forward, NIDDK solicited input from scientific and lay 
experts about future research directions in type 1 diabetes and its 
complications at a workshop held in March 2022 under the auspices of 
the statutorily required Diabetes Mellitus Interagency Coordinating 
Committee. Numerous opportunities were identified at that meeting to 
build upon the significant progress to date. NIDDK's support of type 1 
diabetes research will also continue to be guided by strategic planning 
efforts and input from scientific conferences and workshops. These 
varied streams of input will continue to ensure that NIDDK-supported 
type 1 diabetes research benefits people of all ages and backgrounds 
who are living with or at risk for type 1 diabetes.
                           concluding remarks
    I appreciate this opportunity to share these exciting scientific 
advances, ongoing efforts, and emerging opportunities in type 1 
diabetes research. We are extremely grateful for the continued support 
of Congress that has allowed NIH to vigorously support research to 
combat type 1 diabetes and its complications. We are also grateful for 
the extension and increase in Special Diabetes Program funding 
requested in the Fiscal Year 2024 President's Budget, which would 
extend the Program through Fiscal Year 2026. We look forward to 
continuing our strong partnerships with patient advocacy groups, 
professional organizations, research institutions, and our sister 
Federal agencies. We also thank our dedicated clinical study 
participants, without whom the clinical research I described today 
would not be possible. The Special Diabetes Program has catalyzed 
remarkable progress in type 1 diabetes research and has ushered in a 
new era where individuals with type 1 diabetes have significantly 
improved health, longevity, and, importantly, quality of life. We have 
shown for the first time that type 1 diabetes can be delayed, and NIH 
remains steadfast in our goals of preventing, treating, and ultimately 
curing type 1 diabetes. With continued research, we hope to move even 
closer to the day that all people can be free from the burden of type 1 
diabetes and its complications.
    Thank you, Chair Murray, Vice Chair Collins, and Members of the 
Committee. I will be pleased to answer any questions you have.

    Vice Chair Collins. Thank you very much.
    Dr. Kowalski.

STATEMENT OF AARON J. KOWALSKI, Ph.D., CHIEF EXECUTIVE 
            OFFICER, JDRF
    Dr. Kowalski. Chair Murray, Vice Chair Collins, Senator 
Shaheen, and Members of the Committee, thank you for welcoming 
all of our amazing 2023 Children's Congress delegates, their 
guardians, and our special guests. Also, thank you for allowing 
me to testify before you today. I am honored to be here and be 
joined by Dr. Rodgers, and three of our incredible JDRF 
Advocates, to highlight the important progress advanced by the 
Special Diabetes Program, or SDP, and our hopes for the future.
    I am Dr. Aaron Kowalski, chief executive officer for JDRF. 
I am a trained scientist, and I have been fortunate to work for 
JDRF for the past 19 years, 4 of which in my current role.
    Like every delegate here and far too many people across the 
world, my family and I are impacted by type 1. My family's 
experience dates to 1977 when my brother, Steve, out of the 
blue, was diagnosed at just the age of 3. And then I was 
diagnosed a few years later when I was 13.
    Grappling day to day with T1D was difficult--very, very 
difficult then--and still impacts every aspect of our lives 
today. But we have good news to share. Because of your 
steadfast leadership, Senators Collins and Shaheen, and the 
strong bipartisan support in Congress, the Special Diabetes 
Program has fundamentally changed what it means to live with 
type 1 diabetes. It has put new life-changing therapies in our 
hands and brought us closer to cures. The SDP sister program, 
the Special Diabetes Program for Indians, is yielding similar 
significant results. We must keep this momentum going so we can 
capitalize on the progress to date and ultimately realize 
cures.
    Since our last Children's Congress in 2019, we now have on 
the market a therapy, as Dr. Rodgers pointed out, that can 
delay the onset of type 1 for up to 3 years.
    In June, the FDA approved the first cell therapy for adults 
with T1D, who are unable to maintain their blood glucose levels 
due to severe hypoglycemia problems. This therapy allows some 
patients to live without external insulin for several years. 
The SDP-supported Clinical Islet Transplantation Consortium 
played a major role in this pivotal step forward to identifying 
cures.
    Now, most delegates as you see here in the pit, are wearing 
AP (artificial pancreas) systems now, which is an amazing thing 
for me to see. And the SDP funded the trials that led to the 
approvals of the systems that I use, many of the kids here use, 
and people around the country are using, making diabetes much 
more manageable, and I cannot wait to see what is coming next. 
Continued SDP support would enable several long-term T1D-
oriented research programs and clinical trial networks to 
continue their important work. Plus, it will enable researchers 
to explore new opportunities. For example, SGLT2 (sodium-
glucose co-transporter-2) inhibitors are not yet approved for 
people with type 1. We need to develop strategies to ensure 
these drugs can be safely used by people with type 1 which 
could reduce the costly and devastating impacts of heart and 
kidney disease.
    The SDP is, indeed, improving and saving lives and creating 
hope for those living with this disease. Our future is bright.
    Senators Collins and Shaheen, we are tremendously grateful 
for your leadership. And Committee Members, we are greatly 
appreciative of your support. I know many of you are among the 
60 Senators who signed a letter, led by Senator Shaheen and 
Collins, recognizing the importance of the SDP and its renewal. 
Thank you.
    I urge you also to all vote in favor of S. 1855 which would 
extend SDP funding through December 2025. The program expires 
this September, so please act swiftly. JDRF is doing its part 
having invested over $2.5 billion in research to date.
    I must also mention, until we have cures, people with 
diabetes need access to affordable insulin. We are making 
progress but we must do more. JDRF urges Congress to pass the 
Bipartisan Insulin Act of 2023 which will establish a $35-per-
month cap, copay cap, for people with commercial insurance, and 
includes other provisions that would make insulin more 
affordable for everyone irregardless of their insurance status. 
We need your continued support.
    Thank you, again, for allowing me to testify. And I am 
happy to answer any questions.
    [Applause.]
    [The statement follows:]

             Prepared Statement of Aaron J. Kowalski, Ph.D.
    Chair Murray, Vice Chair Collins, Senator Shaheen, and Members of 
the Committee, thank you for welcoming all our amazing JDRF 2023 
Children's Congress Delegates, their guardians, and our special guests. 
Also, thank you for allowing me to testify before you today. I am 
honored to be here and to be joined by Dr. Rodgers and three of our 
amazing JDRF advocates to highlight the important progress advanced by 
the Special Diabetes Program and our hope for the future.
    I am Dr. Aaron J. Kowalski, Chief Executive Officer for JDRF, the 
leading global organization harnessing the power of research, advocacy, 
and community engagement to advance life-changing breakthroughs for 
type 1 diabetes, or T1D. A scientist by training, I have been fortunate 
to work for JDRF and on behalf of countless individuals and families 
impacted by T1D for the past 19 years, four of which in my current 
role.
    Like every delegate in this room and far too many people across the 
world, my family and I are impacted by T1D. My family's experience 
dates to 1977 when, out of the blue, my younger brother, Stephen, was 
diagnosed at the age of 3. My own T1D diagnosis followed when I was 13.
    Grappling day-to-day with T1D was difficult then and it still 
impacts every aspect of life today. But we have good news to share.
    Because of your steadfast leadership, Senators Collins and Shaheen, 
and the strong bipartisan support in Congress, the Special Diabetes 
Program, or SDP, has fundamentally changed what it means to live with 
diabetes, put new life-changing therapies in our hands, and brought us 
closer to cures. The SDP's sister program, the Special Diabetes Program 
for Indians (SDPI), is yielding similar significant and impactful 
results. We must keep this momentum going so we can capitalize on the 
progress to date and realize cures.
               diabetes--a costly and burdensome disease
    First, let me start by sharing a bit about type 1 diabetes. T1D is 
an autoimmune disease in which a person's pancreas stops producing 
insulin, a hormone that enables a person to utilize energy from food. 
T1D lasts a lifetime, and people with T1D must take insulin to live. 
Type 2 diabetes, also known as T2D, is a metabolic disease. With T2D, 
the body still produces insulin but cannot use it effectively. While 
T1D and T2D are different, the costly and burdensome complications are 
the same.
    Today, more than 37 million Americans have diabetes and 96 million 
have prediabetes \1\. The disease affects people of all ages and races 
across the country. The complications that result from diabetes are 
significant--ranging from heart disease and strokes to lower-limb 
amputations.
---------------------------------------------------------------------------
    \1\ Centers for Disease Control and Prevention. National Diabetes 
Statistics Report website. https://www.cdc.gov/diabetes/data/
statistics-report/index.html. Accessed July 6, 2023.
---------------------------------------------------------------------------
    Due to the disease's breadth and impact, about one in four 
healthcare dollars and one in three Medicare dollars are spent treating 
people with diabetes. The total cost of diagnosed diabetes in the 
United States in 2017 was a staggering $327 billion, with $237 billion 
spent on direct medical costs and another $90 billion on reduced 
productivity \2\. Another astounding fact is that the economic costs of 
diabetes, adjusted for inflation, increased by 26 percent from 2012 to 
2017 \3\. As more people develop diabetes, these costs will be even 
more significant.
---------------------------------------------------------------------------
    \2\ American Diabetes Association. Economic costs of diabetes in 
the US in 2017. Diabetes Care. 2018 May;41(5):917-928.
    \3\ American Diabetes Association. Economic costs of diabetes in 
the US in 2017. Diabetes Care. 2018 May;41(5):917-928.
---------------------------------------------------------------------------
    Fortunately, Congress had the foresight to address the growing 
magnitude of the challenge years ago. With bipartisan support, the SDP 
and SDPI were created as part of the Balanced Budget Act of 1997 and 
have been strongly supported by both chambers of Congress and both 
parties ever since.
              jdrf partnering with the federal government
    Before I share some of the exciting breakthroughs resulting from 
the SDP, I want Congress to know that JDRF's private funding works hand 
in hand with SDP funding to ensure that the most important and 
promising research projects have the support they need. JDRF 
accelerates the path to cures by raising funds and allocating them to 
T1D research and therapy development, as well as by leveraging our 
expertise and leadership to bring in additional funding and supporters.
    I am proud to say that JDRF has invested more than $2.5 billion in 
research funding since our founding in 1970. And through direct 
research investments and partnerships within the public and private 
sectors, including through the SDP, we helped raise $483 million for 
T1D research and therapy development in FY21. This partnership between 
the public and private sectors is what it takes to deliver major 
advances for T1D research.
          special diabetes program accelerating breakthroughs
    Since we held our last Children's Congress in 2019, there has been 
remarkable progress that gives us even more hope for a brighter future. 
These are just a few of the many advancements that are exciting to the 
T1D community where the SDP played a role.
First Disease-Modifying Therapy Brought to Market
    The SDP enabled the creation of TrialNet, the largest clinical 
network for T1D. TrialNet conducted the clinical trials that led to the 
November 22 U.S. Food and Drug Administration (FDA) approval of Tzield, 
the first disease-modifying therapy for T1D. This therapy can delay 
onset for nearly 3 years; others to delay and ultimately prevent onset 
are in the research pipeline.
    A recent study examined how Medicare spending would be impacted by 
delaying the development of T1D by 3, 5, and 10 years. For the current 
and future population living with diabetes, different amounts of time 
delaying diagnosis are expected to generate a range of Medicare savings 
that build over time. Cumulative savings accrued to Medicare range from 
$1.6--$3.0 billion within 10 years. By the 25-year mark, the Medicare 
savings reaches $5.9-$16.6 billion \4\. These analyses do not account 
for the costs associated with delaying diabetes development.
---------------------------------------------------------------------------
    \4\ Winn, A, Skandari, R, O'Grady, M, and Huang, E. ``Potential 
Medicare Savings of Delaying Type 1 Diabetes Onset,'' May 2023. 
Unpublished white paper.
---------------------------------------------------------------------------
Advances in Cell Therapies
    A recent exciting development in diabetes research is the June 2023 
FDA approval of the first cell therapy for adults with T1D. The 
approval is specifically for adults unable to maintain average blood 
glucose levels due to repeated severe episodes of low blood glucose 
levels or hypoglycemia. This therapy, with the use of 
immunosuppression, takes deceased donor islets and places them into 
people with T1D. This is an important first for the diabetes community, 
as it is a therapy that allows some patients to go without any injected 
or infused insulin for several years. Clinical trial data resulting 
from the SDP-supported Clinical Islet Transplantation Consortium 
contributed to this pivotal step toward identifying cures.
Artificial Pancreas Systems
    Another area of progress that is a real game changer for people 
with T1D is in the field of technologies to better manage blood glucose 
levels. An artificial pancreas (AP) system consists of an insulin pump, 
a continuous glucose monitor (CGM), and a computer program called an 
algorithm that allows the pump and CGM to talk to each other to give 
the right amount of insulin at the right time--much like the pancreas 
does in people without T1D. AP systems are not perfect, but they allow 
people to think about their diabetes less and have better blood glucose 
control, which improves the quality of life of those impacted by T1D 
and helps to mitigate costly and burdensome long-term diabetes-related 
complications.
    SDP-funded research laid the early groundwork for developing AP 
systems. In fact, SDP funds contributed to the first fully automated 
insulin-dosing system being made available to patients in 2017, some 
five to 7 years earlier than expected. Positive results from SDP-
supported clinical trials since then have led to other FDA-approved 
systems and next-generation AP devices that have outperformed first-
generation devices in adolescents and young adults.
    The majority of the delegates with us here today have AP systems. 
The SDP funded the clinical trial that led to the FDA approval of the 
system I use, and my blood glucose control is much more manageable 
because of it. I am excited to see what comes next for AP systems, 
which will keep us healthier until we have cures.
                    opportunities for future funding
    In the early years of SDP funding, we were excited to discover a 
few new genes that might unlock clues to understand the origin of this 
disease better, and now we have transformational therapies and 
management tools that are improving lives and bringing us closer to our 
ultimate goal of cures for this disease. While the opportunities before 
us are abundant, these are just a few examples in need of funding with 
the next SDP renewal.
Fund Long-Term Research Programs and Clinical Trials
    Continued support of the SDP would keep several long-term T1D-
oriented research programs and clinical trial networks running strong, 
enabling them to continue their work which has yielded so many exciting 
and promising discoveries. For example, The Environmental Determinants 
of Diabetes in the Young (TEDDY) study of 8,600 children, enrolled at 
birth and being followed until they are 15 years old, seeks to 
understand which environmental factors trigger or protect against T1D 
onset. Information on diet, infections, and other exposures is being 
analyzed from children who are progressing toward--or now have--full 
T1D onset. Results to date indicate that there are multiple pathways 
leading to full T1D onset. Further investigation is needed to develop 
strategies to prevent the onset of the disease, ranging from a vaccine 
to specific dietary changes. The data collected from this study could 
also benefit other autoimmune diseases, such as celiac disease.
Protect Heart and Kidney Health for Those with T1D
    SGLT2 inhibitors protect heart and kidney health for people with 
type 2 diabetes but are not yet approved for people with T1D. There is 
an immediate need to develop evidence-based strategies to ensure these 
drugs can safely be used by people with T1D, which could reduce costly 
and devastating impacts of heart and kidney disease.
    A recent study shows that for the current population living with 
T1D, lowering End Stage Renal Disease rates by 50 percent is expected 
to generate Medicare savings that build over time. At the ten-year 
mark, the cumulative savings to Medicare are $5.1 billion. By the 25-
year mark, Medicare savings reach $13.6 billion \5\. These savings 
estimates do not incorporate individuals who will be diagnosed in the 
future and therefore are conservative.
---------------------------------------------------------------------------
    \5\ Winn, A, Skandari, R, O'Grady, M, and Huang, E. ``Potential 
Medicare Savings of Reduced End Stage Renal Disease in Patients with 
Diabetes,'' May 2023. Unpublished white paper.
---------------------------------------------------------------------------
Investigate Cardiovascular Disease in People with T1D
    Cardiovascular disease (CVD) in people with T1D is not nearly as 
well studied as in people with T2D despite the fact that it is a major 
cause of death in people with T1D. There is a major unmet need to 
identify the mechanisms that promote earlier development of CVD in 
people with T1D, to learn and develop new interventions to prevent and 
treat it.
              long-term, uninterrupted sdp support needed
    The critical research supported by the SDP requires long timeframes 
to achieve optimal results. A long-term reauthorization would allow the 
National Institute of Diabetes and Digestive and Kidney Diseases to 
carefully plan the use of funds, which are directed toward new and 
ongoing clinical trials that take multiple years to complete.
    Technology development also takes time. The noteworthy progress in 
developing artificial pancreas and other glucose management 
technologies has been spurred by long-term SDP support, as I noted 
earlier. A short-term reauthorization would make it much more difficult 
to undertake long-term planning in these areas.
    For the scientists who conduct the research, long-term, sustained 
funding is incredibly important. With the uncertainty of sustained 
funding, they may pursue other research opportunities elsewhere. The 
assurance of long-term funding is also important to attract new talent 
to this field and to maintain a pipeline of future generations of 
scientists to conduct T1D research.
                federal funding for nih, fda, and arpa-h
    While the SDP is a key component in our collective efforts to 
accelerate T1D research breakthroughs, three key agencies--the National 
Institutes of Health, the recently formed Advanced Research Projects 
Agency for Health and the Food and Drug Administration--are also vital 
to speed the advancement of research and access of new therapies for 
people with T1D. We ask that this committee support these agencies with 
the highest funding levels possible.
                         insulin affordability
    While the focus of this hearing is on the Special Diabetes Program, 
research progress, and hopes for the future, it is important to note 
that people with diabetes need access to affordable insulin until we 
have cures. As you have heard from your constituents and our many 
advocates, the current drug pricing system in the United States does 
not work for countless people who need insulin to survive.
    Over a 10-year period, the cost of insulin increased threefold \6\. 
Currently, insulin can cost between $175 and $300 per vial and up to 
$1,000 per month. Studies have shown that these inflated costs can 
cause up to one-quarter of people with diabetes to skip or ration their 
insulin \7\, potentially leading to costly medical emergencies, severe 
complications, or death.
---------------------------------------------------------------------------
    \6\ Centers for Disease Control and Prevention. National Diabetes 
Statistics Report website. https://www.cdc.gov/diabetes/data/
statistics-report/index.html. Accessed July 6, 2023.
    \7\ Centers for Disease Control and Prevention. National Diabetes 
Statistics Report website. https://www.cdc.gov/diabetes/data/
statistics-report/index.html. Accessed July 6, 2023.
---------------------------------------------------------------------------
    We are seeing real progress in addressing this critical issue 
through actions taken by governments, health plans, and insulin 
manufacturers. Medicare now caps the cost of insulin at $35 per month 
due to the Inflation Reduction Act. Earlier this year, Lilly, Novo 
Nordisk, and Sanofi announced reductions in the cost of their insulin. 
And the Civica Insulin Project, of which JDRF is a funder, is on track 
to produce the first of three biosimilar insulins for $30 per vial and 
$55 for a box of five pens. They intend to submit to the FDA next year.
    However, we must do more. We need Congress to take the next step 
this year. JDRF urges Congress to pass the bipartisan INSULIN Act of 
2023, led by Senators Collins and Shaheen, which establishes a $35 per 
month insulin copay cap for people with commercial insurance and 
includes other provisions that would make insulin more affordable for 
everyone, regardless of insurance status.
                               conclusion
    As you can see, the Special Diabetes Program is indeed improving 
and saving lives and creating hope for those with type 1 diabetes. We 
have come so far since I was diagnosed as a teen and even since our 
last Children's Congress in 2019. The future is bright for all these 
delegates with us today and the countless others across the country who 
are impacted by T1D, with continued support for the SDP and your help.
    Senators Collins and Shaheen, we are tremendously grateful for your 
leadership. And members of this committee, we so greatly appreciate 
your support. I know many of you are among the 60 Senators who signed 
the letter, led by Senators Collins and Shaheen, supporting the SDP and 
its renewal. Thank you!
    I urge you all to vote in favor of S. 1855, led by Senators Collins 
and Shaheen, which was approved by the Senate Health, Education, Labor, 
and Pensions Committee. The bill would increase the current funding of 
the SDP from $150 million to $170 million for 2 years and include 
nearly $43 million more to extend the program through December 2025. 
The current funding expires at the end of this September, so I urge you 
to act quickly. And please support next steps on insulin affordability 
and do that promptly as well. We are counting on you.
    Thank you again for the opportunity to testify. I am happy to 
answer any questions.

    Vice Chair Collins. Thank you very much, Doctor.
    Mr. Harris, welcome.

STATEMENT OF JAMES ``JIMMY JAM'' HARRIS, AWARD-WINNING 
            MUSIC PRODUCER AND PHILANTHROPIST
    Mr. Harris. Talk, how about that. Okay.
    Thank you, Chair Murray, Vice Chair Collins, Senator 
Shaheen, and Members of the Committee. My name is Jimmy Jam. I 
am a songwriter, producer, musician, and recording artist. 
Today, I am honored to be testifying, not as a member of the 
music community, but as a parent whose family has been impacted 
by type 1 diabetes for the past 2 decades.
    My son, Max, was just 2 years old when he was first 
diagnosed with type 1 diabetes. At the time I thought I knew 
what T1D was, but I did not really understand what it meant. 
Type 1 diabetes is something you--it does not affect you until 
it really affects you, and once it does you are completely 
immersed in it.
    Our lives quickly revolved around Max's diabetes. Late 
nights working on music for me quickly became working on waking 
my son up to test and manage his blood sugar levels.
    Now, Max is now in his 20s, and we are glad that instead of 
those constant finger pokes to test him, he now uses a 
continuous glucose monitor, or CGM. Those life-changing devices 
never would have come to market as quickly as they did, or 
perhaps even at all, without research funded by the Special 
Diabetes Program and JDRF's funding and extensive involvement.
    But even with the great new technologies to help control 
T1D, we can never take Max's levels for granted. That is the 
thing with diabetes: The second that you think you have it 
down, something else changes, and now the number is too high or 
too low. Congress needs to renew the SDP so that researchers 
can discover new breakthroughs to help families with type 1 
diabetes.
    Through Max's eyes I have also seen the crisis facing 
millions of Americans, insulin affordability. I remember when 
Max was young, we went on a family trip to New York, and in the 
chaos of packing, we forgot to pack his insulin. Now, I did not 
think it would be a big deal because we had insurance. But then 
our insurance would not cover it. We had already used our 
refill. So we ended up having to pay at that point in time, 
probably a couple hundred dollars out of pocket just to get his 
life-saving insulin.
    Now, we were fortunate that we could afford the cost, but 
even as a child, Max realized the problem. I will never forget 
how he asked me that day, ``What about the people that cannot 
afford that?'' There are so many people across the country who 
cannot afford their insulin, and over the years the cost has 
only gotten higher. People like Max need insulin to survive. I 
have heard heartbreaking stories of families forced to ration 
insulin because it is too expensive. Congress should make sure 
no family has to make these impossible choices to keep their 
child alive.
    Aside from my roles as father and musician, I am also 
Chairman Emeritus of the Recording Academy; that is the 
organization behind the Grammy Awards. Like the Members of this 
Committee I know what it is like to sit in a contentious 
meeting and worry that no one will ever agree because our 
differences are too great. But I have also learned, if I start 
playing music, I can look around and I can see the 
commonalities of everyone's head moving at the same time in the 
same way. We all may have our differences, but there are things 
we can all agree upon: Music is one of those things. But type 1 
diabetes should be one of those things we can all agree upon 
too.
    It is a non-partisan condition. Diabetes does not care if 
you are a Democrat or a Republican. And we can all agree there 
should be research to improve the lives of those with diabetes. 
And we can also all agree that insulin should be affordable to 
all that need it.
    Thank you for the opportunity to join you today. And I am 
happy to answer any of your questions. Thank you.
    [Applause.]
    [The statement follows:]

            Prepared Statement of James ``Jimmy Jam'' Harris
    Thank you, Chair Murray, Vice Chair Collins, Senator Shaheen, and 
Members of the Committee. My name is Jimmy Jam. I am a songwriter, 
producer, musician and recording artist. Today, I am honored to be 
testifying not as a member of the music industry, but as a parent whose 
family has been impacted by type 1 diabetes every day for the past two 
decades.
    My son Max was just two years old when he was first diagnosed with 
type 1 diabetes. At the time, though I knew what T1D was, I didn't 
really understand what it meant.
    Type 1 diabetes is something that doesn't affect you until it 
really affects you. Once it does, you are completely immersed in it. 
Our lives quickly revolved around Max's diabetes. Late nights working 
on music became late nights working on music and waking up my son to 
test and manage his blood sugar levels.
    Max is now in his twenties, and we're glad that instead of those 
constant finger pokes to test him, he now uses a continuous glucose 
monitor, or CGM. These life-changing devices never would have come to 
market as quickly as they did--or perhaps even at all--without research 
funded by the Special Diabetes Program and JDRF's funding and extensive 
involvement.
    But even with great new technologies to help control T1D, we can 
never take Max's levels for granted. That's the thing with diabetes: 
the second you think you have it down, something else changes and the 
number is too high or too low. Congress needs to renew the SDP so that 
researchers can discover new breakthroughs to help families with type 1 
diabetes.
    Through Max's eyes, I have also seen the crisis facing millions of 
Americans: insulin affordability. I remember when Max was young, we 
went on a family trip to New York, and in the chaos of packing we 
managed to forget his insulin.
    I didn't think it would be a big deal. We had insurance. But then 
our insurance wouldn't cover it. We had already used our refill, so we 
ended up having to pay a couple hundred dollars out of pocket just to 
get his life-saving insulin. We were fortunate we could afford the 
cost, but even as a child, Max realized the problem. I'll never forget 
how he asked me that day: ``What about the people who can't afford 
that?''
    There are already so many people across the country who can't 
afford their insulin, and over the years the cost has only gotten 
higher. People like Max need insulin to survive. I've heard 
heartbreaking stories of families forced to ration insulin because it 
is too expensive. Congress should make sure no family has to make these 
impossible choices to keep their child alive.
    Aside from my roles as a father and musician, I am also chairman 
emeritus of the Recording Academy--the organization behind the Grammy 
Awards. Like the members of this committee, I know what it's like to 
sit in a contentious meeting and worry no one will ever agree because 
our differences are too great.
    But I've learned that if I start playing music, I can look around 
and see the commonalties of everyone's head nodding the same way. We 
may all have our differences, but there are things we can all agree on. 
Music is one of those things.
    Type 1 diabetes should be one of those things we can all agree on 
too. It is a non-partisan condition--diabetes doesn't care if you're a 
Democrat or a Republican. We can all agree that there should be 
research to improve the lives of those with diabetes. We can all agree 
that insulin should be affordable for all who need it.
    I thank you for the opportunity to join you today. And I'll be 
happy to answer any of your questions.

    Vice Chair Collins. Thank you very much. Thank you so much 
for your testimony.
    Maria, welcome, from the great State of Maine to 
Washington, DC.

STATEMENT OF MARIA MUAYAD, JDRF 2023 CHILDREN'S 
            CONGRESS DELEGATE, YARMOUTH, MN
    Ms. Muayad. Chair Murray, Vice Chair Collins, Senator 
Shaheen and Members of the Committee. Thank you for inviting me 
to speak. I am honored to represent my fellow delegates at JDRF 
2023 Children's Congress in this hearing.
    I am Maria Muayad from Yarmouth, Maine. I am 10 years old, 
and I have been living with type 1 diabetes for 3 years.
    As you can tell from looking at all the delegates in front 
of you, we are a diverse group of people. Some of us are in 
preschool and some are about to go to college. Some, like me, 
love math, and others, well, they prefer other classes at 
school. What brings us together is that we all live with type 1 
diabetes. We know what it feels like to live with the highs and 
lows of diabetes, literally.
    My family and I are a first-generation Americans and proud 
Mainers. We know that with hard work, we can do anything. Every 
delegate knows this, too. And that is why we are here. My 
dream, and my family's big hope, is to cure type 1 diabetes. 
Together, with your help, we can do it.
    The Special Diabetes Program funds research that is leading 
us to cures. We do not have one today, but someday we will, and 
research from the SDP is important to make that happen.
    It is going to be amazing when we cure type 1 diabetes. 
There is so much I am looking forward to. When there is a cure, 
I will not have to wear my devices that itch and hurt and that 
brings me unwanted attention from my classmates when they make 
noises. When there is a cure, I will not have to eat food to 
treat a low after I brush my teeth which is just as annoying as 
any device I have to wear.
    [Laughter.]
    Ms. Muayad. When there is a cure, I will be able to spend 
more time doing the things that I love, like FaceTiming with my 
family and playing outside with my friends.
    Until we cure this disease, I would also like if everyone 
could afford the diabetes supplies they need to live. All the 
medicines and tools I need to stay alive are very expensive, 
but they are necessary, and they work. I hope that you can help 
find a way to--for that to happen.
    When I grow up, I want to become a pediatrician so I can 
help other people, including kids with diabetes. It would be 
even better if, by the time I am a pediatrician, kids do not 
get type 1 diabetes anymore. The only way that will happen is 
if you keep funding diabetes research.
    Thank you very much for letting me share my hopes for the 
future. And thank you, Senator Collins and all the Members of 
the Committee, for all you are doing to help us.
    [Applause.]
    [The statement follows:]

                   Prepared Statement of Maria Muayad
    Chair Murray, Vice Chair Collins, Senator Shaheen, and Members of 
the Committee--thank you for inviting me to speak. I am honored to 
represent my fellow delegates at JDRF 2023 Children's Congress in this 
hearing.
    I am Maria Muayad from Yarmouth, Maine. I am ten years old, and I 
have been living with type 1 diabetes for three years.
    As you can tell from looking at all the delegates in front of you, 
we are a diverse group of people. Some of us are in preschool and some 
are about to go to college. Some, like me, love math and others, well, 
they prefer other classes at school.
    What brings us all together is that we all live with type 1 
diabetes. We know what it feels like to live with the highs and lows of 
diabetes. Literally.
    My family and I are first generation Americans and proud Mainers. 
We know that with hard work, we can do anything. Every delegate knows 
this, too. And that's why we're here.
    My dream, and my family's big hope, is to cure type 1 diabetes. 
Together, with your help, we can do it.
    The Special Diabetes Program funds research that is leading us to 
cures. We don't have one today, but someday we will--and research from 
the SDP is important to making it happen.
    It's going to be AMAZING when we cure type 1 diabetes. There is so 
much I'm looking forward to.
    Where there's a cure, I won't have to wear devices that itch and 
hurt--and that bring me unwanted attention from my classmates when they 
make noise.
    When there's a cure, I won't have to eat food to treat a low right 
after I brush my teeth--which is just as annoying as any device I have 
to wear.
    When there's a cure, I'll be able to spend more time doing the 
things that I love, like FaceTiming with my extended family in Iraq, 
painting my mom's nails, and playing outside with my friends.
    Until we cure this disease, I would also like it if everyone could 
afford the diabetes supplies they need to live. All the medicines and 
tools I need to stay alive are very expensive, but they are necessary, 
and they work. I hope that you can help find a way for that to happen.
    Next year I will start middle school. Later, I want to go to 
college and eventually become a pediatrician so I can help other 
people--including kids with diabetes.
    It would be even better if, by the time I am a pediatrician, kids 
don't get type 1 diabetes anymore. The only way that will happen is if 
you all keep funding diabetes research.
    Thank you very much for letting me share my hope for the future. 
And thank you, Senator Collins and members of the committee, for all 
you are doing to help us.

    Vice Chair Collins. Thank you, Maria.
    Elise, welcome.

STATEMENT OF ELISE CATALDO, JDRF 2023 CHILDREN'S 
            CONGRESS DELEGATE, HOOKSETT, NH
    Ms. Cataldo. Thank you. Chair Murray, Vice Chair Collins, 
Senator Shaheen, and Members of the Committee, thank you for 
inviting me to speak with you today about my life with type 1 
diabetes.
    My name is Elise Cataldo. I am 15 years old, and I am from 
Hooksett, New Hampshire. I was diagnosed with type 1 diabetes 
when I was 18 months old. Many of my fellow delegates here can 
remember a time without diabetes. I cannot. Life with diabetes 
is the only life I have ever known. However, my life with 
diabetes today is drastically different than it was when I was 
diagnosed. Back then, we did not have the same tools we have 
today. Continuous glucose monitors, like the one I am wearing 
today, were not yet widely adopted by the type 1 diabetes 
community. Insulin pumps with artificial pancreas technology 
were not yet available.
    Thanks to brilliant researchers, clinical trial 
participants, advocates, JDRF, and the overwhelming support of 
Senators like you, the tools I have today are vastly superior. 
In fact, I currently use an insulin pump that has an algorithm 
called Control IQ that gives me more insulin when I need it, 
and it decreases the amount of insulin I get to help prevent 
dangerously low blood sugars. The Special Diabetes Program, or 
SDP, funded the final clinical trial for this algorithm. That 
clinical trial led to its FDA approval, and my life is so much 
better because of it. I can sleep better at night, and so can 
my parents, because of SDP-funded research. I am not alone. I 
can guarantee many of my fellow delegates here utilize this or 
other systems like it, and they are all helped in one way or 
another by the SDP. Thank you for your past support of this 
critical program.
    Today, I am incredibly proud to say that I live as close to 
a normal life as possible. I am active, as I play soccer and 
basketball. I am able to spend time with my family where I am 
the oldest of five, and for example, our most recent camping 
trip. In a few years, I hope to go to college, become a D1 
athlete, and study psychology so that I can become a child life 
specialist.
    But as normal as I look on the outside, type 1 diabetes is 
always in the back of my mind. It affects every decision I 
make, every day. When I am playing soccer, I need to ensure my 
blood sugar is in the right range. If it is too high, I can 
become fatigued. But if it is too low, I can become disoriented 
and even pass out. If this sounds like a lot for a 15-year-old 
to keep track of, you are right. It is.
    Many Americans with diabetes have one more thing to keep 
track of: Whether or not they can even afford their insulin. I 
am incredibly lucky to say that I am able to access the insulin 
I need. It makes me so disappointed that there are people just 
like me who have trouble affording their insulin, and have to 
make terrible decisions, like whether to buy groceries or 
insulin, which are both things that we cannot live without. I 
hope that the Members of the Senate and the rest of Congress 
can work together to solve this problem. The diabetes community 
needs your help.
    One day soon, I hope to live free from type 1 diabetes. You 
play a critical role in making that a reality. Please fund the 
SDP and continue to fight for me, the 163 kids here today, and 
the millions more in America affected by this disease.
    Thank you for listening to my story. And thank you for your 
support. I am happy to answer any questions.
    [Applause.]
    [The statement follows:]

                  Prepared Statement of Elise Cataldo
    Chair Murray, Vice Chair Collins, Senator Shaheen, and Members of 
the Committee--thank you for inviting me to speak with you today about 
my life with type 1 diabetes.
    My name is Elise Cataldo. I am 15 years old, and I live in 
Hooksett, New Hampshire.
    I was diagnosed with type 1 diabetes when I was 18 months old. Many 
of my fellow delegates can remember a time without diabetes--I cannot. 
Life with diabetes is the only life I've ever known.
    However, my life with diabetes today is drastically different than 
it was when I was diagnosed. Back then, we didn't have the same tools 
we have today. Continuous glucose monitors, like the one I am wearing 
today, were not yet widely adopted by the type 1 diabetes community. 
Insulin pumps with artificial pancreas technology were not yet 
available.
    Thanks to brilliant researchers, clinical trial participants, 
advocates, JDRF, and the overwhelming support of Senators like you, the 
tools I have today are vastly superior. In fact, I currently use an 
insulin pump that has an algorithm called control IQ that gives me more 
insulin when I need it, and it decreases the amount of insulin I get to 
help prevent dangerous low blood sugars.
    The Special Diabetes Program, or SDP funded the final clinical 
trial for this algorithm. That clinical trial led to its FDA approval--
and my life is so much better because of it. I can sleep better at 
night--and so can my parents--because of SDP funded research.
    I am not alone--I can guarantee many of my fellow delegates utilize 
this or other systems like it--and they were all helped in one way or 
another by the SDP.
    Thank you for your past support of this critical program.
    Today, I am incredibly proud to say that I live as close to a 
normal life as possible. I play many sports, including soccer; I spend 
time with my family; I go camping. In a few years, I hope to go to 
college, be a D1 athlete, and study psychology so that I can become a 
child life specialist.
    But as normal as I look on the outside, type 1 diabetes is always 
in the back of my mind. It affects every decision I make, every day. 
When I'm playing soccer, I need to ensure my blood sugar is in the 
right range. If it's too high, I can become fatigued. If it's low, I 
can become disoriented and even pass out.
    If this sounds like a lot for a 15-year-old to keep track of, 
you're right. It is!
    Many Americans with diabetes have one more thing to keep track of: 
whether or not they can afford their insulin.
    I am incredibly lucky that I am able to access the insulin I need. 
It makes me so sad that there are people just like me who have trouble 
affording insulin and have to make terrible decisions, like whether to 
buy groceries or insulin.
    I hope that all the members of the Senate and the rest of Congress 
can work together to solve this problem. The diabetes community needs 
your help.
    One day soon, I hope to live free from type 1 diabetes. You play a 
critical role in making that a reality. Please fund the SDP and 
continue to fight for me, the 163 kids here today, and the millions 
more in America affected by this disease.
    Thank you for listening to my story and thank you for your support.

    Vice Chair Collins. Thank you very much, Elise.
    We will now do a round of 5 minutes per Senator for 
questions, although I am sure that we could all go on way 
longer than that.
    Let me start with Maria. Maria, first of all, thank you for 
that inspiring testimony. I know that you and your family moved 
to Maine from Iraq, and that you were diagnosed here with--in 
Maine--with type 1 diabetes. I want to ask you whether you 
think that having type 1 led to your decision to become a 
pediatrician when you grow up?
    Ms. Muayad. Yes. It did lead to me wanting to become a 
pediatrician because I think--I know that only kids and adults 
with type 1 diabetes will understand the pain and struggle that 
they go through. And I would like to help kids better 
understand that.
    Vice Chair Collins. Thank you. Dr. Rodgers, I appreciate 
your strong leadership and all that you have done for the 
community with type 1 diabetes and the Special Diabetes Program 
for Indians and the Native Alaskans as well.
    I want you to look ahead and answer two questions for me. 
One, what would happen to those research efforts if Congress 
failed to extend the Special Diabetes Program, if it just went 
away on September 30th?
    And second, since I do not think we are going to allow that 
to happen, I would like you to give us a sense of what exciting 
developments are on the horizon.
    Dr. Rodgers. Well, thank you for that question, Senator 
Collins. I think that if there were to be a circumstance in 
which the funds would lapse, of course our regular 
appropriations would continue to fund existing studies in type 
1 diabetes and type 2 diabetes, but we certainly would not be 
able to do it at the pace that we are able to do it now. 
Clearly, in order to recruit people for clinical trials we 
really follow a philosophy that we do not want to subject 
individuals and their families of these trials if we are not 
sure we can conclude them. And that would be an important 
aspect of what would happen.
    Vice Chair Collins. So, you are saying that the Special 
Diabetes Program allows you to achieve breakthroughs much more 
quickly?
    Dr. Rodgers. Absolutely. Absolutely. In terms of your 
second question, looking towards a future, what would we like 
to see with these funds? You heard from Dr. Kowalski about the 
use of drugs that are currently approved for type 2 diabetes, 
including so-called SGLT2 drugs and GLP-1 receptor agonists. 
These drugs have not only the ability to lower blood sugar and 
actually reduce weight in many instances, but they also have a 
protective effect on the heart and the kidneys. These 
complications of the disease are really what is driving a lot 
of the cost associated with it.
    And so we really look forward to those are continuing, and 
making sure that those drugs are safe and effective for 
individuals with type 1 diabetes as well.
    Vice Chair Collins. Thank you. I am going to do a second 
round later, so I am going to yield to Senator Tester.
    Senator Tester. Well, thank you. Thank you, Ranking Member 
Collins. First of all, it is great to have everybody here in 
the blue shirts. The diabetes folks know how to lobby, I will 
tell you that.
    [Laughter.]
    Senator Tester. Pretty impressive. Let me tell you a story 
about me. I came to school in seventh grade and my best buddy 
was not there. And I wondered why. And he came back to school, 
and he had been diagnosed with diabetes. I have watched--that 
was 1969, by the way--and Jimmy Jam, in 1969, do you know what 
he paid for a vial of insulin? $2.03. That $300 vial of insulin 
today was $2.03. That is, by the way, with a patent that was 
passed along to the pharmaceutical companies. Now, the delivery 
system has changed, and we talked about that.
    But I have watched him for the last 54 years go through 
life, and it has not been easy. And watching him and the 
challenges he has had to deal with every day because he has 
diabetes, has made me, personally, very angry because life is 
much more complicated for him than it is for me.
    My question is for you, Dr. Rodgers. Congratulations on 25 
years. You have talked about some of the successes you have had 
in putting diabetes off for 3 years is no small--I mean that is 
1,000 days that you get. Okay? The glucose monitoring, the 
artificial pancreas, the delivery system where you do not have 
to prick your finger, and take your pants down and give 
yourself a shot in the leg every day--I mean, all that stuff is 
admirable, and I will preface but my question by saying, you 
put the--if the R&D money that Senator Collins and Senator 
Shaheen put up, I am going to support it because it is really 
important. Research is really critical in this area.
    But my question is, as you talked about a biological cure, 
which I think is the goal here. The goal here is not to have to 
have an artificial pancreas. The goal here is not to have to 
have an early potential drug because we have a biological cure; 
whether it is through stem cell or some other method which is 
far beyond my ability to understand as a farmer, just having it 
so kids, and adults, can go through and live a normal life and 
not have to deal with some of the challenges that are out there 
that diabetes creates.
    So my question is, how close are we? We have been at this 
for 25 years, $2.5 billion Dr. Kowalski said we put in. I mean 
it is real money; these folks are real people; these are real 
kids; they are the reason we are in this position. Tell me what 
we got to do to get a biological cure.
    Dr. Rodgers. Thank you for your question, Senator. The SDP 
is supporting and has supported a group of scientists called 
the Human Eyelet Research Network, or HERN. And HERN is trying 
to very much understand and move towards the goal that you set 
forward to try to take stem cells, either from a person's skin 
or some other place, transform it into beta cells producing 
insulin, and get those cells back into the patient, which would 
be a true biologic cure. The problem is, of course, that those 
same cells would be subjected to the immune response which 
caused the type 1 diabetes in the first place.
    An alternate way would be to develop these cells and 
somehow encapsulate it to override the immune effect. And that 
is being actively studied as well, but at the same time we have 
a group of investigators looking at prevention. It may be 
better to prevent the disease than to actually cure it. And 
what we know is that individuals that you see here, have a 
genetic predisposition towards diabetes, and for some reason 
there is a trigger that turns on their immune system against 
those cells producing in the pancreas. And if we were able to 
determine what that trigger is--be it a food, be it a virus, or 
a bacteria--we may be able to prevent that unwanted autoimmune 
disease.
    So we have a program called TEDDY (The Environmental 
Determinants of Diabetes in the Young), which is really 
actively studying that, and we hope to report to you the 
results of these studies. These are kids that we first brought 
into the study when they were born, and we studied them until 
they are 15 years of age. And that is about to come to a 
conclusion. And we have a lot of samples that have been 
collected. And this is the first instance in which we are going 
to be using artificial intelligence and machine learning to 
discern patterns of what it is likely to be the trigger, and it 
is quite likely to be more than one trigger that is turning 
that on. So that is sort of another--obviously it is prudent to 
explore multiple pathways as well, but that is, certainly, two 
of the things I can tell you, Senator.
    Senator Tester. Thank you, Doctor.
    Thank you, Senator Collins.
    Vice Chair Collins. Thank you.
    Senator Kennedy.
    Senator Kennedy. Thank you, Madam Chair, and thanks to all 
of our witnesses.
    Dr. Kowalski, thank you for giving so much. Have you ever 
heard the expression, ``Yada, yada, yada''? What does that 
mean?
    Dr. Kowalski. ``Yada, yada, yada'' mean?
    Senator Kennedy. Yeah.
    Dr. Kowalski. On and on and on.
    Senator Kennedy. We have had so much yada, yada, yada about 
affordable insulin. Not from people like you, but from us. We 
have been nibbling around the edges for years.
    Dr. Rodgers, thank you for giving so much. Let me ask you a 
question. Do you have health insurance?
    Dr. Rodgers. Fortunately, as a government employee, I do 
have health insurance.
    Senator Kennedy. And it is pretty good, isn't it?
    Dr. Kowalski. It is pretty good, Senator.
    Senator Kennedy. Now, who do you think needs affordable 
insulin? Who do you think needs capping the price of insulin at 
30 bucks, or so, more; you or an uninsured person?
    Dr. Rodgers. Is that to me, Senator, or to Dr. Kowalski?
    Senator Kennedy. You.
    Dr. Rodgers. Well, as you asked the question, I think the 
person who is less available to afford it would probably 
benefit more.
    Senator Kennedy. Yeah. We have got 30 million people who 
are uninsured in this country, and some of them are diabetic 
too. Now, Senator Shaheen and Senator Collins have a great 
bill. Senator Warnock and I have a bill, too. It is called the 
Affordable Insulin Now Act, and we are working closely with 
my--with Senator Collins and Senator Shaheen. Our bill would 
cover everybody, everybody, whether you have health insurance 
or you are uninsured because a lot of people become uninsured.
    Now, I know our health insurance companies--and God bless 
them--they are trying to work with us to lower the cost of 
insulin, and they have these programs. They call them Patient 
Assistance Program. So if you are uninsured and you cannot 
afford your insulin, they will work with you. But have you ever 
tried to apply for one of those programs; either of you; any of 
you?
    Oh, my, God. First, the application process: The fine print 
to apply is so much of it, you could hide a dead body in there. 
Nobody would ever find it.
    Number two, they send the medicine to your doctor, not to 
you. So if you got a job, or if you do not have a job, you got 
to go to the expense of driving all the way to your doctor's 
office. You probably have to pay your doctor to get the 
medication. I mean that is a special kind of stupid. It only 
covers--these free programs only cover one or two forms of 
insulin. And get this, yeah, they will give you--they will give 
you cheap insulin, maybe free insulin for a month, or 3 months, 
or at best a year. And then after a year, you go in one day and 
instead of 30 bucks, it is $567.23, and you go, ``Oh, my, God, 
I have got to go sell blood plasma to be able to afford it.''
    We need to stop nibbling around the edges. We need to be 
smart enough to figure this out. And the cost? I think it could 
be done for $250 million a year. And I am not talking about 
taking out a reverse mortgage on Alaska and borrowing more 
money. I am talking about finding it in our budget.
    Elise, let me ask you a quick question. You probably do not 
know the answer; I had to look it up. But if I started counting 
to a billion right now, right this moment in 2023, and I 
counted--you all listen to this, you may know the answer. I 
counted one number a second--one, two, three, four, five--and I 
counted all day and all night, and I counted in the shower, and 
I counted between bites of a Pop-Tart at breakfast. I keep 
counting and counting. How long do you think it would take me 
to count to a billion?
    Ms. Cataldo. A very long time.
    [Laughter.]
    Senator Kennedy. Do you know how long? You are right. I 
told you, you were smart. It would take me, it would take me 32 
years for 1 billion. I would be 55--it would be 2055. I would 
not make it. Now, do you know how big the Federal budget is? 
That is just 1 billion folks. The Federal budget is $6,000 
billion, every year. And we cannot find $250 million to cap the 
price of insulin?
    Let us do it right. No more yada, yada, yada.
    [Applause.]
    Vice Chair Collins. Thank you.
    Senator Baldwin.
    Senator Baldwin. Thank you. I want to start by both 
congratulating and welcoming my constituents, Meredith, Mira, 
Sylvia, and Talon. Welcome to our Nation's Capitol. And I want 
to thank you for your role in the JDRF 2023 Children's Congress 
and for your continued advocacy on behalf of Wisconsinites with 
diabetes. Your advocacy really helps drive the work of 
Congress, and I want to thank you for using your voices for 
this important cause.
    This is for Dr. Rodgers. The Max McGee Diabetes Research 
Center in Milwaukee, Wisconsin, is focused on early 
identification and prevention of type 1 diabetes. Thanks to 
funding from the National Institute of Diabetes and Digestive 
and Kidney Diseases, the Center developed a [inaudible] 
cutting-edge blood test that can detect inflammation associated 
with type 1 diabetes up to 7 years before the disease's onset.
    This test is already helping researchers better understand 
how patients are responding to new therapeutic interventions 
and strengthens our understanding of the development of type 1 
diabetes.
    So Dr. Rodgers, can you describe how research that focuses 
on the development of type 1 diabetes leads to progress in 
preventing juvenile diabetes?
    Dr. Rodgers. Thank you, Senator. That is outstanding work 
that is being done by investigators in your State. You know, I 
have to say the Special Diabetes Program, as I mentioned in my 
introduction, over the years of this continuous funding, has 
really changed the way we think about diabetes in the various 
stages.
    It is not that you have it or you do not, we know that it 
progresses through several stages until one actually develops 
clinical disease associated with abnormal blood sugar levels, 
and it is getting the disease and people who are extremely high 
risk, after they have antibodies, but before their blood sugar 
gets out of whack. It is critically important because that 
leads to the development of studies such as was reported by 
Senator Collins, and has been mentioned, this drug, teplizumab, 
for example, which works in the immune system to actually stop 
the immune system from damaging those insulin producing cells.
    So having ways of defining the disease much earlier is 
critically important for prevention. And we continue to work 
with investigators throughout the country to try to come up 
with a more precise, easy, and a more accurate way of detecting 
that just for that purpose.
    Senator Baldwin. Great. Thank you. Also, Dr. Rodgers, 
thanks to the Special Diabetes Program people with type 1 
diabetes are living longer than ever, but there is much more 
that we can do to improve the lives of those with type 1 and 
make sure that we are working to reduce complications. This is 
especially important for children living with type 1 diabetes, 
including the Wisconsinites who I welcomed earlier.
    Dr. Rodgers, what are some of the understudied 
complications of type 1 diabetes that you hope will be examined 
in the future? And you know, what are the gaps, or things that 
we have not studied enough? And how will this research improve 
the lives of many in this audience?
    Dr. Rodgers. Two aspects of that. I will answer your 
question in two ways. Number one is there are understudied 
groups of individuals with type 1 diabetes that, unfortunately, 
industry is not studying that much, and this is where SDP fills 
in a gap. Those understudied individuals include those who are 
pregnant, those who have frequent episodes of low blood 
glucose, or this condition that Dr. Kowalski mentioned of 
impairment--impaired hypoglycemia when their blood sugar dips 
very low, older adults and younger--very young adults are 
understudied. Those with lower in education levels are also 
tend to be understudied by industry.
    And now, with respect to complications of the disease, 
something that we really need to focus on because this is where 
a lot of the funding for diabetes comes in. People with heart 
disease, and unfortunately, it looks like people that have type 
1 diabetes may have a different form of heart disease in terms 
of its manifestations.
    Diabetic foot ulcers is something that I think is very much 
understudied. We have begun a consortium to study foot ulcers 
because once people get this, you may not be aware, but the 
mortality associated with having foot ulcers actually is very 
close to some people with certain types of cancers.
    And so those are two areas. We have learned a lot in terms 
of diabetic eye disease and other manifestations. But if I had 
to pick two complications that would be where we would want to 
focus, and we have studies already developed in those--in that 
regard.
    Senator Baldwin. Thank you, Dr. Rodgers.
    Dr. Rodgers. Thank you.
    Vice Chair Collins. Thank you.
    Senator Hyde-Smith.
    Senator Hyde-Smith. Thank you Senator Collins. And I want 
to thank everyone for being here today. This means so much. And 
I hope you always remember this day for your effort in trying 
to make your situation, make your lives better. You are playing 
a part today. And I appreciate all of you coming.
    Dr. Rodgers, my question is for you and it is more State-
specific. Mississippi is the State I represent--a very large 
State with a pretty low population for such a large State, a 
lot of rural areas. And so many times we have so many patients 
who go undiagnosed and their chronic disease complications just 
skyrocket. Specialists are few and far between, and the 
patients usually have to travel a long way for their 
appointments.
    We have seen positive impacts of the Special Diabetes 
Programs and Research at the NIH. However, rural communities 
seem to face such a greater challenge. I have more family 
members who suffer from diabetes. I mean, everyone in 
Mississippi is very aware of what this is because we do have 
one of the highest rates.
    During your time as the Director of the National Institute 
of Diabetes and Digestive and Kidney Diseases, how have 
researchers focused on rural populations in their research and 
their studies because this is a great concern in my State?
    Dr. Rodgers. Thank you, Senator, for that question. There 
is a lot of activity in Mississippi. I have visited there 
multiple times to actually speak. And you are right, it is 
rural disease. We have been following and working with the 
Centers for Disease Control who, as you know, follow the 
incidence and prevalence of certain diseases like diabetes, not 
only at a state level, but even sort of at a county level, to 
try to understand what are some of the factors that are 
contributing to the prevalence and changing in the prevalence 
of the disease.
    We are also learning, for example, that in a study that we 
work with the CDC (Centers for Disease Control and Prevention), 
it is called SEARCH (SEARCH for Diabetes in Youth Study). And 
what SEARCH is now telling us--of course everything in 
Government has an acronym, so SEARCH is an acronym, which I 
will not go into at the moment, but we are really searching for 
diabetes in youth and adolescents.
    And we are finding that not only are we seeing an increase 
in the numbers of kids with type 1 diabetes in certain rural 
areas that was totally unexpected, but we are also seeing type 
2 diabetes, for example, in kids as young as 10, 11, or 12. And 
what we know about type 2 diabetes in these kids is that: (a) 
It does not respond at the same way that drugs that are 
commonly available respond in adults with the disease. And 
secondly, it is a much more aggressive disease. This is type 2 
diabetes, not type 1. It seems to be associated with the 
development of complications much, much earlier than what we 
see in adults which, typically, takes 10 or 15 years of the 
disease.
    And so these are studies that are really being actively 
pursued, both at the State and the county level, to try to 
understand this and using, you know, new, sophisticated GPS to 
actually target these. We have some young investigators who are 
coming up with some ideas that will be subject to testing. So 
we are very much focused on the disparities that exist in rural 
America. And that is something that, it really is something 
that is very important to me.
    Senator Hyde-Smith. Can you tell me, Doctor, how we as 
Congress can help address some of those issues? Is there 
anything specific because of the lack of quality health care in 
so many rural areas? Is there anything specific we, as 
Congress, can do to improve that?
    Dr. Rodgers. Well, certainly your support for this program 
and other programs, I think, are certainly critically 
important. We want to make sure that we continue to have 
investigators in the pipeline to continue investigative 
inquiries to be, you know, right there to answer questions that 
they pose. And so making--ensuring that we can not only 
maintain pivotal clinical trials in diabetes and in other areas 
but obviously funding the next generation of investigators both 
to treat patients appropriately, but also to uncover ideas that 
we are not even aware of yet to make sure they are there to 
help us move forward. And your ongoing support for those 
efforts, I think, is totally--is very much valuable.
    Senator Hyde-Smith. Well, I just thank all of you for being 
here. I thank you for your efforts. And I do have one young 
man, 17 years old, in Hattiesburg, Mississippi, who has the CGM 
pump, and it has changed his life. I just want that opportunity 
for every child who suffers from this. I want them to have 
every opportunity that we can possibly provide. So thank you 
for doing the research. Thank you for your diligence.
    Dr. Rodgers. Thank you.
    [Applause.]
    Vice Chair Collins. Thank you.
    Senator Manchin.
    Senator Manchin. Thank you, Madam Chairman. And thank all 
of you for being here. Thank our presenters. And to Maria and 
Elise, thank you all for sharing your stories with us.
    Maybe one question, real quick, for both of you, what would 
you think is something most people do not understand about 
diabetes, as far as childhood diabetes? Something that they 
just do not understand, unless your families and you all live 
with it no one else would understand that. Anything very 
quickly?
    Ms. Cataldo. Yeah. I think a lot of people do not 
understand that it is ongoing. You never get a break from it. 
You cannot ever just say I do not feel like doing this today. 
And a lot of people get it confused with type 2 diabetes----
    Senator Manchin. Mm-hmm.
    Ms. Cataldo [continuing]. Which is really frustrating 
because it is not something we ever wanted to live with; we 
were given it. And I think that is just really frustrating, 
especially as children here, a lot of adults do not want to 
give time to listen to us all the time, and even though some of 
the times we know.
    Senator Manchin. Keep telling, you keep telling your story, 
okay?
    Ms. Cataldo. Yeah.
    Senator Manchin. Maria?
    Ms. Muayad. I think that, and I feel that that kids in my 
school, at least, they think that I do not need my CGM and my 
pump on all the time. And they just come and like poke at it 
and touch it. And when the nurse comes up to my classroom, they 
always crowd around me when my blood sugar is going up or down.
    Senator Manchin. And you just keep telling--keep explaining 
to them. Trust me, they want to know. And I am sure most people 
want to help. But understanding is the most important thing, 
and educating them is something you can do and nobody else can 
do. And I think, you never give up and never be ashamed. Make 
sure that you make people understand what we all can do, 
working together.
    I want to also recognize Mr. Chris Ward from Charleston, 
West Virginia. He is here today, and I want to thank him.
    Let me say this to all the family members, thank you all 
for the support you give your loved ones, and what you do every 
day because people do not understand. And there is not a family 
in America that has not been affected one way or another with 
diabetes, not one family, they have someone in their immediate 
family, extended family, or close relation.
    To all of you, let me just say, you are the hope of 
America. You are sitting here today, you are our hope. I think 
there is going to be many of you sitting where we are sitting 
right now, wondering how you can make life better, how you can 
improve the quality of life. And that is what we are trying to 
do. We want to make sure that you have the greatest opportunity 
that anybody and any generation has ever had. We can only do 
that if you are healthy. And we want to make sure you have that 
opportunity. But I want to make sure you understand you have to 
live and grow to be a living, a loving, caring adult and give 
something back. You have a lot to share with a lot of people, 
and how they can live a better life. And as you grow and become 
responsible for that, you are going to be sharing the greatest 
gift that you have and that is the knowledge of knowing the 
challenges some people have that people do not understand. They 
just do not. And you being here today sharing that with us 
makes the difference of what we do and support. There is not a 
person here, Republican or Democrat, you hear a lot about 
politics, you have united Congress. You made us all understand 
it is not about politics, it is about each individual having 
the opportunity for quality of life. That is why you are here; 
that is what you are accomplishing today. And I hope that you 
understand making an effort to come here today makes a big 
difference in what we do, and how we do our job, and how 
important it is that we do it as quickly as humanly possible.
    We had a piece of legislation called the Inflation 
Reduction Act which put a cap at $35. We tried to cap all 
across the board, everybody, no one would ever pay more than 
$35. We are achieving it a little bit of the time. We got 
Medicare first. Now we got some companies that were shamed into 
knowing that they are making excessive profits to come down to 
$35, we want to make sure that we have a piece of legislation 
that does it.
    And I want to thank the Chairwoman, my good friend from 
Maine, and also my good friend from Washington, the State of 
Washington, for what they have done in leading this cause and 
the charge.
    And I would say one final thing. Dr. Rodgers, on the TEDDY 
Program, that is a very important program. My State of West 
Virginia has the largest percentage of adult diabetes in the 
country. We are over 16 percent of our population as adult, 
when the national average is about 10 percent.
    Can you tell me how that affects the families, and what we 
can do, and how TEDDY is working to also--I have always said 
this, you cannot teach an old dog new trick but you can teach a 
young pup tricks that can help the old dogs. And that is what 
we have got to do. And these kids can basically help educate a 
population that does not know how effective it is.
    Dr. Rodgers. Well, TEDDY is certainly one of these studies 
that I want to emphasize your points that this is something 
that families are very much involved. The study identifies kids 
from birth. They come in periodically--several times a year in 
the first few years, and then maybe three times a year, and 
then quarter--bringing all types of samples, urine, stools, 
saliva, with the, you know, very detailed record of when they 
had colds----
    Senator Manchin. Sure.
    Dr. Rodgers [continuing]. And whether they received 
vaccines, and the like. So it really is quite labor intensive, 
but the product of that, that study, is really going to inform 
us greatly in terms of what some of those triggers are.
    So TEDDY, again an acronym, The Environmental Determinants 
of Diabetes of the Young, we are going to learn quite a bit 
from that, and I would say probably within the next few years. 
So really, stay tuned. And what we learn about that I think 
might give us clues for other autoimmune diseases. That is why 
I am saying this; SDP is really having benefits beyond its 
intended purpose, so really stick with it. And again we really 
appreciate all of your support, as I am sure, the population in 
your State does your support.
    Senator Manchin. And let me say this to all of you. Thank 
you for being here today, you live in the greatest country in 
the world, the United States of America, and it is not the 
``divided'' States, it is the ``United'' States. Today, you 
have helped unite us more than you know, making an effort to be 
here. I want God to bless each and every one of you. Thank you 
for being here.
    [Applause.]
    Vice Chair Collins. Senator Britt.
    Senator Britt. Thank you so much, Ranking Member Collins. I 
want to tell you how much I appreciate your efforts on this 
important issue. I am proud to support the work that you and 
Senator Shaheen are doing, proud to work alongside Senator 
Kennedy and others.
    I want to tell you all how important it is you continue to 
tell your story. So Maria, Elise, the people from my home 
State, Tory and Violet, where are you? Are you out there? Oh, 
yes. This makes such a difference. You are changing hearts and 
minds. For me, it was one of my very dear friends, Elizabeth. 
She has two children diagnosed with type 1 diabetes. Her 
telling her story gave me a window into the struggles and 
sacrifices each and every one of you make.
    To all of the mamas out there: Wow, thank you for your 
vigilance--hey, and the dads, too. We appreciate what you are 
doing each and every day to make sure that every one of these 
kids can live a happy and healthy and fulfilled life. Please 
continue to do what you do so that we can make sure that we do 
our job.
    Dr. Rodgers, your research is needed. It is important so we 
can continue to make the right decisions here, in this body, in 
this chamber. Unfortunately, in Alabama, diabetes continues to 
grow, approximately 568,000 Alabamians suffer with diabetes. 
That is 12 percent of the population in my home State. It is 
estimated that probably 35,000 of these diagnoses have just 
recently happened.
    So my question for you is, this continual increase must be 
stopped. What are we seeing in the research and the development 
that tells us where this is coming from? What are the triggers? 
What do we need to know as we sit here today?
    Dr. Rodgers. Thank you for your question, Senator. What is 
driving the--certainly the increase in type 1 diabetes in 
individuals who, historically, have not had, you know, the sort 
of genetic predisposition seems to be something in the 
environment. And again, I think we are going to learn, as I 
mentioned earlier, from this TEDDY Study, what are some of 
those environmental triggers.
    We are also seeing, in answer to your earlier question, 
diabetes occurring at a much younger age, type 2 diabetes, and 
this may be the increase that you are referring to in the State 
of Alabama in young individuals as well. Some of that is the 
effect of lifestyle choices in terms of getting less physical 
activity, sort of being involved mostly behind a screen, you 
know, the video screen, or a television screen, or some other 
screen----
    Senator Britt. Put those devices down.
    Dr. Rodgers [continuing]. And not being as active as you 
may remember. Our food choices, for example. Those seem to be 
contributing to being overweight, and that in itself acts as--
it makes the insulin that is in our body not work as well as it 
should, a condition called insulin resistance. And so I think, 
you know, there are multiple factors that are driving it, but 
it certainly is related to a change in the environment.
    One final thing that I would say, and it certainly is true 
in Alabama, and others, you know. You may be aware that Alabama 
has one of the highest frequencies of gestational diabetes in 
any State in the country. And research that we have funded 
indicates that a mother who develops type--who develops 
gestational diabetes not only is that a higher risk for 
ultimately developing diabetes themselves, but the infant who 
is in that environment during her developing gestational 
diabetes, is also at a subsequent high risk.
    And that way you can imagine if that individual is a girl, 
ultimately, when she becomes a mother she may also pass that 
down at a younger and younger age. So that certainly is a 
contributing factor as well. And we are trying to break that 
cycle through some very innovative research efforts at the 
moment.
    Senator Britt. Thank you so much. I see that my time has 
expired, but I just want to tell all of you: You inspire me. 
Please keep telling your story. Keep being vigilant. And we 
have work to do up here. And we are certainly committed to 
doing it. Thank you.
    Dr. Rodgers. Thank you, Senator.
    [Applause.]
    Vice Chair Collins. Thank you.
    Senator Murkowski.
    Senator Murkowski. Thank you Madam--thank you Madam 
Chairman. And to those of you who are gathered here, whether 
you are the children in front of us, or the supporters, the 
caregivers, the parents, the friends, thank you. Thank you for 
your advocacy on behalf of yourself and others. Over the years, 
I have had so many different visits from young Alaskans who 
have come to me, and they have got their little story booklet, 
and there is pictures showing them over the years as they 
have--as they have dealt with their diabetes, but also what 
they have done as individuals who are brave enough, willing to 
make the long trip to Washington, DC, to come and tell their 
stories. So I join my colleagues up here to encourage you to do 
more of the same.
    Somewhere out there is Samantha from Wasilla. There, she is 
right up front there. Sam, I am looking forward to visiting 
with you. But it is--it is an effort, it is an effort. And I 
know that as young kids, you just want to be like everybody 
else, and everybody else; does not have an insulin pump; 
everybody else does not have to prick their finger; everybody 
else does not have to do what you are going through; everybody 
else's moms and dads and caregivers do not worry about them and 
what is happening with their blood sugar levels. But this is 
why, this is why, again, you need to share your story. You need 
to make sure that others understand not only what you are going 
through, but why it is so important that we find--we find that 
cure, we find that treatment. So thank you for what you 
continue to do.
    I want to direct my question here to Dr. Rodgers. And many 
of us have asked this same question along the same line, 
Senator Tester, Senator Hyde-Smith, and now just Senator Britt. 
In trying to understand a little bit more about some of the 
environmental exposures that may contribute to risk of 
developing type 1 diabetes in my State. Of course, we are very, 
very rural in Alaska. We have--in the overall Alaskan 
population, we have a rate of 7.5 percent of Alaskans that have 
diabetes. Alaska Natives have a higher rate at 8.5 percent of 
our population. So it is significant for us.
    I was in the North Slope, which is the furthest north area, 
small villages up there, and went through the grocery stores, 
as much as you can call them a grocery stores. But the fact of 
the matter is, there is no fresh produce. In other words, there 
is no lettuce, lettuce; there is no carrots; there is no peas; 
there might be some occasional potatoes; there is no fruit. So 
how do you get--how do you get your vegetables, how do you get 
your fruits? Well, you might get them frozen if you are lucky. 
You might get your fruit in heavy fructose syrup. But the 
reality is, is the diet is a consideration for us and a huge 
concern. So as you are looking at, not only the access in rural 
areas to health care that can provide for screening, that can 
provide for that treatment. I am worried about areas where we 
simply, we are a literal food desert when it comes to those 
healthy foods. And as many in our rural villages have 
transitioned from subsistence foods to the commercial processed 
foods, it has resulted in escalating rises of diabetes.
    So I am assuming, Dr. Rodgers, as you are looking at this 
in your TEDDY Study, this part of your review is also under 
careful consideration.
    Dr. Rodgers. Absolutely, Senator. That is an area that I 
think we are going to learn from some, you know, general 
principles that will illuminate a lot of the origin, you know, 
of this condition, particularly type 1 diabetes. But I think 
the factors that you just outline, particularly, you know, food 
islands, are areas, and the types of food really, may be 
pushing up the numbers of individuals at risk for type 2 
diabetes, as well.
    And even those with type 1 diabetes, of course the food is, 
you know, very important in terms of maintaining, you know, 
relatively constant levels of blood sugar throughout the day. 
You know, our role has really been in trying to develop the 
science basis to allow you to inform your policy decisions. One 
of the things that we are doing, that I will just say quickly, 
as we have an effort called Time-Sensitive Studies in which 
we--when there is going to likely be a change in policy, for 
example, the development of rail systems, or you know, new food 
delivery systems or things like that, in an effort to diminish 
the amount of overweight and obesity or perhaps making foods 
better available.
    And we want to see whether it really does have an impact. 
We try to get these investigators to get rapidly funded for 
these studies so they can get baseline information very 
quickly. And then as policies are enabled or established, one 
can then study 6 months, a year, 2 years later, to really test 
the hypothesis on the effectiveness of such legislation. So 
something to sort of keep in mind, we really try to take a 
multi-faceted approach to our research.
    And again, as I mentioned earlier, rural health is 
certainly an area of enormous disparities that, I think, we 
have to keep our eye on.
    Senator Murkowski. Thank you for that.
    And Madam Chairman, I want to thank you and Senator 
Shaheen, all those that have been working so aggressively on 
this.
    You know, Senator Kennedy articulated very well that the 
efforts that we are making to reduce the costs of insulin, make 
it affordable, well it may be, it may sound like a lot of 
money. I think when we evaluate and consider the cost to our 
overall health care system when not properly diagnosed, when 
not screened early enough, when not given the treatments 
necessary, those are the costs that are out of sight and are 
something that we have to address. So I am with him on his, 
``Yada, yada, yada'' or as I said, ``Blah, blah, blah.'' It is 
kind of the same thing. Let us do more than just talk about it. 
Let us make sure that access is there until we can find the 
treatment.
    Thank you for your leadership on this.
    Senator Kennedy. Thank you for that.
    [Applause.]
    Vice Chair Collins. Senator Peters, thank you so much for 
your patience and your graciousness.
    Senator Peters. Well, thank you, Madam Chair. And all I can 
say is, ``Wow.'' I have never been to a Committee hearing like 
this. I have not been around all that long, but I have been 
long enough to know that this does not normally happen here in 
Washington, to see so many people, all of these folks in front 
of me, all of these young folks. Thank you for coming here to 
Washington. Thank you for making sure your voice is heard. 
Thank you for your activism. It inspires me to see this, and 
also shows our democracy is alive and well when we have young 
folks that are engaged in this. So thank you for being here.
    Dr. Rodgers, I will ask my first question. And first of 
all, I just want to say I am grateful to JDRF for its 
partnership with the Elizabeth Weiser Caswell Diabetes 
Institute at the University of Michigan, in my home State, 
which is improving health outcomes for people with type 1 
diabetes by developing just a comprehensive understanding of 
type 1 diabetes, metabolism, and adolescence in young adults as 
well as people with long-standing type 1 diabetes.
    The Institute was started by the Weiser-Caswell family in 
Michigan, in which the father and two of his three sons were 
diagnosed with type 1 diabetes. And Elizabeth Caswell became 
absolutely relentless in her pursuit for more diabetes 
research, education, and treatment.
    The JDRF Center of Excellence at the Caswell Diabetes 
Institute has been identifying new ways to control diabetes and 
to prevent the absolute devastating consequences of diabetes, 
allowing them to provide better care as well as health outcomes 
for people with type 1 diabetes.
    Specifically, the University of Michigan Center of 
Excellence Research takes cutting-edge approaches to 
identifying predictive markers and therapeutic targets for type 
1 diabetes complications. The Center of Excellence also studies 
relationships among metabolic profiles, brain function, and 
stress allowing us to identify new ways to minimize the mental 
health burdens also associated with type 1 diabetes.
    So my question for you, sir, is, how does the institute at 
the University of Michigan rely on Special Diabetes Program 
funding specifically? And what would the Institute be able to 
accomplish if we increase this funding?
    Dr. Rodgers. Thank you, Senator. I can say that the NIDDK 
has really been supporting research infrastructure at the 
University of Michigan for quite some time. In fact, one of the 
original NIDDK-supported, diabetes research center, going back 
to 1977, was at the University of Michigan, and I think they 
have had a substantial funding from that time moving forward. 
So it really is doing, you know, great work.
    In terms of type 1 diabetes, in fact, it is doing extremely 
cutting-edge research. I had mentioned earlier about the 
TrialNet involvement in developing the first drug that is FDA-
approved that can delay the onset of Type 1 Diabetes by at 
least 3 years. Well, one of those major sites is at the 
University of Michigan. And the University of Michigan is 
actually also very actively involved in a--a co-lead, in fact, 
the SDP-supported Diabetes Foot Consortium, which aims to study 
the diabetic wound healing.
    They also actually have a diabetes--a center for diabetes 
translational research in which you work to develop the 
evidence to then put that into practice and get that 
implemented. And so there are many, many areas that that 
University should be very proud of, and we are certainly proud 
of it.
    So having additional funding will allow some very bright 
ideas of which I am sure there are many, many more at that 
center and others to move forward. And this SDP support will 
allow them to sort of, you know, get some of the things that 
are on the wish list moving forward much more rapidly.
    Senator Peters. Right. Good to hear. As you have talked 
about in some of your previous testimony, diabetes is an 
insidious disease that impacts folks of all age groups. And we 
have to be thinking about it very broadly about all of the 
impact that it has. So I just want to ask a quick question 
related to Medicare and for older adults with Medicare.
    Medicare will not cover nutrition therapy services for 
individuals. And you have talked about the importance of 
nutrition in your testimony. Medical Nutrition Therapy is not 
just a critical service for people with diabetes, it can also 
have the potential to help 88 million Americans with pre-
diabetes.
    So that is why I introduced with Senator Capito, who was 
here earlier, the Preventing Diabetes and Medicare Act, with my 
colleagues on the Committee to extend that coverage--Medicare 
coverage for Medical Nutrition Therapy Services with pre-
diabetes and risk factors for developing type 2 diabetes.
    Real quickly, at Dr. Rodgers, do you believe that this 
coverage is essential and it will actually bring down costs in 
the long run?
    Dr. Rodgers. Senator, I really cannot sort of--to discuss 
or speculate, you know, in terms of the funding of another 
agency. What I can say is that we have worked with diabetes 
prevention program on sort of a landmark study in which we were 
able to show that either a medication or intensive lifestyle 
changes in people who have pre-diabetes and that lifestyle 
changes included changes to their nutrition, and at least 30 
minutes of exercise, five times a week, greatly reduce one's 
risk of going from pre-diabetes, this is type 2 diabetes, to 
diabetes, by some 57 percent.
    The study ultimately led to CMS providing coverage for 
people over 65 because we had included in this diabetes 
prevention a substantial number of individuals that could be 
actually looked at, separately, and ultimately their staff made 
a calculation that providing this as a benefit for people on 
Medicare was cost effective even as early as 2 years. So one 
component of that is nutrition, but again, I cannot begin to 
speculate on more of that.
    Senator Peters. Right. Well, thank you. Just, in closing 
off my comments, Madam Chair, is just to, again, thank you, for 
all of you being here. I think it is clear from what you have 
been hearing from my colleagues on this Committee, we are all 
committed to attacking this insidious disease. We have got to 
stay together, be focused on it, but I want to have a hopeful 
message, too, with all of you sitting here in front of me, with 
your bright, smiling faces, which have a great wonderful life 
ahead of you, yes you do as well. That I think we are probably 
living in one of the most exciting times in human history, in 
what you have to look forward to in the years ahead in terms of 
scientific advances. I mean we are looking at things like 
artificial intelligence, we are looking at synthetic biology, 
we have got all sorts of new technologies that are coming on 
board that will literally revolutionize our world in very 
exciting ways. And I am confident, as long as we stay together, 
as long as we lock arms, as long as we speak with one voice, we 
are going to defeat this disease. We are going to have ability 
to treat people with diabetes, and we are going to do it 
together. And we will succeed. Thank you very much
    [Applause.]
    Vice Chair Collins. Thank you so much, Senator Peters; and 
I am proud to be a co-sponsor of your Medical Nutrition Therapy 
bill. I think it is a great idea.
    I am just going to ask, very quickly, a couple of closing 
questions because we have a vote on, and I know you need to get 
on to the rest of your program.
    Mr. Harris, I wanted to ask a question of you from the 
perspective of being a parent--a parent of a son with type 2--
type 1 rather, who was diagnosed at such an early age, at age 
2. And I would ask you what advice do you have to other 
parents? And I would like you to focus, particularly, on the 
Black community because Black teens have the largest increase 
in prevalence of type 1 diabetes.
    Mr. Harris. Well, I would say that starting off, it is it 
is absolutely a devastating--you know, to find out, the news is 
absolutely devastating. The thing that we really tried to do 
was make sure that we found a support system of people we could 
talk to try to gain some knowledge, and that is one of the 
things that is great about today, is that the awareness, people 
being aware of it, and aware of the need for funding, and all 
of those things is really important.
    But as a parent, I know the thing that we learned early on 
is that it is a moving target, trying to keep your numbers 
correct, trying to keep up with the advances in technology that 
are happening, and all those kinds of things.
    And the thing I would just say to parents is do not beat 
yourself up about it. We actually had a nurse that was helping 
us, that trained us in how to manage the disease back in the 
old days where it was still, you know, the finger pokes, and 
the syringes, and all of that. And she actually came to help us 
one night, and Max actually went low. And this is somebody who 
is a professional, who is teaching people how to, you know, 
deal with the disease, and she called us in a panic and said, 
``Oh, he went low.'' And we said, ``Yeah.''
    [Laughter.]
    Mr. Harris. So I think having that real world experience 
helped her as someone who was then teaching other parents. And 
even the parents I talked to over the last couple of days, that 
is the thing I have tried to always say to them, is just, you 
know, it is a moving target, it is not always going to be 
right, but you figure it out, you deal with it. It is one of 
those things, too, that as soon as you think you have got it 
figured out, you know, something changes, because the thing 
about--particularly the young people here today--is they are 
growing. So you know, their bodies are going to change, their 
attitudes about diabetes are going to change, and all of those 
things. So I think that the parental support is very important.
    I think across all communities--I know we talk about 
insulin affordability, I know that is a big piece of this also, 
that you have the tools to manage the disease in the right way. 
And I am also struck by one of the things that is happening 
where I think a cure is the destination, and I think we all 
agree upon that as the destination. Sometimes we disagree, even 
if we know where the destination is, we disagree on how we are 
going to get there.
    What I have been encouraged in this room is that the 
destination of finding the cure has been the most important 
thing that we all agree upon. But I also have to say that I 
love the fact that we are also talking about, I guess, the road 
to get to the cure, to make sure that that road is an 
affordable road, that it is a smooth road, as smooth as it can 
possibly be.
    And so I would just--I just want to say that I am here to 
support and my son, Max, was honored by JDRF a few years back 
and he said that he vows that he will be here until we find 
that destination--until we get to that destination of a cure.
    And the thing that I am encouraged about with all these 
young people here, is when they look back, and 10 years from 
now, or however many years down the road, they have kids and 
they have their families, and they are not going to have to 
have these conversations with their kids. It is going to be: 
What is diabetes? I have never heard of that before.
    Vice Chair Collins. That would be great.
    Mr. Harris. That is going to be the nice thing. So Senator 
Collins, I want to thank you for having me here today and 
allowing us all to speak and allowing all these young people to 
be here, because this is the future. And when diabetes is 
cured, each and everybody in this room is going to be a part of 
making that happen.
    [Applause.]
    Vice Chair Collins. Thank you. Well said.
    Elise, I know that Senator Shaheen wanted to be here today. 
So on her behalf, I am going to ask you a question. And that 
is, you live a very active life. You play all these sports. 
Could you tell us how important it is that the technology that 
you use allows you to play those sports and to have a very 
fulfilling, active life?
    Ms. Cataldo. Yeah. Well, it is definitely a challenge, but 
the technology that we have nowadays helps so much. I am on the 
Omnipod which, it has a setting called Activity. And I put that 
on 2 hours before training, or practice, or game, and 2 hours 
after. And it basically more closely monitors my blood sugars 
and gives me less insulin so that I do not go low. And that is 
so important. It has helped me so much. And that was also 
funded by the Special Diabetes Program. So I am really grateful 
for that. But it is really important to keep continuing that 
because playing in sports you can go dangerously low.
    Vice Chair Collins. Thank you. A great answer.
    And my final question is going to be for the President of 
JDRF. Doctor, we have worked so closely, Senator Shaheen and I, 
with you on the insulin question. And you have helped us, 
provided us with expertise in drafting our Insulin Act, which 
would reform the market to remove all of the perverse 
incentives that contribute to high prices, plus to put a $35 
cap on monthly co-pays. And I think that is so important. It 
would also have important patient protection so that you do not 
have to go through prior approvals and all of the rigmarole 
that we hear about so often.
    So, we have talked about, today, that some of the 
manufacturers have lowered their price to $35. I do think that 
is in response to our legislation. I am glad they have done it, 
but I think that it is our legislation that caused them to do 
it.
    So, just to get you on the record, do you believe that it 
is important that we still pass Federal legislation like the 
Insulin Act that Senators Shaheen and I have introduced?
    Dr. Kowalski. Well, Senator Collins, thank you, and Senator 
Shaheen, so much, for your leadership on this topic. It is the 
number one topic I face when I travel around the country. And I 
am sure every parent in this room would bend your ear, that it 
is still a problem.
    We are fully aligned and supportive of the Insulin Act. No 
one in this country should go for lack of food or rent or a car 
payment for insulin which sustains their life. So we commend 
your work, and we will be supportive, and we look forward to 
seeing the Insulin Act pass.

                         CONCLUSION OF HEARING

    Vice Chair Collins. Thank you so much. Thank you. I want to 
thank everyone for being here today. I have frequently said 
that every time I chair the Children's Congress, which I have 
done many, many times, I leave with a sense of renewed 
commitment. You inspire me. You saw that you inspired all of 
the Members who are here today, and you can make the difference 
when you go see your Members of Congress and urge them to 
support the Insulin Act, urge them to support the 
reauthorization of the Special Diabetes Program, which has been 
so successful in speeding up new technology that is making your 
lives better.
    Ultimately, we want a cure. And that is what we are all 
working toward.
    So, thank you for coming from all over the country to be 
with us today. And a special thanks to Maria for coming with 
her mother from Yarmouth, Maine, to be with us today.
    With that, this hearing is--I have got to get the gavel to 
make it official--this hearing is now adjourned.
    [Applause.]
    [Whereupon, at 11:52 a.m., Tuesday, July 11, the hearing 
was concluded, and the committee was recessed, to reconvene 
subject to the call of the Chair.]


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