[Senate Hearing 112-314]
[From the U.S. Government Publishing Office]





                                                        S. Hrg. 112-314

              TRANSFORMING LIVES THROUGH DIABETES RESEARCH

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

                                HEARING

                               before the

                              COMMITTEE ON
               HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
                          UNITED STATES SENATE


                      ONE HUNDRED TWELFTH CONGRESS

                             FIRST SESSION

                               __________

                             JUNE 22, 2011

                               __________

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

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        Committee on Homeland Security and Governmental Affairs















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        COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS

               JOSEPH I. LIEBERMAN, Connecticut, Chairman
CARL LEVIN, Michigan                 SUSAN M. COLLINS, Maine
DANIEL K. AKAKA, Hawaii              TOM COBURN, Oklahoma
THOMAS R. CARPER, Delaware           SCOTT P. BROWN, Massachusetts
MARK L. PRYOR, Arkansas              JOHN McCAIN, Arizona
MARY L. LANDRIEU, Louisiana          RON JOHNSON, Wisconsin
CLAIRE McCASKILL, Missouri           ROB PORTMAN, Ohio
JON TESTER, Montana                  RAND PAUL, Kentucky
MARK BEGICH, Alaska                  JERRY MORAN, Kansas

                  Michael L. Alexander, Staff Director
              Aaron M. Firoved, Professional Staff Member
               Nicholas A. Rossi, Minority Staff Director
        Priscilla H. Hanley, Minority Professional Staff Member
                  Trina Driessnack Tyrer, Chief Clerk
                 Patricia R. Hogan, Publications Clerk
                    Laura W. Kilbride, Hearing Clerk





















                            C O N T E N T S

                                 ------                                
Opening statements:
                                                                   Page
    Senator Lieberman............................................     1
    Senator Collins..............................................     1
    Senator Akaka................................................     4
    Senator Brown................................................     5
    Senator Shaheen *............................................     5
    Senator Lautenberg *.........................................     6
    Senator Pryor................................................     6
    Senator Begich...............................................    24
Prepared statements:
    Senator Lieberman............................................    35
    Senator Collins..............................................    36
    Senator Akaka................................................    38
    Senator Brown................................................    39
    Senator Shaheen *............................................    40

* Guest Member

                               WITNESSES
                        Wednesday, June 22, 2011

Kevin Kline, Celebrity Advocate Co-Chairman, Juvenile Diabetes 
  Research Foundation............................................     7
Griffin P. Rodgers, M.D., Director, National Institute of 
  Diabetes and Digestive and Kidney Diseases, National Institutes 
  of Health, U.S. Department of Health and Human Services........     9
Charles Zimliki, Ph.D., Chairman, Artificial Pancreas Critical 
  Path Initiative, Center for Devices and Radiological Health, 
  Food and Drug Administration, U.S. Department of Health and 
  Human Services.................................................    12
Caroline Jacobs, Delegate from Shapleigh, Maine, JDRF Children's 
  Congress.......................................................    26
Jack Schmittlein, Delegate from Avon, Connecticut, JDRF 
  Children's Congress............................................    28
Kerry Morgan, Delegate from Glen Allen, Virginia, JDRF Children's 
  Congress.......................................................    29
Jonathan Platt, Delegate from Tarzana, California, JDRF 
  Children's Congress............................................    30

                     Alphabetical List of Witnesses

Jacobs, Caroline:
    Testimony....................................................    26
    Prepared statement...........................................    79
Kline, Kevin:
    Testimony....................................................     7
    Prepared statement...........................................    42
Morgan, Kerry:
    Testimony....................................................    29
    Prepared statement...........................................    86
Platt, Jonathan:
    Testimony....................................................    30
    Prepared statement...........................................    89
Rodgers, Griffin P., M.D.:
    Testimony....................................................     9
    Prepared statement...........................................    44
Schmittlein, Jack:
    Testimony....................................................    28
    Prepared statement...........................................    82
Zimliki, Charles, Ph.D.:
    Testimony....................................................    12
    Prepared statement...........................................    64

                                APPENDIX

Charts submitted for the Record by Dr. Rodgers...................    61
Letter and prepared statement from Mary Tyler Moore, JDRF 
  International Chairman.........................................    92
Responses to post-hearing questions for the Record from:
    Dr. Rodgers..................................................    96
    Dr. Zimliki..................................................    99

 
              TRANSFORMING LIVES THROUGH DIABETES RESEARCH

                              ----------                              


                        WEDNESDAY, JUNE 22, 2011

                                     U.S. Senate,  
                           Committee on Homeland Security  
                                  and Governmental Affairs,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 1:34 p.m., in 
room SD-G50, Dirksen Senate Office Building, Hon. Joseph I. 
Lieberman, Chairman of the Committee, presiding.
    Present: Senators Lieberman, Akaka, Pryor, Begich, Collins, 
Brown, Shaheen, and Lautenberg.

            OPENING STATEMENT OF CHAIRMAN LIEBERMAN

    Chairman Lieberman. Good morning. The hearing will come to 
order. Thank you very much for being here. This is one of the 
afternoons and days that we look forward to, and I will say 
that the younger people here in front are much better behaved 
than the older people who usually fill this room, so I really 
appreciate it. [Laughter.]
    As a point of personal privilege, I do want to note the 
presence of Secretary of War, Edwin Stanton, from the Lincoln 
cabinet---- [Laughter.]
    Oh, no, that is Kevin Kline. [Laughter and applause.]
    If you have not seen ``The Conspirator,'' it is an 
extraordinary movie, and Mr. Kline is really brilliant in the 
role of Secretary of War Edwin Stanton, so I guess it is not a 
violation of our Senate ethics rules to plug a good movie of 
historical content. [Laughter.]
    Today, as I have traditionally done, with good cause, I am 
going to turn the Chairman's gavel over to Senator Collins in 
recognition of her longstanding leadership on behalf of 
diabetes research, particularly for children, and her truly 
passionate advocacy for Federal support for that research. So 
without further adieu, I give the gavel to my dear friend and 
colleague, the great Senator from the State of Maine, Susan 
Collins.
    [Applause.]

              OPENING STATEMENT OF SENATOR COLLINS

    Senator Collins [presiding]. Thank you. Thank you so much, 
Mr. Chairman. I am particularly grateful that you are allowing 
me to conduct this hearing. This issue is near and dear to my 
heart, and this actually represents the sixth hearing of the 
Children's Congress that I have had the privilege to conduct.
    I very much appreciate the opportunity to hold this hearing 
to examine what is often the devastating impact that juvenile 
diabetes has had on an estimated 3 million American children 
and their families.
    I also want particularly to welcome our distinguished 
witnesses and the more than 150 children who have traveled to 
Washington from every State in the country and from around the 
world to tell Congress exactly what it is like to have 
diabetes, just how serious it is, and why it is so important 
that we work together to fund the research necessary to find a 
cure. I want to give a special welcome to the delegate from 
Maine, 14-year-old Caroline Jacobs of Shapleigh, Maine. She 
will be testifying later.
    I want to also recognize Senator Shaheen, who has joined us 
this afternoon, and I think Senator Lautenberg is coming, as 
well. Both of them have a longstanding commitment to issues 
affecting children with diabetes and their families. Senator 
Shaheen is also my co-chairman on the Senate Diabetes Caucus, 
and her daughter is the ``Chair Mom'' of this year's Children's 
Congress. So we are very delighted that she can join us, as 
well as our colleagues, Senator Akaka and Senator Brown. There 
will be others coming in and out today. Senators have so many 
different duties and obligations, but they care a lot about 
this issue and others will be dropping by, as well.
    I do also want to acknowledge someone who is not able to be 
with us for the first time for the Children's Congress, and 
that is Mary Tyler Moore. I talked to Mary yesterday, and she 
sends all of her best wishes. She is recovering from some 
surgery. She is doing really well, and I know that we miss her, 
but she is here in spirit. And she is delighted that another 
famous American, Kevin Kline, is joining us today, so thank 
you, Mr. Kline, as well.
    Diabetes is a life-long condition, and it is one that does 
not discriminate. It affects people of every age, race, and 
nationality. It is the leading cause of a lot of medical 
problems. Moreover, it is estimated that diabetes accounts for 
more than $174 billion of our Nation's annual health care costs 
and one out of three Medicare dollars. Medical costs for a 
child with type 1 diabetes are six times higher than the cost 
for a child without the disease. These statistics are 
overwhelming. But what really motivated me to devote so much 
energy and time to this issue was meeting with families whose 
lives have been forever changed by diabetes.
    I will never forget, as a new Senator in 1997, meeting with 
a family whose son had diabetes. This was the first time I had 
really learned about type 1 diabetes, and this little boy 
looked up to me and said that he wished he could just take one 
day off from having diabetes, just one day, his birthday or 
Christmas. But, of course, those who have diabetes can never 
take a day off. But it does not mean that you cannot accomplish 
great things, and I am delighted to learn that many of you 
yesterday had the opportunity to meet with Supreme Court 
Justice Sonya Sotomayor and hear her personal story.
    It is so important that you have traveled to Washington 
today to tell your stories. You put a human face on all of the 
statistics, and you help us focus on what Congress can do to 
better understand and ultimately find a cure for this terrible 
disease.
    In individuals with type 1 diabetes, the body's immune 
system attacks the pancreas and destroys the islet cells that 
produce insulin. An average child with diabetes will have to 
take more than 50,000 insulin shots in a lifetime. Of 
particular concern is the fact that the incidence rate of type 
1 diabetes is increasing, particularly in children under the 
age of four. While the discovery of insulin was a landmark 
breakthrough in the treatment of diabetes, it is not a cure. 
People with type 1 diabetes face the constant threat of 
developing life-threatening complications and can face a 
reduction in their quality of life.
    But thankfully, there is some good news. Since I founded 
the Senate Diabetes Caucus, funding for diabetes research has 
more than tripled and now it approaches more than $1 billion 
this year. As a consequence, we have seen some encouraging 
breakthroughs, and we are on the threshold of a number of 
important discoveries.
    I talked today with several of you who have insulin pumps, 
for example. Advances in technology, like continuous glucose 
monitors, are helping people with diabetes control their blood 
glucose levels, which is key to preventing complications.
    We are also moving closer to our goal of an artificial 
pancreas, which would revolutionize diabetes care. An 
artificial pancreas is an external device that people with type 
1 diabetes could use to do what their bodies cannot, and that 
is automatically control both high and low blood sugar levels 
around the clock. This new technology has the potential to 
dramatically improve the health and quality of life for 
individuals with diabetes, and we are going to hear from 
Federal officials today who will tell us about the important 
clinical trials that are going on that are so promising. The 
Food and Drug Administration (FDA) has played a pivotal role in 
moving this research forward and making the artificial pancreas 
one of its Critical Path Initiatives.
    We are making progress in the battle against diabetes, but 
this is no time to take our foot off the accelerator. We have 
two choices. We can sit back and continue to pay the bills and 
endure the suffering, or we can aggressively pursue a national 
strategy aimed at curing this disease.
    And thanks to your efforts, thanks to your coming to 
Washington, there is increased understanding and support in 
Congress for diabetes research funding. Last year, we were able 
to pass legislation to extend the Special Diabetes Program for 
2 additional years, and that program represents more than a 
third of our Federal commitment to diabetes research. As such, 
it is critical to our efforts to find better treatments, a 
means of prevention, and ultimately a cure.
    So welcome to Washington. We are glad that you are here. 
Chairman Lieberman, thank you.
    [Applause.]
    Chairman Lieberman. Thank you, Senator Collins, and really, 
what I want to say is ``amen'' to everything you said, so I 
will be brief.
    I said at the beginning that I look forward to these 
hearings every session, and I do because they are so 
constructive. In a government in which, too often, too little 
happens that is constructive these days, this is a cause that 
unites people across party lines and has enabled us, certainly 
in recent years, to come together to be supportive of diabetes 
research and to help facilitate some of the really miraculous 
advances that have occurred in dealing with diabetes in our 
time.
    The fact that all you young people are here is the most 
important thing of all because you are the best advocates for 
this cause. First off, you show everybody how well you are 
doing, dealing with diabetes. But the second thing is you make 
us all want to make the investments that are necessary to make 
sure that we not only better treat diabetes, but really in your 
lifetime that we have a cure for diabetes.
    It is with that sense of optimism that I am really honored 
to welcome you and all the other witnesses here today, and I 
thank Senator Collins.
    Senator Collins. Thank you, Mr. Chairman. Senator Akaka.

               OPENING STATEMENT OF SENATOR AKAKA

    Senator Akaka. Thank you very much, Senator Collins. I deem 
it an honor to join you here and to say thank you very much for 
chairing this important hearing again on type 1 diabetes and to 
share a commitment and really a passion in trying to move this 
along to improve the lives and quality of life for young people 
and people of our country.
    I also want to welcome our distinguished panelists to this 
hearing who have been so committed to this issue. I also want 
to send a very special aloha to those Children's Congress 
delegates waiting to testify and those in the audience, all of 
you who are seated here. These are courageous young ambassadors 
who have traveled from all over the country and the world to 
educate us. They are here to share their stories of their own 
experiences, to bring a real human dimension to the policy 
debate. This shows how critical research and support is for 
diabetes and a hope for a cure.
    Diabetes is a significant health problem in my home State 
of Hawaii, and it is an increasing challenge for our Nation. It 
is an issue that we will look at in the Indian Affairs 
Committee. It will be part of the minority health legislation 
that I plan to introduce. And it is the subject of the ongoing 
budget and regulatory policy debate.
    In this context, I am proud to support the development of 
the artificial pancreas, and I will continue to support funding 
for research at the National Institutes of Health (NIH), which 
gives us the chance for better detection, better treatment, and 
the hope for a cure.
    All the more reason that I am so pleased to see the 
children here every 2 years. They remind my colleagues and me 
about the struggle of living with type 1 diabetes and the 
importance of supporting diabetes research.
    I would like to extend a special thanks to Aaron 
Tsuchitori, who traveled all the way from Honolulu with his 
mother to meet with me today. If you are sitting here, Aaron, 
please just hold your hand up. Oh, there you are. Yes. Thank 
you, Aaron, for coming all the way from Hawaii.
    I look forward to continuing to work with all of you to 
improve the lives of individuals with diabetes. I am glad to be 
here with you and join you in this. Thank you very much.
    [Applause.]
    Senator Collins. Thank you, Senator Akaka. Senator Brown.

               OPENING STATEMENT OF SENATOR BROWN

    Senator Brown. Thank you, Madam Chairman and Senator 
Lieberman. It is good to see you all, and good to see a lot of 
the children here and their families coming out and supporting 
diabetes research. I have the honor of having met four young 
people from Massachusetts, Jackson Savage, Jordan Beals, 
Jonathan Beals, and Joshua Fish--I see some of them out there 
in the audience. They gave me a lot of good information. It is 
something that I have certainly been aware of and our families 
have been working on long before I got to Washington, so I want 
to thank you for your leadership in doing it.
    I look forward to hearing all of our witnesses. I am going 
to be bouncing back and forth because of other hearings, but I 
look forward to staying for as long as I can. Thank you.
    Senator Collins. Thank you, Senator Brown.
    I mentioned that Senator Shaheen is the co-chairman with me 
of the Diabetes Caucus and has a special connection to this 
particular Congress, and we are delighted to have you here.

 OPENING STATEMENT OF HON. JEANNE SHAHEEN, A U.S. SENATOR FROM 
                   THE STATE OF NEW HAMPSHIRE

    Senator Shaheen. Thank you, Madam Chairman, and thank you 
to Senator Lieberman, to both of you, for holding this hearing 
today. I have a statement that I would like to submit for the 
record.\1\
---------------------------------------------------------------------------
    \1\ The prepared statement of Senator Shaheen appears in the 
Appendix on page 40.
---------------------------------------------------------------------------
    Senator Collins. Without objection.
    Senator Shaheen. I know we want to get to our panelists, so 
I just want to take a minute to introduce my granddaughter, 
Ellie, who is a delegate here with the Children's Congress--
thank you--and her mother, Stephanie, and father, Craig, who 
are here, and they are co-chairing the Children's Congress this 
year. I also want to recognize Abigail Lore and her mother, 
Jeanine, who are from Merrimack, New Hampshire. Thank you both 
for being here, as well. And thank you to all of the families 
and all of the delegates who are here today.
    I am very happy and proud to be able to join you in 
advocating for research for a cure for juvenile diabetes and 
also for moving forward as quickly as we can with the 
development of an artificial pancreas.
    So again, thank you all very much for being here.
    [Applause.]
    Senator Collins. Thank you, Senator Shaheen.
    Senator Lautenberg, we are delighted that you could join us 
again this year. I mentioned in my opening statement that you, 
too, have a personal connection to diabetes and have 
demonstrated tremendous leadership in this area.

 OPENING STATEMENT OF HON. FRANK R. LAUTENBERG, A U.S. SENATOR 
                  FROM THE STATE OF NEW JERSEY

    Senator Lautenberg. I have a granddaughter, also, that I am 
fortunate enough to have who has diabetes. And I want to say 
thanks to the Chairman for inviting me here today. It is a 
personal issue for me, and I appreciate the chance to work with 
you, Senator Lieberman, but particularly with Senator Collins, 
our colleague from Maine. She has been so diligent, so 
persistent, so determined to help our country by making sure 
that those with diabetes can conduct their lives with a decent 
attitude and participation in all of the activities.
    When my granddaughter was here during the Obama 
inauguration, I saw that she looked pale. I saw that she seemed 
tired, 12 years of age, and I said to my daughter, ``Is there 
something wrong with Maddie?'' And she said, ``I do not think 
so, Dad, but some signs tell me we have to get her to a 
doctor.'' Therefore, they did that, and we visited her in the 
hospital a day after she got back to Florida, where she lived. 
She had her first treatment with insulin. She was bright. She 
was positive. She was hopeful. And I thought, all this 
devastation that came upon us when we learned that she had 
diabetes. And I can tell you, that granddaughter of mine is now 
on a soccer team that was running for the State championship in 
Florida. She is never too tired to take on an activity.
    And she has been an inspiration to my life, just as all of 
you are an inspiration here. You do not know how much you do 
for us. You know that we try to do things for you, but you do 
more for us when we see your faces and we see your smiles and 
we see your parents, and we know that life is good for you and 
we are going to keep on working to make it better.
    I thank our friends here and all of my colleagues for 
participating in this important hearing. Thank you, Senator 
Collins.
    [Applause.]
    Senator Collins. Thank you very much, Senator Lautenberg.
    Senator Pryor, welcome.

               OPENING STATEMENT OF SENATOR PRYOR

    Senator Pryor. Thank you, and thanks for having me. I think 
everybody understands this now, but if we do not get it, I want 
to make sure that everybody understands what a tremendous 
advocate you have in Senator Collins. Let us give her one more 
hand. She is great.
    [Applause.]
    Senator Pryor. I really just want to say one more thing. I 
know that Davis Moore from Arkansas is here. Thank you for 
being here, and all of you who are wearing the blue shirts, you 
are making a difference. Thank you for coming to Washington, 
and thank you for fighting the good fight. It is certainly a 
fight worth fighting, and thank you for all the things you 
represent and all the great things you are going to accomplish. 
Thank you.
    [Applause.]
    Senator Collins. Thank you very much, Senator Pryor.
    Leading off our first panel this morning is Academy Award 
winning actor and longtime Juvenile Diabetes Research 
Foundation (JDRF) advocate Kevin Kline. One of our country's 
finest film and stage actors, as Senator Lieberman mentioned, 
Mr. Kline may have been virtually unrecognizable in his recent 
appearance as Edwin Stanton, the Secretary of War, in the 
movie, ``The Conspirator,'' but he is no stranger to us. He 
testified before our Committee 10 years ago at our 2001 
hearing, and I am delighted that he has made a return 
performance, an encore, I guess I will call it, because I look 
forward to hearing his perspective on the progress that has 
been made during the past decade and the road ahead.
    So welcome. We are delighted to have you here.

 TESTIMONY OF KEVIN KLINE,\1\ CELEBRITY ADVOCATE CO-CHAIRMAN, 
             JUVENILE DIABETES RESEARCH FOUNDATION

    Mr. Kline. Senator Collins, thank you. Senator Lieberman, 
thank you, and thank you for the nice mention of ``The 
Conspirator,'' and my performance as a historical figure. 
Members of the Committee, thank you all for inviting me to 
appear today with this distinguished panel and amidst this 
collection of such remarkably poised, self-possessed, quiet, 
but ultimately very vocal delegates, I hope.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Kline appears in the Appendix on 
page 42.
---------------------------------------------------------------------------
    Ten years ago, as you mentioned, I had the honor of joining 
Mary Tyler Moore and the 100-plus delegates at the 2001 JDRF 
Children's Congress. Since then, I am happy to report that we 
have made remarkable progress in understanding this disease. We 
are many steps closer to a cure, and even as we are gathered 
here today, new tools are being developed to improve the day-
to-day management of type 1 diabetes. But we still have a ways 
to go, which is why we are here now, not only championing the 
science, but pushing to accelerate programs.
    Today, these great young delegates are getting the 
attention that they so richly deserve. But I would like to take 
a few moments to recognize all of the parents, siblings, and 
other special people that these young advocates have brought 
with them today. They know firsthand the challenges that we 
face as we shepherd our children and loved ones through life 
with the added burden of diabetes.
    You see, when a child is first diagnosed with type 1 
diabetes, the parents are thrust immediately into the 
additional roles of doctors, nurses, nutritionists, and even 
psychologists. They are on duty 24 hours a day, 7 days a week, 
365 days a year, monitoring their child's blood sugar levels 
and physical activity, counting the carbohydrates in their 
meals and snacks, calculating insulin dosages, giving 
injections, as well as managing the emotional stresses which 
come from dealing with the daily rigors of this disease.
    Each day, as I am sure these children will testify to, 
brings its own unique challenge to control blood sugar levels, 
even with the best of plans and the use of the latest 
technology. It is not unusual for parents to wake up routinely 
in the middle of the night to check their children's blood 
sugar to make sure it did not become too high or so low as to 
result in a seizure or a coma or worse. These blood sugar 
emergencies are all too common, and a number of parents here 
have had to call 911 to save their children's lives.
    Many parents have become their children's advocates in the 
fight to cure diabetes by joining JDRF. As JDRF's National Walk 
Chairperson, I had the great pleasure of rallying people across 
the country to join the JDRF Walk to Cure Diabetes, and I am 
happy to report that thanks to the outpouring of enthusiastic 
support, we have raised millions of dollars with the walk. JDRF 
has put this money to work in a direct and efficient manner to 
support research for better treatments, prevention, and 
ultimately for a cure for type 1 diabetes.
    The Federal Government has also played a critical role in 
the fight to cure diabetes, in particular with the strong 
bipartisan support for the Special Diabetes Program. I thank 
you, Senator Collins, for your leadership, and I thank your 
colleagues in the Senate and House who recognized the great 
return on investment from the Special Diabetes Program and who 
supported the 2-year $300 million extension this past December.
    Together, JDRF and the Federal Government have made and 
will continue to make powerful partners in advancing research 
to cure, treat, and prevent type 1 diabetes.
    Since I testified here before this panel 10 years ago, more 
than 40 of the genes have been discovered which put people at 
risk for type 1 diabetes. Numerous therapies to halt the 
autoimmune attack which causes type 1 diabetes are being tested 
in human clinical trials. New therapies have also been shown 
not only to halt the progression of diabetic eye disease, but 
also to improve the vision in those who already suffer from it. 
And finally, the artificial pancreas has gone from being merely 
a theory to a cutting-edge technology that has been shown in 
early trials to prevent dangerous low and high blood sugars.
    Apart from finding a cure, the artificial pancreas 
represents a watershed moment in the management of diabetes and 
happens to also be a parent's dream come true. Imagine, if you 
will, going to bed at night without having to worry about 
dangerous nighttime high or low blood sugar levels, or knowing 
that your child will have a great day at school without the 
burden of pricking his or her fingers, counting carbohydrates, 
taking the right amount of insulin, and treating high and low 
blood sugars, or just getting so caught up in being a kid and 
forgetting to do some of these things and coming home from 
school dangerously ill. Best of all, imagine knowing that your 
child will live a long, productive life since these artificial 
pancreas technologies have the potential to keep him or her 
healthier longer, forestalling or completely circumventing the 
devastating complications until a cure is found.
    I know the Food and Drug Administration has made the 
artificial pancreas a priority, and I commend Commissioner 
Margaret Hamburg for her leadership. But there is more that the 
FDA needs to do. Many of these children here today are, in 
fact, wearing the components of what will ultimately constitute 
an artificial pancreas, namely, insulin pumps that deliver 
insulin as well as continuous glucose monitors which give blood 
sugar readouts every few minutes. The challenge that we face 
now, however, is to get these devices, which do not yet work 
together automatically, to talk to each other and to control 
the blood sugar levels.
    In other countries, there are devices now available that 
take the first step in this process, by automatically shutting 
off the insulin pump when someone is going low. This is an 
important step and one that we need to take in the United 
States right now.
    And we can do more than that. JDRF and federally funded 
research have, in hospital settings, tested artificial pancreas 
technologies that automatically turn insulin both on and off, 
and the results have been overwhelmingly positive. The next 
step is testing these artificial pancreas devices in real-world 
settings. To do this without delay, however, the FDA needs to 
provide clear and reasonable guidance. Many of the world's best 
diabetes researchers and leading clinician organizations have 
joined together with JDRF to propose artificial pancreas 
guidance to the FDA, and the majority of the Senate and the 
House have urged the FDA to give this proposal immediate 
consideration.
    We now need the FDA to act. Parents who are up every night 
and worrying every day about their children simply cannot 
afford to wait any longer. It is past time for the artificial 
pancreas technologies to be tested in real-world settings. We 
urge, we implore the FDA to issue draft guidance for public 
comment on the artificial pancreas so that outpatient trials 
can begin and the oppressive burdens of type 1 diabetes can be 
lifted from millions of Americans as soon as possible.
    Thank you for the opportunity to participate in the hearing 
today, and I would be pleased to answer any questions that I 
can.
    [Applause.]
    Senator Collins. Thank you very much for that excellent 
testimony, Mr. Kline.
    Next, we will hear from Dr. Griffin Rodgers, who is the 
Director of the National Institute of Diabetes and Digestive 
and Kidney Diseases at NIH. He will bring us up to date on the 
advances in research, and I also hope that he will provide some 
examples of the research that is specifically supported by the 
Special Diabetes Program. Dr. Rodgers, welcome.

 TESTIMONY OF GRIFFIN P. RODGERS, M.D.,\1\ DIRECTOR, NATIONAL 
   INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES, 
 NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF HEALTH AND 
                         HUMAN SERVICES

    Dr. Rodgers. Thank you very much. Mr. Chairman, Senator 
Collins, and Members of the Committee, as the Director of the 
National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK), I thank you for the invitation to testify at 
this hearing on type 1 diabetes.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Rodgers appears in the Appendix 
on page 44.
---------------------------------------------------------------------------
    And on behalf of NIDDK and the other institutes and centers 
at NIH, I am pleased to report that we are vigorously pursuing 
research to prevent, treat, and ultimately cure type 1 diabetes 
and its complications. Through collaborative and coordinated 
research efforts with our partners, including the Juvenile 
Diabetes Research Foundation, and with the support of the 
Special Statutory Funding Program for Type 1 Diabetes Research, 
we are making critical steps toward these goals that I have 
outlined.
    Now, before I highlight some of the exciting advances, I 
would like to acknowledge the important contribution of my 
fellow witnesses. Mary Tyler Moore, here in spirit, you 
continue to motivate us with your unwavering devotion to 
improve the lives of others with type 1 diabetes.
    Kevin Kline, you tirelessly raise awareness of the disease 
and promote efforts toward a cure.
    I am also pleased to share the table today with Dr. 
Zimliki, who will describe the complementary efforts of the FDA 
to advance the artificial pancreas.
    I would also like to acknowledge the children, parents, and 
families who will testify and who sit in this room proudly 
representing their States and the many other Americans with 
type 1 diabetes. Many of you have participated in clinical 
trials to help improve diabetes care, not only for yourself, 
but for future generations. We are inspired by your dedicated 
efforts and your enthusiasm.
    Now, research in type 1 diabetes has made a tremendous 
impact on the health and quality of life of people with this 
disease. I will reference three handouts during my testimony to 
illustrate these points, and these handouts are attached to the 
copies of my written testimony.\1\
---------------------------------------------------------------------------
    \1\ The charts referenced by Dr. Rodgers appear in the Appendix on 
page 61.
---------------------------------------------------------------------------
    On the first handout, a bar graph shows that the survival 
rate for people with type 1 diabetes has dramatically improved 
over time. For people diagnosed, for example, in the 1950s, 
represented by the blue bar on the far left side of the graph, 
only about 70 percent survived for 25 years with the disease. 
This number has dramatically increased to about 95 percent for 
people diagnosed in the 1970s, represented by the purple bars 
on the far right side of the graph. The outlook is even 
brighter for today's children, due to improvements in diabetes 
care and technologies. Still, the burden of living with 
diabetes, as my colleagues have mentioned, is enormous, and so 
it is critical to build on research progress to find ways to 
prevent and cure the disease.
    On the second handout, you will see that even before type 1 
diabetes becomes apparent, the immune systems of people who 
will develop the disease are destroying their insulin-producing 
beta cells, leading to a decrease in beta cell mass, and I will 
describe how the NIH is focusing our research on different 
stages of the disease progression.
    Now, as indicated on the far left of this graph, 
understanding the causes of type 1 diabetes is essential to our 
preventing the onset of autoimmunity, a preclinical sign of the 
disease, and of the disease itself, and significant progress 
has been made in unraveling the genetic causes of type 1 
diabetes. As was mentioned, just a few years ago, we only had 
three genes that we understood contributed to the risk of the 
disease. Today, due to the efforts of the Type 1 Diabetes 
Genetics Consortium and other researchers, nearly 50 genetic 
regions have been identified.
    We know that there are likely factors that exist in the 
environment that interact with these genetics to turn disease 
risk into disease reality. And because the genetic risk for 
type 1 diabetes is now well characterized, we can identify 
those at risk and follow them, and this has allowed us to 
embark on a bold, long-term, systematic study to identify these 
environmental factors.
    This study, the Environmental Determinants of Diabetes in 
the Young (TEDDY), has enrolled over 8,600 newborns with high 
genetic risk for the disease, and we plan to follow them for 15 
years. We will be collecting biological samples and information 
about their lives. Identification, for example, of an 
infectious agent that triggers this autoimmunity could lead to 
a vaccine to protect against this disorder. On the other hand, 
if we find that dietary factors protect from or contribute to 
the development of the disease, we can recommend changes to 
infant feeding practices. TEDDY may also shed light on other 
autoimmune diseases, like celiac disease.
    The NIH also supports research in preclinical and early 
disease stages, as shown by the blue and red arrows. Today, 
blood tests can accurately identify relatives of people with 
type 1 diabetes who are at high or moderate risk of developing 
the disease within 5 years. This important advance has enabled 
Type 1 Diabetes TrialNet to launch clinical trials of promising 
prevention strategies to stop the autoimmune attack.
    It is also important to identify ways to halt or reverse 
disease progression soon after onset to preserve any remaining 
beta cells. In collaboration with the Immune Tolerance Network, 
TrialNet is also conducting trials of promising therapies in 
newly diagnosed patients.
    Now, the third handout continues along the spectrum of 
disease progression, and this next stage of the disease 
research, shown in green, focuses on people with established 
type 1 diabetes. A high priority for research at this stage is 
the development of new tools and technology to help people 
improve their blood glucose control because that can reduce 
disease complication by up to 70 percent. Certainly, an 
artificial pancreas to automatically link glucose monitoring 
with insulin delivery can make a positive impact on people's 
health and their quality of life. NIDDK is supporting 
innovations in technology critical to the development of an 
artificial pancreas. Working closely with our partners at the 
FDA, we are pursuing research to test artificial pancreas 
technology and ensure that it is safe and effective.
    In recent advances, scientists developed and are testing a 
bi-hormonal closed-loop artificial pancreas, one that delivers 
not only insulin, but a counterbalancing hormone, glucagon, to 
more finely reproduce the activity of the human pancreas. In 
another recent study, researchers looked at overnight closed-
loop insulin delivery following two different real-life dinner 
scenarios. Testing closed-loop technologies in real-life 
situations is really a key step toward moving this technology 
out of the clinic and into the real world.
    A major goal of research at the next stage, shown in 
purple, is to investigate ways to replace the destroyed beta 
cells and restore beta cell function, and one approach to 
replace these cells is through islet transplantation, and the 
Clinical Islet Transplantation Consortium is conducting trials 
to study and to refine this therapeutic strategy. Scientists 
like those in the Beta Cell Biology Consortium are also 
pursuing strategies to replace islet cells by growing cells in 
the laboratory for transplantation into people or by expanding 
their remaining beta cells or by coaxing other types of cells 
in the pancreas to become beta cells.
    Finally, until prevention or cure of type 1 diabetes is 
possible, research toward preventing, arresting, and reversing 
the complications of the disease is critically important, shown 
on the far right of that graph. Just recently, we saw the 
biggest advance in diabetes eye disease treatment in 25 years. 
A landmark study from the Diabetic Retinopathy Clinical 
Research Network found that patients who received a combination 
of a drug and standard laser therapy showed substantial vision 
improvement after 1 year. Advances like these in treating 
diabetic complications also benefit patients who have type 2 
diabetes and are at risk of these complications, as well.
    Hundreds of thousands of individuals have participated in 
research supported by the Special Diabetes Program. Remarkably, 
nearly 30 years after one pivotal trial study began, about 95 
percent of the participants in this landmark trial, which 
showed that glucose control dramatically reduced type 1 
diabetes complications, continue to participate in a follow-up 
study known as Epidemiology of Diabetes Interventions and 
Complications (EDIC), and as a result of their commitment, this 
long-term investment in research continues to identify ways to 
improve the health of people with diabetes.
    I am grateful for the opportunity to share with you just a 
few examples of the many recent advances in ongoing research in 
type 1 diabetes. We continue to be inspired by the dedicated 
efforts of individuals affected by type 1 diabetes and by the 
organizations like JDRF that represent them. We look forward to 
continuing our partnership with JDRF and our sister Federal 
agencies on research to combat type 1 diabetes and its 
complications, and we will continue to be diligent in our fight 
against type 1 diabetes to help all the children here and the 
many Americans whom they represent today, and we will strive to 
improve their quality of life with the ultimate goal of curing 
this disease.
    Thank you, Mr. Chairman and Senator Collins, for your 
leadership in calling for this hearing to continue to bring 
attention to the importance of type 1 diabetes research and for 
your continued support of NIH research. I will be pleased to 
answer any questions that you might have.
    [Applause.]
    Senator Collins. Thank you, Dr. Rodgers.
    Our last witness on this panel, before we hear from the 
children, is Dr. Charles Zimliki. He is the Chairman of the 
Food and Drug Administration's Artificial Pancreas Critical 
Path Initiative. There is tremendous interest and excitement 
about this research and technology, and I look forward to 
hearing your statement.

 TESTIMONY OF CHARLES ZIMLIKI, PH.D.,\1\ CHAIRMAN, ARTIFICIAL 
   PANCREAS CRITICAL PATH INITIATIVE, CENTER FOR DEVICES AND 
    RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION, U.S. 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Dr. Zimliki. Well, I share that excitement, as well. Madam 
Chairman and Members of the Committee, I am Dr. Chip Zimliki, 
Chairman of the Artificial Pancreas Critical Path Initiative, 
located within the Center for Devices and Radiological Health 
at the FDA.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Zimliki appears in the Appendix 
on page 64.
---------------------------------------------------------------------------
    I would like to thank the Committee for the opportunity to 
discuss the artificial pancreas system and what the FDA is 
doing to assist in the development of these critically needed 
and potentially life-changing devices. As a person living with 
type 1 diabetes, I am personally and professionally committed 
to seeing this important, novel medical device approved in the 
United States.
    And I just want to go offline here and say, Mr. Kline, I 
fully support the proposal about issuing guidance, and I 
believe the FDA will submit guidance for all types of 
artificial pancreas systems before December of this year.
    [Applause.]
    Dr. Zimliki. Diabetes is a disease that affects the entire 
family, especially when a child is diagnosed. I know this 
because I was diagnosed with diabetes when I was 13 years old. 
When I was diagnosed, the technology was a great deal 
different. They were just coming out with glucose meters, and 
it took much longer than it does today to obtain a blood 
glucose measurement. Technology has come a long way, and I am 
very grateful for that.
    But even now, with today's technology, we still must prick 
our fingers to test our blood multiple times a day, and over 
time, it can really hurt. I am sure the children here can 
attest to that. We must also calculate insulin doses, 
administer necessary insulin via syringes or infusion pumps in 
order to lower blood glucose, and, as always, we have to be 
prepared for the inevitable lows and highs associated with 
diabetes. I admit, it is really tough being a diabetic.
    While great strides have been made in diabetes management, 
current treatment is constant and pervades all aspects of a 
person's life, presenting a particularly arduous burden for 
children and their parents. An artificial pancreas system is an 
innovative device for treatment of type 1 diabetes that, once 
fully developed, will automatically monitor blood glucose and 
administer appropriate insulin doses. This life-changing 
technology will positively impact diabetic patients' health and 
quality of life.
    As a person with diabetes, I am acutely aware of the 
benefits an artificial pancreas system will provide. I say 
``will'' because I am highly optimistic that industry, 
researchers, and the FDA will bring this device to market. An 
artificial pancreas system will allow people with diabetes, 
especially children, to live active lives without the constant 
need to adjust glucose levels.
    While I know the potential benefits are enormous, an 
artificial pancreas system is a significant risk device, 
meaning it presents a potential for serious risk to the health, 
safety, or welfare of the patient. If not properly designed, 
use of an artificial pancreas device in an outpatient setting 
can place patients at significant risk because the device 
controls the administration of insulin. As such, an 
Investigational Device Exemption (IDE) from the FDA is needed 
to allow the investigational device to be used in a clinical 
study.
    Currently, the FDA has approved over 17 clinical studies 
for artificial pancreas systems at various levels of 
development, and we have seen promising results. The FDA is 
helping advance the development of an artificial pancreas 
system by prioritizing the review of IDE studies, fostering 
discussion, shortening study and review times, and providing 
clear guidelines and a path to market for industry.
    In 2007, the FDA created the Artificial Pancreas Critical 
Path Initiative, bringing together a multi-disciplinary group 
of scientists and clinicians from the FDA and NIH. One of the 
major goals of this initiative is to identify roadblocks and 
possible solutions to streamline the regulatory process. A 
shining example of this effort was how the FDA worked with the 
developer of a software program so that researchers working on 
an artificial pancreas system could test control algorithms and 
use the results in support of regulatory submissions. This 
important software tool enables researchers to quickly test 
artificial pancreas control algorithms and is accepted in place 
of costly and time-consuming animal studies. This effort saved 
investigators 6 months to a year in clinical study time and 
expedited the transition to human trials.
    The FDA also encourages researchers to contact the agency 
early to discuss clinical study plans and get informal feedback 
that can improve their study designs and facilitate the review 
process. This quick, informal feedback can help investigators 
develop better and more complete study plans for the FDA 
review. When investigators submit their final study plan, the 
FDA gives these submissions the highest priority and works 
interactively with investigators to move them quickly and 
efficiently through the review process. Questions and research 
challenges are often quickly resolved, helping researchers 
start their study sooner.
    The FDA guidance and industry standards help manufacturers 
and researchers understand the minimum requirements for making 
a device that is safe and effective. This helps them make the 
best use of resources and streamlines the regulatory review 
process. We agree with JDRF and others that guidance to 
industry is useful for product development.
    On June 22, 2011, the FDA issued draft guidance that will 
help advance the development and approval of an artificial 
pancreas system to treat type 1 diabetes in the United States. 
This guidance document addresses an early version of an 
artificial pancreas system known as a Low Glucose Suspend (LGS) 
system. The LGS system can help reduce or lessen the severity 
of hypoglycemia by temporarily reducing or stopping delivery of 
insulin. Patients using this kind of system still must test 
their glucose levels on a regular basis with a glucose meter 
and give themselves insulin. The draft guidance provides 
recommendations for those planning to develop and submit for 
FDA approval an application for an LGS system.
    The FDA is also seeking input from industry, researchers, 
and the clinical community on the draft LGS guidance. 
Specifically, the agency is interested in feedback about the 
types of clinical studies that should be conducted and what 
their target outcomes should be to demonstrate safety and 
effectiveness. Your input is also very welcome.
    The FDA is also working on the second draft guidance, as I 
discussed. The FDA has been working with research communities, 
such as JDRF, to expedite this guidance, and we have promised 
the publication of the draft guidance by the end of this year.
    Finally, the FDA is working with NIH and other interested 
parties in planning the next artificial pancreas workshop, 
which will focus on developing better technology for creation 
of a more accurate and reliable artificial pancreas system. 
This is the system that you can just put on and not worry 
about. I cannot wait for that day.
    The FDA is fully committed to the development of an 
artificial pancreas to meet this critical health need. It is 
the goal of the agency to provide a clear pathway for 
manufacturers to provide people with diabetes with innovative, 
safe, and effective medical devices to treat their disease.
    Madam Chairman, this concludes my formal remarks, and I 
will be pleased to answer any questions the Committee may have.
    Senator Collins. Thank you, Dr. Zimliki.
    [Applause.]
    Senator Collins. Thank you so much for your testimony.
    We are going to do a 6-minute round of questions so that we 
can get to the next panel. We could keep you here all day.
    Dr. Zimliki, it is great news that you have given us today, 
and I saw the guidance on Monday about the draft guidance. In 
early May, 59 of us signed a letter that I spearheaded that 
encouraged the FDA to move forward with issuing guidance that 
would enable clinical trials for testing the artificial 
pancreas to move from an inpatient to an outpatient basis. Does 
this guidance help us along to achieve that goal of moving to 
the outpatient guidance?
    Dr. Zimliki. Yes, indeed, it does. This is the complete 
package guidance. This will help academicians start their 
investigations, get them approval for the clinical studies in 
the in-clinic, and it outlines what type of information the FDA 
needs to assure safety as we transition from the in-clinic to 
the outpatient settings.
    Senator Collins. And on a related question for you, I have 
heard--and there are some delegates from Canada here today--
that the Low Glucose Suspend system technology is available now 
in Canada and other parts of the world. Could you explain to 
us, and I am not trying to put you on the hot seat--well, maybe 
I am trying to put you on the hot seat---- [Laughter.]
    But why is it not available here if it is available next 
door in Canada?
    Dr. Zimliki. Well, it is hard to draw comparisons across 
the various regulatory agencies around the world. The FDA has 
to operate within U.S. law, which states medical devices must 
be safe and effective.
    I will give you an example. The European Union's law states 
that medical devices need to be safe and perform. That might 
not sound like a big difference, but there is a significant 
difference between the two, and I will use the Veo system as 
the example. This is going to be a long answer, I am sorry, 
Senator Collins.
    The Veo system shuts off insulin when the continuing 
glucose monitoring (CGM) value is low. To evaluate the 
performance of that, all you need to do is show that the 
insulin pump shuts off when the sensor reads low. That is a 
perfect engineering question that can easily be tested on the 
bench side. The FDA agrees that type of performance is needed.
    But what the FDA also needs for effectiveness is to know 
what happens to the patient when the pump actually turns off. 
That information is critical because it allows the prescribing 
clinician to look at the information that is provided in that 
clinical study and determine whether or not the patient can use 
this device beneficially.
    With regard to the Veo system, I will say Medtronic and the 
FDA have been continually working together. The Aspire study is 
an ongoing study to provide sufficient safety data within the 
United States, and it is the hope of the FDA that this safety 
data will allow the transition to an outpatient setting and 
finally approval of that device.
    Senator Collins. Thank you.
    Dr. Rodgers, last year, Congress passed legislation 
extending the funding for the Special Diabetes Program through 
September 2013. How important is it for Congress to do multiple 
years as opposed to year-to-year renewals of funding? Does that 
have an impact on the kinds of studies that you can fund?
    Dr. Rodgers. Well, Senator, we were very pleased to receive 
that multi-year renewal of the Special Diabetes Program through 
fiscal year 2013. The multi-year renewal greatly improves the 
planning process that goes on in NIDDK. For example, many 
clinical studies take multiple years to perform, and it would 
be very difficult, if not impossible, to start such a multi-
year clinical trial without knowledge of whether the funds will 
exist in future years to continue those types of studies.
    One area that we are absolutely looking at is to bring new 
people and new talent into this field. For example, in the 
artificial pancreas field, we have obviously very dedicated and 
talented clinicians and we have people in the device industry, 
but what needs to link them or, as my colleague Mr. Kline says, 
to actually get them to talk together are bioengineers. And so 
with this multi-year funding, we are trying to put in training 
efforts to bring bioengineers into this field, and training 
occurs over long time horizons, and therefore, multi-year 
funding is also critically important for them.
    One final thing that I would say is that as we move toward 
the artificial pancreas, clearly, we would recognize that there 
might be some issues related to compliance, and so now we are 
trying to get people who have been previously engaged in 
behavioral science to tell us what particular challenges we 
might face, and we are trying to get them involved in research 
in diabetes. So training and bringing in new talent are 
critically important, and multi-year funding greatly assists in 
that regard.
    Senator Collins. Thank you.
    Mr. Kline, you mentioned in your statement that when there 
is a diagnosis of type 1 diabetes, it affects the whole family 
and involves the whole family. You also talked about the fact 
that there are different challenges at different ages. Could 
you, having lived with this for quite some time now, elaborate 
on the impact on the family and the challenges at different 
ages, from toddler to teenager?
    Mr. Kline. Well, it affects the entire family. It 
transforms the entire family, and it changes with age and the 
various vicissitudes that the disease can go through. Suddenly, 
in the teenage years with the hormones being what they are, 
there are chaotic glucose levels.
    Senator Collins. People are agreeing.
    Mr. Kline. And it is just a vast improvisation of figuring 
out how to react to this. Is this a real high number or is this 
the hormones? It is not unlike life that way, I guess, trying 
to find what is the absolute cause for any particular symptom.
    But, obviously, when a child is diagnosed at 6 months, he 
cannot tell you that he is feeling low or feeling high. It is 
too horrible to imagine. It does get easier. All things being 
relative and given our human nature and our marvelous 
adaptability, we can adapt to a surprising number of things. 
Children get more and more used to it, get more and more on top 
of it, depending on the nature of the child. There are some 
type A personalities who are just all over their diabetes and 
are really in control of it, and there are others who are more 
in denial of it, who do not want to be bothered with it, who 
want those days of not having diabetes that you spoke of 
earlier, just one day, and sometimes they will just take that 
day, even though it is not an officially appointed day for such 
behavior. [Laughter.]
    But they will take it upon themselves and havoc will be 
wreaked.
    It gets easier and harder, but most of all, it does not 
stop. When your child gets older, goes off to college, you are 
still calling incessantly. You are still checking up. You are 
still worried. You are still making trips at strange hours of 
the night to deal with sudden insulin emergencies. It is moment 
to moment, hour by hour, day to day. It is ongoing, which is, I 
think, why JDRF wants to stress the urgency and the need to 
keep the research going and to get the artificial pancreas done 
because, I think, as these marvelous children can attest, 
tomorrow is going to be here sooner than we would like and we 
would like to have the artificial pancreas tomorrow, please, or 
yesterday, or today.
    Senator Collins. Thank you. Senator Brown.
    [Lights go out.]
    Senator Brown. That happens regularly with me. [Laughter.]
    It is a conspiracy.
    Mr. Kline. I guess we have not paid our electric bill.
    Senator Collins. You are not in Massachusetts, so I do not 
know why this happened.
    Senator Brown. It is following me everywhere.
    Mr. Kline. I asked for that. It is a very dramatic device 
called blackout. [Laughter.]
    Senator Collins. That was very dramatic.
    Mr. Kline. Thank you.
    [Laughter and applause.]
    Mr. Kline. That is what this button is.
    Senator Collins. That was a good stage trick, Mr. Kline. 
[Laughter.]
    Senator Brown. That was perfect.
    Mr. Kline. How do you follow that?
    Senator Brown. Everyone is awake now. [Laughter.]
    Mr. Kline, thank you very much for coming and offering your 
star power to a cause such as this. I think everybody I know 
has some type of experience with diabetes, whether it is in 
their own family or with their friends, so we really would like 
to just thank you for taking time out of your schedule. I think 
we all respect your acting ability and what you also do with 
philanthropic causes, so thank you.
    Dr. Zimliki, I have 225 medical device companies in 
Massachusetts. I visited Medtronic and others, and the biggest 
challenge is the fact that there is a tremendous amount of 
delay and inefficiency within the FDA. I have met with 
Commissioner Hamburg, and I will say that she recognizes that 
problem, and she is making great efforts to try to streamline, 
consolidate, and eliminate a lot of that duplication. The No. 1 
issue I find in Massachusetts and as I travel throughout the 
country is you have a company that is trying to make a 
difference for people like this, and they are marching along 
with a checklist, and then in the middle of the checklist, they 
have to go back to square one at tremendous cost. And I look at 
those medical devices that are approved in Ireland and Canada, 
and our companies are saying to me, as their U.S. Senator, why 
are we not being approved here in Massachusetts and in the 
United States?
    [Applause.]
    Senator Brown. So on the one hand, I have been very 
critical of the FDA and its delay because there needs to be 
consistency, stability, and certainty in the process for 
development and the ability to find cures.
    On the other hand, I have also been very public in saying 
``thank you'' to her and the agency for finally realizing that 
there is a problem and trying to fix it. So I wanted to let you 
know that, and I am wondering, how are you finding the new 
leadership and that new process? Is it moving along as 
expeditiously as you would like? It is a softball. [Laughter.]
    Dr. Zimliki. And I am due for promotion, too. [Laughter.]
    Senator Brown. Well, go for it.
    Dr. Zimliki. Absolutely. [Laughter.]
    Yes, absolutely. We have new leadership, and Dr. Jeffrey 
Shuren has certainly said that there is room for improvement 
for the review process by increasing predictability, 
consistency, and transparency. There is an entire action plan 
in place regarding the improvements in the review process.
    My focus here today is about the artificial pancreas, and I 
am very happy and pleased to know that Dr. Hamburg and Dr. 
Shuren give me their fullest support, and we are going to make 
sure that this device gets approved. We are hopeful that this 
guidance improves transparency so that a company like you 
referenced does not go halfway through the development process 
and then have to start back at square one.
    Senator Brown. Right. Well, thank you. It is a tremendous 
job killer in my State and throughout the country.
    I think you stated that you want a device that performs 
precisely, reliably, and individually as a unit. What steps are 
you taking to ensure the quality and safety of these systems in 
the clinical trials, specifically in your Phase II guidance?
    Dr. Zimliki. Just give me one second here.
    Senator Brown. You thought you were going to get easy 
questions.
    Dr. Zimliki. The Phase II guidance will adopt some of the 
information from JDRF. Now, granted, the Phase II guidance, 
which I will call the more advanced artificial pancreas 
guidance, is using some of the information that the clinical 
panel's recommendation by JDRF submitted to the FDA. It is a 
three-phased approach, and the idea would be to understand the 
device in the clinic, then transition into a more realistic 
version of home life except under mitigation or supervision, 
such as a diabetes camp. I am sure most of these people here 
have been to a diabetes camp, is that correct?
    [Chorus of yes.]
    Dr. Zimliki. Thank you. I like it, too. Then the last phase 
would be the transition to the outpatient setting. That is 
consistent with the recommendations from the JDRF as well as 
most of the medical community.
    The guidance is still under development, and we are going 
to be finalizing and publishing it in December of this year.
    Senator Brown. Dr. Rodgers, what is NIH's current role in 
supporting the FDA in this process in terms of how do you 
foresee NIH's role changing in the current months, and will you 
be facilitating the transition to clinical trials with the 
translational research?
    Dr. Rodgers. Yes. Under the auspices of the Diabetes 
Mellitus Interagency Coordinating Committee, we regularly meet 
with not only our colleagues at the FDA, the Centers for 
Disease Control and Prevenion (CDC), and other Federal 
agencies, but other institutes within NIH that have a role to 
play in diabetes research. We work very closely with Dr. 
Zimliki and his colleagues in an Interagency Artificial 
Pancreas Working Group.
    In fact, just a few months ago, we held a meeting in 
conjunction with the JDRF, and we are actually planning to have 
a follow-on meeting in the fall of this year to develop a 
working understanding of what are some of the challenges, what 
are the other groups that we need to bring into the question, 
particularly bioengineers, mathematicians, theoreticians, to 
try to assist us in moving more expeditiously along this 
pathway.
    So we have an essential role. We have been working together 
very closely. This is not only with the FDA and the NIH, but 
the meeting in the fall of this year will also involve the 
JDRF, as well.
    Senator Brown. Very well. Madam Chairman, you surprise me 
more and more each day. I was not aware until this year that 
you were advocating for this cause, so thank you for that. Will 
there be an opportunity to submit questions to our panel 
members?
    Senator Collins. Absolutely.
    Senator Brown. I just want to say, also, thank you to our 
panel and all the parents and children who came. It means a 
lot. I am going to be bouncing back and forth as I have done, 
so I will try to get back for the children. Thanks.
    Senator Collins. Thank you. Senator Shaheen.
    Senator Shaheen. Thank you, Madam Chairman, and thank you 
to all of our panelists this afternoon.
    Dr. Zimliki, as you are aware, I share the frustration that 
both Senator Collins and Senator Brown have expressed about the 
pace at which the FDA has moved on getting the guidance out on 
the artificial pancreas. I am pleased to hear you say that you 
expect that to happen by December, but I wonder if you could 
then outline what the next steps are once that happens, on the 
way to getting approval for the artificial pancreas.
    Dr. Zimliki. Can you clarify which artificial pancreas type 
system you are asking about?
    Senator Shaheen. I know there are a number of those systems 
in development----
    Dr. Zimliki. Right.
    Senator Shaheen [continuing]. And I am interested in seeing 
something that can be commercially available, on the market, 
that will be approved by the FDA and be safe and available to 
my family and all the families who are here. And I do not 
particularly care who the producer of that system is.
    Dr. Zimliki. I was just asking for clarification on the 
type. There are many types of artificial pancreas systems. We 
talk about the Veo system, which is a Low Glucose Suspend 
system. The agency believes that this is a type of artificial 
pancreas that should be on the market sooner than later.
    Senator Shaheen. I appreciate that. I think for many of the 
people in this audience, they do not see that as the artificial 
pancreas that we are really hoping will be on the market. I 
agree, that is a step in the right direction, but as has been 
pointed out, that device is available on the market in other 
countries, and we would like to see not only that device 
available here, but to go to the next step, to have a 
continuous system available for people.
    Dr. Zimliki. Is the question that you would like to know 
the time line?
    Senator Shaheen. I would like to know what steps the FDA 
sees that it is going to require in order to move forward. You 
said you expect to see draft guidance on that by December. So 
then what happens? I wonder if you could just outline the 
steps.
    Dr. Zimliki. The draft guidance is out for public comment 
for anywhere between 60 and 90 days, and we look forward to all 
the comments from the scientific community to help shape and 
modify that guidance in the hopes of making it final. It will 
become a guideline to an approval package.
    Now, the timing and the ability to get a device approved 
depends on a lot of people. It really depends on the FDA being 
transparent and providing this guidance so that industry can 
follow it and actually conduct studies. That takes time, and it 
takes people like you out here in the blue shirts to volunteer 
and be part of these studies.
    The process is that by probably mid-year or next year, the 
guidance will be finalized. Even when it is not finalized but 
published in December, industry can start developing their 
process in getting to an outpatient study and a pivotal study, 
which will lead to an approval.
    In November 2010, I believe, one of the JDRF-sponsored 
investigators at our Artificial Pancreas Workshop estimated 
anywhere between 2013 and 2014 before getting to a pivotal 
study. There is a lot of information that needs to be built up 
to get to that final stage for product approval, and it is 
contingent on the research for glucose sensing. We need better 
sensors. We absolutely need more reliable continuous glucose 
monitor sensors, and we need the research to really find out 
how to make that happen.
    Senator Shaheen. Dr. Rodgers, you talked about the role 
that NIH has with the FDA. Can you talk about how NIH can be 
helpful in moving this process forward.
    Dr. Rodgers. Well, Senator, in addition to working on a 
collaborative and coordinating basis, some of the vital 
research that Dr. Zimliki is mentioning is something that we 
see as our major contribution in moving the process forward and 
making it in fairly reliable and practical steps. Just 
recently, as I had mentioned, for example, in a closed-loop 
system, not only using insulin, but to try to more closely 
replicate what the pancreas does, scientists who we funded used 
two hormones, both insulin and the counter-regulatory hormone 
glucagon, to see whether one could get more precise blood 
glucose control over time. But again, these are done in a 
clinical setting.
    Ultimately, for this to be effective in the real world, we 
have to try to replicate that to a great extent, and this is 
why the more recent studies are actually looking at two 
different meal scenarios, particularly at night, because that 
would be a critical step, if we could use this closed-loop 
system so that parents do not have to get up in the middle of 
the night to check their child's blood glucose. That would 
really be an enormous benefit. For example, these two 
scenarios, one was an eat-in scenario in which one ate a modest 
medium-sized meal to see how well the closed-loop system could 
look at the various levels of glucose control and how that 
occurred over the night setting. The second scenario was an 
eat-out, so you go out and replicate more of a larger meal that 
you would have if you were to go out dining and how well were 
you able to maintain that level of glucose control.
    These are both very basic investigations that we are hoping 
to do, but then, in addition, the more practical, real-life 
scenarios, and moving this research forward from the clinic to 
the bedside.
    Senator Shaheen. Thank you. Madam Chairman, my time is up, 
but I wonder if you would allow me to just ask Mr. Kline one 
question.
    Senator Collins. Sure.
    Senator Shaheen. Thank you very much, Mr. Kline, for being 
here and for being willing to testify on what we need to do. If 
you had one comment that you could leave with policymakers 
after today's hearing, what would it be? What would you like us 
to take away from this hearing?
    Mr. Kline. Well, I love the questions that you are posing 
because they are asking in simple language to explain what the 
steps are because so many things get lost along the way in the 
byzantine labyrinthine hallways of bureaucracy. I love that you 
are asking for a timetable and for really simple explanations 
of when this will happen and what needs to happen in order to 
get the artificial pancreas that will alleviate for these 
children and for type 1 diabetics around the world the constant 
burden of self-monitoring, something that will effectively work 
as a pancreas works and doles out the appropriate amounts of 
insulin and glucagon and takes the worry out of the constant 
vigilance that type 1 diabetics have to practice.
    Senator Shaheen. Thank you. Thank you all very much.
    Mr. Kline. Thank you.
    Senator Collins. Thank you. Senator Pryor.
    Senator Pryor. Thank you, Madam Chairman.
    I would like to start with you, Dr. Zimliki. You have given 
us great news on the artificial pancreas. You have said some 
really positive, encouraging things about it, but another 
question that I do not think I have heard yet is will it be 
affordable for the average household? Tell us what you 
anticipate. What is your expectation on cost?
    Dr. Zimliki. I wish I could give you that answer. The FDA 
does not focus on cost. We work on getting the product 
approved. I will say that we are collaborating with the Centers 
for Medicare and Medicaid Services (CMS) for reimbursement, and 
the hope is that one day, not only will the study design I 
mentioned earlier provide approval for marketing within the 
United States, but also for CMS reimbursement.
    Senator Pryor. You mentioned that there are several models 
that may be headed to the marketplace?
    Dr. Zimliki. Several types of artificial pancreas systems? 
Yes.
    Senator Pryor. Do you anticipate that they will all be 
approximately the same cost, or will there be a big cost 
disparity?
    Dr. Zimliki. Again, I would have to defer to industry, 
which sets these prices. I apologize, but I cannot provide an 
answer to that question.
    Senator Pryor. So as part of your process, though, you do 
not really look at the cost?
    Dr. Zimliki. The FDA looks at the safety and effectiveness 
of the device.
    Senator Pryor. Well, we will have to work through the cost, 
maybe in another setting, but thank you for that answer.
    Dr. Rodgers, let me ask you, if I may, how does the United 
States compare to other countries when it comes to diabetes 
research and treatment? Are we leading the world? Are we 
behind? How do we rank?
    Dr. Rodgers. I think the research that is conducted in the 
United States really does lead the world. I think we can be 
proud of, in particular, NIH-sponsored research, as well as 
research that is sponsored by public groups. In diabetes, in 
particular, we are making great strides in understanding the 
genetic susceptibility.
    As I mentioned, in type 1 diabetes, just a few years ago, 
we had three genes, now it is up to 50, and we know that among 
these 50, for example, there is a small number of genes that 
contribute a large amount of the genetic risk, and there is a 
large number of genes that have only a small component.
    In this country, for the first time, and as a direct result 
of the Special Statutory Funding, we are beginning to see now 
that the incidence rate of this disease is increasing at an 
earlier age. We have to assume that over this period of time, 
it really is not the genes that are changing, but it is 
actually something in the environment. That is why it is 
critically important to undertake bold studies to determine 
what these factors are in the environment that are contributing 
to accentuating or initiating that autoimmune attack.
    And this is why this TEDDY study that I reference in my 
comments really is going to provide us with a lot of 
information. Early on, we are using new technologies, for 
example, the human micro biome, in which we are looking at 
these samples that we are collecting from these children over 
time, and it is already giving us information about potential 
viruses, bacteria, or other agents that they are exposed to.
    Although we are not focusing on type 2 diabetes, the story 
is quite similar. Just a few years ago, we just had a few 
number of genes. Now we are up to 60 or 70 genes that explain 
type 2 diabetes. We are seeing that understanding a lot more 
about type 1 diabetes is really contributing to prevention, 
potentially treatment, of type 2 diabetes, as well, which 
contributes to that $174 billion annual cost that Senator 
Collins referenced in her opening statement.
    Senator Pryor. So as we do research in the United States, 
we are sharing that with the world and others are benefiting 
from that research, as well?
    Dr. Rodgers. Yes. Certainly, our investigators' work that 
is performed and funded through the NIH is made publicly 
available so that others can potentially mine the data and ask 
other promising questions. This is how one can really leverage 
the investments to get the greatest return on one's investment.
    Senator Pryor. And have we not designated a certain amount 
of funding or a percentage of funding to NIH specifically for 
diabetes research?
    Dr. Rodgers. Well, obviously, the Special Statutory Funding 
is exclusively for that----
    Senator Pryor. Right.
    Dr. Rodgers [continuing]. But over and above that, 
regularly appropriated funds also go to diabetes research.
    Senator Pryor. And you can see the results of that 
statutory funding?
    Dr. Rodgers. Oh, absolutely. I just listed a few highlights 
to give you a glimpse of that. But over the period of time in 
which this funding has occurred, we have really advanced by 
leaps and bounds in understanding all steps of the progression 
of the disease.
    Senator Pryor. My impression is that the number of cases of 
diabetes has gone up in this country. Are you seeing that all 
around the world?
    Dr. Rodgers. Of the number of cases of type 1 diabetes that 
have been followed, largely, the highest prevalence is in the 
Scandinavian countries. Finland, for example, has the highest 
incidence rate of the disease. The lowest incidence rate, by 
comparison, is in Venezuela. And so this clearly may be related 
to racial, ethnic differences, perhaps exposure in the 
environment to factors in diet, maybe sunlight exposure or 
other things.
    But for the first time and as a direct result of the 
Special Statutory Funding, we have developed a program in 
collaboration with the CDC to begin to search for the incidence 
rate in certain sites around the country to determine whether 
our incidence rate is static or whether it is increasing, and 
we are beginning to see the same thing that is occurring over 
in the Scandinavian countries, that not only over time is the 
incidence rate increasing, but it is occurring at a much 
earlier age.
    Senator Pryor. And one last thing, if I may, Madam 
Chairman. We are seeing that same disparity geographically in 
this country. In Arkansas, we have a few counties where the 
incidence rate is over 10 percent, and that is not true in 
other counties. Is it more concentrated in the Southeastern 
part of the United States, is that fair to say?
    Dr. Rodgers. I am unaware of any particular predilection 
for type 1 diabetes within the United States, but what I would 
say is that the Search for Diabetes in Youth Study (SEARCH), in 
conjunction with the CDC, is allowing us to begin to look at 
particular clusters where they may exist. When one sees the 
clustering of events, that has a high possibility, or at least 
opens the possibility, that there might be local environmental 
factors, and that is something that we are now poised to be 
able to look at as the CDC does for other types of clusters of 
disease.
    Senator Pryor. Thank you. Thank you, Madam Chairman.
    Senator Collins. Thank you very much, Senator Pryor. 
Senator Begich, welcome.

              OPENING STATEMENT OF SENATOR BEGICH

    Senator Begich. Thank you very much, Madam Chairman. I know 
you have an important bill on the floor, so being here today is 
a great statement to the group that is here, so thank you for 
being here. I know Senator Lieberman also is on the floor. You 
are playing tag team, so thank you very much.
    I want to make a statement, then I want to ask a couple 
questions, probably, if I could, to Dr. Zimliki.
    First, I am pleased to be here and pleased to get the 
update on the current research and hear from so many folks and 
also from these young people. I have to tell you, you have been 
very patient for the entire presentation and discussion. We 
could take a lot of lessons from the young people who sit here 
so calm and collected, so thank you very much.
    As Mr. Pryor just whispered, if only the Senate could do 
this, and I agree with him. [Laughter.]
    We have come truly a long way in managing type 1 diabetes 
on a day-to-day basis. As a matter of fact, yesterday, I spent 
some time with two Alaskans, part of the Children's Congress, 
Hugo and Gus, who I think are right over there. We actually 
watched the Nationals and the Mariners--we are Seattle fans. We 
thought we were winning until the bottom of the ninth, and if 
anyone watched that game, it was a pretty exciting game. If you 
are going to go see a baseball game, that is the one that was 
well worth it. So we had a great chance to talk. They are 
nodding their heads ``yes.''
    But we also had a chance to talk briefly, and we will talk 
again later today, but I know their attendance, and the 
attendance of their parents, Karen and Steve, and all the 
families and children who are here will help us understand 
better.
    But it is exciting, and particularly exciting to see the 
development of the artificial pancreas that can truly transform 
lives, and I understand that we must continue to invest in the 
tools that help better manage the disease. I also know that we 
all really want and need to invest in research to help find a 
cure. To this end, we must continue to forge the public-private 
partnerships and leverage funding to find a cure.
    Diabetes is common and growing in the State that I 
represent, Alaska. In 2009, nearly 7 percent of Alaska's 
population had been diagnosed with diabetes. In 2007, the 
direct and indirect cost to our State was approximately $419 
million. We can talk about the cost to the system, but when you 
look at the other impact, the human impact to families, the 
burden of the disease and what families have to do, it is 
significant.
    This is why I am very glad to have so many people here 
today to deliver the impactful and memorable messages. I will 
tell you, 2 years ago, when I first got here, an Alaskan 
teenager came and visited me to advocate on behalf of the 
Special Diabetes Program, and she brought me a photo book of 
her life and what she has been doing to deal with type 1 
diabetes, and it was very amazing because you can talk about 
it, but when you see the photos of her life unfold from day one 
and as she went through it, it was pretty impactful to me. It 
is a document and a booklet that I still keep in my office to 
remind me of the impact and the stories that are all around 
this issue.
    Again, I want to thank the parents and the children who are 
here. Thank you for your advocacy.
    To Dr. Zimliki, if I can ask a couple of quick questions. 
One, I want to follow up on your response to Senator Pryor, and 
that is you had mentioned the CMS reimbursement.
    Dr. Zimliki. Yes.
    Senator Begich. You said you were working through that, and 
no disrespect, but when I have Federal folks in front of me, it 
is always, ``soon,'' ``maybe,'' ``we are working on it,'' and I 
am going to ask you very specifically. You are working on it. 
What do you think the time table is for CMS to actually respond 
and resolve the issue of how it is going to be paid for?
    Dr. Zimliki. I cannot speak on behalf of CMS, but I can 
tell you that the first priority is to develop the appropriate 
clinical studies necessary for product approval and marketing 
within the United States. We have contacted our CMS affiliates, 
and we would like to make sure that the clinical study proposed 
can not only have the clinical data necessary for product 
approval, but also for reimbursement. We are hopeful that we 
can work with CMS to accomplish that.
    We have also communicated with----
    Senator Begich. Let me pause you there for a second.
    Dr. Zimliki. Yes.
    Senator Begich. When do you think you will have that, 
because that is obviously in your control. You are having that 
discussion. So when do you think that will get some results so 
you can say, we have some partners. We are ready to roll.
    Dr. Zimliki. We need to finalize the draft guidance first, 
and then----
    Senator Begich. So from December to when, then?
    Dr. Zimliki. Developing and publishing this guidance is not 
a trivial task.
    Senator Begich. I understand.
    Dr. Zimliki. This is a huge, monumental effort that the 
agency is putting forward. I would like to say that we would 
have that information available at the same time of the 
publication of guidance, but I simply cannot guarantee that 
date. I apologize for that.
    Senator Begich. No problem. Based on your experience for 
something of this magnitude, is it for CMS to say, yes, we can 
do this; it will be 2 or 3 years?
    Dr. Zimliki. I do not have the experience or the luxury of 
knowing how long that will take. I will talk to my 
Commissioner----
    Senator Begich. Perfect. You went right to my next 
question----
    Dr. Zimliki [continuing]. And provide you with an answer.
    Senator Begich. Great. And then maybe you could give me, 
from whomever would be the appropriate person at the FDA, 
experiences of the past and how long it took.
    Dr. Zimliki. Absolutely.
    Senator Begich. I would think that would be important. I 
would appreciate that for the record.
    The last thing, I will just ask very quickly, and then I 
apologize, I have to depart. How many clinical locations do you 
anticipate for the trials? Do you have a sense on that yet?
    Dr. Zimliki. No. It really depends on how quickly industry 
wants to do it and how much variability they want to introduce 
in their clinical study design. Certainly, it is more than one 
location, but it really is dependent. We have introduced enough 
flexibility to allow industry to dictate how many sites they 
would like to study and where they would like to study it.
    Senator Begich. Great. Thank you very much, and I 
appreciate the comments, and I look forward to what you can put 
into the record. Thank you, Madam Chairman.
    Senator Collins. Thank you very much.
    I want to thank this panel of witnesses for excellent and 
highly encouraging testimony this morning. We will continue to 
work closely with all of you. Thank you.
    [Applause.]
    Senator Collins. Our next panel of witnesses consists of 
children who know firsthand the burdens of living with 
diabetes. Our witnesses are Caroline Jacobs from Maine; Jack 
Schmittlein from Connecticut; Kerry Morgan from Virginia; and 
Jonathan Platt from California. All of these children are JDRF 
Children's Congress delegates, and we are very happy to have 
them here today.
    Caroline, since you are from my home State, you get to go 
first. [Laughter.]

   TESTIMONY OF CAROLINE JACOBS,\1\ DELEGATE FROM SHAPLEIGH, 
                MAINE, JDRF CHILDREN'S CONGRESS

    Ms. Jacobs. Good afternoon, Chairman Collins and Members of 
the Committee. Thank you for asking me to testify before you 
today.
---------------------------------------------------------------------------
    \1\ The prepared statement of Ms. Jacobs appears in the Appendix on 
page 79.
---------------------------------------------------------------------------
    My name is Caroline Jacobs. I am 14 years old. I am from 
the great State of Maine, where we say Maine is the way life 
should be. I am here as a Children's Congress delegate to talk 
about living with diabetes, the importance of technology for me 
and other children with diabetes, and my hope for a cure.
    I was diagnosed with diabetes when I was 10 years old. It 
changed my life forever. With this disease, I must always think 
and be aware of how I am feeling, and I have had to grow up 
fast. I feel the burden on my friends and my family who are 
always worrying about me, always asking me questions about my 
blood sugar. So I am doing what I can to make a difference in 
finding a cure for juvenile diabetes.
    I brought a ``School Walk for a Cure'' to my school, and 
this year is the third year for my family's walk team for the 
Walk for a Cure in Portland. I also make jewelry and bags to 
benefit JDRF. I do all of these things so we can continue 
research to find a cure for diabetes.
    While we wait for a cure, I hope to see that more 
technologies are made available for children like me. One of 
the delegates here is from Canada and has a kind of insulin 
pump and continuous glucose monitoring system that protects 
against episodes of hypoglycemia when the patient is ignoring 
the dropping sugar levels. With this ability to stop insulin 
delivery when it detects a low blood sugar, this pump could 
lighten the burden and the worry for me and those around me. 
This technology is approved in Canada and other countries, but 
not here in the United States. It is hard for me to understand 
how a device like that can be available in a place just over 
the border from me.
    Because I will be driving in the next 2 years, it would be 
important for me to have access to a technology that could help 
prevent my blood sugar from dropping. Having diabetes can make 
your blood glucose levels go too high or too low and make me 
feel sleepy or dizzy, confused, or have blurred vision, making 
it too dangerous to drive.
    I would like Congress to encourage the FDA to move forward 
on next steps relating to the artificial pancreas, a 
combination of a continuous glucose monitor and an insulin pump 
with software that communicates between the two. The device 
will prevent highs and lows, especially at night when lows can 
be most dangerous. But it also would keep control of my sugars 
while I am driving, as well.
    I hope we will not have to wait too long for this device. 
That way, I will no longer have to worry about others always 
worrying about me. More importantly, my family will feel less 
of the burden and my friends will not always have to adjust 
around me because of this disease, and I hope that this means I 
will have the opportunity to travel freely without worrying 
about this disease and enjoy the world and those who live on 
it. After all, is that not the way life should be?
    Thank you, Members of the Committee, especially my home 
State Senator, Senator Collins.
    [Applause.]
    Senator Collins. Thank you. That was terrific. You sound 
like a pro.
    Mr. Schmittlein, we are glad to hear from you next.

     TESTIMONY OF JACK SCHMITTLEIN,\1\ DELEGATE FROM AVON, 
             CONNECTICUT, JDRF CHILDREN'S CONGRESS

    Mr. Schmittlein. Thank you, Senator Collins, Senator 
Lieberman, and Members of the Committee for inviting me to 
testify. My name is Jack Schmittlein. I am 13 years old, and I 
have had juvenile diabetes for over 6 years.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Schmittlein appears in the 
Appendix on page 82.
---------------------------------------------------------------------------
    On October 4, 2004, my life changed forever with my 
diagnosis. Instead of being a carefree kindergartner, I was 
faced with pricking my fingers 8 to 10 times a day, counting 
carbohydrates, and taking insulin shots. Managing diabetes is 
hard work that lasts 24 hours a day, every day.
    Two years ago, my best friend, Peter, was diagnosed with 
type 1 diabetes. Before, he had been incredibly helpful in 
managing my disease, even keeping me company when I walked to 
the nurse's office to check my blood sugar. Peter and his 
family learned everything they could about diabetes so that I 
could come over to play at their house safely. Peter's 
diagnosis is just one more reason why I work to raise awareness 
about type 1 diabetes and one more reason why I am here today.
    Important research to find a cure is happening all over the 
Nation, even at Yale University in my home State of 
Connecticut, to better understand the causes of type 1 diabetes 
and ways to prevent it.
    I am grateful that Congress passed legislation to renew the 
Special Diabetes Program last year. This program is essential 
to helping find a cure for type 1 diabetes. The Special 
Diabetes Program has allowed for research that has led to the 
artificial pancreas. An artificial pancreas would help prevent 
my blood sugar from dropping and give me insulin if my blood 
sugar gets too high. Right now, I have to get up to check my 
blood sugar in the middle of the night, every night. It would 
make participating in activities I love a whole lot easier. I 
really enjoy playing basketball and football, but I often have 
to come out in the middle of a game to test my blood sugar. It 
would give me my life back so I can just feel like a kid again, 
not a kid with diabetes.
    Despite this incredible technology, we need to do 
everything we can to find a cure. I am doing my part to help 
continue to push life-saving research forward. I have been a 
JDRF walk team captain for 4 years. I have organized a walk at 
my school to benefit JDRF. And I have also spoken about life 
with diabetes at two walks, a school assembly, and a Promise 
Ball fundraiser as a JDRF Youth Ambassador.
    It is my hope that Congress will continue to support 
research at NIH, specifically the Special Diabetes Program. I 
really believe that we will find a cure for type 1 diabetes. 
The artificial pancreas is a promising result after strong 
investment in research.
    I look forward to the day that I can say, ``I used to have 
diabetes.'' Until that day, an artificial pancreas will greatly 
improve my daily life and the lives of other children who have 
type 1 diabetes. I know that Congress and JDRF are doing all 
that they can to make this possible for children like me. Just 
think, if we can improve the lives of millions of children and 
adults around the world, why would we not? Research being 
conducted all over the country is bringing us closer to a cure, 
and the development of the artificial pancreas could keep us 
healthy while we wait for a cure.
    Thank you, Senator Collins and Members of the Committee, 
for providing me the opportunity to give you a glimpse into 
what my life is like with diabetes. I look forward to answering 
any questions you may have.
    [Applause.]
    Senator Collins. Thank you, Mr. Schmittlein. You did a 
great job.
    Ms. Morgan, we will hear from you next.

    TESTIMONY OF KERRY MORGAN,\1\ DELEGATE FROM GLEN ALLEN, 
               VIRGINIA, JDRF CHILDREN'S CONGRESS

    Ms. Morgan. Good afternoon, Senator Collins, Senator 
Lieberman, and Members of the Committee. Thank you for inviting 
me to testify today.
---------------------------------------------------------------------------
    \1\ The prepared statement of Ms. Morgan appears in the Appendix on 
page 86.
---------------------------------------------------------------------------
    I am Kerry Morgan from Glen Allen, Virginia, and I was 
diagnosed with diabetes 13 years ago, when I was 4 years old. 
Unfortunately, diabetes was not new to me when I was diagnosed. 
My older sister was diagnosed with the disease when she was 
four, too. Shortly after her diagnosis, I was enrolled in a 
clinical trial for first-degree relatives of people with type 1 
diabetes to determine if they were at risk for developing the 
disease. On the trial, I received daily insulin injections in 
hopes to avoid or delay development of diabetes, but it did not 
work. Sometimes clinical trials do not. I was formally 
diagnosed with type 1 diabetes 1 year later.
    Then, in what seemed like a flash, 10 years passed--10 
years filled with thousands of insulin injections, finger 
sticks, tubing changes, endless carbohydrate counting, and 
worry. Ten years of toting around an awful green fannypack 
containing the vital necessities for everyday life. Even with 
my best efforts, I still have days with severe high and low 
blood sugars. My family and I hoped, just like the millions of 
people impacted by this disease do, for a better way to control 
this.
    I was 14 when I enrolled in a clinical trial that was 
testing a continuous glucose monitoring system. This ingenious 
device, which I named ``my little buddy,'' gave me instant 
knowledge of what my blood sugar was doing and where it was 
going. While on this trial, my A1c dropped from an 8 to a 7. 
This technology made living with the disease not only easier, 
but gave me hope that it was truly possible to manage diabetes 
better. It was not a cure, but it was more than I had before.
    Living with diabetes is a daily struggle. It creates this 
cloud of fear and doubt. Thoughts of blood sugars and 
carbohydrates are always on my mind. I am constantly asking 
myself, am I OK? I always have to remember snacks and extra 
supplies to ensure that, in case of incident, I am covered 
because things can get scary quickly. I have had my pump stop 
working while out of town, unprompted by dropping it or 
submerging it in water. I do not just worry about now. I worry 
about my future. Diabetes never takes a break, so neither can I 
or my family.
    Then last October, I enrolled in a clinical trial testing 
artificial pancreas technology. For 2 days, I was admitted into 
a hospital where they tested the closed-loop artificial 
pancreas system. After participating in clinical research since 
I was 3 years old, I can honestly say the closed-loop 
artificial pancreas trial was the most amazing experience of my 
life and holds so much promise for people living with this 
disease.
    For 2 days, I had perfect control of my blood sugar levels. 
Two days of living with this technology provided me with the 
vision of what life could be like--life with far less 
complications, both short- and long-term. Creation of an 
artificial pancreas is within reach. I know it. I have been a 
part of it, and I will do all I can to get it into the hands of 
people living with diabetes, and I hope you will, too, so on 
the day the artificial pancreas is finally approved and 
released, people with this disease can say, ``Diabetes? There 
is an app for that.''
    [Laughter and applause.]
    Ms. Morgan. Thank you, Members of the Committee, for all 
you do for those living with diabetes and working to make the 
artificial pancreas technology available to all those living 
with this disease.
    Senator Collins. Thank you very much, Ms. Morgan, for great 
testimony.
    [Applause.]
    Senator Collins. Mr. Platt, you are up next.

    TESTIMONY OF JONATHAN PLATT,\1\ DELEGATE FROM TARZANA, 
              CALIFORNIA, JDRF CHILDREN'S CONGRESS

    Mr. Platt. Good afternoon, Chairman Collins and other 
Members of the Committee. Thank you for inviting me to testify.
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    \1\ The prepared statement of Mr. Platt appears in the Appendix on 
page 89.
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    My name is Jonathan Platt. I am from Tarzana, California, a 
suburb of Los Angeles. I am 7 years old. I was diagnosed with 
juvenile diabetes at age 6. I had been losing weight, wetting 
the bed at night, and had extreme thirst. I was always very 
tired and emotional. My mom and dad thought I was adjusting to 
a new school and kindergarten. My blood sugar was over 650 when 
I was diagnosed with juvenile diabetes. I will never forget the 
day I was diagnosed. We found out later that the little red-
headed girl who rode in the elevator with us was diagnosed with 
juvenile diabetes, also. That had never happened before in this 
doctor's office, two children diagnosed at the same time. I was 
thinking, how did I get this disease? I did not know what it 
was. I was very scared and nervous.
    I am here as a Children's Congress delegate to tell you 
that I manage my disease, but I do not let it control my life. 
With this disease, I am able to swim, play basketball, and 
build Legos, but I am different. Unlike other children, I have 
to check my blood sugar 8 to 10 times a day. Everything I eat 
is measured and every carbohydrate counted. My blood sugar kit, 
juice, glucagon, and ketone strips go with me everywhere I go.
    It is hard when I go to summer camp or do a sleepover or 
even go to a friend's house. Too much exercise or not eating 
all my food can be very dangerous. I think I am too young to 
have to worry about all this stuff.
    My parents have had to adjust their life because of my 
diabetes, but they say we all have it, not just me. Managing 
diabetes is a 24-hour job. We are doing our part to help find a 
cure by raising money for the JDRF Walk for a Cure. I am here 
to ask you to continue to do your part and fund research to 
find a cure.
    A cure for diabetes means that I could go to any summer 
camp and have sleepovers whenever and wherever I want. It means 
I could be a regular kid again, and most of all, it would mean 
I would not have diabetes. Please help me make this possible. 
My life depends on it. Thank you.
    Senator Collins. You did a great job.
    [Applause.]
    Senator Collins. I think this entire panel deserves another 
round of applause.
    [Applause.]
    Senator Collins. Now, I know that the children here have 
been sitting a very long time and that many of them could use a 
snack or water or need to test themselves, so I am going to ask 
the panel to each just ask one question, and then we will just 
wrap up the hearing because I know it has been a long 
afternoon, particularly for some of the younger delegates who 
are here.
    First of all, thank you all for just wonderful testimony. 
You really have put a human face on what it is like to have 
diabetes, and that is far more powerful than statistics. You 
are the best advocates for funding for diabetes research that 
we could possibly have.
    So, Caroline, my question is going to be for you. You were 
diagnosed in the summer, and you had some time with your family 
to get used to the idea of having diabetes and to learn what 
you needed to do in order to manage your disease. But I would 
like you to share with us what it was like when you went back 
to school in the fall.
    Ms. Jacobs. Well, I was going to a new school at the time, 
so I was teaching my teachers how to deal with having a kid 
with diabetes and teaching my new friends how to count 
carbohydrates and all that stuff. Even at lunch, we would all 
try to figure out how many carbohydrates were in my food. I had 
a lot of support from friends, teachers, and my family, of 
course.
    Senator Collins. I am sure that made a real difference.
    Ms. Jacobs. Yes.
    Senator Collins. Senator Begich referred to the scrapbook, 
and you gave me yours, and it is wonderful to go through it 
because I have learned so much more about the disease and about 
you. I want to thank you especially for being here, but I also 
want to thank all of our delegates.
    Ms. Jacobs. Thank you very much.
    Senator Collins. Senator Brown.
    Senator Brown. Thanks, Madam Chairman, again, for holding 
this hearing. Looking out there, I think I am at the Academy 
Awards. I see Mr. Kline right there, and then I come back to 
reality, and I see that we are here to discuss something very 
serious. Obviously, it affects everybody in this room. The 
wonderful part about being a U.S. Senator is, each day, you can 
learn and grow and you can understand new and different things, 
and if you do not understand them, you obviously have an 
opportunity to actually find out the answers, which I find 
intellectually very stimulating.
    Jonathan, I agree with you. You are too little to have to 
worry about this stuff. That being said, what has been the 
biggest challenge for you since you recently found out? What is 
the most difficult part of everything that you are going 
through right now?
    Mr. Platt. Well.
    Senator Brown. Is it keeping the daily requirements? Is it 
worrying about what happens if you do not do it right? I mean, 
what is the biggest challenge, do you think?
    Well, you think about it for a minute. I am going to ask 
Mr. Schmittlein. What is your biggest challenge?
    Mr. Schmittlein. Probably my biggest challenge with 
diabetes is at school, when all of my friends go to lunch, I 
have to always go to the nurse, and I have to bolus through my 
lunch, and sometimes, if we are in class and doing something 
fun, my blood sugar might be too low or too high, and so I will 
have to go down to the nurse and miss out on all the fun. So 
that is kind of hard for me because it is not fun to miss out 
on things you really want to do with your friends, so that is 
one of the things that is challenging for me.
    Senator Brown. Jonathan, you said earlier that your blood 
sugar was over 650, and I learned something today, that the 
average is 100 or below. I find that amazing that you were able 
to really function and now, obviously, address it. Have you 
thought of something that is challenging yet for you?
    Mr. Platt. Yes. Every time I feel low, there is no nurse at 
the school, and while in the library when there is something 
fun, if I feel low, I will have to go back to the class and 
check my blood sugar with the teachers.
    Senator Brown. So you are missing out on some things.
    Mr. Platt. Yes.
    Senator Brown. Well, thank you for that.
    Thank you, Madam Chairman, for holding this hearing, and 
thank you, panelists.
    Senator Collins. Thank you very much, Senator Brown.
    Senator Shaheen.
    Senator Shaheen. Thank you. Thank you all very much for 
your testimony. You are great advocates for the need to do more 
to address research.
    Ms. Morgan, since you have not answered a question, my 
question is for you. We still have Dr. Zimliki and Dr. Rodgers 
here, and there has been a lot of discussion today about the 
artificial pancreas. Since you participated in one of those 
trials, is there anything that you would like to tell them 
about that trial that you hope they will bear in mind as they 
go back to the NIH and the FDA and continue work on trying to 
get an artificial pancreas that can be available to people?
    Ms. Morgan. The first thing I am going to say is it is 
awesome, so keep that in mind. And being on the artificial 
pancreas was so different than just living every day with 
diabetes because for that time, I did not have to worry. I did 
not have to think about it, and that was a new experience for 
me because I have had this disease since I was so young, I do 
not really know anything else. And so not having to do that was 
such a weight off of my shoulders, and I think everyone here 
could use that. And so bear in mind that I think we need it and 
we need it soon, so keep working, keep funding, keep 
researching, and hopefully, it will be out soon.
    Senator Shaheen. Thank you very much.
    [Applause.]
    Senator Shaheen. And thank you, Madam Chairman, for holding 
the hearing and for all of your work chairing the Diabetes 
Caucus. As we can see, it really is making a difference.
    Senator Collins. Ms. Morgan, I really think that your final 
words sum up why we are here and what our purpose is. But I do 
want to take this opportunity to thank everyone for coming to 
this hearing, the wonderful witnesses that we had, the 
delegates who were chosen to testify, all of the delegates who 
are sitting in the well and around the room, and their families 
because diabetes truly is a disease that affects the entire 
family.
    I want to thank the Juvenile Diabetes Research Foundation 
for working so closely with us. Mary Tyler Moore sent a letter 
and some testimony that we are going to put into the record, 
and we will have the record open for an additional 15 days in 
case anyone else has any words of wisdom for us or additional 
questions.\1\
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    \1\ The letter and prepared statement of Ms. Moore appear in the 
Appendix on page 92.
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    But most of all, I want to thank the children who are here 
today. When you come to Washington and you meet with your 
Senators and Members of Congress, you make such a difference. 
It is because you are willing to come here and tell your 
personal stories that we have been successful in tripling the 
funding for research that goes for diabetes. And I know that 
with your help, we will one day soon have better treatments--
the artificial pancreas that we have talked about today--but 
also, ultimately, the goal of all of us here, and that is a 
cure.
    So I thank you all for coming to Washington, for being here 
with us, and for being such great advocates.
    This hearing is now adjourned.
    [Whereupon, at 3:32 p.m., the Committee was adjourned.]






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