[Senate Hearing 109-961]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 109-961
 
THE POTENTIAL OF AN ARTIFICIAL PANCREAS: IMPROVING CARE FOR PEOPLE WITH 
                                DIABETES 

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

                                HEARING

                               before the

                              COMMITTEE ON
               HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
                          UNITED STATES SENATE


                       ONE HUNDRED NINTH CONGRESS

                             SECOND SESSION


                               __________

                           SEPTEMBER 27, 2006

                               __________

        Available via http://www.access.gpo.gov/congress/senate

                       Printed for the use of the
        Committee on Homeland Security and Governmental Affairs

                              -------

                     U.S. GOVERNMENT PRINTING OFFICE

30-602 PDF                 WASHINGTON DC:  2007
---------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing
Office  Internet: bookstore.gpo.gov Phone: toll free (866)512-1800
DC area (202)512-1800  Fax: (202) 512-2250 Mail Stop SSOP, 
Washington, DC 20402-0001

























        COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS

                   SUSAN M. COLLINS, Maine, Chairman
TED STEVENS, Alaska                  JOSEPH I. LIEBERMAN, Connecticut
GEORGE V. VOINOVICH, Ohio            CARL LEVIN, Michigan
NORM COLEMAN, Minnesota              DANIEL K. AKAKA, Hawaii
TOM COBURN, Oklahoma                 THOMAS R. CARPER, Delaware
LINCOLN D. CHAFEE, Rhode Island      MARK DAYTON, Minnesota
ROBERT F. BENNETT, Utah              FRANK LAUTENBERG, New Jersey
PETE V. DOMENICI, New Mexico         MARK PRYOR, Arkansas
JOHN W. WARNER, Virginia

             Priscilla H. Hanley, Professional Staff Member
             Michael L. Alexander, Minority Staff Director
   Wilson O. Wang, Legislative Assistant, Office of Senator Lieberman
                  Trina Driessnack Tyrer, Chief Clerk




















                            C O N T E N T S

                                 ------                                
Opening statements:
                                                                   Page
    Senator Collins..............................................     1
    Senator Coburn...............................................     2
    Senator Coleman..............................................     3
    Senator Lautenberg...........................................    18
Prepared statement:
    Senator Lieberman............................................    29

                               WITNESSES
                     Wednesday, September 27, 2006

Griffin P. Rodgers, M.D., Acting Director, National Institute of 
  Diabetes and Digestive and Kidney Diseases, National Institutes 
  of Health, U.S. Department of Health and Human Services........     4
Chris Dudley, Chief Executive Officer, The Dudley Foundation.....     7
Arnold W. Donald, President and Chief Executive Officer, Juvenile 
  Diabetes Research Foundation International.....................     9
Caroline K. Sweeney, accompanied by her son, Aidan T. Sweeney, 
  Gray, Maine....................................................    12

                     Alphabetical List of Witnesses

Donald, Arnold W.:
    Testimony....................................................     9
    Prepared statement...........................................    49
Dudley, Chris:
    Testimony....................................................     7
    Prepared statement...........................................    43
Rodgers, Griffin P., M.D.:
    Testimony....................................................     4
    Prepared statement with attachments..........................    30
Sweeney, Caroline K.:
    Testimony....................................................    12
    Prepared statement...........................................    54

                                APPENDIX

Andrew P. Rasdal, President and CEO of DexCom, Inc., prepared 
  statement......................................................    58
Responses to post-hearing questions for the Record:
    Dr. Rodgers..................................................    60


                     THE POTENTIAL OF AN ARTIFICIAL



                      PANCREAS: IMPROVING CARE FOR



                          PEOPLE WITH DIABETES

                              ----------                              


                     WEDNESDAY, SEPTEMBER 27, 2006

                                       U.S. Senate,
                           Committee on Homeland Security  
                                  and Governmental Affairs,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:03 a.m., in 
room SD-342, Dirksen Senate Office Building, Hon. Susan M. 
Collins, Chairman of the Committee, presiding.
    Present: Senators Collins, Coleman, Coburn, and Lautenberg.

             OPENING STATEMENT OF CHAIRMAN COLLINS

    Chairman Collins. The Committee will come to order. Good 
morning.
    As the founder and co-chair of the Senate Diabetes Caucus, 
I have learned a great deal during the past 10 years about 
diabetes and the difficulties and heartbreak that it causes for 
so many families as they await a cure. This hearing will 
examine the potential that new technologies have for improving 
the care and quality of life for people living with diabetes.
    Diabetes is a costly and devastating illness. Nearly 21 
million Americans have diabetes, and one in three American 
children born today will develop the disease.
    Diabetes is a lifelong condition that affects people of 
every age, race, and nationality. It is the leading cause of 
kidney failure, blindness in adults, and amputations not 
related to injury. Moreover, it is estimated that diabetes 
accounts for more than $132 billion of our Nation's annual 
health care costs and one out of every three Medicare dollars.
    The burden of diabetes is particularly heavy for children 
and young adults with type 1, or juvenile diabetes. They not 
only have the disease from an early age, but must also endure a 
lifetime of treatment and related complications from the 
disease. It is a disease that they will never outgrow.
    I will never forget the first family that I met who had a 
son with juvenile diabetes. He was, as I recall, about 10 at 
the time. He looked up at me and he said that he wished he 
could just take one day off from having diabetes, his birthday 
or maybe Christmas. But he knew that he could not. And that 
conversation with that little boy is what motivated me to be 
the founder of the Diabetes Caucus in the Senate so that we 
could push for greater Federal investment in research.
    In individuals with juvenile diabetes, the body's immune 
system attacks the pancreas and destroys the islet cells that 
produce insulin. The average child with type 1 diabetes will 
have to take some 50,000 insulin shots in a lifetime. Moreover, 
these children and adults must closely monitor their blood 
sugar levels throughout their lives with frequent testing.
    While the discovery of insulin was a landmark breakthrough 
in the treatment of diabetes, insulin is not a cure, and people 
with diabetes face the constant threat of developing serious 
complications, as well as a drastic reduction in their quality 
of life.
    Fortunately, however, there are new technologies on the 
horizon that hold great promise for treating diabetes.
    The fact is that current diabetes technology is inadequate. 
Some studies have found that even patients who aggressively 
manage their disease--for example, those who measure their 
blood glucose levels an average of nine times a day--still 
spend less than 30 percent of their day in the normal range. 
The rest of the time, unfortunately, their blood sugar levels 
are either too high or too low.
    This morning's hearing will explore the potential for the 
development of a closed-loop artificial pancreas that could 
revolutionize diabetes care. The artificial pancreas would link 
two existing technologies, the insulin pump and the continuous 
glucose monitor. This is a sensor that is used. If we could 
bring these technologies together, they have the potential to 
dramatically improve blood glucose control, which would in turn 
improve the quality of diabetes care and help to prevent the 
serious and costly complications of the disease.
    In addition to testimony about the personal and economic 
toll that diabetes imposes, this hearing will also feature 
testimony about the limitations of current technologies and the 
promise of new technologies. We will hear why an artificial 
pancreas would make such a difference until a cure is found, 
and we will discuss the progress in its development. Finally, 
we will look at the ongoing collaborative efforts on the part 
of the Federal Government, the Juvenile Diabetes Research 
Foundation, and private industry to develop these innovative 
technologies and make them more widely available.
    I look forward to hearing from our witnesses this morning 
about what we in Congress can do to help move this effort 
forward.
    I am very pleased that we have with us today someone who 
knows very well the toll that diabetes takes on patients, a 
physician, our Senator, Tom Coburn. Dr. Coburn.

              OPENING STATEMENT OF SENATOR COBURN

    Senator Coburn. Thank you, Madam Chairman. I appreciate 
your having this hearing. This is a disease that affects almost 
every family in the country, and if you have a family member 
with it, you understand the nature of this disease. As a 
practicing physician for over 20 years, it is the most 
difficult disease that I deal with in my practice. I continue 
to see people with it on Monday mornings.
    Technology is advancing, but not fast enough. The costs 
both in terms of time constraints to individuals and 
limitations on what you can and cannot do impact every family 
that is out there.
    I think we are on the horizon of new treatments, not only 
in preventing juvenile diabetes, but also curing it--whether it 
be with ductile cell transplants for stem cells or with 
automated devices, such as continuous glucose and insulin 
pumps.
    I look forward to hearing the testimony, and I thank you 
for having this hearing.
    Chairman Collins. Thank you.
    We are also very pleased to be joined by Senator Coleman. 
He has come to, I think, every single hearing that this 
Committee has had looking at diabetes over the years, and we 
are very pleased that he is able to join us this morning.

              OPENING STATEMENT OF SENATOR COLEMAN

    Senator Coleman. Thank you. Thank you, Madam Chairman, and 
thanks for your leadership on this issue. It is important.
    We have a very active JDRF group in my State, which is 
wonderful. They say Washington is a town of a thousand issues 
and a few priorities, and an issue becomes a priority when Moms 
and Dads and others step forward and say, this is important and 
this is affecting my child. And when you look in the face of 
that child and others, you say we have to do better.
    What I also find exciting here is the public-private 
partnerships. I am a big fan. We cannot do it by ourselves. We 
have in Minnesota, for instance, Medtronics doing, I think, 
some tremendous, cutting-edge research in this area. But this 
really is an opportunity, Madam Chairman, to pull together the 
public side, the tech companies, the public entities, the 
universities, and others.
    And so I am an optimist, and I listen to my colleague Dr. 
Coburn and his expertise on this issue. It is probably not 
moving fast enough, but I am really hopeful. We have some 
really smart people out there, and I think forums like this, 
Madam Chairman, really move the ball forward and are critically 
important.
    So I just want to thank you for your leadership, and I look 
forward to hearing the testimony.
    Chairman Collins. Thank you.
    I am very pleased to welcome our panel of witnesses this 
morning. First we will hear from Dr. Griffin Rodgers, the 
Acting Director of the National Institute of Diabetes and 
Digestive and Kidney Diseases at the National Institutes of 
Health. Dr. Rodgers will provide us with an overview of how the 
new technologies work and why they are so important. He will 
also give us a review of the research funded by NIH in this 
area.
    Next we are very pleased to hear from Chris Dudley, a 16-
year veteran of the NBA and the founder and CEO of the Dudley 
Foundation. Chris would be a stand-out in almost any crowd, and 
it is not just because he is almost 7 feet tall. In 1994, he 
founded the Dudley Foundation, which encourages all children, 
and particularly children with diabetes, to pursue their 
dreams. He will tell us about the kids at a basketball camp 
that he founded in Oregon for children with diabetes, and he 
will also share his personal story of living with type 1 
diabetes.
    Next we will hear from Arnold Donald, the President and CEO 
of the Juvenile Diabetes Research Foundation International. Mr. 
Donald will tell us about the JDRF's artificial pancreas 
project and will talk about the regulatory and reimbursement 
challenges that we face as we attempt to make the technologies 
more widely available.
    And last, but in my view, first, we will hear from one of 
my constituents, Caroline Sweeney, who has traveled to 
Washington with her family all the way from Gray, Maine. She 
has with her today her three children, including her 4-year-old 
son, Aidan, who has diabetes, who was diagnosed at 22 months of 
age. And I think her story will tell us why this hearing 
matters so much. So, Caroline, thank you so much for traveling 
here to share your family's story with us.
    We will start with Dr. Rodgers.

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

    Dr. Rodgers. Chairman Collins and Members of the Committee, 
good morning. Thank you for the invitation to testify today on 
the scientific quest to develop an artificial pancreas as a 
treatment for diabetes, the progress we have seen, and the 
outlook for the future.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Rodgers with attachments appears 
in the Appendix on page 30.
---------------------------------------------------------------------------
    As the Deputy Director and the Acting Director of the 
National Institute of Diabetes and Digestive and Kidney 
Diseases, one of the institutes at the NIH, or National 
Institutes of Health, within the U.S. Department of Health and 
Human Services, I am really pleased to provide you with some 
brief highlights of my formal testimony, which I have submitted 
for the record.
    Before I begin, though, I would like to acknowledge your 
leadership, Chairman Collins, in focusing attention on diabetes 
research, including the development of new technology that will 
benefit patients and their families.
    As you indicated, diabetes affects 21 million Americans. 
People with diabetes are more likely to die of heart disease or 
a stroke, have lower life expectancy, and really face a long-
term threat of severe eye disease, kidney disease, and nerve 
damage. Landmark NIH-supported clinical trials and other 
clinical studies have demonstrated that carefully controlling 
blood glucose or sugar is really the key to reducing the risk 
for these serious and costly health complications.
    Yet current strategies for diabetes management are far from 
perfect. Less than half of diabetes patients achieve 
recommended targets for blood glucose control as measured by 
the hemoglobin A1c levels. Achieving good control is especially 
challenging for people with type 1 diabetes whose disease 
attacks the pancreas and robs the patients of their ability to 
produce insulin.
    Intensive therapy with insulin helps patients achieve 
control but really requires numerous daily finger sticks to 
check their blood glucose levels. It also requires that 
patients carefully calibrate their food intake and physical 
activity to calculate their insulin doses, which are 
administered by a pump that delivers the insulin under the 
skin. Most worrisome, though, is that intensive insulin therapy 
raises the risk of sudden episodes of life-threatening low 
blood sugar, or hypoglycemia, especially at night and 
especially in children. Clearly, improved therapeutic options 
are needed.
    An artificial pancreas is a device still under development 
that would close the loop between glucose-sensing technology 
and insulin-delivery technology. Patients would automatically 
receive the correct dose of insulin in real time in a way not 
currently possible, and in this way the device would mimic how 
a healthy pancreas senses the need for insulin and produces the 
right amount at the right time, around the clock, to control 
blood glucose levels. Some technology could potentially benefit 
not just type 1 diabetes but also patients with type 2 diabetes 
or other forms of the disease who have to use insulin to manage 
their disease.
    Recent developments in continuous glucose-sensing 
technologies have vaulted us over a major hurdle toward 
realizing the artificial pancreas. The NIH has helped to propel 
this research, and casting as wide a net as possible, the NIH-
supported investigators in academia and in industry have been 
exploring a variety of approaches to glucose sensing.
    These studies are cross-cutting, bringing together basic 
researchers, mathematicians, engineers, and clinicians at the 
same table to work on these advances. As the technology has 
bloomed, we have also supported validation and optimization 
studies. These multifaceted approaches have really borne fruit 
already. Three new minimally invasive, continuous glucose 
monitors have recently been approved or are currently under 
study by the Food and Drug Administration.
    If I can have the first slide,\1\ this shows you an example 
of three of those continuous glucose-monitoring devices, and I 
think that Chairman Collins indicated one as well. We clearly 
know that continuous glucose monitoring facilitates tight 
glucose control, and the importance of that fact is indicated 
on the right. For every 1-percent fall in the hemoglobin A1c 
level, which measures the glucose over time, there is a 37-
percent reduction in eye, kidney, and nerve complications. 
Tight glucose control cuts heart disease in half in patients 
with type 1 diabetes. Only about 44 percent of people with 
diabetes are able to achieve the recommended glucose control 
with the current technology.
---------------------------------------------------------------------------
    \1\ The chart referred to appears in the Appendix on page 41.
---------------------------------------------------------------------------
    I am pleased to note that the NIDDK helped support this 
technology development in two of the three devices that are 
currently available or being studied. These devices measure 
glucose every minute, day and night, from a slender sensor 
inserted under the skin and trigger an alarm if the glucose 
becomes either too high or too low.
    The devices let patients see the current glucose readings, 
reducing the need for frequent finger sticks. Importantly, they 
can see whether the glucose levels are rising or falling and 
how quickly, thereby allowing them to take immediate action to 
avoid episodes of either very high blood sugars or very low 
blood sugars.
    This type of device still has limitations and is under 
study to assess the full range of health benefits that it may 
provide, but we are really encouraged by published research 
that shows the potential of these continuous glucose monitors 
to help patients achieve good glucose control and make a 
difference in their care now, even before we realize the 
artificial pancreas.
    If I can have the next slide,\1\ this just gives you an 
indication of how patients have benefited from that. If you 
look at the upper panel, this is a baseline profile taken for 
two consecutive days on a patient who had relatively good 
control, as indicated by a hemoglobin A1c value of 7.2. 
Indicated in the green box there is the healthy range that we 
try to achieve, and you can see that on Day 1, indicated by the 
green triangles, or Day 2, indicated by the pink triangles, 
that there was a very small period of time that the patient 
actually was in that healthy range.
---------------------------------------------------------------------------
    \1\ The chart referred to appears in the Appendix on page 42.
---------------------------------------------------------------------------
    This patient was entered into a clinical trial and was 
given intensive knowledge and education on the use of this 
device, and you can see at the 13-week follow-up profile that 
there is a much larger period of time in which that patient is 
within that healthy range. And you can see that there is only a 
small change in the overall hemoglobin A1c value.
    These studies are especially important to continue this 
technology because the FDA has only approved these devices at 
the moment for individuals who are 18 years of age or older, 
and so we really need to follow through with these studies, 
particularly in young children. And the reason that this is so 
critically important is that, in collaboration with one of our 
sister Institutes, the National Institute of Child Health and 
Human Development, we have developed DirecNet, which is a way 
of evaluating this technology in young children. Work is 
already ongoing to develop information needed for complex 
computer programs that will be necessary, an essential step to 
link the sensing with the insulin delivery and thereby close 
the loop.
    This may first be successful during the night when there 
are not as many major changes in either eating or physical 
activity that can clearly affect glucose levels. This effort 
will be furthered by studies using new monitors in children 
admitted to NIH-supported general research centers. And, 
finally, insulin delivery technologies are being included in 
studies to ensure that they will be compatible and effective in 
future artificial pancreases.
    Our significant progress to date toward a goal of an 
artificial pancreas really reflects effective public-private 
partnerships in which NIH and other HHS agencies, working with 
industry and with health advocacy groups such as the Juvenile 
Diabetes Research Foundation, have clearly worked together very 
effectively. We look to continue these partnerships in the 
future. For example, NIDDK, together with JDRF, the American 
Diabetes Association, and the FDA, convened a scientific 
workshop in December 2005 to assess the state of the science of 
glucose-sensing devices and insulin-delivery technology, and we 
are incorporating these outcomes from that meeting into our 
research planning efforts.
    To foster new opportunities, we have just released a 
strategic plan for research on type 1 diabetes, which will help 
in the development of this research program as we move forward 
in the field. The plan was developed under the auspices of the 
statutory Diabetes Mellitus Interagency Coordinating Committee, 
which will continue to coordinate efforts across the NIH and 
with other relevant Federal agencies.
    Finally, over the past several decades, technological 
advances have reduced the treatment burden on patients, 
improved diabetes management, and reduced premature mortality 
from type 1 diabetes. We can now foresee a future when 
technology will be so advanced that we will have nearly 
invisible technology in patients. We will continue to foster 
vigorous and productive research to achieve this goal. I would 
like to again thank you for this invitation, and I am pleased 
to answer any questions that the Committee may have.
    Chairman Collins. Thank you, Doctor, for an excellent 
presentation. Your full statement as well as the statements of 
all the witnesses will be entered into the record.
    Mr. Dudley.

  TESTIMONY OF CHRIS DUDLEY,\1\ CHIEF EXECUTIVE OFFICER, THE 
                       DUDLEY FOUNDATION

    Mr. Dudley. Good morning, Senator Collins and distinguished 
Members of the Committee. Thank you for the invitation to 
appear before you today. Also, thank you for your tireless 
leadership, Senator Collins, in championing issues that will 
get us to our shared goal of a cure.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Dudley appears in the Appendix on 
page 43.
---------------------------------------------------------------------------
    My name is Chris Dudley, and I played in the National 
Basketball Association for 16 years with Cleveland, New Jersey, 
Portland, and New York. I am the proud husband of a beautiful 
wife and father of three wonderful, healthy children, ages 7, 
6, and 4. I also have been living with juvenile diabetes for 
over 25 years.
    In 1994, I formed the Dudley Foundation. The following year 
we started a basketball camp for kids with diabetes. Ever since 
that time, I have been an outspoken advocate for encouraging 
kids with diabetes to pursue their passions--whether it be in 
sports or other activities. Our foundation emphasizes that kids 
can achieve their dreams to be whatever it is that they want to 
be, whether it is being a doctor, professional athlete, or even 
a U.S. Senator, provided that they take care of their diabetes. 
Our goal is to empower these children.
    But today I want to express the challenges of having 
diabetes and how new technology is imperative to help diminish 
both the short- and long-term effects that all those with 
diabetes have to face.
    I tell children to be proactive and positive in managing 
their diabetes, and I will continue empowering them. But, 
still, I have to acknowledge that they will face difficulties, 
great difficulties, and agree with them that it is a cruel 
disease.
    I myself have been proactive with my diabetes and yet have 
experienced difficulties. I have tested my blood sugar over 
40,000 times. I exercise, eat healthy, and follow my doctor's 
instructions. I, like all those with juvenile diabetes, 
experience unexplained high and low blood sugars. I have had 
double vision and have even endured violent seizures. The need 
for this new technology is vital. We need help in preventing 
erratic blood sugars. Greater control of blood sugar levels is 
imperative to prevent tragic accidents, seizures, and long-term 
complications. This disease needs to be controlled instead of 
it controlling us.
    This is a disease you never get a break from. You have to 
be aware of this disease every single day. Children have to 
overcome the hurdle of diabetes, just as I have, but it was not 
and is not an easy hurdle. I have been able to fulfill my 
childhood dream of playing professional basketball. I have 
walked onto the court to hear 20,000 fans. That feeling is 
incredible, and I was blessed to have experienced it. But I 
always wished I could play one game without worrying about my 
blood sugar, one game where I could just concentrate on the 
game and not have to worry about whether my blood sugar was 
heading higher or dangerously low, one game where I did not 
have to worry about the possibility of a loss of equilibrium, 
lightheadedness, double vision, or even the worst case, 
seizure.
    I tested my blood sugar level 14 times a day on game days 
in order to be at my peak for the games. But I still knew that 
there were too many variables in the control of diabetes to 
feel in total control. This reality is why I am so excited 
about today's hearing and about the promise of new 
technologies, like the continuous glucose sensors and the 
closed-loop system, to help people manage their diabetes 
until--until--we find a biological cure.
    If I had a continuous glucose sensor when I was in the NBA, 
I could have seen the trends in my blood sugar levels and taken 
proactive action to keep myself in even better control. As 
valuable as the snapshot of a blood sugar test is, it would 
have been invaluable to see the whole picture and to know what 
direction my blood sugar was heading and, even more 
importantly, where it had been. I could have been proactive to 
my blood sugar level instead of having to be reactive to the 
symptoms.
    There are even greater needs for this technology away from 
the court. As a potentially life-saving feature, a sensor could 
give a warning that the blood sugar level is or is about to be 
dangerously low. This would give the person the chance to 
adjust their blood sugar level upward, thus avoiding a 
potentially fatal car accident. This device could also enable 
parents to set the device so it alarms when a child's sugar 
level goes too high or too low, giving parents peace of mind 
and the ability to sleep through the night and not have to 
awake once or twice a night to test their child's blood sugar 
for fear of hypoglycemic reaction. Many of our campers' parents 
only get to sleep through the night uninterrupted 1 week a 
year, and that is the week when their kids are at our camp and 
we are the ones checking their blood sugar twice a night.
    A lot has changed since I was diagnosed with diabetes, and 
I am excited about new technologies that will help people to 
better manage their diabetes and hopefully avoid the 
devastating complications that can occur over time.
    Ultimately, what we all want is a cure, but improvements in 
care along the road to a cure would make a tremendous 
difference to so many people who struggle every day, and it is 
incumbent upon all of us to do our part to help accelerate the 
progress on both of these fronts.
    I would like to close by reading an excerpt of a letter 
recently sent to me from a teenage boy who attended my camp in 
August:

    ``After camp each year, I return to my home in Three Rivers, 
California, a community of 3,000 in the southern Sierra foothills. I 
have always been the only one in my school with type 1 diabetes. In my 
elementary school, there was no school nurse. Each year since I was 
diagnosed with diabetes in the spring of my third-grade year, my mom 
and I would educate my current teacher, as well as the office staff, 
about type 1 diabetes and what to do in the event of an emergency. As 
of the 2006-2007 school year, I am a junior and travel 20 miles each 
day to my high school. There is a school nurse on the campus one day a 
week, and most of my teachers are not even aware that I have diabetes. 
My basketball and baseball coaches are informed that I have the 
disease, but most are not knowledgeable about it. During my first 
season of playing tackle football, my coaches did not give me playing 
time because they thought I was `sick.'
    ``My parents are self-employed, and the medical costs have proven 
to be staggering and never-ending. Their monthly health insurance 
costs--including supplies not covered--are in excess of $1,000 per 
month for our family of four. Ironically, there are new products coming 
onto the market that could ease some of the burdens of having type 1 
diabetes, but they are cost-prohibitive and our insurance company won't 
provide coverage on certain brands or products.
    ``No child deserves to live with type 1 diabetes with its risks of 
debilitating complications looming over them their entire life. And at 
a cost of more than a half-million dollars in their lifetime for 
medical supplies and care, no child should have to pay that price 
either.''

    Senator Collins, thank you again for this opportunity. It 
has been an honor to appear before you today. I worry every day 
that one of my kids will be diagnosed with juvenile diabetes. 
And even though I have been very blessed in my life and have 
been able to achieve great things even with diabetes, this is 
not the life I want for my children. I want this cure for the 
children who come to my camp, my children, and all of the kids 
who are afflicted with this disease. Thank you.
    Chairman Collins. Thank you. Mr. Donald.

TESTIMONY OF ARNOLD W. DONALD,\1\ PRESIDENT AND CHIEF EXECUTIVE 
  OFFICER, JUVENILE DIABETES RESEARCH FOUNDATION INTERNATIONAL

    Mr. Donald. Good morning, and thank you, Senator Collins. 
It is truly an honor to be here before you and the other 
Members of the Committee, and as Senator Coburn already pointed 
out, about an issue that affects so many American families.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Donald appears in the Appendix on 
page 49.
---------------------------------------------------------------------------
    I would like to thank you not only for your work on the 
issue that brings us together today, the promise of a closed-
loop artificial pancreas, but for your truly outstanding 
leadership on the wide range of issues that affect so many 
people with diabetes.
    As you mentioned, JDRF estimates that as many as 3 million 
Americans now have type 1, or what was previously called 
``juvenile diabetes.'' It is an autoimmune disease in which the 
body attacks the cells in the pancreas that sense blood sugar 
and produce insulin to convert that sugar into energy. And 
because people with type 1 diabetes cannot produce insulin on 
their own, they need to inject insulin into their bodies, 
either using syringes or a mechanized insulin pump, throughout 
the day just to survive.
    The financial burden of diabetes is staggering, costing the 
Nation and its health care system more than $130 billion a 
year. That is because, over time, people with diabetes are at a 
staggeringly high risk for complications--complications like 
heart disease, kidney disease, blindness, and amputation.
    While JDRF's singular mission is to find a cure for type 1 
diabetes, we believe that the support of rapidly emerging 
technology can play a crucial role in improving the lives of 
people with type 1 diabetes and reducing or even eliminating 
the complications of the disease.
    JDRF has, therefore, launched a new initiative to help 
accelerate the availability of an artificial pancreas, and that 
is one of our foundation's six cure therapeutic pathways. The 
overall goal of the project is to accelerate the development, 
regulatory approval, insurance coverage, and clinical 
acceptance of an artificial pancreas. The long-term goal is for 
broad patient access and a thriving competitive market for 
these technologies.
    An artificial pancreas, as you know, combines two pieces of 
technology that are actually available to people with diabetes 
in some form today, although separately: an insulin pump, which 
has long been available--though a number of developments and 
improvements have been made, with new pumps coming out that 
make quality of life a little bit better in terms of ease of 
use and convenience--and a continuous glucose sensor, a 
promising new technology which provides real-time data about 
trends in glucose levels, as Dr. Rodgers pointed out, and 
alarms if levels are heading too high or too low. Now, this 
information enables people with diabetes to intervene by eating 
food or taking insulin to prevent glucose levels from going too 
high or too low.
    An artificial pancreas would tie these two technologies 
together, using a mathematical algorithm to determine how much 
or how little insulin is provided to maintain glucose levels in 
the normal range 24 hours a day, 7 days a week. There are 
incredibly encouraging clinical trials already underway at Yale 
Medical School showing that you can ``close the loop,'' as we 
say. Researchers in that clinical setting have teenage patients 
with diabetes on a closed-loop system that maintains near 
perfect blood sugar levels, especially at night. JDRF is 
funding this research at Yale and at five other top scientific 
facilities throughout the country, testing a variety of ways to 
close the loop. Questions about miniaturization, regulatory 
approval, insurance reimbursement, and clinical acceptance by 
doctors and patients will follow quickly on the heels of the 
basic science and resulting medical product development.
    Now, even before a closed-loop artificial pancreas is 
available, continuous glucose sensors show great promise in 
improving the health outcomes of people with diabetes. One 
study found patients using continuous sensors spent 26 percent 
more time in the normal glucose range. Another found patients 
had statistically significant improvements in HbA1c levels, an 
important measure of glucose control. Because better glucose 
control means fewer complications, JDRF is making accelerating 
the availability of continuous glucose sensors a top priority 
as we work toward ultimately an artificial pancreas.
    Now, over the past decade, research conducted by the 
National Institutes of Health and others clearly shows that 
blood glucose control is far and away the most important 
predictor of the devastating complications of diabetes. The 
better the control, the lower the risk of eye disease, heart 
disease, kidney disease, and other problems. In fact, lowering 
blood glucose dramatically lowers the risk of serious 
complications by as much as 75 percent for some of these 
problems. Yet recent research shows that even the best 
controlled patients with traditional methods are rarely within 
the normal blood sugar range. The test-and-inject or test-and-
pump method of controlling blood sugar, though light years 
ahead of clinical standards from just a few decades ago, does 
not come close to approximating how the human pancreas really 
works. To significantly increase blood sugar control, you need 
to more closely mimic the human pancreas, and that is an issue 
where technology can provide startling answers in the not-too-
distant future.
    With tighter glucose control will come reduced risk of 
diabetic complications. And here is the power of this issue. 
Fewer complications can, arguably, lead to one of the greatest 
health advances and financial savings in medical expenditures 
in U.S. history. Consider this: Diabetes is among the leading 
causes of heart disease, of stroke, of kidney disease, and of 
peripheral nerve disease. It is the single largest cause of eye 
disease in the United States. It is the cause of more 
amputations in the United States than any other reason, save 
accidents. Decreasing the rate of diabetic complications in the 
United States can mean savings of literally billions of dollars 
in health care costs annually.
    JDRF's role in all this is to speedup those timetables in 
any way possible. We are spending some $6 million on research 
to assess the clinical and economic benefits from use of 
continuous glucose sensors and testing versions of a closed-
loop artificial pancreas. We are working with regulators to 
understand what research outcomes they need to see before 
approving these new technologies. We are working with private 
insurers and Medicare officials to make certain that when 
approvals come, reimbursement will be fast on its heels. And we 
are working with physicians and other diabetes care 
practitioners to ensure that when these technologies are 
available, they will be fully adopted and supported.
    This project has in many ways been a perfect example of how 
medical research can and should successfully take place in the 
United States. The Federal Government, primarily NIH, has 
funded basic research showing the benefits of better glucose 
control and identifying promising new methods to help achieve 
it. Private companies have picked up the ball to begin 
developing products and therapeutics they could eventually 
bring to the market. And organizations like Juvenile Diabetes 
Research Foundation have been filling the gaps, funding 
additional research that focuses on concepts like perfecting 
the algorithms that can lead to commercially available 
artificial pancreas devices or the clinical and economic 
studies that can ultimately determine regulatory, insurer, and 
medical practitioner acceptance.
    This project has also been an example of how different 
parts of the Federal Government can work effectively together. 
And as I have already mentioned, the National Institutes of 
Health has played a critically important role in funding 
research making the artificial pancreas possible. The Food and 
Drug Administration has made the artificial pancreas one of its 
Critical Path goals. The Centers for Medicare and Medicaid 
Services has convened an expert panel to advise on these 
technologies. And the Congress, under your leadership, has made 
this issue a priority, with 68 Senators and 245 Representatives 
highlighting the promise of these technologies to HHS Secretary 
Michael Leavitt in letters this spring.
    We are profoundly grateful for your leadership--
profoundly--and we look forward to continuing to work with you 
in the months ahead to achieve an artificial pancreas and help 
millions of Americans with diabetes live longer and healthier 
lives.
    Thank you very much.
    Chairman Collins. Thank you for your excellent testimony.
    Mrs. Sweeney, we are delighted to have you here today. I 
think that your son may set a record in terms of the youngest 
witness, certainly before this Committee, if not the entire 
Senate. So, Aidan, we are glad to have you here, too. You are a 
good waver.
    Mrs. Sweeney, you may proceed.

 TESTIMONY OF CAROLINE K. SWEENEY,\1\ ACCOMPANIED BY HER SON, 
                 AIDAN T. SWEENEY, GRAY, MAINE

    Mrs. Sweeney. Good morning, Senator Collins and Members of 
the Committee. I am Caroline Sweeney from Gray, Maine. I am 
here today with my 4-year-old son, Aidan. Before I begin, I 
want to say a special thank you to you, Senator Collins, for 
all that you do to help find a cure for diabetes. You give my 
family so much hope that one day my son will not have to 
struggle with the daily burden of diabetes. I am proud to live 
in Maine and to have you as my Senator. Thank you.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mrs. Sweeney appears in the Appendix 
on page 54.
---------------------------------------------------------------------------
    Chairman Collins. Thank you.
    Mrs. Sweeney. On February 10, 2004, my world fell apart. I 
had taken my son, Aidan, then 22 months old, to the 
pediatrician because he had been up all night drinking water 
and soaking diapers. Twenty-six weeks pregnant with my second 
child, and tired of waiting for the doctor to return to the 
examining room with Aidan's blood sugar results, I opened the 
door and was quickly escorted back into the room by the nurse. 
I will never forget the look on her face as I asked, 
``Everything is all right, isn't it?'' She looked at me with 
tears in her eyes and shook her head, ``No.'' Covered in urine, 
I held my crying son tightly and gasped for breath as I fell 
against the examining table. My son, the child I had longed for 
my entire life, was sick--sick with a disease for which there 
is yet no cure: type 1 (juvenile) diabetes. Aidan was in 
diabetic ketoacidosis, a complication which threatened his 
life. My life, but importantly, my son's, would never be the 
same. I went through every emotion. I wanted to scream; I 
wanted to hit; I wanted to run; I wanted to be numb. Most of 
all, I wanted it to go away.
    But diabetes never goes away. Aidan is now 4 years old. He 
receives insulin through a pump, which he wears on a belt 
around his waist, 24 hours a day. The pump is connected to an 
inch-long catheter tunneled beneath the skin on his bottom. So 
far, we have changed his catheter over 500 times. Not 
surprisingly, he does not like the catheters. Most site changes 
become bargaining sessions, and despite the anesthetic cream, 
he feels every stick. His little bottom is studded with scars.
    His fingertips are scarred from being tested up to 12 times 
a day. That is more than 11,000 tests in 2\1/2\ years. Like the 
site changes, he does not like the testing. Sometimes, Aidan 
will run away when it is time to test his blood sugar or hide 
his hands behind his back, crying for me not to test him. At 
preschool, he has asked his teacher to test his blood sugar in 
the bathroom so the other kids will not watch.
    Despite his efforts, he can never escape his tests. He is 
forced to test his blood sugar everywhere--at preschool, at the 
grocery store, at restaurants, at the playground, at friends' 
homes, and even in his bed during sleep. The tests are 
constant, frustrating, and exhausting. Growth spurts and minor 
illnesses can cause his blood sugar levels to rise or fall 
unpredictably and change his insulin demands as well. His 
emotions shift with every blood sugar fluctuation, making it 
impossible to distinguish between ``typical 4-year-old 
behavior'' and ``low'' or ``high blood sugar behavior.'' Often 
he has been unable to warn me even when his sugars are at life-
threatening levels. Two and a half years into his illness, he 
will still sleep through dangerously low blood sugars and be 
asymptomatic while awake. And so I test.
    And I worry. I am always fearful--fearful that my son's 
blood sugar will rise so high that he will enter into a coma or 
drop so low that he will seize or even worse. Every night, I 
check his blood sugar before I go to bed and pray to God that 
he will wake up in the morning. I never sleep through the 
night. I keep a baby monitor on my pillow just so I can hear 
him breathe. I have found myself running into his bedroom in 
the middle of the night, carrying glucagon and a syringe, 
thinking that I have heard him seizing. I am always relieved 
when morning comes and I hear his little footsteps entering my 
bedroom.
    I have become not only Aidan's mother but his health care 
provider. With each good morning and good night kiss comes a 
finger stick. The responsibilities of his diabetes care are 
many--endless testing, counting and recording and interpreting 
everything that he eats, calculating insulin doses, giving 
insulin, changing catheter sites, keeping his supplies in 
stock, trying to explain to him just why it is that he cannot 
eat the chocolate cake that his friends are eating when his 
sugar is too high. The list goes on.
    Still, despite diligent care and tight glucose control, I 
am aware my son is still more likely to suffer from heart 
disease, kidney failure, nerve damage, stroke, blindness, 
amputations, and an early death. This is most difficult to face 
as a parent. I try to live day by day with my son, but find 
myself wondering: Will he one day lose a limb? Will he end up 
on dialysis? Will he go blind? Will he live to see the age of 
50?
    Aidan can only be left in the care of others who are 
trained in diabetes, including babysitters and school. Fourteen 
weeks after Aidan was diagnosed with diabetes, I gave birth to 
our second son, Michael, now 2, and just 3 months ago gave 
birth to our daughter, Caitlin. Both deliveries put us in a 
state of panic over who would take care of Aidan. Families on 
both sides were forced to pick up their busy lives and come to 
Maine in the weeks before both deliveries so they could be 
trained in diabetes care. I can vividly remember my mother 
learning how to operate Aidan's insulin pump while timing my 
contractions. While my biggest concern should have been my 
unborn child, I could not seem to escape the worry about 
Aidan's care.
    From the moment little Michael and Caitlin were born, they 
have never been able to have my complete attention because of 
Aidan's diabetes. Aidan's illness comes first--before nursing, 
diaper changes, cries, baths, even hugs and kisses. I recently 
realized the impact of this when Michael, my 2-year-old, 
insisted on having his blood sugar checked, claiming to have 
diabetes, too. Much of his life is also dependent on Aidan's 
blood sugars. He knows that if Aidan's blood sugar is high at 
dinnertime that he has to wait with the rest of the family 
before he can eat. He knows that sometimes Aidan needs to drink 
juice really fast and sometimes only he can have juice and 
Aidan cannot. He knows that his Mommy and Daddy sometimes stick 
a needle into Aidan's bottom and that Aidan does not like that. 
I do not know what impact this will have on Michael in the 
years to come. I can only try to help him understand the 
severity of his brother's disease, while praying that he and 
his sister do not one day get diabetes.
    As parents, we try from the moment our children are born to 
protect them from any harm. Two years ago, I never felt more 
helpless when all I could do was hold the tiny hand of my 22-
month-old son in the intensive care unit and pray he would not 
die. I vowed at that moment to do everything I could to find a 
cure for diabetes. I stand before you today with my son, my 
hero, asking for your support in saving his life. While the 
continuous glucose monitor and artificial pancreas are not 
cures, they can offer Aidan, and children like him, a 
tremendous improvement in his quality of life, free from 
thousands of finger stick tests, and offer me the gift of 
peace--peace in knowing that my son is safe and hopefully able 
to live a longer life with this terrible disease.
    I encourage Congress to continue to show its support for 
these promising technologies and to help ensure that they are 
available and accessible to all who could benefit. Thank you.
    Chairman Collins. Thank you so much for your eloquent 
testimony. It leaves me speechless, and we are not speechless 
very often up here, I will tell you that.
    You did such a good job of explaining to us that diabetes 
has an impact not only on Aidan but on your entire family. And 
that is one reason that your testimony inspires all of us to 
work even harder for a cure and for the research dollars that 
will lead to better treatments and to support what is a truly 
impressive partnership with private companies, the NIH, the 
Juvenile Diabetes Research Foundation, all working together 
toward a common goal.
    Mr. Dudley, your testimony also was so eloquent when you 
talked about not being able to play a single game without being 
worried about the impact on your diabetes. It really hits home 
also.
    Mrs. Sweeney, it is my understanding that you were a 
dietician prior to finding out about Aidan's diagnosis.
    Mrs. Sweeney. Yes.
    Chairman Collins. Has that made it easier for you to manage 
his illness than someone who did not have that background?
    Mrs. Sweeney. It probably has made it a little bit easier, 
but to be honest, I expected it to make a bigger difference 
than it has. Both my husband and I are health care 
professionals. My husband is an emergency room physician, the 
same emergency room where Aidan had to go after he was 
diagnosed. And we both find this just a maddening and 
frustrating disease. It does not work the way that we were both 
taught.
    Chairman Collins. I think that is so telling, that even 
people with your expertise in health care have found this to be 
such a challenge. And when we look at the charts that Dr. 
Rodgers showed us and we hear the statistics, virtually 
everyone who has diabetes has a very difficult time controlling 
their blood sugar, and yet that is so critical. And that is why 
I am so excited about this potential technology.
    We know it would help to even out the blood sugar levels 
for your son, but can you also give us a sense of how this 
technology would make your life a bit easier?
    Mrs. Sweeney. It would make my life a lot easier in 
numerous ways. One would be sending Aidan off to school. That 
has been a big concern of ours. Every day, when I drop him off 
at preschool, I have to meet with his teachers to make sure 
that they are aware as to how to check his blood sugar, correct 
his blood sugar if it is high or low, and give the proper 
insulin for his snack. I carry a cell phone with me at all 
times so that anyone who is with Aidan at any point can reach 
me with questions.
    Chairman Collins. Dr. Rodgers, you mentioned in your 
testimony that the continuous glucose sensors to date have only 
been approved for use in adults. Are you hopeful that they can 
be extended so they can be used for children? What is the 
barrier in that area?
    Dr. Rodgers. Absolutely. As you indicated, the continuous 
glucose monitors are only currently available or FDA-approved 
for individuals 18 years of age or older. It is certainly 
understandable that the manufacturers wanted to get their 
product to the market, and it is generally well appreciated 
that it takes much longer to get such devices FDA approved.
    Your question also speaks really to the importance of 
having NIH-supported research to support the types of 
investigations that are needed, particularly in pediatric 
patients, to move these devices through the approval process. 
And it was really for this reason that we developed, in 
collaboration with the National Institute of Child Health and 
Human Development, the so-called DirecNet, because up until 
this time, these devices that we showed had only been tested in 
adults. And while we are hopeful that the results and the 
efficacy of this device are equally good in children, it is 
really important that we have that database, that knowledge to 
effectively determine how to best use these devices in 
children.
    Chairman Collins. I think most of us are motivated by 
wanting to help little Aidan and wanting to help Chris Dudley 
live lives free of diabetes. But there are also very 
considerable economic consequences of this disease. Nearly one 
out of three Medicare dollars are spent in treatment of people 
with diabetes. I think the estimate that either you or Mr. 
Donald gave was $132 billion in health care costs. So this 
makes sense, even if you are putting aside your concern for 
people, which none of us are, but from clearly a cost/benefit 
analysis.
    Are we giving you--``we'' meaning Congress--sufficient 
funding for projects in this area, which are clearly going to 
pay off in lower health care costs down the road?
    Dr. Rodgers. Well, we are certainly very appreciative of 
the support that you have given us over these years, and we 
really try to deploy those resources that the Congress has 
generously appropriated to us to the most cutting-edge, the 
highest-priority, the most innovative types of research.
    I think Mr. Donald indicated in his testimony it is 
estimated that the direct and indirect costs of diabetes are 
about $132 billion a year. Actually, that number is taken from 
an article published in ``Diabetes Care'' in 2003 based upon 
2002 numbers. So almost certainly that number is much higher 
and likely to continue to rise unless we are able to find 
better ways to manage diabetes care more effectively. And the 
human toll, as I think you have heard, the human suffering 
factor is also a critical point.
    So we really have to think every day about the best ways to 
manage diabetes, both for the human toll, but also to protect 
against the complications which really lead to these 
expenditures.
    Chairman Collins. Thank you. We are going to do a second 
round of questioning, so, Mr. Donald and Mr. Dudley, I will 
have questions for each of you on the second round.
    Senator Lautenberg.
    Senator Lautenberg. Madam Chairman, since Senator Coburn 
has been here and he has a professional understanding of what 
is taking place, I do not mind if he goes first.
    Chairman Collins. Senator Coburn.
    Senator Coburn. Thank you, Senator Lautenberg. That is very 
kind of you.
    Dr. Rodgers, a couple of things. At the NIH, are we working 
on genetic identification of those more susceptible to immune 
destruction of the pancreas?
    Dr. Rodgers. We absolutely are. We have studies currently 
ongoing to try to identify the genetic susceptibility factors 
related to the development of type 1 diabetes in particular. 
Some think that it may be some viral agent. Some think that it 
may be some food product. But we are committed to a study that 
will follow kids from the time of birth, looking at the most 
common susceptibility gene that we currently have, something 
related to their HLA locus.
    Senator Coburn. Right.
    Dr. Rodgers. We will follow them to the age of 15 for the 
disease onset to see whether we can determine causation, based 
upon very careful surveys of their food intake, viruses, and 
other factors. We are collecting a number of samples very 
frequently to look for bacterial, viral, and other etiologies. 
So that is critically important.
    Senator Coburn. This is just a general statement, and you 
can take it any way you want. Our health care system in this 
country is about disease treatment rather than investing in 
health, and we have it wrong. We should be investing in 
preventing juvenile diabetes. I do not disagree that we should 
be investing heavily in treating it with an artificial 
pancreas, but you all have at the NIH $7.2 billion for 
prevention research. When I look at diabetes in our country and 
you take out type 1, or juvenile diabetes, we know the vast 
majority of that is preventable. And yet what we are seeing is 
an ever increasing number of people in this country developing 
type 2 diabetes, and our approach seems to be to treat the 
disease rather than prevent it from ever occurring in the first 
place.
    As one Senator who is working on global health care reform, 
it would certainly seem important to me that we look at our 
priorities to make sure we are investing in prevention.
    You are familiar with metabolic syndrome. You are familiar 
with all the risk factors associated with it. And yet we do not 
invest the dollars both in terms of diet, in terms of 
education, and in terms of prevention, which is far cheaper 
than paying for an artificial pancreas for somebody with type 2 
diabetes.
    So I think it is very important that you get the message 
that we need to be investing in health rather than always 
treating disease because we are going to lose. We are never 
going to have the dollars to treat the disease if we fail to 
invest the dollars in preventing it in the first place.
    The second thing, long ago when I was in the optical 
business, we worked on research on sorbitol and aqueous humor. 
Is there anything going on in that now in terms of continuous 
glucose monitoring or sorbitol monitoring in the aqueous humor 
that might make a much less invasive glucose-monitoring system?
    Dr. Rodgers. We are actually investing and trying to bring 
in new talent and new ideas through a variety of strategies. 
And, in fact, that area, in actually looking at fluid in the 
eye, is one way to optically sort of track glucose, and those 
investigations are all in very early phases.
    Senator Coburn. For people that are not familiar, we could 
actually design a contact lens to put on a child that would 
measure the glucose in the anterior chamber of the eye, the 
aqueous humor, with a little chip on it that could 
automatically communicate to an insulin pump. And so it would 
be much less invasive in terms of a device. One of the things 
that was not mentioned, especially for your son, is infections. 
You are much more prone to infection when you are a diabetic. 
And that is because the microvasculature is not there to fight 
those infections.
    The other question I had on the study with the continuous 
glucose monitoring, was that in conjunction with an insulin 
pump, or was that in conjunction with individual application of 
insulin subcutaneously?
    Dr. Rodgers. These were patients who were admitted to a 
general clinical research setting, and so in that context, they 
were being monitored very carefully, and they were being 
treated with an insulin pump.
    Senator Coburn. So you did have glucose monitoring with the 
insulin pump, but not necessarily monitoring tied to----
    Dr. Rodgers. That is right. The loop had not been closed.
    Senator Coburn. But when we see that, what we see is that 
actually goes and stays in the normal range.
    Dr. Rodgers. Absolutely. In fact, you can see in that slide 
that despite the fact that there were these wide variations--
particularly in the pre-education period, there were wide 
variations--our overall ability to sort of measure what we 
think is the average value of control really did not change 
demonstrably. It went from 7.2 to 6.8. So we think that these 
fluctuations can be almost as important as the average value 
over a period of time, and that is why it is critically 
important to further research and correlate that with the 
specific complications.
    Senator Coburn. I would just put out the challenge that 
outside of the NIH and outside the CDC, we spend $6.9 billion 
on prevention every year in this country through 19 government 
agencies. And I think we have it wrong. I mean, if you go out 
and ask a typical American, ``Is my being overweight associated 
with me developing diabetes?'' Most of them do not make that 
connection at all. So, therefore, they do not see an importance 
for exercise, weight control, and things such as that.
    Madam Chairman, we are going to be working on this next 
year to bring bills to the floor that we are going to remodel 
the prevention strategy of this country to invest in health and 
educate the American people and give them a chance to do that.
    I want to say one other thing to Mr. Dudley. One of the 
things that is lacking in our country is leadership, and I want 
to praise your leadership. You did not have to do what you are 
doing, but you chose to do it. And the thing that makes our 
country strong, that makes us greater than any other place, is 
when individuals stand up and take the lead. They do not wait 
on the government to do it. They do not wait on somebody else. 
They do not become a victim. What they do is they change and 
say, ``I will defeat this by empowering other people.''
    And I think what you have done is very laudable. Sure, you 
get pats on the back for it, but the fact is that it took real 
courage to take this on. It took real finances of your own to 
take it on and invest in it. And that is what makes us great. 
Your model of leadership should be commended, and I do so 
today. I would encourage others. There is not anything that 
this country cannot whip if we have great leadership. That is 
demonstrated by what you are doing today, so I thank you.
    Mr. Dudley. Thank you, and I would like to thank you, 
Senators, for your leadership as well in fighting this disease. 
Thank you.
    Chairman Collins. Thank you. Senator Lautenberg.

            OPENING STATEMENT OF SENATOR LAUTENBERG

    Senator Lautenberg. Thanks very much, Madam Chairman. I 
think this is as important a hearing as we have ever had, and I 
commend you for bringing it to our attention to remind us what 
happens to lots and lots of people across this country. So I 
personally thank you and assume that Mrs. Sweeney's testimony 
will wind up in the Congressional Record also so that people 
will read and understand what it is like to have a child with 
diabetes. We understand love of a child, all of us do. I am a 
professional grandfather, and I have 10 grandchildren. The 
oldest is 12 and the youngest is three, and what I think about 
constantly is thank goodness that they are healthy. I have one 
grandchild who has asthma, and we have plenty of allergies, but 
nothing like the kinds of things that the Sweeneys go through.
    Mr. Dudley, I think you traveled around New Jersey a little 
bit in your professional days. We wish you were back there. 
[Laughter.]
    And I commend each one of you for your testimony. The value 
that you bring to the issue is immeasurable. And to know that 
we face an epidemic of diabetes, with forecasts of one in three 
born in the year 2000 will contract diabetes before their lives 
are over, it is a really ominous prediction.
    One thing I find, as a grandparent, I instantly fall in 
love with little kids, and when you see someone like Aidan, who 
suffers from this terrible disease, there is something 
fascinating about the faces of those children. They are 
especially beautiful, and I see it time and time again because 
I meet a lot with families who have a diabetic child and listen 
very carefully to their experiences, and I learn things about 
not only the pain but the interference in normal life. But 
these kids seem to have a special look about them, almost 
angelic. And I do not know whether there is just a natural plea 
for understanding and help, but they bring it with them. And, 
Mrs. Sweeney, your testimony was particularly moving, and we 
thank you for being so candid in talking about the experiences 
as clearly as you have.
    One of the things that I learned when I had a group of 
children with diabetes in my office in Newark, New Jersey, I 
asked them, ``Well, what is it like? And what are the things 
that bother you the most?'' And one child said the pinprick is 
the thing that is most bothersome, another said getting ill, 
becoming ill in class and having to expose their weakness. But 
one little boy, 10 years old, said, ``Well, I cannot go to 
sleepovers anymore.'' So I said, ``Well, what do you mean?'' He 
said, ``Well, I slept over at a friend's house, and during the 
night I got sick. And we woke his mother, and she got mad. And 
my parents said I cannot ever go do that anymore.'' And just 
something as normal as that is part of the pain and the 
frustration.
    So I ask you, Dr. Rodgers, can more funds accelerate the 
process? Because despite Dr. Coburn's learned view of things, 
do you think diverting funds from treatment to research is a 
good idea? I think these are all wonderful ideas, but families 
who are burdened with this condition are looking for relief as 
quickly as it can come. So it is not enough, in my view, to 
fund the treatment side instead of the research side; both need 
funding. But did you say that you had enough funding to 
maintain the quickest pace as thoroughly as you can, or could 
you use more?
    Dr. Rodgers. Well, Senator, as I mentioned, we are 
certainly very appreciative of the funds that we have, and we 
really try to deploy those in the best manner, working together 
with our other colleagues at the NIH. There is a very broad 
portfolio of activity that we try to encompass, not only in 
understanding better the basic biology of this disease, the 
treatments for people who have the existing disease, but as 
Senator Coburn mentioned, also trying to develop ways to 
actually prevent the disease.
    In the case of type 1 diabetes, we know that there is a 
susceptibility, and those studies are the kinds of research 
that we would like to certainly do more of. They are long-term 
studies--they go out 15 years--in order to understand what 
makes someone susceptible to disease, what kind of 
environmental factors may contribute to that. And so it is not 
a study that you can answer very soon. These long-term studies, 
of course, need long-term funding, and we are really committed 
to them, and we would certainly like to continue these studies 
for the long term because our patients invest in these clinical 
trials, and we certainly want to see them through their 
fruition.
    Senator Lautenberg. Madam Chairman, if I may extend for 
just a minute more?
    Chairman Collins. Certainly.
    Senator Lautenberg. Dr. Rodgers, how do you get data that 
are being compiled from commercial--from voluntary 
institutions, for example the pharmaceutical industry? What 
kind of a flow of data are there that permits you to know what 
is happening in the various places and how do you put that all 
together?
    Dr. Rodgers. There are a couple of avenues in which we get 
input on what are really the most cutting-edge activities and 
what are very promising areas of exploration. There is a 
statutory, mandated Diabetes Mellitus Interagency Coordinating 
Committee in which our Institute takes the lead on, and we work 
with a number of people from sister agencies within HHS as well 
as other Federal agencies, including the VA and so forth. They 
bring to our attention cutting-edge research, areas that are 
prime for further exploration.
    In addition to that, we have an Advisory Council to our 
Institute, oftentimes members of academia but also members of 
the public, who bring to our attention important developments 
and ideas that really are prime for exploration.
    And then through frequent meetings that we fund, we bring 
in members of the private sector, industry as well, to learn 
about where we might invest. In fact, this meeting that we 
convened in December 2005, which was entitled ``Closing the 
Loop,'' brought in a number of people from industry to discuss 
some of the obstacles and opportunities.
    And so we get a lot of feedback, and a lot of good ideas 
are generated, and then it is a matter of, with consultation 
from outside groups and members on our own staff, really trying 
to prioritize, given the resources that are available, the best 
and most compelling areas of research to explore.
    Senator Lautenberg. Madam Chairman, I would ask consent 
that my opening statement be included in the record.
    Chairman Collins. Without objection.
    [The prepared statement of Senator Lautenberg follows:]
                PREPARED STATEMENT OF SENATOR LAUTENBERG
    Madam Chairman, thank you for your leadership on diabetes--and for 
holding today's hearing on the potential for an artificial pancreas.
    I have met with some great kids from New Jersey who live with 
Juvenile Diabetes. And an artificial pancreas holds great promise for 
them.
    Twenty-one million Americans have diabetes, according to the CDC.
    Children with diabetes are at risk for kidney failure, blindness, 
and losing their limbs. And diabetes lowers their life expectancy by 15 
years.
    In 2002--the most recent year CDC has data for--the total cost for 
diabetes care in the United States was more than $132 billion. And even 
with all that money spent, we know the current treatments are not good 
enough.
    Thanks to science and technology, a better treatment is on the 
rise.
    With an artificial pancreas, kids--and adults--would have their 
glucose monitored all day, every day--and the pancreas would send out 
insulin when the patient needs it.
    It would help a diabetes patient maintain ``normal'' glucose, just 
like a pancreas in a person without the disease. It would reduce 
diabetes-related illnesses, like kidney disease and stroke. And it 
would give patients more freedom--and help them live their life, not 
live their disease.
    From stem cell research to care for Americans with AIDS, we must 
support science anytime it can advance medicine. Today we have that 
opportunity. I urge my colleagues to embrace it.

    Senator Lautenberg. I would also make another suggestion, 
that if we had a film of Mrs. Sweeney's presentation, just as 
she did it, I think it would be a wonderful tool in educating 
our colleagues about the toll of diabetes and the pain and the 
anguish that families are going through. Thank you, Mrs. 
Sweeny, and your family and Aidan, for your testimony. Aidan, 
in his silence, did more to let us know what life is about than 
anything else, and all of you, thank you for your testimony and 
your help.
    Thank you, Madam Chairman.
    Mrs. Sweeney. Thank you, Senator.
    Chairman Collins. Thank you, Senator.
    Mr. Dudley, I want to echo the praise that Senator Coburn 
gave you for your leadership, and that includes your 
establishing the summer camp for children who have diabetes. 
You had mentioned--and certainly Mrs. Sweeney's testimony 
confirms--that so many parents never get a full night's sleep 
once their child is diagnosed with diabetes, and your camp 
gives them a bit of a respite.
    But I think another huge benefit of your camp is it brings 
children who all have the same problem together so that they do 
not feel that they have got to go to the bathroom and hide when 
they are having their blood sugar checked.
    Could you talk about that aspect?
    Mr. Dudley. Sure, absolutely. When I started the camp 11 
years ago, part of it was to help kids with diabetes be able to 
play sports and believe that they could achieve whatever it is 
they wanted to achieve. And at that time--it has gotten better, 
but some doctors were not even encouraging kids to be active. 
And now we know that exercise is so important for diabetes. And 
so I was really trying to help kids be able to do sports while 
having diabetes.
    The bigger impact in my mind, which I did not realize when 
I first started, was not only helping kids have that dream that 
they can achieve whatever it is they want to achieve, but also 
it is so important to that age group--my camp is for boys and 
girls ages 10 through 17--to not feel alone or different. As 
the camper whose letter I read said, he is the only kid in his 
town or school that has diabetes, and so often these kids feel 
so isolated and so alone that it means so much for them to come 
to a camp where not only everybody has diabetes, but they all 
love basketball, and they have so much in common. And these 
kids stay in touch with each other all throughout the year, and 
I think it really gives them hope just to see that they are not 
out there alone, that there are a lot of kids walking in the 
same shoes. I underestimated how valuable that was when I first 
started the camp, and it has been a tremendous blessing to just 
help them in their outlook on life.
    Chairman Collins. That is great.
    Mr. Donald, you mentioned that you had very encouraging 
results from the clinical trials at Yale that JDRF is 
financing. From your perspective, what are the biggest barriers 
that we face in getting these new technologies to the market, 
assuming the clinical trials continue to be so positive? Are 
the obstacles primarily regulatory or scientific or a matter of 
getting insurers to reimburse for that technology? What are the 
biggest barriers?
    Mr. Donald. There are a number of barriers, regulatory 
first. When you deal with a mathematical algorithm which will 
connect the continuous glucose sensor to the insulin pump and 
basically be an artificial pancreas, there are issues because 
they cover so many different aspects of regulatory approval. 
Getting all of the various regulatory groups within the FDA to 
define what it will take for them to be comfortable to approve 
this entire system for use is a challenge.
    Now, it is something that FDA is proactive on. They are 
working proactively with us and our volunteers, and obviously 
with the medical profession as well and NIH and others, to 
define for safety reasons as well as efficacy how we are going 
to define that, what are the important measures and metrics so 
we can assure we can get this in the market quickly.
    Then you have access issues. Let's assume this closed loop 
actually works, which it will eventually. Now you have the 
issue of access for patients, which probably will be a staged 
type of thing. We will have some challenges with little guys, 
like Aidan, versus big guys, like Chris, just to get the timing 
right and to make certain that we process through all that 
properly.
    But then there is the insurance coverage. There is the cost 
associated with that. And then, lastly, there is the medical 
professionals themselves getting them up to speed, the 
practitioners who are going to recommend these systems for 
people.
    In the meantime, it is all very positive. The glucose 
sensors themselves, as we mentioned, and as you can see from 
the charts,\1\ offer a huge advance in terms of reducing the 
possibility of complications. They do not eliminate 
complications, but they reduce them. And just the fact we are 
engaged in this activity collectively, all of us together, is 
making a huge positive impact on the quality of life for those 
who suffer from the disease.
---------------------------------------------------------------------------
    \1\ The charts referred to appear in the Appendix on page 41 and 42 
respectively.
---------------------------------------------------------------------------
    Chairman Collins. Thank you.
    Mr. Donald. Thank you, Senator.
    Chairman Collins. Senator Coburn.
    Senator Coburn. Mr. Donald, what can we do to streamline 
that once you get there?
    Mr. Donald. I think there are many things we can do to 
streamline it. First of all--and I do have to acknowledge the 
FDA, in particular, has been very proactive in organizing under 
interim Director von Eschenbach to make certain that they have 
defined things well enough so there is no delay as the 
technology advances. So that has been very positive.
    The second thing we can do is to continue to invest in the 
research, and we do need more research dollars. I also agree 
with you, Senator, that we need more education dollars, and we 
need more general knowledge dollars. We need more of 
everything, and there is a fixed pie at some point. But we 
definitely need dollars, more research dollars, so that we can 
get larger sample bases, find ways to accelerate the research, 
and we need some new technologies. One thing that would be a 
huge advance in diabetes research are biomarkers or imaging 
technology. Today we cannot image the disease. We cannot image 
the pancreas and the beta cells. Those would be huge advances. 
We are going to do some things to accelerate the number of 
people engaged in developing the mathematical algorithms so we 
can get more people engaged. And as you know, JDRF is the 
largest charitable funder of diabetes research in the world. We 
have given over $1 billion over the last 30 years, and we did 
$123 million last year, we will do $140 million this year. And 
we are looking for ways to leverage the dollars we spend and 
that NIH spends and the private companies spend to get more 
people engaged in developing these algorithms faster and more 
accurately.
    Then from the insurance provider standpoint, having the 
economic data to demonstrate that by reducing these 
complications you are actually reducing medical costs will be 
an important metric for them to have so they can go ahead and 
include these devices as something that they cover.
    So those would be some examples, Senator.
    Senator Coburn. I note that when I first came to Congress 
in 1995, between now and then diabetes research has increased 
250 percent to over $1 billion a year. The thing that concerns 
me--and the Chairman will get a tickle out of this--is that 
there are limited dollars, and actually the American people do 
not know really how severe that is going to be.
    We need help from groups like the JDRF to get on the 
bandwagon and help us get rid of the $200 billion waste that is 
there now (so we can put the dollars where they will do some 
good) and take the conflicts of interest out of Congress. If 
JDRF, in their lobbying, would lobby just as hard to get rid of 
the $200 billion worth of waste, fraud, and abuse we have in 
discretionary programs, we would not have trouble spending 
another $10 billion or $15 billion a year at NIH, and a good 
portion of that on diabetes.
    We hear the asking--``We need more money''--but we never 
hear the pressure to help us get rid of these terrible 
conflicts and this terrible waste that we have. I would just 
hope that when you lobby us, you will say, ``Cut some of these 
programs out that are not benefiting the country.'' Cut some of 
these earmarks like building $2 million garages for museums 
that have $50 million in the bank--$2 million could go a long 
way on a contact lens measuring the aqueous humor in the eye. 
We do not have that kind of debate. My hope is that we will get 
everybody engaged as the finances get tighter so that we really 
pay attention. We ought to spend the first dollar on the most 
important thing to this country, and then it ought to decrease 
in terms of priorities rather than doing what the politicians 
want to benefit the politicians and not the country.
    So my message to you is that I hear you on wanting to send 
more money to NIH. Help me and the Chairman get rid of the 
waste and fraud so that we will not continue to waste money and 
dollars that could make a difference in Aidan's life because we 
are doing something politically expedient rather than the right 
thing for our country.
    Mr. Donald. Well, I assure you, Senator, families like the 
Sweeneys and all the families that are in the JDRF family, and 
as you know, there are thousands, tens of thousands of them, 
the constituencies all across this country of you all--resonate 
with the message that we need to spend on the most important 
things.
    Senator Coburn. Just one last comment, and I have to go. 
Mrs. Sweeney, I want to tell you as a doctor--I remember as a 
resident at Oklahoma Children's Hospital staying up all night 
with kids just like your Aidan, pumping insulin into them, 
checking their sugars, keeping their fluids right, measuring 
their arterial blood gases, the same thing you went through 
doing that. And I also know that the youngest child I have ever 
diagnosed with diabetes was 9 months old, and there is not just 
a difficulty with you. It also is a difficulty for the 
pediatricians. This is a tough thing for them to do as they see 
you struggle with it, and they know you are eventually going to 
get to the level that you need to get to care for your child 
and the disease. But, I would praise the health care 
professionals in this country that are doing this because they 
are not only treating the disease and the child, they have to 
treat the family. And the recognition of that should go out--
the kudos, especially to the pediatric endocrinologists in this 
country that do such a fantastic job with this in terms of 
supporting it. And my hope is in the future that they do not 
have a job. That is my hope.
    And I will just end thanking the Chairman again for having 
the hearing. I know nobody from the HELP Committee was against 
us having this hearing, much like many of my Subcommittee's 
hearings. I want to thank you for doing it. I think it is a 
subject well worth our discussion and time. Thank you.
    Chairman Collins. Thank you, Senator. Senator Lautenberg.
    Senator Lautenberg. One of the things that you will learn 
in your visits here is that occasionally we have differences of 
opinion with one another. My distinguished colleague, Dr. 
Coburn, and I sometimes disagree on budgets and things of that 
nature, surprising as that may be. And so there is money that 
we spend sometimes foolishly. Our budget numbers stagger the 
imagination. You folks have got one tough war in front of you. 
Fight that war. In my view, you are going to have to depend on 
us, all of us, to do the right thing. And when we touch things 
like children's diseases, diabetes, AIDS, or asthma--we make a 
difference.
    So we are not wasting money--we are doing all kinds of 
things, and we are spending a lot of money on another war, not 
the one that you are engaged in here, but there is another one 
that you read about every day when sometimes hundreds of 
people, American and otherwise, die each day as a result of 
violence. So maybe we can save money there, or maybe we can 
save some money in tax write-offs for companies or maybe tax 
cuts for wealthy individuals, just to keep a balance.
    But I would ask the Sweeneys, was there any history, 
anything genetic that would lead to Aidan's illness?
    Mrs. Sweeney. No. We both do not have any diabetes on both 
sides of our families, so we were completely shocked with this 
diagnosis.
    Senator Lautenberg. Is there evidence that there is 
sometimes a genetic line that comes from families where 
diabetes has been discovered?
    Dr. Rodgers. The answer to the question is yes, but that is 
really the minority of cases.
    Senator Lautenberg. I see.
    Dr. Rodgers. People do inherit the susceptibility gene that 
I mentioned, but not everyone with that susceptibility gene--
and there are quite likely to be other genes--will go on to 
develop diabetes, type 1 diabetes. Undoubtedly it has something 
to do with the environmental factors and their exposure, for 
example, and that is precisely the type of thing that we are 
trying to quantitate and get a better handle on.
    Senator Lautenberg. Is there a program that is recommended 
to lessen the likelihood of a genetic transfer, a propensity 
for diabetes?
    Dr. Rodgers. No. At the moment, until we really have a 
better handle on what these susceptibility genes are and how 
they interact with environmental exposures, it is going to be 
very difficult for us to make an informed decision.
    If it turns out, for example, that one of these 
environmental factors is a virus, within the context of someone 
who is very susceptible, then immunizing him or her against 
that virus would be a very cost-effective way of preventing 
diabetes. But, again, those studies really need to be completed 
through their fruition before we are able to be able to say 
something definitive about that.
    Senator Lautenberg. If the artificial pancreas is 
developed, is that implanted into the patient or is it an 
external device?
    Dr. Rodgers. At the moment, the manufacturers and those 
developing the technologies are actually looking at both 
external devices as well as implantable devices. Both of these 
have pros and cons associated with them. In the implantable 
devices, at least the early ones that are in development, they 
can be implanted, but over time the body develops a reaction to 
them, and that reaction can interfere with the efficiency with 
which these devices can both sense the glucose level, on the 
one hand, and deliver the insulin, on the other hand. So people 
are looking to see whether there is a way to interfere with 
that process.
    The other devices, the external devices, also have their 
limitations. They do not measure glucose directly. The current 
ones measure glucose that gets into what is called the 
interstitial space, and there is a lag period. Part of these 
algorithms that Mr. Donald has described, which is really 
critically important to finally closing this loop, is to have 
mathematical ways of predicting what is happening in real time 
based upon what you are able to measure with these optical and 
other electrochemical sensors. That is really a critical 
limitation of all of these devices.
    Senator Lautenberg. Once again, thanks, each one of you, 
for your contribution here today. It is very important. We have 
great respect for what you do and urge you to carry on. And, 
Mrs. Sweeney, we are going to keep on working on this, and I am 
sure that one day you will see a product that can make Aidan's 
life easier and help him live longer. We promise you that.
    Mrs. Sweeney. Thank you very much. And on another note, 
Aidan has asthma as well, so I do feel for your grandchild.
    Senator Lautenberg. How come he is so beautiful? 
[Laughter.]
    I think it is parental contribution, husband and wife. You 
look like you have come from Central Casting. [Laughter.]
    Thank you very much.
    Chairman Collins. It is the good Maine air. [Laughter.]
    Senator Lautenberg. I believe that, by the way.
    Chairman Collins. Thank you, Senator. I know you care 
deeply about this issue. We have worked together on juvenile 
diabetes projects in the past, and I know we will continue to 
do so.
    I want to thank all of our witnesses for being here today 
and sharing your personal stories, your expertise, and your 
unique perspectives. I was hoping we could end before Aidan had 
to go for a walk because I was going to encourage him to wave 
at the cameras because he loves to wave hello and good-bye. He 
is an adorable little boy.
    I want to end this hearing on a more upbeat note because it 
is hard to hear what you have been through, Mrs. Sweeney, and 
what you have been through, Mr. Dudley. But I also am 
optimistic. I believe that there are promising new technologies 
on the horizon that are going to make such a difference in the 
care of children and adults living with diabetes that will ease 
the burden somewhat on their families, that will reduce the 
likelihood of the serious complications that we know can 
otherwise occur. And the support that the Juvenile Diabetes 
Research Foundation has given to families with diabetes is just 
tremendous, not to mention your extraordinary financial 
contributions. And I am very happy to have been your partner in 
helping people be more aware of juvenile diabetes and of 
diabetes in general.
    The NIH is such an essential partner in this fight in 
providing the funding for the basic research that then the 
private sector and JDRF can build on. So I want to end this 
hearing on a note of hope and optimism. Every time--Aidan's 
waving in the back there, so I am going to wave, too. Thank 
you, Aidan, for being here today. You were great, and you are a 
very brave little boy, and we are really happy to have you 
here. So thank you.
    He is a good waver. [Laughter.]
    So I leave this hearing with a renewed, stronger than ever 
commitment to the cause, and working together, I am confident 
that we can make a difference. We have already made a 
difference. In the time since I founded the Diabetes Caucus in 
1997, we have, I think, tripled the funding for diabetes 
research. That makes a difference. And I am convinced that this 
is something where money does make a difference. Research is 
expensive, and I just want to assure you of my personal 
commitment--and I know it is shared by Senator Lautenberg, by 
Senator Coburn, by Senator Coleman, and so many others on this 
Committee--to providing the resources that are needed. It is 
the least we can do to support you as you go forth and fight 
for people with this devastating disease.
    I also want to recognize Priscilla Hanley on my staff, who 
has worked on this issue for 10 years as my health policy 
adviser. It was to Priscilla that I first said, ``Why isn't 
there a Diabetes Caucus in the Senate?'' She said, ``Well, 
there has always been one in the House, but never in the 
Senate.'' And I said, ``Well, Priscilla, it looks like we are 
going to have to start one.'' And we did, back in 1997, and I 
am very proud of that because I think it has made and is making 
a difference.
    So thank you for being here today. The hearing record will 
remain open for 15 days for additional materials. And to the 
Sweeney family in particular, I cannot thank you enough for 
sharing your personal story. It really makes a difference as we 
advocate for increased funding, better technology, and better 
reimbursement policies. So thank you for being here.
    Mrs. Sweeney. Thank you, Senator Collins. It was an honor 
to be here today.
    Chairman Collins. Thank you. This hearing is now adjourned.
    [Whereupon, at 11:39 a.m., the Committee was adjourned.]
                            A P P E N D I X

                              ----------                              

                PREPARED STATEMENT OF SENATOR LIEBERMAN
    Chairman Collins, I would like to take a moment to thank you and 
your distinguished panel for taking the time to focus your expertise 
and the Nation's attention on the scourge of diabetes and the promise 
of new treatments for the disease. Every one of us here in this room 
knows someone with diabetes and we have taken up the fight against the 
disease and its frightening complications on their behalf.
    The facts are compelling. Diabetes is a major risk factor for heart 
disease and stroke. It is the No. 1 cause of new blindness between the 
ages of 20-74 and responsible for 60 percent of none traumatic 
amputations. It is the leading cause of end stage renal disease 
responsible for over 44 percent of new cases.
    But, it's more than the facts. The reality of diabetes in the lives 
of millions of children, adults, and elderly is equally compelling. Who 
here knows what it is like to prick your fingers four times a day until 
they bleed in order to check the body's sugar? Who here knows what it 
is like to administer insulin to the body four times a day with a 
needle usually stuck right here in the abdomen? And if you get it wrong 
and the insulin dose is too low, you feel sluggish. Or if the dose is 
too high you get the shakes. You may even seize. Who knows what it is 
like to consciously play the role of a vital organ in the body--in this 
case the pancreas? This is an awesome responsibility and it 
simultaneously amazes me and saddens me that so many Americans must do 
this day after day, year after year, simply to survive.
    But this hearing is as much about prioritization, resolve, and team 
work as it is about new technologies that will prevent the 
complications of the chronically high blood sugar levels, which is the 
problem in diabetes. The Juvenile Diabetes Research Foundation (JDRF) 
right now is building upon the dollars invested by the National 
Institute of Diabetes and Digestive and Kidney Diseases' (NIDDK) to 
bring together people from industry, the basic science community, those 
affected by diabetes, and other stakeholders to tackle the problem of 
how to measure body sugar and respond to it with insulin in real time 
in the form of a small, convenient, you-don't-even-have-to-think-about-
it machine. In effect, they are trying to create an artificial 
pancreas!
    Without JDRF's initiatives those in the scientific community and in 
industry tend to work in silos. In the Congress, it is cubicles. New 
ideas only go as far as the individual or organization can and want to 
take them. This works for easy problems. But for complex problems like 
diabetes and technology to control diabetes this requires simultaneous 
knowledge of biology, physiology, medicine, math, computer programming, 
engineering, immunology, pharmacology, endocrinology, and law. Which 
individual or organization possesses all of this? How do you build a 
fast dependable car if you are only an expert in ignition systems? Or 
how do you get access to a better car if the car companies in your town 
only sell slow ones?
    The answer is getting smart people from across disciplines and 
sectors to work together to solve important problems. JDRF is doing 
this. And I propose this in my American Center for Cures legislation--a 
$5 billion proposal introduced by Senator Cochran (R-Miss.) and myself 
last year. CURES establishes a new center in the NIH to develop new 
diagnostics, treatments, and even cures to our country's most important 
diseases as well as diseases poised for research promise. CURES does 
this by leveraging large amounts of money to encourage research 
collaboration that tackles diseases like diabetes once and for all. 
CURES addresses research and developmental barriers such as reluctance 
by the research community to take risks, information hoarding and 
industry involvement too late in the research process. It simplifies 
and funds large clinical trials and strengthens support of small 
innovative businesses critical to the innovation process.
    I am excited and encouraged by what you at NIDDK, JDRF, and our 
universities are undertaking with families and those affected by 
diabetes to push innovation even faster. We in Congress are with you. 
We will help you with legislation like CURES that complements your 
work. I look forward to hearing your ideas today and promise to work 
with you in whatever way I can. Thank you.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] 

                                 
