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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

(

(II)

COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS 

SUSAN M. COLLINS, Maine, Chairman 

TED STEVENS, Alaska 

GEORGE V. VOINOVICH, Ohio 

NORM COLEMAN, Minnesota 

TOM COBURN, Oklahoma 

LINCOLN D. CHAFEE, Rhode Island 

ROBERT F. BENNETT, Utah 

PETE V. DOMENICI, New Mexico 

JOHN W. WARNER, Virginia 

JOSEPH I. LIEBERMAN, Connecticut 

CARL LEVIN, Michigan 

DANIEL K. AKAKA, Hawaii 

THOMAS R. CARPER, Delaware 

MARK DAYTON, Minnesota 

FRANK LAUTENBERG, New Jersey 

MARK PRYOR, Arkansas

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 

(III)

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

(1)

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 

2

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. 

3

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. 

4

1The prepared statement of Dr. Rodgers with attachments appears in the Appendix on page 

30. 

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. 

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 

5

1The chart referred to appears in the Appendix on page 41. 

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. 

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. 

6

1The chart referred to appears in the Appendix on page 42. 

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. 

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. 

7

1The prepared statement of Mr. Dudley appears in the Appendix on page 43. 

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. 

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 

8

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. 

9

1The prepared statement of Mr. Donald appears in the Appendix on page 49. 

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 halfmillion 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. 

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 

10

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 

11

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. 

12

1The prepared statement of Mrs. Sweeney appears in the Appendix on page 54. 

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. 

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. 

13

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 21⁄2 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-yearold behavior’’ and ‘‘low’’ or ‘‘high blood sugar behavior.’’ Often he 

has been unable to warn me even when his sugars are at lifethreatening 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? 

14

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. 

15

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 imVerDate 0ct 09 2002 08:46 Aug 28, 2007 Jkt 030602 PO 00000 Frm 00019 Fmt 6633 Sfmt 6601 C:\DOCS\30602.TXT SAFFAIRS PsN: PAT
16

portant 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 

17

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. 

18

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 

19

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 

20

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:]

21

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 

22

1The charts referred to appear in the Appendix on page 41 and 42 respectively. 

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. 

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? 

23

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 band- wagon 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 

24

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, AmerVerDate 0ct 09 2002 08:46 Aug 28, 2007 Jkt 030602 PO 00000 Frm 00028 Fmt 6633 Sfmt 6601 C:\DOCS\30602.TXT SAFFAIRS PsN: PAT
25

ican 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 

26

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 

27

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.] 

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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’teven-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.

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