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TRANSFORMING LIVES THROUGH DIABETES 

RESEARCH 

HEARING 

BEFORE THE

COMMITTEE ON 

HOMELAND SECURITY AND 

GOVERNMENTAL AFFAIRS 

UNITED STATES SENATE 

ONE HUNDRED TWELFTH CONGRESS 

FIRST SESSION 

JUNE 22, 2011 

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

Printed for the use of the 

Committee on Homeland Security and Governmental Affairs 

( 

(II) 

COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS 

JOSEPH I. LIEBERMAN, Connecticut, Chairman 

CARL LEVIN, Michigan 

DANIEL K. AKAKA, Hawaii 

THOMAS R. CARPER, Delaware 

MARK L. PRYOR, Arkansas 

MARY L. LANDRIEU, Louisiana 

CLAIRE MCCASKILL, Missouri 

JON TESTER, Montana 

MARK BEGICH, Alaska 

SUSAN M. COLLINS, Maine 

TOM COBURN, Oklahoma 

SCOTT P. BROWN, Massachusetts 

JOHN MCCAIN, Arizona 

RON JOHNSON, Wisconsin 

ROB PORTMAN, Ohio 

RAND PAUL, Kentucky 

JERRY MORAN, Kansas 

MICHAEL L. ALEXANDER, Staff Director 

AARON M. FIROVED, Professional Staff Member 

NICHOLAS A. ROSSI, Minority Staff Director 

PRISCILLA H. HANLEY, Minority Professional Staff Member 

TRINA DRIESSNACK TYRER, Chief Clerk 

PATRICIA R. HOGAN, Publications Clerk 

LAURA W. KILBRIDE, Hearing Clerk 

(III) 

C O N T E N T S 

Opening statements: Page 

Senator Lieberman ........................................................................................... 1 

Senator Collins ................................................................................................. 1 

Senator Akaka .................................................................................................. 4 

Senator Brown .................................................................................................. 5 

Senator Shaheen * ............................................................................................ 5 

Senator Lautenberg * ....................................................................................... 6 

Senator Pryor .................................................................................................... 6 

Senator Begich .................................................................................................. 24 

Prepared statements: 

Senator Lieberman ........................................................................................... 35 

Senator Collins ................................................................................................. 36 

Senator Akaka .................................................................................................. 38 

Senator Brown .................................................................................................. 39 

Senator Shaheen * ............................................................................................ 40 

* Guest Member 

WITNESSES 

WEDNESDAY, JUNE 22, 2011 

Kevin Kline, Celebrity Advocate Co-Chairman, Juvenile Diabetes Research 

Foundation ............................................................................................................ 7 

Griffin P. Rodgers, M.D., Director, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, U.S. Department 

of Health and Human Services ........................................................................... 9 

Charles Zimliki, Ph.D., Chairman, Artificial Pancreas Critical Path Initiative, 

Center for Devices and Radiological Health, Food and Drug Administration, 

U.S. Department of Health and Human Services ............................................. 12 

Caroline Jacobs, Delegate from Shapleigh, Maine, JDRF Children’s Congress . 26 

Jack Schmittlein, Delegate from Avon, Connecticut, JDRF Children’s Congress ...................................................................................................................... 28 

Kerry Morgan, Delegate from Glen Allen, Virginia, JDRF Children’s Congress ...................................................................................................................... 29 

Jonathan Platt, Delegate from Tarzana, California, JDRF Children’s Congress ...................................................................................................................... 30 

ALPHABETICAL LIST OF WITNESSES

Jacobs, Caroline: 

Testimony .......................................................................................................... 26 

Prepared statement .......................................................................................... 79 

Kline, Kevin: 

Testimony .......................................................................................................... 7 

Prepared statement .......................................................................................... 42 

Morgan, Kerry: 

Testimony .......................................................................................................... 29 

Prepared statement .......................................................................................... 86 

Platt, Jonathan: 

Testimony .......................................................................................................... 30 

Prepared statement .......................................................................................... 89 

Rodgers, Griffin P., M.D.: 

Testimony .......................................................................................................... 9 

Prepared statement .......................................................................................... 44 

Page

IV 

Schmittlein, Jack: 

Testimony .......................................................................................................... 28 

Prepared statement .......................................................................................... 82 

Zimliki, Charles, Ph.D.: 

Testimony .......................................................................................................... 12 

Prepared statement .......................................................................................... 64 

APPENDIX 

Charts submitted for the Record by Dr. Rodgers .................................................. 61 

Letter and prepared statement from Mary Tyler Moore, JDRF International 

Chairman .............................................................................................................. 92 

Responses to post-hearing questions for the Record from: 

Dr. Rodgers ....................................................................................................... 96 

Dr. Zimliki ......................................................................................................... 99 

(1) 

TRANSFORMING LIVES THROUGH DIABETES 

RESEARCH 

WEDNESDAY, JUNE 22, 2011 

U.S. SENATE, COMMITTEE ON HOMELAND SECURITY

AND GOVERNMENTAL AFFAIRS, Washington, DC. 

The Committee met, pursuant to notice, at 1:34 p.m., in room 

SD–G50, Dirksen Senate Office Building, Hon. Joseph I. Lieberman, Chairman of the Committee, presiding. 

Present: Senators Lieberman, Akaka, Pryor, Begich, Collins, 

Brown, Shaheen, and Lautenberg. 

OPENING STATEMENT OF CHAIRMAN LIEBERMAN 

Chairman LIEBERMAN. Good morning. The hearing will come to 

order. Thank you very much for being here. This is one of the afternoons and days that we look forward to, and I will say that the 

younger people here in front are much better behaved than the 

older people who usually fill this room, so I really appreciate it. 

[Laughter.] 

As a point of personal privilege, I do want to note the presence 

of Secretary of War, Edwin Stanton, from the Lincoln cabinet—— 

[Laughter.] 

Oh, no, that is Kevin Kline. [Laughter and applause.] 

If you have not seen ‘‘The Conspirator,’’ it is an extraordinary 

movie, and Mr. Kline is really brilliant in the role of Secretary of 

War Edwin Stanton, so I guess it is not a violation of our Senate 

ethics rules to plug a good movie of historical content. [Laughter.] 

Today, as I have traditionally done, with good cause, I am going 

to turn the Chairman’s gavel over to Senator Collins in recognition 

of her longstanding leadership on behalf of diabetes research, particularly for children, and her truly passionate advocacy for Federal 

support for that research. So without further adieu, I give the gavel 

to my dear friend and colleague, the great Senator from the State 

of Maine, Susan Collins. 

[Applause.] 

OPENING STATEMENT OF SENATOR COLLINS 

Senator COLLINS [presiding]. Thank you. Thank you so much, 

Mr. Chairman. I am particularly grateful that you are allowing me 

to conduct this hearing. This issue is near and dear to my heart, 

and this actually represents the sixth hearing of the Children’s 

Congress that I have had the privilege to conduct. 

2 

I very much appreciate the opportunity to hold this hearing to 

examine what is often the devastating impact that juvenile diabetes has had on an estimated 3 million American children and their 

families. 

I also want particularly to welcome our distinguished witnesses 

and the more than 150 children who have traveled to Washington 

from every State in the country and from around the world to tell 

Congress exactly what it is like to have diabetes, just how serious 

it is, and why it is so important that we work together to fund the 

research necessary to find a cure. I want to give a special welcome 

to the delegate from Maine, 14-year-old Caroline Jacobs of 

Shapleigh, Maine. She will be testifying later. 

I want to also recognize Senator Shaheen, who has joined us this 

afternoon, and I think Senator Lautenberg is coming, as well. Both 

of them have a longstanding commitment to issues affecting children with diabetes and their families. Senator Shaheen is also my 

co-chairman on the Senate Diabetes Caucus, and her daughter is 

the ‘‘Chair Mom’’ of this year’s Children’s Congress. So we are very 

delighted that she can join us, as well as our colleagues, Senator 

Akaka and Senator Brown. There will be others coming in and out 

today. Senators have so many different duties and obligations, but 

they care a lot about this issue and others will be dropping by, as 

well. 

I do also want to acknowledge someone who is not able to be 

with us for the first time for the Children’s Congress, and that is 

Mary Tyler Moore. I talked to Mary yesterday, and she sends all 

of her best wishes. She is recovering from some surgery. She is 

doing really well, and I know that we miss her, but she is here in 

spirit. And she is delighted that another famous American, Kevin 

Kline, is joining us today, so thank you, Mr. Kline, as well. 

Diabetes is a life-long condition, and it is one that does not discriminate. It affects people of every age, race, and nationality. It 

is the leading cause of a lot of medical problems. Moreover, it is 

estimated that diabetes accounts for more than $174 billion of our 

Nation’s annual health care costs and one out of three Medicare 

dollars. Medical costs for a child with type 1 diabetes are six times 

higher than the cost for a child without the disease. These statistics are overwhelming. But what really motivated me to devote so 

much energy and time to this issue was meeting with families 

whose lives have been forever changed by diabetes. 

I will never forget, as a new Senator in 1997, meeting with a 

family whose son had diabetes. This was the first time I had really 

learned about type 1 diabetes, and this little boy looked up to me 

and said that he wished he could just take one day off from having 

diabetes, just one day, his birthday or Christmas. But, of course, 

those who have diabetes can never take a day off. But it does not 

mean that you cannot accomplish great things, and I am delighted 

to learn that many of you yesterday had the opportunity to meet 

with Supreme Court Justice Sonya Sotomayor and hear her personal story. 

It is so important that you have traveled to Washington today to 

tell your stories. You put a human face on all of the statistics, and 

you help us focus on what Congress can do to better understand 

and ultimately find a cure for this terrible disease. 

3 

In individuals with type 1 diabetes, the body’s immune system 

attacks the pancreas and destroys the islet cells that produce insulin. An average child with diabetes will have to take more than 

50,000 insulin shots in a lifetime. Of particular concern is the fact 

that the incidence rate of type 1 diabetes is increasing, particularly 

in children under the age of four. While the discovery of insulin 

was a landmark breakthrough in the treatment of diabetes, it is 

not a cure. People with type 1 diabetes face the constant threat of 

developing life-threatening complications and can face a reduction 

in their quality of life. 

But thankfully, there is some good news. Since I founded the 

Senate Diabetes Caucus, funding for diabetes research has more 

than tripled and now it approaches more than $1 billion this year. 

As a consequence, we have seen some encouraging breakthroughs, 

and we are on the threshold of a number of important discoveries. 

I talked today with several of you who have insulin pumps, for 

example. Advances in technology, like continuous glucose monitors, 

are helping people with diabetes control their blood glucose levels, 

which is key to preventing complications. 

We are also moving closer to our goal of an artificial pancreas, 

which would revolutionize diabetes care. An artificial pancreas is 

an external device that people with type 1 diabetes could use to do 

what their bodies cannot, and that is automatically control both 

high and low blood sugar levels around the clock. This new technology has the potential to dramatically improve the health and 

quality of life for individuals with diabetes, and we are going to 

hear from Federal officials today who will tell us about the important clinical trials that are going on that are so promising. The 

Food and Drug Administration (FDA) has played a pivotal role in 

moving this research forward and making the artificial pancreas 

one of its Critical Path Initiatives. 

We are making progress in the battle against diabetes, but this 

is no time to take our foot off the accelerator. We have two choices. 

We can sit back and continue to pay the bills and endure the suffering, or we can aggressively pursue a national strategy aimed at 

curing this disease. 

And thanks to your efforts, thanks to your coming to Washington, there is increased understanding and support in Congress 

for diabetes research funding. Last year, we were able to pass legislation to extend the Special Diabetes Program for 2 additional 

years, and that program represents more than a third of our Federal commitment to diabetes research. As such, it is critical to our 

efforts to find better treatments, a means of prevention, and ultimately a cure. 

So welcome to Washington. We are glad that you are here. Chairman Lieberman, thank you. 

[Applause.] 

Chairman LIEBERMAN. Thank you, Senator Collins, and really, 

what I want to say is ‘‘amen’’ to everything you said, so I will be 

brief. 

I said at the beginning that I look forward to these hearings 

every session, and I do because they are so constructive. In a government in which, too often, too little happens that is constructive 

these days, this is a cause that unites people across party lines and 

4 

has enabled us, certainly in recent years, to come together to be 

supportive of diabetes research and to help facilitate some of the 

really miraculous advances that have occurred in dealing with diabetes in our time. 

The fact that all you young people are here is the most important 

thing of all because you are the best advocates for this cause. First 

off, you show everybody how well you are doing, dealing with diabetes. But the second thing is you make us all want to make the 

investments that are necessary to make sure that we not only better treat diabetes, but really in your lifetime that we have a cure 

for diabetes. 

It is with that sense of optimism that I am really honored to welcome you and all the other witnesses here today, and I thank Senator Collins. 

Senator COLLINS. Thank you, Mr. Chairman. Senator Akaka. 

OPENING STATEMENT OF SENATOR AKAKA 

Senator AKAKA. Thank you very much, Senator Collins. I deem 

it an honor to join you here and to say thank you very much for 

chairing this important hearing again on type 1 diabetes and to 

share a commitment and really a passion in trying to move this 

along to improve the lives and quality of life for young people and 

people of our country. 

I also want to welcome our distinguished panelists to this hearing who have been so committed to this issue. I also want to send 

a very special aloha to those Children’s Congress delegates waiting 

to testify and those in the audience, all of you who are seated here. 

These are courageous young ambassadors who have traveled from 

all over the country and the world to educate us. They are here to 

share their stories of their own experiences, to bring a real human 

dimension to the policy debate. This shows how critical research 

and support is for diabetes and a hope for a cure. 

Diabetes is a significant health problem in my home State of Hawaii, and it is an increasing challenge for our Nation. It is an issue 

that we will look at in the Indian Affairs Committee. It will be part 

of the minority health legislation that I plan to introduce. And it 

is the subject of the ongoing budget and regulatory policy debate. 

In this context, I am proud to support the development of the artificial pancreas, and I will continue to support funding for research at the National Institutes of Health (NIH), which gives us 

the chance for better detection, better treatment, and the hope for 

a cure. 

All the more reason that I am so pleased to see the children here 

every 2 years. They remind my colleagues and me about the struggle of living with type 1 diabetes and the importance of supporting 

diabetes research. 

I would like to extend a special thanks to Aaron Tsuchitori, who 

traveled all the way from Honolulu with his mother to meet with 

me today. If you are sitting here, Aaron, please just hold your hand 

up. Oh, there you are. Yes. Thank you, Aaron, for coming all the 

way from Hawaii. 

I look forward to continuing to work with all of you to improve 

the lives of individuals with diabetes. I am glad to be here with you 

and join you in this. Thank you very much. 

5 

1The prepared statement of Senator Shaheen appears in the Appendix on page 40. 

[Applause.] 

Senator COLLINS. Thank you, Senator Akaka. Senator Brown. 

OPENING STATEMENT OF SENATOR BROWN 

Senator BROWN. Thank you, Madam Chairman and Senator 

Lieberman. It is good to see you all, and good to see a lot of the 

children here and their families coming out and supporting diabetes research. I have the honor of having met four young people 

from Massachusetts, Jackson Savage, Jordan Beals, Jonathan 

Beals, and Joshua Fish—I see some of them out there in the audience. They gave me a lot of good information. It is something that 

I have certainly been aware of and our families have been working 

on long before I got to Washington, so I want to thank you for your 

leadership in doing it. 

I look forward to hearing all of our witnesses. I am going to be 

bouncing back and forth because of other hearings, but I look forward to staying for as long as I can. Thank you. 

Senator COLLINS. Thank you, Senator Brown. 

I mentioned that Senator Shaheen is the co-chairman with me of 

the Diabetes Caucus and has a special connection to this particular 

Congress, and we are delighted to have you here. 

OPENING STATEMENT OF HON. JEANNE SHAHEEN, A U.S. 

SENATOR FROM THE STATE OF NEW HAMPSHIRE 

Senator SHAHEEN. Thank you, Madam Chairman, and thank you 

to Senator Lieberman, to both of you, for holding this hearing 

today. I have a statement that I would like to submit for the 

record.1

Senator COLLINS. Without objection. 

Senator SHAHEEN. I know we want to get to our panelists, so I 

just want to take a minute to introduce my granddaughter, Ellie, 

who is a delegate here with the Children’s Congress—thank you— 

and her mother, Stephanie, and father, Craig, who are here, and 

they are co-chairing the Children’s Congress this year. I also want 

to recognize Abigail Lore and her mother, Jeanine, who are from 

Merrimack, New Hampshire. Thank you both for being here, as 

well. And thank you to all of the families and all of the delegates 

who are here today. 

I am very happy and proud to be able to join you in advocating 

for research for a cure for juvenile diabetes and also for moving forward as quickly as we can with the development of an artificial 

pancreas. 

So again, thank you all very much for being here. 

[Applause.] 

Senator COLLINS. Thank you, Senator Shaheen. 

Senator Lautenberg, we are delighted that you could join us 

again this year. I mentioned in my opening statement that you, 

too, have a personal connection to diabetes and have demonstrated 

tremendous leadership in this area. 

6 

OPENING STATEMENT OF HON. FRANK R. LAUTENBERG, A U.S. 

SENATOR FROM THE STATE OF NEW JERSEY 

Senator LAUTENBERG. I have a granddaughter, also, that I am 

fortunate enough to have who has diabetes. And I want to say 

thanks to the Chairman for inviting me here today. It is a personal 

issue for me, and I appreciate the chance to work with you, Senator 

Lieberman, but particularly with Senator Collins, our colleague 

from Maine. She has been so diligent, so persistent, so determined 

to help our country by making sure that those with diabetes can 

conduct their lives with a decent attitude and participation in all 

of the activities. 

When my granddaughter was here during the Obama inauguration, I saw that she looked pale. I saw that she seemed tired, 12 

years of age, and I said to my daughter, ‘‘Is there something wrong 

with Maddie?’’ And she said, ‘‘I do not think so, Dad, but some 

signs tell me we have to get her to a doctor.’’ Therefore, they did 

that, and we visited her in the hospital a day after she got back 

to Florida, where she lived. She had her first treatment with insulin. She was bright. She was positive. She was hopeful. And I 

thought, all this devastation that came upon us when we learned 

that she had diabetes. And I can tell you, that granddaughter of 

mine is now on a soccer team that was running for the State championship in Florida. She is never too tired to take on an activity. 

And she has been an inspiration to my life, just as all of you are 

an inspiration here. You do not know how much you do for us. You 

know that we try to do things for you, but you do more for us when 

we see your faces and we see your smiles and we see your parents, 

and we know that life is good for you and we are going to keep on 

working to make it better. 

I thank our friends here and all of my colleagues for participating in this important hearing. Thank you, Senator Collins. 

[Applause.] 

Senator COLLINS. Thank you very much, Senator Lautenberg. 

Senator Pryor, welcome. 

OPENING STATEMENT OF SENATOR PRYOR 

Senator PRYOR. Thank you, and thanks for having me. I think 

everybody understands this now, but if we do not get it, I want to 

make sure that everybody understands what a tremendous advocate you have in Senator Collins. Let us give her one more hand. 

She is great. 

[Applause.] 

Senator PRYOR. I really just want to say one more thing. I know 

that Davis Moore from Arkansas is here. Thank you for being here, 

and all of you who are wearing the blue shirts, you are making a 

difference. Thank you for coming to Washington, and thank you for 

fighting the good fight. It is certainly a fight worth fighting, and 

thank you for all the things you represent and all the great things 

you are going to accomplish. Thank you. 

[Applause.] 

Senator COLLINS. Thank you very much, Senator Pryor. 

Leading off our first panel this morning is Academy Award winning actor and longtime Juvenile Diabetes Research Foundation 

(JDRF) advocate Kevin Kline. One of our country’s finest film and 

7 

1The prepared statement of Mr. Kline appears in the Appendix on page 42. 

stage actors, as Senator Lieberman mentioned, Mr. Kline may have 

been virtually unrecognizable in his recent appearance as Edwin 

Stanton, the Secretary of War, in the movie, ‘‘The Conspirator,’’ but 

he is no stranger to us. He testified before our Committee 10 years 

ago at our 2001 hearing, and I am delighted that he has made a 

return performance, an encore, I guess I will call it, because I look 

forward to hearing his perspective on the progress that has been 

made during the past decade and the road ahead. 

So welcome. We are delighted to have you here. 

TESTIMONY OF KEVIN KLINE,1 CELEBRITY ADVOCATE COCHAIRMAN, JUVENILE DIABETES RESEARCH FOUNDATION 

Mr. KLINE. Senator Collins, thank you. Senator Lieberman, 

thank you, and thank you for the nice mention of ‘‘The Conspirator,’’ and my performance as a historical figure. Members of 

the Committee, thank you all for inviting me to appear today with 

this distinguished panel and amidst this collection of such remarkably poised, self-possessed, quiet, but ultimately very vocal delegates, I hope. 

Ten years ago, as you mentioned, I had the honor of joining Mary 

Tyler Moore and the 100-plus delegates at the 2001 JDRF Children’s Congress. Since then, I am happy to report that we have 

made remarkable progress in understanding this disease. We are 

many steps closer to a cure, and even as we are gathered here 

today, new tools are being developed to improve the day-to-day 

management of type 1 diabetes. But we still have a ways to go, 

which is why we are here now, not only championing the science, 

but pushing to accelerate programs. 

Today, these great young delegates are getting the attention that 

they so richly deserve. But I would like to take a few moments to 

recognize all of the parents, siblings, and other special people that 

these young advocates have brought with them today. They know 

firsthand the challenges that we face as we shepherd our children 

and loved ones through life with the added burden of diabetes. 

You see, when a child is first diagnosed with type 1 diabetes, the 

parents are thrust immediately into the additional roles of doctors, 

nurses, nutritionists, and even psychologists. They are on duty 24 

hours a day, 7 days a week, 365 days a year, monitoring their 

child’s blood sugar levels and physical activity, counting the carbohydrates in their meals and snacks, calculating insulin dosages, 

giving injections, as well as managing the emotional stresses which 

come from dealing with the daily rigors of this disease. 

Each day, as I am sure these children will testify to, brings its 

own unique challenge to control blood sugar levels, even with the 

best of plans and the use of the latest technology. It is not unusual 

for parents to wake up routinely in the middle of the night to check 

their children’s blood sugar to make sure it did not become too high 

or so low as to result in a seizure or a coma or worse. These blood 

sugar emergencies are all too common, and a number of parents 

here have had to call 911 to save their children’s lives. 

Many parents have become their children’s advocates in the fight 

to cure diabetes by joining JDRF. As JDRF’s National Walk ChairVerDate Nov 24 2008 14:22 Mar 26, 2012 Jkt 068012 PO 00000 Frm 00011 Fmt 6633 Sfmt 6633 P:\DOCS\68012.TXT SAFFAIRS PsN: PAT
8 

person, I had the great pleasure of rallying people across the country to join the JDRF Walk to Cure Diabetes, and I am happy to 

report that thanks to the outpouring of enthusiastic support, we 

have raised millions of dollars with the walk. JDRF has put this 

money to work in a direct and efficient manner to support research 

for better treatments, prevention, and ultimately for a cure for type 

1 diabetes. 

The Federal Government has also played a critical role in the 

fight to cure diabetes, in particular with the strong bipartisan support for the Special Diabetes Program. I thank you, Senator Collins, for your leadership, and I thank your colleagues in the Senate 

and House who recognized the great return on investment from the 

Special Diabetes Program and who supported the 2-year $300 million extension this past December. 

Together, JDRF and the Federal Government have made and 

will continue to make powerful partners in advancing research to 

cure, treat, and prevent type 1 diabetes. 

Since I testified here before this panel 10 years ago, more than 

40 of the genes have been discovered which put people at risk for 

type 1 diabetes. Numerous therapies to halt the autoimmune attack which causes type 1 diabetes are being tested in human clinical trials. New therapies have also been shown not only to halt the 

progression of diabetic eye disease, but also to improve the vision 

in those who already suffer from it. And finally, the artificial pancreas has gone from being merely a theory to a cutting-edge technology that has been shown in early trials to prevent dangerous 

low and high blood sugars. 

Apart from finding a cure, the artificial pancreas represents a 

watershed moment in the management of diabetes and happens to 

also be a parent’s dream come true. Imagine, if you will, going to 

bed at night without having to worry about dangerous nighttime 

high or low blood sugar levels, or knowing that your child will have 

a great day at school without the burden of pricking his or her fingers, counting carbohydrates, taking the right amount of insulin, 

and treating high and low blood sugars, or just getting so caught 

up in being a kid and forgetting to do some of these things and 

coming home from school dangerously ill. Best of all, imagine 

knowing that your child will live a long, productive life since these 

artificial pancreas technologies have the potential to keep him or 

her healthier longer, forestalling or completely circumventing the 

devastating complications until a cure is found. 

I know the Food and Drug Administration has made the artificial 

pancreas a priority, and I commend Commissioner Margaret Hamburg for her leadership. But there is more that the FDA needs to 

do. Many of these children here today are, in fact, wearing the components of what will ultimately constitute an artificial pancreas, 

namely, insulin pumps that deliver insulin as well as continuous 

glucose monitors which give blood sugar readouts every few minutes. The challenge that we face now, however, is to get these devices, which do not yet work together automatically, to talk to each 

other and to control the blood sugar levels. 

In other countries, there are devices now available that take the 

first step in this process, by automatically shutting off the insulin 

9 

1The prepared statement of Dr. Rodgers appears in the Appendix on page 44. 

pump when someone is going low. This is an important step and 

one that we need to take in the United States right now. 

And we can do more than that. JDRF and federally funded research have, in hospital settings, tested artificial pancreas technologies that automatically turn insulin both on and off, and the 

results have been overwhelmingly positive. The next step is testing 

these artificial pancreas devices in real-world settings. To do this 

without delay, however, the FDA needs to provide clear and reasonable guidance. Many of the world’s best diabetes researchers 

and leading clinician organizations have joined together with JDRF 

to propose artificial pancreas guidance to the FDA, and the majority of the Senate and the House have urged the FDA to give this 

proposal immediate consideration. 

We now need the FDA to act. Parents who are up every night 

and worrying every day about their children simply cannot afford 

to wait any longer. It is past time for the artificial pancreas technologies to be tested in real-world settings. We urge, we implore 

the FDA to issue draft guidance for public comment on the artificial pancreas so that outpatient trials can begin and the oppressive 

burdens of type 1 diabetes can be lifted from millions of Americans 

as soon as possible. 

Thank you for the opportunity to participate in the hearing 

today, and I would be pleased to answer any questions that I can. 

[Applause.] 

Senator COLLINS. Thank you very much for that excellent testimony, Mr. Kline. 

Next, we will hear from Dr. Griffin Rodgers, who is the Director 

of the National Institute of Diabetes and Digestive and Kidney Diseases at NIH. He will bring us up to date on the advances in research, and I also hope that he will provide some examples of the 

research that is specifically supported by the Special Diabetes Program. Dr. Rodgers, welcome. 

TESTIMONY OF GRIFFIN P. RODGERS, M.D.,1 DIRECTOR, 

NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND 

KIDNEY DISEASES, NATIONAL INSTITUTES OF HEALTH, U.S. 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Dr. RODGERS. Thank you very much. Mr. Chairman, Senator Collins, and Members of the Committee, as the Director of the National Institute of Diabetes and Digestive and Kidney Diseases 

(NIDDK), I thank you for the invitation to testify at this hearing 

on type 1 diabetes. 

And on behalf of NIDDK and the other institutes and centers at 

NIH, I am pleased to report that we are vigorously pursuing research to prevent, treat, and ultimately cure type 1 diabetes and 

its complications. Through collaborative and coordinated research 

efforts with our partners, including the Juvenile Diabetes Research 

Foundation, and with the support of the Special Statutory Funding 

Program for Type 1 Diabetes Research, we are making critical 

steps toward these goals that I have outlined. 

Now, before I highlight some of the exciting advances, I would 

like to acknowledge the important contribution of my fellow witVerDate Nov 24 2008 14:22 Mar 26, 2012 Jkt 068012 PO 00000 Frm 00013 Fmt 6633 Sfmt 6633 P:\DOCS\68012.TXT SAFFAIRS PsN: PAT
10 

1The charts referenced by Dr. Rodgers appear in the Appendix on page 61. 

nesses. Mary Tyler Moore, here in spirit, you continue to motivate 

us with your unwavering devotion to improve the lives of others 

with type 1 diabetes. 

Kevin Kline, you tirelessly raise awareness of the disease and 

promote efforts toward a cure. 

I am also pleased to share the table today with Dr. Zimliki, who 

will describe the complementary efforts of the FDA to advance the 

artificial pancreas. 

I would also like to acknowledge the children, parents, and families who will testify and who sit in this room proudly representing 

their States and the many other Americans with type 1 diabetes. 

Many of you have participated in clinical trials to help improve diabetes care, not only for yourself, but for future generations. We are 

inspired by your dedicated efforts and your enthusiasm. 

Now, research in type 1 diabetes has made a tremendous impact 

on the health and quality of life of people with this disease. I will 

reference three handouts during my testimony to illustrate these 

points, and these handouts are attached to the copies of my written 

testimony.1

On the first handout, a bar graph shows that the survival rate 

for people with type 1 diabetes has dramatically improved over 

time. For people diagnosed, for example, in the 1950s, represented 

by the blue bar on the far left side of the graph, only about 70 percent survived for 25 years with the disease. This number has dramatically increased to about 95 percent for people diagnosed in the 

1970s, represented by the purple bars on the far right side of the 

graph. The outlook is even brighter for today’s children, due to improvements in diabetes care and technologies. Still, the burden of 

living with diabetes, as my colleagues have mentioned, is enormous, and so it is critical to build on research progress to find ways 

to prevent and cure the disease. 

On the second handout, you will see that even before type 1 diabetes becomes apparent, the immune systems of people who will 

develop the disease are destroying their insulin-producing beta 

cells, leading to a decrease in beta cell mass, and I will describe 

how the NIH is focusing our research on different stages of the disease progression. 

Now, as indicated on the far left of this graph, understanding the 

causes of type 1 diabetes is essential to our preventing the onset 

of autoimmunity, a preclinical sign of the disease, and of the disease itself, and significant progress has been made in unraveling 

the genetic causes of type 1 diabetes. As was mentioned, just a few 

years ago, we only had three genes that we understood contributed 

to the risk of the disease. Today, due to the efforts of the Type 1 

Diabetes Genetics Consortium and other researchers, nearly 50 genetic regions have been identified. 

We know that there are likely factors that exist in the environment that interact with these genetics to turn disease risk into disease reality. And because the genetic risk for type 1 diabetes is 

now well characterized, we can identify those at risk and follow 

them, and this has allowed us to embark on a bold, long-term, systematic study to identify these environmental factors. 

11 

This study, the Environmental Determinants of Diabetes in the 

Young (TEDDY), has enrolled over 8,600 newborns with high genetic risk for the disease, and we plan to follow them for 15 years. 

We will be collecting biological samples and information about their 

lives. Identification, for example, of an infectious agent that triggers this autoimmunity could lead to a vaccine to protect against 

this disorder. On the other hand, if we find that dietary factors protect from or contribute to the development of the disease, we can 

recommend changes to infant feeding practices. TEDDY may also 

shed light on other autoimmune diseases, like celiac disease. 

The NIH also supports research in preclinical and early disease 

stages, as shown by the blue and red arrows. Today, blood tests can 

accurately identify relatives of people with type 1 diabetes who are 

at high or moderate risk of developing the disease within 5 years. 

This important advance has enabled Type 1 Diabetes TrialNet to 

launch clinical trials of promising prevention strategies to stop the 

autoimmune attack. 

It is also important to identify ways to halt or reverse disease 

progression soon after onset to preserve any remaining beta cells. 

In collaboration with the Immune Tolerance Network, TrialNet is 

also conducting trials of promising therapies in newly diagnosed 

patients. 

Now, the third handout continues along the spectrum of disease 

progression, and this next stage of the disease research, shown in 

green, focuses on people with established type 1 diabetes. A high 

priority for research at this stage is the development of new tools 

and technology to help people improve their blood glucose control 

because that can reduce disease complication by up to 70 percent. 

Certainly, an artificial pancreas to automatically link glucose monitoring with insulin delivery can make a positive impact on people’s 

health and their quality of life. NIDDK is supporting innovations 

in technology critical to the development of an artificial pancreas. 

Working closely with our partners at the FDA, we are pursuing research to test artificial pancreas technology and ensure that it is 

safe and effective. 

In recent advances, scientists developed and are testing a bi-hormonal closed-loop artificial pancreas, one that delivers not only insulin, but a counterbalancing hormone, glucagon, to more finely reproduce the activity of the human pancreas. In another recent 

study, researchers looked at overnight closed-loop insulin delivery 

following two different real-life dinner scenarios. Testing closedloop technologies in real-life situations is really a key step toward 

moving this technology out of the clinic and into the real world. 

A major goal of research at the next stage, shown in purple, is 

to investigate ways to replace the destroyed beta cells and restore 

beta cell function, and one approach to replace these cells is 

through islet transplantation, and the Clinical Islet Transplantation Consortium is conducting trials to study and to refine this 

therapeutic strategy. Scientists like those in the Beta Cell Biology 

Consortium are also pursuing strategies to replace islet cells by 

growing cells in the laboratory for transplantation into people or by 

expanding their remaining beta cells or by coaxing other types of 

cells in the pancreas to become beta cells. 

12 

1The prepared statement of Dr. Zimliki appears in the Appendix on page 64. 

Finally, until prevention or cure of type 1 diabetes is possible, research toward preventing, arresting, and reversing the complications of the disease is critically important, shown on the far right 

of that graph. Just recently, we saw the biggest advance in diabetes eye disease treatment in 25 years. A landmark study from the 

Diabetic Retinopathy Clinical Research Network found that patients who received a combination of a drug and standard laser 

therapy showed substantial vision improvement after 1 year. Advances like these in treating diabetic complications also benefit patients who have type 2 diabetes and are at risk of these complications, as well. 

Hundreds of thousands of individuals have participated in research supported by the Special Diabetes Program. Remarkably, 

nearly 30 years after one pivotal trial study began, about 95 percent of the participants in this landmark trial, which showed that 

glucose control dramatically reduced type 1 diabetes complications, 

continue to participate in a follow-up study known as Epidemiology 

of Diabetes Interventions and Complications (EDIC), and as a result of their commitment, this long-term investment in research 

continues to identify ways to improve the health of people with diabetes. 

I am grateful for the opportunity to share with you just a few 

examples of the many recent advances in ongoing research in type 

1 diabetes. We continue to be inspired by the dedicated efforts of 

individuals affected by type 1 diabetes and by the organizations 

like JDRF that represent them. We look forward to continuing our 

partnership with JDRF and our sister Federal agencies on research 

to combat type 1 diabetes and its complications, and we will continue to be diligent in our fight against type 1 diabetes to help all 

the children here and the many Americans whom they represent 

today, and we will strive to improve their quality of life with the 

ultimate goal of curing this disease. 

Thank you, Mr. Chairman and Senator Collins, for your leadership in calling for this hearing to continue to bring attention to the 

importance of type 1 diabetes research and for your continued support of NIH research. I will be pleased to answer any questions 

that you might have. 

[Applause.] 

Senator COLLINS. Thank you, Dr. Rodgers. 

Our last witness on this panel, before we hear from the children, 

is Dr. Charles Zimliki. He is the Chairman of the Food and Drug 

Administration’s Artificial Pancreas Critical Path Initiative. There 

is tremendous interest and excitement about this research and 

technology, and I look forward to hearing your statement. 

TESTIMONY OF CHARLES ZIMLIKI, PH.D.,1 CHAIRMAN, ARTIFICIAL PANCREAS CRITICAL PATH INITIATIVE, CENTER FOR 

DEVICES AND RADIOLOGICAL HEALTH, FOOD AND DRUG 

ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Dr. ZIMLIKI. Well, I share that excitement, as well. Madam 

Chairman and Members of the Committee, I am Dr. Chip Zimliki, 

13 

Chairman of the Artificial Pancreas Critical Path Initiative, located 

within the Center for Devices and Radiological Health at the FDA. 

I would like to thank the Committee for the opportunity to discuss the artificial pancreas system and what the FDA is doing to 

assist in the development of these critically needed and potentially 

life-changing devices. As a person living with type 1 diabetes, I am 

personally and professionally committed to seeing this important, 

novel medical device approved in the United States. 

And I just want to go offline here and say, Mr. Kline, I fully support the proposal about issuing guidance, and I believe the FDA 

will submit guidance for all types of artificial pancreas systems before December of this year. 

[Applause.] 

Dr. ZIMLIKI. Diabetes is a disease that affects the entire family, 

especially when a child is diagnosed. I know this because I was diagnosed with diabetes when I was 13 years old. When I was diagnosed, the technology was a great deal different. They were just 

coming out with glucose meters, and it took much longer than it 

does today to obtain a blood glucose measurement. Technology has 

come a long way, and I am very grateful for that. 

But even now, with today’s technology, we still must prick our 

fingers to test our blood multiple times a day, and over time, it can 

really hurt. I am sure the children here can attest to that. We must 

also calculate insulin doses, administer necessary insulin via syringes or infusion pumps in order to lower blood glucose, and, as 

always, we have to be prepared for the inevitable lows and highs 

associated with diabetes. I admit, it is really tough being a diabetic. 

While great strides have been made in diabetes management, 

current treatment is constant and pervades all aspects of a person’s 

life, presenting a particularly arduous burden for children and 

their parents. An artificial pancreas system is an innovative device 

for treatment of type 1 diabetes that, once fully developed, will 

automatically monitor blood glucose and administer appropriate insulin doses. This life-changing technology will positively impact diabetic patients’ health and quality of life. 

As a person with diabetes, I am acutely aware of the benefits an 

artificial pancreas system will provide. I say ‘‘will’’ because I am 

highly optimistic that industry, researchers, and the FDA will 

bring this device to market. An artificial pancreas system will 

allow people with diabetes, especially children, to live active lives 

without the constant need to adjust glucose levels. 

While I know the potential benefits are enormous, an artificial 

pancreas system is a significant risk device, meaning it presents a 

potential for serious risk to the health, safety, or welfare of the patient. If not properly designed, use of an artificial pancreas device 

in an outpatient setting can place patients at significant risk because the device controls the administration of insulin. As such, an 

Investigational Device Exemption (IDE) from the FDA is needed to 

allow the investigational device to be used in a clinical study. 

Currently, the FDA has approved over 17 clinical studies for artificial pancreas systems at various levels of development, and we 

have seen promising results. The FDA is helping advance the development of an artificial pancreas system by prioritizing the reVerDate Nov 24 2008 14:22 Mar 26, 2012 Jkt 068012 PO 00000 Frm 00017 Fmt 6633 Sfmt 6633 P:\DOCS\68012.TXT SAFFAIRS PsN: PAT
14 

view of IDE studies, fostering discussion, shortening study and review times, and providing clear guidelines and a path to market for 

industry. 

In 2007, the FDA created the Artificial Pancreas Critical Path 

Initiative, bringing together a multi-disciplinary group of scientists 

and clinicians from the FDA and NIH. One of the major goals of 

this initiative is to identify roadblocks and possible solutions to 

streamline the regulatory process. A shining example of this effort 

was how the FDA worked with the developer of a software program 

so that researchers working on an artificial pancreas system could 

test control algorithms and use the results in support of regulatory 

submissions. This important software tool enables researchers to 

quickly test artificial pancreas control algorithms and is accepted 

in place of costly and time-consuming animal studies. This effort 

saved investigators 6 months to a year in clinical study time and 

expedited the transition to human trials. 

The FDA also encourages researchers to contact the agency early 

to discuss clinical study plans and get informal feedback that can 

improve their study designs and facilitate the review process. This 

quick, informal feedback can help investigators develop better and 

more complete study plans for the FDA review. When investigators 

submit their final study plan, the FDA gives these submissions the 

highest priority and works interactively with investigators to move 

them quickly and efficiently through the review process. Questions 

and research challenges are often quickly resolved, helping researchers start their study sooner. 

The FDA guidance and industry standards help manufacturers 

and researchers understand the minimum requirements for making 

a device that is safe and effective. This helps them make the best 

use of resources and streamlines the regulatory review process. We 

agree with JDRF and others that guidance to industry is useful for 

product development. 

On June 22, 2011, the FDA issued draft guidance that will help 

advance the development and approval of an artificial pancreas 

system to treat type 1 diabetes in the United States. This guidance 

document addresses an early version of an artificial pancreas 

system known as a Low Glucose Suspend (LGS) system. The LGS 

system can help reduce or lessen the severity of hypoglycemia by 

temporarily reducing or stopping delivery of insulin. Patients using 

this kind of system still must test their glucose levels on a regular 

basis with a glucose meter and give themselves insulin. The draft 

guidance provides recommendations for those planning to develop 

and submit for FDA approval an application for an LGS system. 

The FDA is also seeking input from industry, researchers, and 

the clinical community on the draft LGS guidance. Specifically, the 

agency is interested in feedback about the types of clinical studies 

that should be conducted and what their target outcomes should be 

to demonstrate safety and effectiveness. Your input is also very 

welcome. 

The FDA is also working on the second draft guidance, as I discussed. The FDA has been working with research communities, 

such as JDRF, to expedite this guidance, and we have promised the 

publication of the draft guidance by the end of this year. 

15 

Finally, the FDA is working with NIH and other interested parties in planning the next artificial pancreas workshop, which will 

focus on developing better technology for creation of a more accurate and reliable artificial pancreas system. This is the system that 

you can just put on and not worry about. I cannot wait for that 

day. 

The FDA is fully committed to the development of an artificial 

pancreas to meet this critical health need. It is the goal of the 

agency to provide a clear pathway for manufacturers to provide 

people with diabetes with innovative, safe, and effective medical 

devices to treat their disease. 

Madam Chairman, this concludes my formal remarks, and I will 

be pleased to answer any questions the Committee may have. 

Senator COLLINS. Thank you, Dr. Zimliki. 

[Applause.] 

Senator COLLINS. Thank you so much for your testimony. 

We are going to do a 6-minute round of questions so that we can 

get to the next panel. We could keep you here all day. 

Dr. Zimliki, it is great news that you have given us today, and 

I saw the guidance on Monday about the draft guidance. In early 

May, 59 of us signed a letter that I spearheaded that encouraged 

the FDA to move forward with issuing guidance that would enable 

clinical trials for testing the artificial pancreas to move from an inpatient to an outpatient basis. Does this guidance help us along to 

achieve that goal of moving to the outpatient guidance? 

Dr. ZIMLIKI. Yes, indeed, it does. This is the complete package 

guidance. This will help academicians start their investigations, get 

them approval for the clinical studies in the in-clinic, and it outlines what type of information the FDA needs to assure safety as 

we transition from the in-clinic to the outpatient settings. 

Senator COLLINS. And on a related question for you, I have 

heard—and there are some delegates from Canada here today— 

that the Low Glucose Suspend system technology is available now 

in Canada and other parts of the world. Could you explain to us, 

and I am not trying to put you on the hot seat—well, maybe I am 

trying to put you on the hot seat—— [Laughter.] 

But why is it not available here if it is available next door in 

Canada? 

Dr. ZIMLIKI. Well, it is hard to draw comparisons across the various regulatory agencies around the world. The FDA has to operate 

within U.S. law, which states medical devices must be safe and effective. 

I will give you an example. The European Union’s law states that 

medical devices need to be safe and perform. That might not sound 

like a big difference, but there is a significant difference between 

the two, and I will use the Veo system as the example. This is 

going to be a long answer, I am sorry, Senator Collins. 

The Veo system shuts off insulin when the continuing glucose 

monitoring (CGM) value is low. To evaluate the performance of 

that, all you need to do is show that the insulin pump shuts off 

when the sensor reads low. That is a perfect engineering question 

that can easily be tested on the bench side. The FDA agrees that 

type of performance is needed. 

16 

But what the FDA also needs for effectiveness is to know what 

happens to the patient when the pump actually turns off. That information is critical because it allows the prescribing clinician to 

look at the information that is provided in that clinical study and 

determine whether or not the patient can use this device beneficially. 

With regard to the Veo system, I will say Medtronic and the FDA 

have been continually working together. The Aspire study is an ongoing study to provide sufficient safety data within the United 

States, and it is the hope of the FDA that this safety data will 

allow the transition to an outpatient setting and finally approval 

of that device. 

Senator COLLINS. Thank you. 

Dr. Rodgers, last year, Congress passed legislation extending the 

funding for the Special Diabetes Program through September 2013. 

How important is it for Congress to do multiple years as opposed 

to year-to-year renewals of funding? Does that have an impact on 

the kinds of studies that you can fund? 

Dr. RODGERS. Well, Senator, we were very pleased to receive that 

multi-year renewal of the Special Diabetes Program through fiscal 

year 2013. The multi-year renewal greatly improves the planning 

process that goes on in NIDDK. For example, many clinical studies 

take multiple years to perform, and it would be very difficult, if not 

impossible, to start such a multi-year clinical trial without knowledge of whether the funds will exist in future years to continue 

those types of studies. 

One area that we are absolutely looking at is to bring new people 

and new talent into this field. For example, in the artificial pancreas field, we have obviously very dedicated and talented clinicians and we have people in the device industry, but what needs 

to link them or, as my colleague Mr. Kline says, to actually get 

them to talk together are bioengineers. And so with this multi-year 

funding, we are trying to put in training efforts to bring bioengineers into this field, and training occurs over long time horizons, 

and therefore, multi-year funding is also critically important for 

them. 

One final thing that I would say is that as we move toward the 

artificial pancreas, clearly, we would recognize that there might be 

some issues related to compliance, and so now we are trying to get 

people who have been previously engaged in behavioral science to 

tell us what particular challenges we might face, and we are trying 

to get them involved in research in diabetes. So training and bringing in new talent are critically important, and multi-year funding 

greatly assists in that regard. 

Senator COLLINS. Thank you. 

Mr. Kline, you mentioned in your statement that when there is 

a diagnosis of type 1 diabetes, it affects the whole family and involves the whole family. You also talked about the fact that there 

are different challenges at different ages. Could you, having lived 

with this for quite some time now, elaborate on the impact on the 

family and the challenges at different ages, from toddler to teenager? 

Mr. KLINE. Well, it affects the entire family. It transforms the 

entire family, and it changes with age and the various vicissitudes 

17 

that the disease can go through. Suddenly, in the teenage years 

with the hormones being what they are, there are chaotic glucose 

levels. 

Senator COLLINS. People are agreeing. 

Mr. KLINE. And it is just a vast improvisation of figuring out how 

to react to this. Is this a real high number or is this the hormones? 

It is not unlike life that way, I guess, trying to find what is the 

absolute cause for any particular symptom. 

But, obviously, when a child is diagnosed at 6 months, he cannot 

tell you that he is feeling low or feeling high. It is too horrible to 

imagine. It does get easier. All things being relative and given our 

human nature and our marvelous adaptability, we can adapt to a 

surprising number of things. Children get more and more used to 

it, get more and more on top of it, depending on the nature of the 

child. There are some type A personalities who are just all over 

their diabetes and are really in control of it, and there are others 

who are more in denial of it, who do not want to be bothered with 

it, who want those days of not having diabetes that you spoke of 

earlier, just one day, and sometimes they will just take that day, 

even though it is not an officially appointed day for such behavior. 

[Laughter.] 

But they will take it upon themselves and havoc will be wreaked. 

It gets easier and harder, but most of all, it does not stop. When 

your child gets older, goes off to college, you are still calling incessantly. You are still checking up. You are still worried. You are still 

making trips at strange hours of the night to deal with sudden insulin emergencies. It is moment to moment, hour by hour, day to 

day. It is ongoing, which is, I think, why JDRF wants to stress the 

urgency and the need to keep the research going and to get the artificial pancreas done because, I think, as these marvelous children 

can attest, tomorrow is going to be here sooner than we would like 

and we would like to have the artificial pancreas tomorrow, please, 

or yesterday, or today. 

Senator COLLINS. Thank you. Senator Brown. 

[Lights go out.] 

Senator BROWN. That happens regularly with me. [Laughter.] 

It is a conspiracy. 

Mr. KLINE. I guess we have not paid our electric bill. 

Senator COLLINS. You are not in Massachusetts, so I do not know 

why this happened. 

Senator BROWN. It is following me everywhere. 

Mr. KLINE. I asked for that. It is a very dramatic device called 

blackout. [Laughter.] 

Senator COLLINS. That was very dramatic. 

Mr. KLINE. Thank you. 

[Laughter and applause.] 

Mr. KLINE. That is what this button is. 

Senator COLLINS. That was a good stage trick, Mr. Kline. 

[Laughter.] 

Senator BROWN. That was perfect. 

Mr. KLINE. How do you follow that? 

Senator BROWN. Everyone is awake now. [Laughter.] 

Mr. Kline, thank you very much for coming and offering your 

star power to a cause such as this. I think everybody I know has 

18 

some type of experience with diabetes, whether it is in their own 

family or with their friends, so we really would like to just thank 

you for taking time out of your schedule. I think we all respect 

your acting ability and what you also do with philanthropic causes, 

so thank you. 

Dr. Zimliki, I have 225 medical device companies in Massachusetts. I visited Medtronic and others, and the biggest challenge is 

the fact that there is a tremendous amount of delay and inefficiency within the FDA. I have met with Commissioner Hamburg, 

and I will say that she recognizes that problem, and she is making 

great efforts to try to streamline, consolidate, and eliminate a lot 

of that duplication. The No. 1 issue I find in Massachusetts and as 

I travel throughout the country is you have a company that is trying to make a difference for people like this, and they are marching 

along with a checklist, and then in the middle of the checklist, they 

have to go back to square one at tremendous cost. And I look at 

those medical devices that are approved in Ireland and Canada, 

and our companies are saying to me, as their U.S. Senator, why are 

we not being approved here in Massachusetts and in the United 

States? 

[Applause.] 

Senator BROWN. So on the one hand, I have been very critical of 

the FDA and its delay because there needs to be consistency, stability, and certainty in the process for development and the ability 

to find cures. 

On the other hand, I have also been very public in saying ‘‘thank 

you’’ to her and the agency for finally realizing that there is a problem and trying to fix it. So I wanted to let you know that, and I 

am wondering, how are you finding the new leadership and that 

new process? Is it moving along as expeditiously as you would like? 

It is a softball. [Laughter.] 

Dr. ZIMLIKI. And I am due for promotion, too. [Laughter.] 

Senator BROWN. Well, go for it. 

Dr. ZIMLIKI. Absolutely. [Laughter.] 

Yes, absolutely. We have new leadership, and Dr. Jeffrey Shuren 

has certainly said that there is room for improvement for the review process by increasing predictability, consistency, and transparency. There is an entire action plan in place regarding the improvements in the review process. 

My focus here today is about the artificial pancreas, and I am 

very happy and pleased to know that Dr. Hamburg and Dr. Shuren 

give me their fullest support, and we are going to make sure that 

this device gets approved. We are hopeful that this guidance improves transparency so that a company like you referenced does not 

go halfway through the development process and then have to start 

back at square one. 

Senator BROWN. Right. Well, thank you. It is a tremendous job 

killer in my State and throughout the country. 

I think you stated that you want a device that performs precisely, reliably, and individually as a unit. What steps are you taking to ensure the quality and safety of these systems in the clinical 

trials, specifically in your Phase II guidance? 

Dr. ZIMLIKI. Just give me one second here. 

19 

Senator BROWN. You thought you were going to get easy questions. 

Dr. ZIMLIKI. The Phase II guidance will adopt some of the information from JDRF. Now, granted, the Phase II guidance, which I 

will call the more advanced artificial pancreas guidance, is using 

some of the information that the clinical panel’s recommendation 

by JDRF submitted to the FDA. It is a three-phased approach, and 

the idea would be to understand the device in the clinic, then transition into a more realistic version of home life except under mitigation or supervision, such as a diabetes camp. I am sure most of 

these people here have been to a diabetes camp, is that correct? 

[Chorus of yes.] 

Dr. ZIMLIKI. Thank you. I like it, too. Then the last phase would 

be the transition to the outpatient setting. That is consistent with 

the recommendations from the JDRF as well as most of the medical community. 

The guidance is still under development, and we are going to be 

finalizing and publishing it in December of this year. 

Senator BROWN. Dr. Rodgers, what is NIH’s current role in supporting the FDA in this process in terms of how do you foresee 

NIH’s role changing in the current months, and will you be facilitating the transition to clinical trials with the translational research? 

Dr. RODGERS. Yes. Under the auspices of the Diabetes Mellitus 

Interagency Coordinating Committee, we regularly meet with not 

only our colleagues at the FDA, the Centers for Disease Control 

and Prevenion (CDC), and other Federal agencies, but other institutes within NIH that have a role to play in diabetes research. We 

work very closely with Dr. Zimliki and his colleagues in an Interagency Artificial Pancreas Working Group. 

In fact, just a few months ago, we held a meeting in conjunction 

with the JDRF, and we are actually planning to have a follow-on 

meeting in the fall of this year to develop a working understanding 

of what are some of the challenges, what are the other groups that 

we need to bring into the question, particularly bioengineers, mathematicians, theoreticians, to try to assist us in moving more expeditiously along this pathway. 

So we have an essential role. We have been working together 

very closely. This is not only with the FDA and the NIH, but the 

meeting in the fall of this year will also involve the JDRF, as well. 

Senator BROWN. Very well. Madam Chairman, you surprise me 

more and more each day. I was not aware until this year that you 

were advocating for this cause, so thank you for that. Will there 

be an opportunity to submit questions to our panel members? 

Senator COLLINS. Absolutely. 

Senator BROWN. I just want to say, also, thank you to our panel 

and all the parents and children who came. It means a lot. I am 

going to be bouncing back and forth as I have done, so I will try 

to get back for the children. Thanks. 

Senator COLLINS. Thank you. Senator Shaheen. 

Senator SHAHEEN. Thank you, Madam Chairman, and thank you 

to all of our panelists this afternoon. 

Dr. Zimliki, as you are aware, I share the frustration that both 

Senator Collins and Senator Brown have expressed about the pace 

20 

at which the FDA has moved on getting the guidance out on the 

artificial pancreas. I am pleased to hear you say that you expect 

that to happen by December, but I wonder if you could then outline 

what the next steps are once that happens, on the way to getting 

approval for the artificial pancreas. 

Dr. ZIMLIKI. Can you clarify which artificial pancreas type system you are asking about? 

Senator SHAHEEN. I know there are a number of those systems 

in development—— 

Dr. ZIMLIKI. Right. 

Senator SHAHEEN [continuing]. And I am interested in seeing 

something that can be commercially available, on the market, that 

will be approved by the FDA and be safe and available to my family and all the families who are here. And I do not particularly care 

who the producer of that system is. 

Dr. ZIMLIKI. I was just asking for clarification on the type. There 

are many types of artificial pancreas systems. We talk about the 

Veo system, which is a Low Glucose Suspend system. The agency 

believes that this is a type of artificial pancreas that should be on 

the market sooner than later. 

Senator SHAHEEN. I appreciate that. I think for many of the people in this audience, they do not see that as the artificial pancreas 

that we are really hoping will be on the market. I agree, that is 

a step in the right direction, but as has been pointed out, that device is available on the market in other countries, and we would 

like to see not only that device available here, but to go to the next 

step, to have a continuous system available for people. 

Dr. ZIMLIKI. Is the question that you would like to know the time 

line? 

Senator SHAHEEN. I would like to know what steps the FDA sees 

that it is going to require in order to move forward. You said you 

expect to see draft guidance on that by December. So then what 

happens? I wonder if you could just outline the steps. 

Dr. ZIMLIKI. The draft guidance is out for public comment for 

anywhere between 60 and 90 days, and we look forward to all the 

comments from the scientific community to help shape and modify 

that guidance in the hopes of making it final. It will become a 

guideline to an approval package. 

Now, the timing and the ability to get a device approved depends 

on a lot of people. It really depends on the FDA being transparent 

and providing this guidance so that industry can follow it and actually conduct studies. That takes time, and it takes people like you 

out here in the blue shirts to volunteer and be part of these studies. 

The process is that by probably mid-year or next year, the guidance will be finalized. Even when it is not finalized but published 

in December, industry can start developing their process in getting 

to an outpatient study and a pivotal study, which will lead to an 

approval. 

In November 2010, I believe, one of the JDRF-sponsored investigators at our Artificial Pancreas Workshop estimated anywhere 

between 2013 and 2014 before getting to a pivotal study. There is 

a lot of information that needs to be built up to get to that final 

stage for product approval, and it is contingent on the research for 

21 

glucose sensing. We need better sensors. We absolutely need more 

reliable continuous glucose monitor sensors, and we need the research to really find out how to make that happen. 

Senator SHAHEEN. Dr. Rodgers, you talked about the role that 

NIH has with the FDA. Can you talk about how NIH can be helpful in moving this process forward. 

Dr. RODGERS. Well, Senator, in addition to working on a collaborative and coordinating basis, some of the vital research that Dr. 

Zimliki is mentioning is something that we see as our major contribution in moving the process forward and making it in fairly reliable and practical steps. Just recently, as I had mentioned, for example, in a closed-loop system, not only using insulin, but to try 

to more closely replicate what the pancreas does, scientists who we 

funded used two hormones, both insulin and the counter-regulatory 

hormone glucagon, to see whether one could get more precise blood 

glucose control over time. But again, these are done in a clinical 

setting. 

Ultimately, for this to be effective in the real world, we have to 

try to replicate that to a great extent, and this is why the more recent studies are actually looking at two different meal scenarios, 

particularly at night, because that would be a critical step, if we 

could use this closed-loop system so that parents do not have to get 

up in the middle of the night to check their child’s blood glucose. 

That would really be an enormous benefit. For example, these two 

scenarios, one was an eat-in scenario in which one ate a modest 

medium-sized meal to see how well the closed-loop system could 

look at the various levels of glucose control and how that occurred 

over the night setting. The second scenario was an eat-out, so you 

go out and replicate more of a larger meal that you would have if 

you were to go out dining and how well were you able to maintain 

that level of glucose control. 

These are both very basic investigations that we are hoping to 

do, but then, in addition, the more practical, real-life scenarios, and 

moving this research forward from the clinic to the bedside. 

Senator SHAHEEN. Thank you. Madam Chairman, my time is up, 

but I wonder if you would allow me to just ask Mr. Kline one question. 

Senator COLLINS. Sure. 

Senator SHAHEEN. Thank you very much, Mr. Kline, for being 

here and for being willing to testify on what we need to do. If you 

had one comment that you could leave with policymakers after today’s hearing, what would it be? What would you like us to take 

away from this hearing? 

Mr. KLINE. Well, I love the questions that you are posing because 

they are asking in simple language to explain what the steps are 

because so many things get lost along the way in the byzantine labyrinthine hallways of bureaucracy. I love that you are asking for 

a timetable and for really simple explanations of when this will 

happen and what needs to happen in order to get the artificial pancreas that will alleviate for these children and for type 1 diabetics 

around the world the constant burden of self-monitoring, something 

that will effectively work as a pancreas works and doles out the appropriate amounts of insulin and glucagon and takes the worry out 

of the constant vigilance that type 1 diabetics have to practice. 

22 

Senator SHAHEEN. Thank you. Thank you all very much. 

Mr. KLINE. Thank you. 

Senator COLLINS. Thank you. Senator Pryor. 

Senator PRYOR. Thank you, Madam Chairman. 

I would like to start with you, Dr. Zimliki. You have given us 

great news on the artificial pancreas. You have said some really 

positive, encouraging things about it, but another question that I 

do not think I have heard yet is will it be affordable for the average 

household? Tell us what you anticipate. What is your expectation 

on cost? 

Dr. ZIMLIKI. I wish I could give you that answer. The FDA does 

not focus on cost. We work on getting the product approved. I will 

say that we are collaborating with the Centers for Medicare and 

Medicaid Services (CMS) for reimbursement, and the hope is that 

one day, not only will the study design I mentioned earlier provide 

approval for marketing within the United States, but also for CMS 

reimbursement. 

Senator PRYOR. You mentioned that there are several models 

that may be headed to the marketplace? 

Dr. ZIMLIKI. Several types of artificial pancreas systems? Yes. 

Senator PRYOR. Do you anticipate that they will all be approximately the same cost, or will there be a big cost disparity? 

Dr. ZIMLIKI. Again, I would have to defer to industry, which sets 

these prices. I apologize, but I cannot provide an answer to that 

question. 

Senator PRYOR. So as part of your process, though, you do not 

really look at the cost? 

Dr. ZIMLIKI. The FDA looks at the safety and effectiveness of the 

device. 

Senator PRYOR. Well, we will have to work through the cost, 

maybe in another setting, but thank you for that answer. 

Dr. Rodgers, let me ask you, if I may, how does the United 

States compare to other countries when it comes to diabetes research and treatment? Are we leading the world? Are we behind? 

How do we rank? 

Dr. RODGERS. I think the research that is conducted in the 

United States really does lead the world. I think we can be proud 

of, in particular, NIH-sponsored research, as well as research that 

is sponsored by public groups. In diabetes, in particular, we are 

making great strides in understanding the genetic susceptibility. 

As I mentioned, in type 1 diabetes, just a few years ago, we had 

three genes, now it is up to 50, and we know that among these 50, 

for example, there is a small number of genes that contribute a 

large amount of the genetic risk, and there is a large number of 

genes that have only a small component. 

In this country, for the first time, and as a direct result of the 

Special Statutory Funding, we are beginning to see now that the 

incidence rate of this disease is increasing at an earlier age. We 

have to assume that over this period of time, it really is not the 

genes that are changing, but it is actually something in the environment. That is why it is critically important to undertake bold 

studies to determine what these factors are in the environment 

that are contributing to accentuating or initiating that autoimmune 

attack. 

23 

And this is why this TEDDY study that I reference in my comments really is going to provide us with a lot of information. Early 

on, we are using new technologies, for example, the human micro 

biome, in which we are looking at these samples that we are collecting from these children over time, and it is already giving us 

information about potential viruses, bacteria, or other agents that 

they are exposed to. 

Although we are not focusing on type 2 diabetes, the story is 

quite similar. Just a few years ago, we just had a few number of 

genes. Now we are up to 60 or 70 genes that explain type 2 diabetes. We are seeing that understanding a lot more about type 1 diabetes is really contributing to prevention, potentially treatment, of 

type 2 diabetes, as well, which contributes to that $174 billion annual cost that Senator Collins referenced in her opening statement. 

Senator PRYOR. So as we do research in the United States, we 

are sharing that with the world and others are benefiting from that 

research, as well? 

Dr. RODGERS. Yes. Certainly, our investigators’ work that is performed and funded through the NIH is made publicly available so 

that others can potentially mine the data and ask other promising 

questions. This is how one can really leverage the investments to 

get the greatest return on one’s investment. 

Senator PRYOR. And have we not designated a certain amount of 

funding or a percentage of funding to NIH specifically for diabetes 

research? 

Dr. RODGERS. Well, obviously, the Special Statutory Funding is 

exclusively for that—— 

Senator PRYOR. Right. 

Dr. RODGERS [continuing]. But over and above that, regularly appropriated funds also go to diabetes research. 

Senator PRYOR. And you can see the results of that statutory 

funding? 

Dr. RODGERS. Oh, absolutely. I just listed a few highlights to give 

you a glimpse of that. But over the period of time in which this 

funding has occurred, we have really advanced by leaps and 

bounds in understanding all steps of the progression of the disease. 

Senator PRYOR. My impression is that the number of cases of diabetes has gone up in this country. Are you seeing that all around 

the world? 

Dr. RODGERS. Of the number of cases of type 1 diabetes that 

have been followed, largely, the highest prevalence is in the Scandinavian countries. Finland, for example, has the highest incidence 

rate of the disease. The lowest incidence rate, by comparison, is in 

Venezuela. And so this clearly may be related to racial, ethnic differences, perhaps exposure in the environment to factors in diet, 

maybe sunlight exposure or other things. 

But for the first time and as a direct result of the Special Statutory Funding, we have developed a program in collaboration with 

the CDC to begin to search for the incidence rate in certain sites 

around the country to determine whether our incidence rate is static or whether it is increasing, and we are beginning to see the same 

thing that is occurring over in the Scandinavian countries, that not 

only over time is the incidence rate increasing, but it is occurring 

at a much earlier age. 

24 

Senator PRYOR. And one last thing, if I may, Madam Chairman. 

We are seeing that same disparity geographically in this country. 

In Arkansas, we have a few counties where the incidence rate is 

over 10 percent, and that is not true in other counties. Is it more 

concentrated in the Southeastern part of the United States, is that 

fair to say? 

Dr. RODGERS. I am unaware of any particular predilection for 

type 1 diabetes within the United States, but what I would say is 

that the Search for Diabetes in Youth Study (SEARCH), in conjunction with the CDC, is allowing us to begin to look at particular 

clusters where they may exist. When one sees the clustering of 

events, that has a high possibility, or at least opens the possibility, 

that there might be local environmental factors, and that is something that we are now poised to be able to look at as the CDC does 

for other types of clusters of disease. 

Senator PRYOR. Thank you. Thank you, Madam Chairman. 

Senator COLLINS. Thank you very much, Senator Pryor. Senator 

Begich, welcome. 

OPENING STATEMENT OF SENATOR BEGICH 

Senator BEGICH. Thank you very much, Madam Chairman. I 

know you have an important bill on the floor, so being here today 

is a great statement to the group that is here, so thank you for 

being here. I know Senator Lieberman also is on the floor. You are 

playing tag team, so thank you very much. 

I want to make a statement, then I want to ask a couple questions, probably, if I could, to Dr. Zimliki. 

First, I am pleased to be here and pleased to get the update on 

the current research and hear from so many folks and also from 

these young people. I have to tell you, you have been very patient 

for the entire presentation and discussion. We could take a lot of 

lessons from the young people who sit here so calm and collected, 

so thank you very much. 

As Mr. Pryor just whispered, if only the Senate could do this, 

and I agree with him. [Laughter.] 

We have come truly a long way in managing type 1 diabetes on 

a day-to-day basis. As a matter of fact, yesterday, I spent some 

time with two Alaskans, part of the Children’s Congress, Hugo and 

Gus, who I think are right over there. We actually watched the Nationals and the Mariners—we are Seattle fans. We thought we 

were winning until the bottom of the ninth, and if anyone watched 

that game, it was a pretty exciting game. If you are going to go see 

a baseball game, that is the one that was well worth it. So we had 

a great chance to talk. They are nodding their heads ‘‘yes.’’ 

But we also had a chance to talk briefly, and we will talk again 

later today, but I know their attendance, and the attendance of 

their parents, Karen and Steve, and all the families and children 

who are here will help us understand better. 

But it is exciting, and particularly exciting to see the development of the artificial pancreas that can truly transform lives, and 

I understand that we must continue to invest in the tools that help 

better manage the disease. I also know that we all really want and 

need to invest in research to help find a cure. To this end, we must 

25 

continue to forge the public-private partnerships and leverage 

funding to find a cure. 

Diabetes is common and growing in the State that I represent, 

Alaska. In 2009, nearly 7 percent of Alaska’s population had been 

diagnosed with diabetes. In 2007, the direct and indirect cost to our 

State was approximately $419 million. We can talk about the cost 

to the system, but when you look at the other impact, the human 

impact to families, the burden of the disease and what families 

have to do, it is significant. 

This is why I am very glad to have so many people here today 

to deliver the impactful and memorable messages. I will tell you, 

2 years ago, when I first got here, an Alaskan teenager came and 

visited me to advocate on behalf of the Special Diabetes Program, 

and she brought me a photo book of her life and what she has been 

doing to deal with type 1 diabetes, and it was very amazing because you can talk about it, but when you see the photos of her life 

unfold from day one and as she went through it, it was pretty 

impactful to me. It is a document and a booklet that I still keep 

in my office to remind me of the impact and the stories that are 

all around this issue. 

Again, I want to thank the parents and the children who are 

here. Thank you for your advocacy. 

To Dr. Zimliki, if I can ask a couple of quick questions. One, I 

want to follow up on your response to Senator Pryor, and that is 

you had mentioned the CMS reimbursement. 

Dr. ZIMLIKI. Yes. 

Senator BEGICH. You said you were working through that, and 

no disrespect, but when I have Federal folks in front of me, it is 

always, ‘‘soon,’’ ‘‘maybe,’’ ‘‘we are working on it,’’ and I am going to 

ask you very specifically. You are working on it. What do you think 

the time table is for CMS to actually respond and resolve the issue 

of how it is going to be paid for? 

Dr. ZIMLIKI. I cannot speak on behalf of CMS, but I can tell you 

that the first priority is to develop the appropriate clinical studies 

necessary for product approval and marketing within the United 

States. We have contacted our CMS affiliates, and we would like 

to make sure that the clinical study proposed can not only have the 

clinical data necessary for product approval, but also for reimbursement. We are hopeful that we can work with CMS to accomplish 

that. 

We have also communicated with—— 

Senator BEGICH. Let me pause you there for a second. 

Dr. ZIMLIKI. Yes. 

Senator BEGICH. When do you think you will have that, because 

that is obviously in your control. You are having that discussion. 

So when do you think that will get some results so you can say, 

we have some partners. We are ready to roll. 

Dr. ZIMLIKI. We need to finalize the draft guidance first, and 

then—— 

Senator BEGICH. So from December to when, then? 

Dr. ZIMLIKI. Developing and publishing this guidance is not a 

trivial task. 

Senator BEGICH. I understand. 

26 

1The prepared statement of Ms. Jacobs appears in the Appendix on page 79. 

Dr. ZIMLIKI. This is a huge, monumental effort that the agency 

is putting forward. I would like to say that we would have that information available at the same time of the publication of guidance, 

but I simply cannot guarantee that date. I apologize for that. 

Senator BEGICH. No problem. Based on your experience for something of this magnitude, is it for CMS to say, yes, we can do this; 

it will be 2 or 3 years? 

Dr. ZIMLIKI. I do not have the experience or the luxury of knowing how long that will take. I will talk to my Commissioner—— 

Senator BEGICH. Perfect. You went right to my next question—— 

Dr. ZIMLIKI [continuing]. And provide you with an answer. 

Senator BEGICH. Great. And then maybe you could give me, from 

whomever would be the appropriate person at the FDA, experiences of the past and how long it took. 

Dr. ZIMLIKI. Absolutely. 

Senator BEGICH. I would think that would be important. I would 

appreciate that for the record. 

The last thing, I will just ask very quickly, and then I apologize, 

I have to depart. How many clinical locations do you anticipate for 

the trials? Do you have a sense on that yet? 

Dr. ZIMLIKI. No. It really depends on how quickly industry wants 

to do it and how much variability they want to introduce in their 

clinical study design. Certainly, it is more than one location, but 

it really is dependent. We have introduced enough flexibility to 

allow industry to dictate how many sites they would like to study 

and where they would like to study it. 

Senator BEGICH. Great. Thank you very much, and I appreciate 

the comments, and I look forward to what you can put into the 

record. Thank you, Madam Chairman. 

Senator COLLINS. Thank you very much. 

I want to thank this panel of witnesses for excellent and highly 

encouraging testimony this morning. We will continue to work 

closely with all of you. Thank you. 

[Applause.] 

Senator COLLINS. Our next panel of witnesses consists of children who know firsthand the burdens of living with diabetes. Our 

witnesses are Caroline Jacobs from Maine; Jack Schmittlein from 

Connecticut; Kerry Morgan from Virginia; and Jonathan Platt from 

California. All of these children are JDRF Children’s Congress delegates, and we are very happy to have them here today. 

Caroline, since you are from my home State, you get to go first. 

[Laughter.] 

TESTIMONY OF CAROLINE JACOBS,1 DELEGATE FROM 

SHAPLEIGH, MAINE, JDRF CHILDREN’S CONGRESS 

Ms. JACOBS. Good afternoon, Chairman Collins and Members of 

the Committee. Thank you for asking me to testify before you 

today. 

My name is Caroline Jacobs. I am 14 years old. I am from the 

great State of Maine, where we say Maine is the way life should 

be. I am here as a Children’s Congress delegate to talk about living 

27 

with diabetes, the importance of technology for me and other children with diabetes, and my hope for a cure. 

I was diagnosed with diabetes when I was 10 years old. It 

changed my life forever. With this disease, I must always think 

and be aware of how I am feeling, and I have had to grow up fast. 

I feel the burden on my friends and my family who are always worrying about me, always asking me questions about my blood sugar. 

So I am doing what I can to make a difference in finding a cure 

for juvenile diabetes. 

I brought a ‘‘School Walk for a Cure’’ to my school, and this year 

is the third year for my family’s walk team for the Walk for a Cure 

in Portland. I also make jewelry and bags to benefit JDRF. I do all 

of these things so we can continue research to find a cure for diabetes. 

While we wait for a cure, I hope to see that more technologies 

are made available for children like me. One of the delegates here 

is from Canada and has a kind of insulin pump and continuous 

glucose monitoring system that protects against episodes of hypoglycemia when the patient is ignoring the dropping sugar levels. 

With this ability to stop insulin delivery when it detects a low 

blood sugar, this pump could lighten the burden and the worry for 

me and those around me. This technology is approved in Canada 

and other countries, but not here in the United States. It is hard 

for me to understand how a device like that can be available in a 

place just over the border from me. 

Because I will be driving in the next 2 years, it would be important for me to have access to a technology that could help prevent 

my blood sugar from dropping. Having diabetes can make your 

blood glucose levels go too high or too low and make me feel sleepy 

or dizzy, confused, or have blurred vision, making it too dangerous 

to drive. 

I would like Congress to encourage the FDA to move forward on 

next steps relating to the artificial pancreas, a combination of a 

continuous glucose monitor and an insulin pump with software 

that communicates between the two. The device will prevent highs 

and lows, especially at night when lows can be most dangerous. 

But it also would keep control of my sugars while I am driving, as 

well. 

I hope we will not have to wait too long for this device. That way, 

I will no longer have to worry about others always worrying about 

me. More importantly, my family will feel less of the burden and 

my friends will not always have to adjust around me because of 

this disease, and I hope that this means I will have the opportunity 

to travel freely without worrying about this disease and enjoy the 

world and those who live on it. After all, is that not the way life 

should be? 

Thank you, Members of the Committee, especially my home 

State Senator, Senator Collins. 

[Applause.] 

Senator COLLINS. Thank you. That was terrific. You sound like 

a pro. 

Mr. Schmittlein, we are glad to hear from you next. 

28 

1The prepared statement of Mr. Schmittlein appears in the Appendix on page 82. 

TESTIMONY OF JACK SCHMITTLEIN,1 DELEGATE FROM AVON, 

CONNECTICUT, JDRF CHILDREN’S CONGRESS 

Mr. SCHMITTLEIN. Thank you, Senator Collins, Senator Lieberman, and Members of the Committee for inviting me to testify. My 

name is Jack Schmittlein. I am 13 years old, and I have had juvenile diabetes for over 6 years. 

On October 4, 2004, my life changed forever with my diagnosis. 

Instead of being a carefree kindergartner, I was faced with pricking 

my fingers 8 to 10 times a day, counting carbohydrates, and taking 

insulin shots. Managing diabetes is hard work that lasts 24 hours 

a day, every day. 

Two years ago, my best friend, Peter, was diagnosed with type 

1 diabetes. Before, he had been incredibly helpful in managing my 

disease, even keeping me company when I walked to the nurse’s office to check my blood sugar. Peter and his family learned everything they could about diabetes so that I could come over to play 

at their house safely. Peter’s diagnosis is just one more reason why 

I work to raise awareness about type 1 diabetes and one more reason why I am here today. 

Important research to find a cure is happening all over the Nation, even at Yale University in my home State of Connecticut, to 

better understand the causes of type 1 diabetes and ways to prevent it. 

I am grateful that Congress passed legislation to renew the Special Diabetes Program last year. This program is essential to helping find a cure for type 1 diabetes. The Special Diabetes Program 

has allowed for research that has led to the artificial pancreas. An 

artificial pancreas would help prevent my blood sugar from dropping and give me insulin if my blood sugar gets too high. Right 

now, I have to get up to check my blood sugar in the middle of the 

night, every night. It would make participating in activities I love 

a whole lot easier. I really enjoy playing basketball and football, 

but I often have to come out in the middle of a game to test my 

blood sugar. It would give me my life back so I can just feel like 

a kid again, not a kid with diabetes. 

Despite this incredible technology, we need to do everything we 

can to find a cure. I am doing my part to help continue to push 

life-saving research forward. I have been a JDRF walk team captain for 4 years. I have organized a walk at my school to benefit 

JDRF. And I have also spoken about life with diabetes at two 

walks, a school assembly, and a Promise Ball fundraiser as a JDRF 

Youth Ambassador. 

It is my hope that Congress will continue to support research at 

NIH, specifically the Special Diabetes Program. I really believe 

that we will find a cure for type 1 diabetes. The artificial pancreas 

is a promising result after strong investment in research. 

I look forward to the day that I can say, ‘‘I used to have diabetes.’’ Until that day, an artificial pancreas will greatly improve my 

daily life and the lives of other children who have type 1 diabetes. 

I know that Congress and JDRF are doing all that they can to 

make this possible for children like me. Just think, if we can improve the lives of millions of children and adults around the world, 

29 

1The prepared statement of Ms. Morgan appears in the Appendix on page 86. 

why would we not? Research being conducted all over the country 

is bringing us closer to a cure, and the development of the artificial 

pancreas could keep us healthy while we wait for a cure. 

Thank you, Senator Collins and Members of the Committee, for 

providing me the opportunity to give you a glimpse into what my 

life is like with diabetes. I look forward to answering any questions 

you may have. 

[Applause.] 

Senator COLLINS. Thank you, Mr. Schmittlein. You did a great 

job. 

Ms. Morgan, we will hear from you next. 

TESTIMONY OF KERRY MORGAN,1 DELEGATE FROM GLEN 

ALLEN, VIRGINIA, JDRF CHILDREN’S CONGRESS 

Ms. MORGAN. Good afternoon, Senator Collins, Senator Lieberman, and Members of the Committee. Thank you for inviting me 

to testify today. 

I am Kerry Morgan from Glen Allen, Virginia, and I was diagnosed with diabetes 13 years ago, when I was 4 years old. Unfortunately, diabetes was not new to me when I was diagnosed. My 

older sister was diagnosed with the disease when she was four, too. 

Shortly after her diagnosis, I was enrolled in a clinical trial for 

first-degree relatives of people with type 1 diabetes to determine if 

they were at risk for developing the disease. On the trial, I received 

daily insulin injections in hopes to avoid or delay development of 

diabetes, but it did not work. Sometimes clinical trials do not. I 

was formally diagnosed with type 1 diabetes 1 year later. 

Then, in what seemed like a flash, 10 years passed—10 years 

filled with thousands of insulin injections, finger sticks, tubing 

changes, endless carbohydrate counting, and worry. Ten years of 

toting around an awful green fannypack containing the vital necessities for everyday life. Even with my best efforts, I still have days 

with severe high and low blood sugars. My family and I hoped, just 

like the millions of people impacted by this disease do, for a better 

way to control this. 

I was 14 when I enrolled in a clinical trial that was testing a continuous glucose monitoring system. This ingenious device, which I 

named ‘‘my little buddy,’’ gave me instant knowledge of what my 

blood sugar was doing and where it was going. While on this trial, 

my A1c dropped from an 8 to a 7. This technology made living with 

the disease not only easier, but gave me hope that it was truly possible to manage diabetes better. It was not a cure, but it was more 

than I had before. 

Living with diabetes is a daily struggle. It creates this cloud of 

fear and doubt. Thoughts of blood sugars and carbohydrates are always on my mind. I am constantly asking myself, am I OK? I always have to remember snacks and extra supplies to ensure that, 

in case of incident, I am covered because things can get scary 

quickly. I have had my pump stop working while out of town, 

unprompted by dropping it or submerging it in water. I do not just 

worry about now. I worry about my future. Diabetes never takes 

a break, so neither can I or my family. 

30 

1The prepared statement of Mr. Platt appears in the Appendix on page 89. 

Then last October, I enrolled in a clinical trial testing artificial 

pancreas technology. For 2 days, I was admitted into a hospital 

where they tested the closed-loop artificial pancreas system. After 

participating in clinical research since I was 3 years old, I can honestly say the closed-loop artificial pancreas trial was the most 

amazing experience of my life and holds so much promise for people living with this disease. 

For 2 days, I had perfect control of my blood sugar levels. Two 

days of living with this technology provided me with the vision of 

what life could be like—life with far less complications, both shortand long-term. Creation of an artificial pancreas is within reach. I 

know it. I have been a part of it, and I will do all I can to get it 

into the hands of people living with diabetes, and I hope you will, 

too, so on the day the artificial pancreas is finally approved and released, people with this disease can say, ‘‘Diabetes? There is an app 

for that.’’ 

[Laughter and applause.] 

Ms. MORGAN. Thank you, Members of the Committee, for all you 

do for those living with diabetes and working to make the artificial 

pancreas technology available to all those living with this disease. 

Senator COLLINS. Thank you very much, Ms. Morgan, for great 

testimony. 

[Applause.] 

Senator COLLINS. Mr. Platt, you are up next. 

TESTIMONY OF JONATHAN PLATT,1 DELEGATE FROM 

TARZANA, CALIFORNIA, JDRF CHILDREN’S CONGRESS 

Mr. PLATT. Good afternoon, Chairman Collins and other Members of the Committee. Thank you for inviting me to testify. 

My name is Jonathan Platt. I am from Tarzana, California, a 

suburb of Los Angeles. I am 7 years old. I was diagnosed with juvenile diabetes at age 6. I had been losing weight, wetting the bed 

at night, and had extreme thirst. I was always very tired and emotional. My mom and dad thought I was adjusting to a new school 

and kindergarten. My blood sugar was over 650 when I was diagnosed with juvenile diabetes. I will never forget the day I was diagnosed. We found out later that the little red-headed girl who rode 

in the elevator with us was diagnosed with juvenile diabetes, also. 

That had never happened before in this doctor’s office, two children 

diagnosed at the same time. I was thinking, how did I get this disease? I did not know what it was. I was very scared and nervous. 

I am here as a Children’s Congress delegate to tell you that I 

manage my disease, but I do not let it control my life. With this 

disease, I am able to swim, play basketball, and build Legos, but 

I am different. Unlike other children, I have to check my blood 

sugar 8 to 10 times a day. Everything I eat is measured and every 

carbohydrate counted. My blood sugar kit, juice, glucagon, and ketone strips go with me everywhere I go. 

It is hard when I go to summer camp or do a sleepover or even 

go to a friend’s house. Too much exercise or not eating all my food 

can be very dangerous. I think I am too young to have to worry 

about all this stuff. 

31 

My parents have had to adjust their life because of my diabetes, 

but they say we all have it, not just me. Managing diabetes is a 

24-hour job. We are doing our part to help find a cure by raising 

money for the JDRF Walk for a Cure. I am here to ask you to continue to do your part and fund research to find a cure. 

A cure for diabetes means that I could go to any summer camp 

and have sleepovers whenever and wherever I want. It means I 

could be a regular kid again, and most of all, it would mean I 

would not have diabetes. Please help me make this possible. My 

life depends on it. Thank you. 

Senator COLLINS. You did a great job. 

[Applause.] 

Senator COLLINS. I think this entire panel deserves another 

round of applause. 

[Applause.] 

Senator COLLINS. Now, I know that the children here have been 

sitting a very long time and that many of them could use a snack 

or water or need to test themselves, so I am going to ask the panel 

to each just ask one question, and then we will just wrap up the 

hearing because I know it has been a long afternoon, particularly 

for some of the younger delegates who are here. 

First of all, thank you all for just wonderful testimony. You really have put a human face on what it is like to have diabetes, and 

that is far more powerful than statistics. You are the best advocates for funding for diabetes research that we could possibly have. 

So, Caroline, my question is going to be for you. You were diagnosed in the summer, and you had some time with your family to 

get used to the idea of having diabetes and to learn what you needed to do in order to manage your disease. But I would like you to 

share with us what it was like when you went back to school in 

the fall. 

Ms. JACOBS. Well, I was going to a new school at the time, so 

I was teaching my teachers how to deal with having a kid with diabetes and teaching my new friends how to count carbohydrates and 

all that stuff. Even at lunch, we would all try to figure out how 

many carbohydrates were in my food. I had a lot of support from 

friends, teachers, and my family, of course. 

Senator COLLINS. I am sure that made a real difference. 

Ms. JACOBS. Yes. 

Senator COLLINS. Senator Begich referred to the scrapbook, and 

you gave me yours, and it is wonderful to go through it because I 

have learned so much more about the disease and about you. I 

want to thank you especially for being here, but I also want to 

thank all of our delegates. 

Ms. JACOBS. Thank you very much. 

Senator COLLINS. Senator Brown. 

Senator BROWN. Thanks, Madam Chairman, again, for holding 

this hearing. Looking out there, I think I am at the Academy 

Awards. I see Mr. Kline right there, and then I come back to reality, and I see that we are here to discuss something very serious. 

Obviously, it affects everybody in this room. The wonderful part 

about being a U.S. Senator is, each day, you can learn and grow 

and you can understand new and different things, and if you do not 

32 

understand them, you obviously have an opportunity to actually 

find out the answers, which I find intellectually very stimulating. 

Jonathan, I agree with you. You are too little to have to worry 

about this stuff. That being said, what has been the biggest challenge for you since you recently found out? What is the most difficult part of everything that you are going through right now? 

Mr. PLATT. Well. 

Senator BROWN. Is it keeping the daily requirements? Is it worrying about what happens if you do not do it right? I mean, what 

is the biggest challenge, do you think? 

Well, you think about it for a minute. I am going to ask Mr. 

Schmittlein. What is your biggest challenge? 

Mr. SCHMITTLEIN. Probably my biggest challenge with diabetes is 

at school, when all of my friends go to lunch, I have to always go 

to the nurse, and I have to bolus through my lunch, and sometimes, if we are in class and doing something fun, my blood sugar 

might be too low or too high, and so I will have to go down to the 

nurse and miss out on all the fun. So that is kind of hard for me 

because it is not fun to miss out on things you really want to do 

with your friends, so that is one of the things that is challenging 

for me. 

Senator BROWN. Jonathan, you said earlier that your blood sugar 

was over 650, and I learned something today, that the average is 

100 or below. I find that amazing that you were able to really function and now, obviously, address it. Have you thought of something 

that is challenging yet for you? 

Mr. PLATT. Yes. Every time I feel low, there is no nurse at the 

school, and while in the library when there is something fun, if I 

feel low, I will have to go back to the class and check my blood 

sugar with the teachers. 

Senator BROWN. So you are missing out on some things. 

Mr. PLATT. Yes. 

Senator BROWN. Well, thank you for that. 

Thank you, Madam Chairman, for holding this hearing, and 

thank you, panelists. 

Senator COLLINS. Thank you very much, Senator Brown. 

Senator Shaheen. 

Senator SHAHEEN. Thank you. Thank you all very much for your 

testimony. You are great advocates for the need to do more to address research. 

Ms. Morgan, since you have not answered a question, my question is for you. We still have Dr. Zimliki and Dr. Rodgers here, and 

there has been a lot of discussion today about the artificial pancreas. Since you participated in one of those trials, is there anything that you would like to tell them about that trial that you 

hope they will bear in mind as they go back to the NIH and the 

FDA and continue work on trying to get an artificial pancreas that 

can be available to people? 

Ms. MORGAN. The first thing I am going to say is it is awesome, 

so keep that in mind. And being on the artificial pancreas was so 

different than just living every day with diabetes because for that 

time, I did not have to worry. I did not have to think about it, and 

that was a new experience for me because I have had this disease 

since I was so young, I do not really know anything else. And so 

33 

1The letter and prepared statement of Ms. Moore appear in the Appendix on page 92. 

not having to do that was such a weight off of my shoulders, and 

I think everyone here could use that. And so bear in mind that I 

think we need it and we need it soon, so keep working, keep funding, keep researching, and hopefully, it will be out soon. 

Senator SHAHEEN. Thank you very much. 

[Applause.] 

Senator SHAHEEN. And thank you, Madam Chairman, for holding 

the hearing and for all of your work chairing the Diabetes Caucus. 

As we can see, it really is making a difference. 

Senator COLLINS. Ms. Morgan, I really think that your final 

words sum up why we are here and what our purpose is. But I do 

want to take this opportunity to thank everyone for coming to this 

hearing, the wonderful witnesses that we had, the delegates who 

were chosen to testify, all of the delegates who are sitting in the 

well and around the room, and their families because diabetes 

truly is a disease that affects the entire family. 

I want to thank the Juvenile Diabetes Research Foundation for 

working so closely with us. Mary Tyler Moore sent a letter and 

some testimony that we are going to put into the record, and we 

will have the record open for an additional 15 days in case anyone 

else has any words of wisdom for us or additional questions.1

But most of all, I want to thank the children who are here today. 

When you come to Washington and you meet with your Senators 

and Members of Congress, you make such a difference. It is because you are willing to come here and tell your personal stories 

that we have been successful in tripling the funding for research 

that goes for diabetes. And I know that with your help, we will one 

day soon have better treatments—the artificial pancreas that we 

have talked about today—but also, ultimately, the goal of all of us 

here, and that is a cure. 

So I thank you all for coming to Washington, for being here with 

us, and for being such great advocates. 

This hearing is now adjourned. 

[Whereupon, at 3:32 p.m., the Committee was adjourned.] 

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