"Transforming Lives Through Diabetes Research"
There is new hope in our long fight against diabetes. The Food and Drug Administration (FDA) recently issued draft guidelines for clinical trials that will help advance the development and approval of an early version of an artificial pancreas system to treat Type 1, or juvenile, diabetes in the United States. Known as a Low Glucose Suspend system, this device can help to reduce or lessen the severity of a dangerous drop in blood sugar levels by temporarily reducing or stopping the delivery of insulin. Low blood sugar levels can cause seizures, coma, and even death, and are a significant and constant concern for people with type 1 diabetes.
This device has been available outside the United States for several years, and the fact that it has not yet been approved by the FDA for sale here has been a source of frustration for many Americans with Type 1 diabetes. This action by the FDA is a long overdue, but it is an important first step toward the eventual availability of a truly automated artificial pancreas that people with juvenile diabetes can use to do what their bodies cannot - automatically control both high and low blood sugar levels around the clock.
Diabetes is a life-long condition that does not discriminate. It affects people of every age, race and nationality. It is the leading cause of kidney failure, blindness in adults and amputations not related to injury. The burden of diabetes is particularly heavy for children with juvenile diabetes, the second most common chronic disease affecting young people. Moreover, it is one that they never outgrow.
Despite these facts, it was enthusiasm and optimism that filled the room during a recent Senate hearing that I chaired. Every two years, I am delighted to chair the Juvenile Diabetes Research Foundation's "Children's Congress" to examine the devastating impact that juvenile diabetes has had on an estimated three million Americans and their families. More than 150 energetic children and their families traveled to Washington from every state in the country to tell Congress what it's like to live with diabetes and why it is so important that we fund the research necessary to find a cure.
One special delegate was 14-year old Caroline Jacobs of Shapleigh. Doctors diagnosed Caroline with diabetes when she was just ten years old. "With this disease," she told us "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 family and my friends who are always worrying about me." Such powerful words and emotional stories continue to motivate me to devote much energy to this issue.
This is a battle that we simply cannot afford to lose. 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 costs for a child without the disease.
In individuals with juvenile diabetes, the body's immune system attacks the pancreas and destroys the islet cells that produce insulin. A child with diabetes will have to take, on average, more than 50,000 insulin shots in a lifetime. Moreover, these injections must be carefully balanced with regular meals and daily exercise, and blood sugar levels must be closely monitored throughout their lives through frequent testing.
Of particular concern is the fact that the incidence of juvenile 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 this disease face the constant threat of developing life-threatening complications, as well as a reduction in their quality of life.
Since I founded the Senate Diabetes Caucus, funding for diabetes research has more than tripled. As a consequence, we have seen some encouraging breakthroughs in diabetes research, and we are on the threshold of a number of important new discoveries, including continuous glucose monitors and the artificial pancreas which would revolutionize diabetes care. The artificial pancreas would link two existing technologies - the insulin pump and the continuous glucose monitor - with sophisticated computer software to provide just the right amount of insulin at just the right time.
We are making progress in the battle against this disease. This is no time to take our foot off the accelerator because this progress is giving hope to the many children, like Caroline, who live with this disease every day of their lives. The FDA has played a pivotal role in moving research forward by approving clinical trials in hospital settings and making the artificial pancreas one of its Critical Path initiatives. Earlier this year, along with a bipartisan group of my colleagues, I sent a letter to FDA urging it to issue the guidance necessary to take the clinical trials on a truly autonomous artificial pancreas from a hospital inpatient to an outpatient basis. At our recent hearing, the FDA announced that it expects to issue these long-awaited guidelines by early December. This will take us one step closer to making a safe and effective automatic pancreas a reality for Caroline and the three million Americans who live with this serious disease.
"I hope this means that I will have the opportunity to travel freely without worrying about this disease," Caroline told our committee. "I will no longer have to worry about others always worrying about me. I can enjoy the world and those who live in it. After all, isn't that the way life should be?"
###
This device has been available outside the United States for several years, and the fact that it has not yet been approved by the FDA for sale here has been a source of frustration for many Americans with Type 1 diabetes. This action by the FDA is a long overdue, but it is an important first step toward the eventual availability of a truly automated artificial pancreas that people with juvenile diabetes can use to do what their bodies cannot - automatically control both high and low blood sugar levels around the clock.
Diabetes is a life-long condition that does not discriminate. It affects people of every age, race and nationality. It is the leading cause of kidney failure, blindness in adults and amputations not related to injury. The burden of diabetes is particularly heavy for children with juvenile diabetes, the second most common chronic disease affecting young people. Moreover, it is one that they never outgrow.
Despite these facts, it was enthusiasm and optimism that filled the room during a recent Senate hearing that I chaired. Every two years, I am delighted to chair the Juvenile Diabetes Research Foundation's "Children's Congress" to examine the devastating impact that juvenile diabetes has had on an estimated three million Americans and their families. More than 150 energetic children and their families traveled to Washington from every state in the country to tell Congress what it's like to live with diabetes and why it is so important that we fund the research necessary to find a cure.
One special delegate was 14-year old Caroline Jacobs of Shapleigh. Doctors diagnosed Caroline with diabetes when she was just ten years old. "With this disease," she told us "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 family and my friends who are always worrying about me." Such powerful words and emotional stories continue to motivate me to devote much energy to this issue.
This is a battle that we simply cannot afford to lose. 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 costs for a child without the disease.
In individuals with juvenile diabetes, the body's immune system attacks the pancreas and destroys the islet cells that produce insulin. A child with diabetes will have to take, on average, more than 50,000 insulin shots in a lifetime. Moreover, these injections must be carefully balanced with regular meals and daily exercise, and blood sugar levels must be closely monitored throughout their lives through frequent testing.
Of particular concern is the fact that the incidence of juvenile 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 this disease face the constant threat of developing life-threatening complications, as well as a reduction in their quality of life.
Since I founded the Senate Diabetes Caucus, funding for diabetes research has more than tripled. As a consequence, we have seen some encouraging breakthroughs in diabetes research, and we are on the threshold of a number of important new discoveries, including continuous glucose monitors and the artificial pancreas which would revolutionize diabetes care. The artificial pancreas would link two existing technologies - the insulin pump and the continuous glucose monitor - with sophisticated computer software to provide just the right amount of insulin at just the right time.
We are making progress in the battle against this disease. This is no time to take our foot off the accelerator because this progress is giving hope to the many children, like Caroline, who live with this disease every day of their lives. The FDA has played a pivotal role in moving research forward by approving clinical trials in hospital settings and making the artificial pancreas one of its Critical Path initiatives. Earlier this year, along with a bipartisan group of my colleagues, I sent a letter to FDA urging it to issue the guidance necessary to take the clinical trials on a truly autonomous artificial pancreas from a hospital inpatient to an outpatient basis. At our recent hearing, the FDA announced that it expects to issue these long-awaited guidelines by early December. This will take us one step closer to making a safe and effective automatic pancreas a reality for Caroline and the three million Americans who live with this serious disease.
"I hope this means that I will have the opportunity to travel freely without worrying about this disease," Caroline told our committee. "I will no longer have to worry about others always worrying about me. I can enjoy the world and those who live in it. After all, isn't that the way life should be?"
###
