“Renewed Hope For Americans With Diabetes”
There is exciting news in our fight against diabetes, one of the most costly and devastating diseases affecting nearly 21 million Americans. The Food and Drug Administration (FDA) recently released guidance that will allow outpatient clinical trials to begin on the artificial pancreas, a device that could dramatically improve the lives of individuals with diabetes, especially for those with Type 1 or juvenile diabetes.
The artificial pancreas combines medical devices that already exist - insulin pumps and continuous glucose monitors - to control blood sugar levels automatically. 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 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.
Every two years, I 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. One special delegate at our most recent hearing 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 time and effort to this issue.
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. Medical costs for a child with Type 1 diabetes are six times higher than the costs for a child without the disease.
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.
We are on the threshold of a number of important new discoveries. That is why FDA's guidance to allow outpatient clinical trials on the artificial pancreas is so important. I am hopeful that this will move us one step closer to making a safe and effective automatic pancreas a reality for Caroline and so many others who live with this serious disease.
###
The artificial pancreas combines medical devices that already exist - insulin pumps and continuous glucose monitors - to control blood sugar levels automatically. 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 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.
Every two years, I 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. One special delegate at our most recent hearing 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 time and effort to this issue.
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. Medical costs for a child with Type 1 diabetes are six times higher than the costs for a child without the disease.
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.
We are on the threshold of a number of important new discoveries. That is why FDA's guidance to allow outpatient clinical trials on the artificial pancreas is so important. I am hopeful that this will move us one step closer to making a safe and effective automatic pancreas a reality for Caroline and so many others who live with this serious disease.
###
