Success! FDA Agrees to Accelerate Artificial Pancreas Technology
The FDA has agreed to move forward with accelerating the development of an artificial pancreas that could free children and adults with type 1 diabetes from painful injections. In just 23 days, over 100,000 people — including Care2 members who signed this petition — joined together to call for swift action on the creation of artificial pancreas technology.
The artificial pancreas is an external device. People with type 1 diabetes could use it to “do what their bodies cannot — control both high and low blood sugar around the clock.” The device has both a continuous glucose monitor (CGM) and an insulin pump which, via sophisticated computer software, can provide the right amount of insulin at the right time and automatically. With such a device, those with type 1 diabetes would be “freed from the daily burden of managing the disease.”
Senator Susan Collins (R-ME) noted that, just last week, results from an outpatient trial of an artificial pancreas were announced in France and Italy. Clinical experts have described the artificial pancreas as nothing less than than the most “revolutionary development in diabetes care since the discovery of insulin.”
The FDA is to issue guidance for research into this potentially life-changing technology by December 1.
At a press conference, Jeffrey Brewer, President and CEO of the Juvenile Diabetes Research Foundation , an organization dedicated to finding a cure for type 1 diabetes, described the artificial pancreas as a “life saving and game changing device for kids and adults living with type 1 diabetes” and encouraged the FDA to issue guidance that will adopt leading clinical researchers’ recommendations, lest there be delays in patient access to the new technology. Senator Collins and Senator Jeanne Shaheen (D-NH) also asked the FDA to take into serious consideration recommendations recently put forth by leading clinical organizations regarding the guidance about the artificial pancreas, in order to “avoid the shortcomings of the recently proposed guidance for Low Glucose Suspend Systems, an AP precursor technology.”
Type 1 diabetes accounts for 5% of all cases of diabetes; it is an autoimmune disease whose cause may be genetic, environmental or other factors. While usually diagnosed in children and young adults, it can occur at any age. The majority of those with diabetes have type 2 diabetes, which is linked to older age, obesity, physical inactivity, family history of type 2 diabetes and a personal history of gestational diabetes, according to the Center for Disease Control and Prevention. Currently, 25.8 million Americans — about 8.3% of the population — have diabetes (type 1 or type 2), with 7 million having the condition while being unaware of it.
The CDC says that those with diabetes have “shorter life expectancy and about twice the risk of dying on any given day as a person of similar age without diabetes.” The need to accelerate research into promising new technologies like the artificial pancreas for those with type 1 diabetes is extremely urgent. Τhanks to the advocacy of people with type 1 diabetes, clinical experts, politicians and Care2 members, this new device could soon become a reality and make a difference in the lives of many.
Related Care2 Coverage
Photo by stevendepolo