-- The U.S. Food and Drug Administration approved a first-of-its-kind insulin device today designed to automatically deliver insulin for type 1 diabetics. The device has many in the diabetic and health care community hoping it could lead to the development of fully artificial pancreas.
“The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases -- especially those that require day-to-day maintenance and ongoing attention,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement today.
“This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin," he added.
The device, called the the MiniMed 670G hybrid closed loop system, is designed to adjust insulin levels with almost no assistance from the user, according to the FDA.
Created by Medtronic, this device works by having a sensor measure glucose levels under the skin and using a pump and patch that can deliver varying levels of insulin at the right time, without a person manually monitoring their blood sugar. However, since a user has to manually change the insulin levels to counteract meals, the device is not considered a fully automated "artificial pancreas," according to the FDA.
"The FDA approval of the world's first hybrid closed loop system is a culmination of many years of hard work and close collaboration with the clinical and patient communities to generate the body of evidence needed to advance this technology for those living with diabetes," said Dr. Francine Kaufman, chief medical officer of the Diabetes Group at Medtronic.
Derek Rapp, president and CEO of the Juvenile Diabetes Research Foundation, said that the device could be a "life-changing breakthrough."
"Today's announcement is a historical achievement for JDRF [Juvenile Diabetes Research Foundation] and the entire T1D [type 1 diabetics] community," Rapp said in a statement. "After years of laying the ground work, this life-changing breakthrough is a true testament to the reason JDRF exists, which is to accelerate ways to cure, prevent and treat this disease."
Les Hazelton used the device in a medical trial and said he felt better after having his insulin automatically regulated, according to the JDRF.
"Bottom line: I feel better today and since going into this study, than at any point after I was diagnosed -- physically, emotionally, confident in how I'm managing my diabetes," Hazelton said in a statement released by the JDRF. "You can get emotional about it. On the good days, if there are enough of them, you recall how you feel -- that's how I feel almost every day now. That's what it has done to help me."
The FDA has been working to advance the development of an artificial pancreas systems for years.
Type 1 diabetes, also called juvenile diabetes, is a chronic condition in which the pancreas produces little or no insulin because the immune system has attacked and destroyed cells that create insulin, according to the U.S. Centers for Disease Control and Prevention. Type 2 diabetes, once called adult-onset diabetes, develops when the body starts to become resistant to the effects of insulin, forcing the pancreas to create more insulin. Eventually the pancreas will not be able to make enough insulin to respond to blood sugar levels.