Device Could Improve the Lives of Millions of Americans Living with Diabetes
Announcement Comes on Heels of Bennet Letter Urging Swift Release of FDA Guidance on Artificial Pancreas
Colorado U.S. Senator Michael Bennet today applauded news that the Food and Drug Administration (FDA) released guidance today that will allow outpatient clinical trials to begin on the artificial pancreas, a device that could improve the lives of millions of Americans living with diabetes.
“I have met with many Coloradans suffering with diabetes, and this technology could drastically improve their lives and the lives of millions of Americans like them,” said Bennet. “I am glad the FDA has released this formal guidance, so we can bring the artificial pancreas one step closer to reality for all those with diabetes. I will continue to work with the FDA and those in Colorado’s diabetes community to ensure this important technology reaches the patients who need it most as quickly and safely as possible.”
The artificial pancreas combines medical devices that already exist – insulin pumps and continuous glucose monitors – to control blood sugar levels automatically. For people living with diabetes, it would mean the end of burdensome frequent blood tests and injections.
The draft guidance issued today will allow developers of the device to begin outpatient trials. Bennet intends to work with stakeholders to review the draft guidance to ensure it is clear, reasonable, and flexible. Colorado’s juvenile diabetes community, including those at Colorado’s two Juvenile Diabetes Research Foundation locations, and the world-renowned Barbara Davis Center for Childhood Diabetes at the University of Colorado has been looking forward to this guidance, so trials can begin. Data collected from outpatient trials can help lead to final FDA approval of the device for public use.
In May, Bennet, along with 58 other senators, sent a letter to FDA Commissioner Margaret Hamburg encouraging the agency to move forward quickly with formal guidance necessary for trials to begin.