WASHINGTON – U.S. Representatives Diana DeGette (D-CO) and Ed Whitfield (R-KY), Co-chairs of the Congressional Diabetes Caucus, commended the Food and Drug Administration (FDA) today for their release of draft artificial pancreas guidance. Today’s release marks a first important step towards outpatient clinical trials of an artificial pancreas to improve the lives of those living with Type 1 diabetes.  Earlier this year, DeGette and Whitfield led a bipartisan group of 245 Members of the House of Representatives in sending a letter to the FDA urging them to move forward on development of this guidance.  

“The artificial pancreas has the potential to dramatically improve the health and quality of life of the millions of Americans suffering from Type 1 diabetes, and to be a crucial tool in containing both the public health and economic costs of this terrible disease,” said DeGette. “I am pleased the FDA has released this draft guidance and, in particular, encouraged that it seems to include an accelerated timetable to bring us to outpatient clinical trials in a timely manner. After a thorough review of this guidance, I look forward to working with the FDA to drive towards responsible and effective outpatient trials that could demonstrate whether the artificial pancreas can safely deliver on its enormous promise.”  

“I’m pleased that the FDA has issued draft guidance for the artificial pancreas on time and appears to have taken into account the recommendations of clinical experts in the field of diabetes,” said Whitfield. “It’s also encouraging that the FDA has laid out an expeditious plan to move from inpatient to outpatient trials, a critical stage in moving this potentially life saving device one step closer to helping those suffering from type 1 diabetes. While this is encouraging news, there is still much work ahead of us and I look forward to working with the FDA to advance this initiative.” 

The artificial pancreas – which continually monitors a patient’s insulin levels and automatically delivers insulin in controlled amounts when a deficiency is detected – has demonstrated enormous potential during inpatient clinical trials.  Studies have demonstrated that better blood glucose control can postpone the onset of costly and devastating diabetes-related complications.  

In the near term, an artificial pancreas will be a combination of two external devices -- an insulin pump and a continuous glucose monitor (CGM) – which will work together to regulate blood glucose levels.  The FDA has approved clinical trials in a hospital setting of this technology and the results are quite promising.  Now, testing of the artificial pancreas needs to take place in more real world conditions.  These outpatient studies are an essential next step to ensuring the artificial pancreas is safe and effective and becomes available to individuals with diabetes.  

The draft guidelines, which the FDA developed with input from Congress, stakeholders, and the medical device industry, prioritize the review of research protocol studies and provide flexible recommendations to guide Sponsors in designing and testing the artificial pancreas.  It also recommends a three-phase clinical study progression so that the process can more quickly move into the outpatient setting.  Once published in the Federal Register, the guidelines will remain open for public comment for a period of 90 days.