FDA Releases Draft Guidance for Artificial Pancreas Clinical Trials and Production

In a move that has been long anticipated by the diabetes community, the FDA has finally issued a draft guidance that is designed to aid investigators and manufacturers who plan on seeking approval for and developing devices which are becoming known as “artificial pancreases.”

The draft guidance outlines flexible recommendations in regards to choice of study endpoints, number of participants to be studied, and the length of the trial; it also offers design and testing recommendations that will allow manufacturers to meet statutory requirements for safety and efficiency.

Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, reported that the “FDA is focused on improving the process for the study and approval of artificial pancreas systems, and developed this guidance to provide maximum flexibility to manufacturers seeking to bring this device to U.S. patients.”

The artificial pancreas does not have synthetic or artificial tissue or organs; the mechanism is comprised of two medical devices: an insulin pump and a continuous glucose monitor, a device which receives data on glucose levels from a sensor placed under the patient’s skin. The artificial pancreas uses both devices to monitor the body’s glucose levels and automatically pump the proper dosage of insulin into the blood stream.

While this device is not a cure for type 1 diabetes, the artificial pancreas has the ability to diminish the danger associated with diabetics constantly having to self-medicate with insulin in order to avoid high and low blood sugar levels. The artificial pancreas will provide type 1 diabetics with a better quality of life, and will decrease the risk of future complications connected to diabetes.

This new draft guidance advises a three-phase clinical study progression, which will allow trials to shift to an outpatient setting swiftly. Also, the guidance suggests ways sponsors may utilize preexisting safety and effectiveness data for parts that may make up an artificial pancreas system, as well as information taken from clinical research performed outside of the US.

Advocates for the approval of the device have been begging the FDA to hurry along the process in order to better aid type 1 diabetics. Last month, members of the diabetic community gathered in Washington, DC, in order to call attention to the FDA’s sluggish nature regarding the approval of the artificial pancreas.

Jeffrey Brewer, the president and CEO of the Juvenile Diabetes Research Foundation, stated, “FDA policies have delayed introductions of products such as the artificial pancreas to Americans by up to three years that are being safely used by people around the world with type 1 diabetes, and they prevent us from doing vital research in the US.”

“Diabetics have to self-prescribe insulin all day long, and they can makes mistakes and occasionally kill themselves,” Brewer continued.

The FDA reported that they were doing all they could to quickly make the apparatus available to the American public, while at the same time ensuring it was safe and effective.

“We understand how this device could change the lives of millions of Americans with diabetes,” Shuren stated, “and we want our safety and effectiveness review to give patients the confidence that the device works.”

The FDA will be publishing a Federal Register notice within the next several days which will offer the American public the chance to comment on the draft guidance.