FDA Pushes for Artificial Pancreas

Artificial pancreas research and approval process

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) For people with type 1 diabetes, controlling blood sugar levels can be exhausting. With the help of an artificial pancreas, patients would spend less time worrying about blood sugar and more time enjoying their lives.

Now, the Food and Drug Administration (FDA) is pushing harder for the creation of a working artificial pancreas. The FDA recently issued draft guidelines to help researchers and manufacturers in their efforts to develop an artificial pancreas to treat type 1 diabetes.

"An artificial pancreas may be on the horizon."

An artificial pancreas is a device that combines an insulin pump and continuous glucose monitor, which receives information about blood sugar levels from a sensor under the patient's skin. The glucose monitor reads blood sugar levels and tells the insulin pump how much insulin a patient needs.

The guidelines issued by the FDA are designed to give researchers and manufacturers more flexibility when it comes to the development and approval process of artificial pancreas device systems.

According to Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, "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." He adds, "We understand how this device could change the lives of millions of Americans with diabetes, and we want our safety and effectiveness review to give patients the confidence that the device works."

Even though an artificial pancreas is not a cure for type 1 diabetes, it could lower the risk of dangerously high and low blood sugar levels. The devices could give patients a better quality of life while also reducing the risk of diabetes-related complications.

Type 1 diabetes is a disease that happens when the pancreas can no longer produce enough insulin, a hormone that manages blood sugar levels. The millions of Americans with type 1 diabetes have to regularly check their blood sugar throughout the day in order to see how much insulin they need to inject to keep their blood sugar low. An artificial pancreas would take over this task for type 1 patients.

The FDA guidelines recommend a three-phase clinical study process so that artificial pancreases can be studied in the outpatient setting as soon as possible. In order to make the research process even more efficient, the guidelines suggest ways to pull existing safety and effectiveness information from other studies.

When studies are completed, the guidelines help researchers and manufacturers prepare product approval submissions.

Even though these guidelines may be encouraging to those waiting for improved type 1 diabetes treatments, it is unclear when an effective artificial pancreas will be available to patients. 

Reviewed by: 
Review Date: 
December 6, 2011
Last Updated:
December 10, 2011