Guidance outlines recommendations for clinical trials and pathway to market approval
The U.S. Food and Drug Administration today issued draft guidance that will help advance the development and approval of an artificial pancreas system to treat type 1 diabetes in the United States.
Type 1 diabetes is a chronic condition in which the pancreas produces little or no insulin, a hormone needed to properly control blood glucose (sugar) levels. Without enough insulin, glucose builds up in the bloodstream instead of going into the cells.
People with type 1 diabetes must regulate their blood glucose levels by checking their levels with a glucose meter multiple times daily, calculating how much insulin is needed to lower their blood glucose levels, and administering the necessary dose using a syringe or insulin pump.
An artificial pancreas system is an automated, closed-loop system that combines a continuous glucose monitor, an insulin infusion pump, and a glucose meter for calibrating the monitor. The devices are designed to work together, monitoring the body’s glucose levels and automatically pumping appropriate doses of insulin as determined by a computer algorithm.
Today’s draft guidance document addresses an early version of an artificial pancreas system, known as a Low Glucose Suspend system. The Low Glucose Suspend system can help reduce or lessen the severity of a dangerous drop in glucose levels (hypoglycemia) by temporarily reducing or stopping the delivery of insulin. However, patients must still manage their glucose levels with a glucose meter and give themselves insulin, if necessary. The draft guidance provides recommendations for those planning to develop and submit an application for a Low Glucose Suspend (LGS) system intended for single patient use in the home environment.
The FDA is seeking input from industry, researchers, the clinical community, and other stakeholders on the draft Low Glucose Suspend guidance. Specifically, the agency is interested in the types of clinical studies that should be conducted and what their target outcomes should be to demonstrate safety and effectiveness, necessary requirements for FDA approval.
“Our goal is to provide a clear pathway for artificial pancreas development so that people with diabetes can benefit from innovative medical devices,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Getting a safe and effective artificial pancreas system to Americans with type 1 diabetes is an FDA priority.”
The FDA currently is working on a second draft guidance that will help manufacturers and researchers develop more autonomous artificial pancreas systems. That guidance is expected to be issued by the end of the year.