The FDA has issued draft guidance that will help advance the development and approval of an artificial pancreas system to treat type 1 diabetes in the U.S.
Type 1 diabetes is a chronic condition in which the pancreas produces little or no insulin, a hormone needed to properly control blood glucose levels. Without enough insulin, glucose builds up in the bloodstream instead of going into the cells.
Patients with type 1 diabetes must regulate their blood glucose levels by checking them 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.
The draft guidance document addresses an early version of an artificial pancreas system, known as a Low Glucose Suspend system.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 The draft guidance provides recommendations for those planning to develop and submit an application for a Low Glucose Suspend system intended for single patient use in the home environment.
The FDA currently is working on a second draft guidance that will help manufacturers and researchers develop more autonomous artificial pancreas systems.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.