SILVER SPRING, Md., June 20, 2011 /PRNewswire-USNewswire/ — 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U.S. Food and Drug Administration today issued draft guidance that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Today’s draft guidance document addresses an early version of an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 The draft guidance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 inp