In
a study published this month in Diabetes Technology & Therapeutics, researchers
concluded that the automatic suspension of insulin delivery by a low glucose
suspend (LGS) system greatly reduces the severity and duration of hypoglycemia (extreme
low blood sugar) in people with type 1 diabetes (T1D). An LGS system is built into
an insulin pump and halts insulin delivery when it detects low blood glucose
levels from a continuous glucose monitor (CGM). When blood sugars are low,
insulin delivery could increase the risk of hypoglycemia, which, if untreated,
could lead to a multitude of complications, including lack of consciousness,
coma, and even death. LGS systems are precursors to a fully automated closed-loop
artificial pancreas, which could revolutionize the way of life and the health of
people with T1D.

The
study was conducted by Satish Garg, M.D., editor-in-chief of Diabetes Technology & Therapeutics
and professor of pediatrics at the University of Colorado in Denver, along with
colleagues from the Barbara Davis Center for Childhood Diabetes in Colorado;
Rainier Clinical Research Center in Washington; and the AMCR Institute, Inc.,
Stanford University Medical Center, Mills-Peninsula Health Services, and
Medtronic Inc. in California.

In
the randomized cross-over trial, subjects with T1D fasted overnight and
exercised to induce hypoglycemia. In random order, the LGS feature was turned
on in some exercise sessions, and turned off in others. After comparing data
from the successful sessions, researchers found that use of the LGS feature
reduced the length and intensity of hypoglycemic episodes, without resulting in
a rebound effect of hyperglycemia.

LGS
systems would be key to the safety and effectiveness of an artificial pancreas—
which would combine an insulin pump with a CGM, allowing the devices to
“talk” to one another via sophisticated computer software—making this
latest study a step forward for people with T1D.

JDRF
is driven toward improving the lives of every person living with T1D, and
toward preventing, treating, and curing the disease and its complications
through the support of research. That is why the artificial pancreas is one of JDRF’s research priorities, and why we have been a
leader in propelling its development and testing. Not only would an artificial
pancreas allow people with T1D to take a break from their full-time jobs of managing
their diabetes; studies have shown that blood glucose regulation improves with
its use—particularly during sleeping hours, when the
risk of hypoglycemia increases. A myriad of benefits continue to surface as research progresses, showing the
potential of an artificial pancreas to vastly improve lives, and keep people
with T1D safe.

The
Food and Drug Administration (FDA) issued guidance for the testing of LGS
systems
in June 2011, and in December 2011, following strong advocacy efforts by JDRF and
other supporters, the FDA issued its draft guidance for
artificial pancreas systems. This guidance is needed to move research to the
next stage of testing outside the hospital setting, in more real-life conditions. JDRF plans to submit its comments to the FDA on
the draft AP guidance in March.