Key Component of Artificial Pancreas Shown Successful in Reducing Hypoglycemia in People with T1D

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.