A new grant from the HEDCO Foundation (Danville, Calif.) will advance Oregon Health & Science University’s effort to help diabetes patients safely control their condition with an automated insulin delivery device controlled by a continuous glucose monitor.

The three-year, $411,420 grant will support OHSU’s pioneering initiative to engineer a unique artificial pancreas, a sophisticated medical device aimed at doing what a diabetes patient’s own pancreas cannot do: produce the hormones that control glucose levels in the blood. OHSU’s design combines two essential performance features not found together on any other artificial pancreas device now under development: dual blood sensors (for heightened accuracy and safety) and dual hormone pumps that deliver both of the pancreatic hormones key to diabetes control: insulin and glucagon.

The OHSU team developing the artificial pancreas is led by OHSU’s Kenneth Ward, M.D., an associate professor of medicine (endocrinology, diabetes and clinical nutrition) and a provider at the OHSU Harold Schnitzer Diabetes Health Center. Ward explained that, in diabetes, the pancreas loses its insulin-producing cells that regulate glucose levels. To avoid the serious risk of damage to the heart, eyes, kidneys or nervous system, people with diabetes must test their blood about four times every day and carefully administer the correct amount of insulin to balance their glucose levels — usually by injection. The advent of insulin pumps has made this chore less burdensome for many patients, but Ward said diabetes control remains less than ideal in most people with this disease.

By replacing the normal pancreatic functions lost to diabetes, such a device could dramatically improve the quality of life of patients with insulin-dependent diabetes. More precise management of blood glucose levels helps to prevent dangerous complications of both high and low blood sugar levels. The premise is to provide a discrete, automated way to test and regulate a patient’s glucose levels using a handheld unit to control miniaturized sensors and hormone pumps inserted in the body. The task at hand at OHSU is to refine each of these components, miniaturize them and integrate them into a compact package that can be worn with minimal impact on patient’s physical movements.

“Great strides have already been made in addressing the complex biochemical, engineering, mathematical and clinical issues of diabetes management,” Ward said. “The HEDCO Foundation’s support will now allow us to bring all this knowledge together in a compact, automated prototype. This is a tremendous boon to progress.”

The artificial pancreas is something of a holy grail in the world of endocrinology. To accelerate research in the field, the Juvenile Diabetes Research Foundation has launched a 10-institution consortium with the mandate to work collaboratively to develop viable prototypes. Each consortium member pursues its own unique vision for its device, but is required to share progress with other members. OHSU’s design stands apart because of its robust sensing capability and because it is one of the few that addresses the dangers of both high and low blood sugar levels. Insulin is the front line of therapeutic defense against peaks in blood glucose, but the low levels of glucose connected to a shortage of glucagon cause other, potentially lethal complications.

For example, Ward said controlling glucagon levels could help prevent crises such as “dead in bed” syndrome, a fatal outcome that can occur when a patient’s blood sugar falls to extreme lows during sleep. Fear of excessively low blood sugar leads some patients to under-dose themselves with insulin, in turn increasing their risk of the long-term complications of high blood sugar. The artificial pancreas’s capability of continuous blood monitoring is intended to eliminate these peaks and valleys of blood glucose throughout the day. OHSU’s approach is one of only two designs that address the valleys as well as the peaks.

“A portable device capable of mimicking the role of a healthy pancreas in patients with diabetes could help save lives, improve health outcomes and provide peace of mind for millions of patients with insulin-treated diabetes in the United States and worldwide,” said Dody Jernstedt, president of the HEDCO Foundation. “We’re pleased to be associated with such exciting and important work.”

The grant will fund engineering supplies and device design work over three years, as well as provide support for the clinical studies that will evaluate the safety and effectiveness of the prototype as it evolves into a marketable product. The grant leverages more than $5 million in support from several public and private sources.

“With one in three children born in 2000 expected to get diabetes at some point in life, there are few initiatives with more potential impact than the artificial pancreas project,” said Allan Price, OHSU Foundation president. “This grant is the HEDCO Foundation’s third major investment in OHSU research in the past decade, and as with their previous support of OHSU’s shared laboratory resources for genomics and proteomics, this investment will provide OHSU with the means to lead in a vitally important area of biomedical research. We are grateful for the support of such judicious and forward-thinking partners.”

OHSU is seeking companies with which to partner for the further development of this technology. Please contact the office of Technology Transfer and Business Development at 503 494-8200 for additional information.

ABOUT OHSU
Oregon Health & Science University is the state’s only health and research university and Oregon’s only academic health center. OHSU includes two teaching hospitals; highly ranked schools of medicine, nursing and dentistry; more than 200 health and education outreach programs; and a nationally acclaimed research community comprising dozens of centers and institutes focused on basic, clinical and translational science in the search for new paradigms in the treatment of disease.