Media Contact: Joana Casas, (212) 479-7560, mcasas@jdrf.org
NEW YORK, April 14, 2010 — In a clinical trial that studied the benefits of a unique artificial pancreas system utilizing two hormones to control blood sugar, patients were able to achieve near-normal sugar levels for more than 24 hours without hypoglycemia, or low blood sugar. The results from the study, co-funded by the Juvenile Diabetes Research Foundation, are reported today in the journal Science Translational Medicine.
Researchers from Boston University and Massachusetts General Hospital tested the safety and efficacy of a novel closed-loop system that incorporated the use of glucagon, in addition to insulin. Glucagon is a naturally occurring hormone that raises blood sugars in response to hypoglycemia and is impaired in people with type 1 diabetes.
The addition of glucagon to the closed-loop system was designed to more closely mimic the physiology of a person without diabetes. Currently, glucagon is not used as a routine part of type 1 diabetes therapy, but is used in large doses to treat people in low blood sugar emergencies.
Maintaining recommended blood sugar levels is a major challenge for people with type 1 diabetes because of the possibility of blood glucose dropping dangerously low, which can lead to seizures, coma, and in some cases death.
The system combined a sensor placed into a vein to monitor glucose levels and infusion pumps that were controlled by a sophisticated computer program that determined insulin and glucagon dosage based on blood glucose levels.
According to Edward Damiano, Ph.D., associate professor of Biomedical Engineering at Boston University and senior author of the study, the system was designed to counteract moderate drops in blood sugar with minute doses of glucagon spread out throughout the day, similar to what the body does in people without diabetes.
The trial involved 11 adult subjects with type 1 diabetes, who wore the system for 27 hours. The participants ate three standardized, high-carbohydrate meals and slept overnight at the hospital. In the first phase of the study, six participants achieved average blood glucose levels (140 mg/dl) in the target range with the artificial pancreas system without hypoglycemia, but other participants had some hypoglycemia.
In a second phase of the study, the researchers adjusted the system to reflect a slower insulin absorption rate and none of the participants experienced significant hypoglycemia in repeat experiments. Although average blood sugar levels were slightly higher,in the repeat experiments, they still remained near the target range.
Overall, the research team demonstrated that glucagon consistently helped reverse the downward slope of blood-glucose levels. ”This study is proof of principle that the use of glucagon in artificial pancreas systems can be beneficial and important in lowering the risk of low blood-sugar emergencies,” said Aaron Kowalski, Ph.D., Assistant Vice President of Metabolic Control at JDRF and Director of the JDRF Artificial Pancreas Project.
“In addition, it also provides us with important insight about the role that the rate of insulin absorption will play in customizing algorithms that will drive these systems so that they function optimally.”
Type 1 diabetes is an autoimmune disease in which the immune system attacks and kills the cells in the pancreas that produce insulin, a hormone that enables people to convert food into energy.Although the glucagon-producing cells are not destroyed, glucagon is no longer released in response to low blood sugars, leaving people with type 1 diabetes vulnerable to hypoglycemia. Type 1 diabetes affects 3 million American children, adolescents, and adults.
To manage their disease, people with type 1 diabetes need to measure their blood sugar multiple times throughout the day (typically by pricking a finger for a drop of blood), and pump insulin or inject themselves multiple times daily to keep blood sugar levels within a healthy range. That daily routine continues for life, because insulin administration does not cure diabetes.
Research has shown that good blood-sugar control is a key factor in reducing the risk of the devastating long-term complications of the disease, such as blindness and kidney disease — but that the fear of low blood-sugar emergencies often prevents many people from achieving tight control, and remains a constant concern for those who manage their diabetes well.
The landmark Diabetes Control and Complications Trial (DCCT) showed that with intensive insulin therapy with multiple daily injections, excellent blood-glucose control was obtained, but at the expense of a considerable increase in hypoglycemia.
About JDRF’s Artificial Pancreas Project
This study is the latest development within JDRF’s Artificial Pancreas Project, and stems from the progress made since 2006 in the JDRF-funded Artificial Pancreas Consortium, a group of university-based mathematicians, engineers, and diabetes experts that has developed the computer programs needed for an artificial pancreas, and established their scientific feasibility.
These academic studies within the Artificial Pancreas Project are an excellent complement to JDRF’s work with industry participants to develop first-generation systems.
JDRF announced the first major non-exclusive industry initiatives of the Artificial Pancreas Project earlier this year, when it entered into a non-exclusive partnership with Animas, a Johnson & Johnson company, to develop a first-generation artificial pancreas system. JDRF also announced a non-exclusive partnership with BD (Becton, Dickinson and Company) aimed at developing novel insulin delivery products — a key component of developing safe and effective artificial pancreas systems.
The goal of the JDRF Artificial Pancreas Project is to speed the development of automated diabetes management systems. The goal of an artificial pancreas has also been embraced by the U.S. Food and Drug Administration, which along with JDRF and National Institutes of Health, brought people with diabetes together with scientists, regulators, and industry in scientific workshops on the subject in 2005 and 2008. The FDA has designated an artificial pancreas as one of its “critical path” initiatives.
An artificial pancreas would measure blood sugar through a continuous glucose monitor (CGM), which continuously reads the glucose levels through a hair-thin tube inserted just below the skin, typically on the stomach. The CGM would beam those readings to an insulin pump. In an advanced system, the pump would house a sophisticated computer program that would automatically calculate the necessary amount of insulin, and in some designs glucagon, based on the CGM’s glucose readings, and deliver the right amounts of these drugs.
The development of an artificial pancreas system is an essential step towards an ultimate cure for type 1 diabetes — a “bridge to a cure.”
More information about the JDRF Artificial Pancreas Project can be found online at jdrf.org/artificialpancreasproject. The site includes information for people with type 1 diabetes about research leading to the development of an artificial pancreas, as well as interactive tools, project timelines, chats with researchers, and access to information about clinical trials.
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Having a child with Type 1, this is great and very promising! I hope all research and trials prove to be very successful. Great Work!!! It is nice to see our money being spent on something that will greatly change the lives of many!!!