JDRF-Funded Researchers Report Success with First Automated Real-World Study in Type 1 Diabetes Patients; JDRF Applauds Recent FDA Approval to Conduct Low-Glucose Suspend Device Clinical Trial at Home
NEW YORK, October 28, 2011 --- Pivotal advances toward the development of an artificial pancreas were announced today, furthering the prospect of bringing this innovative and life-saving device to market.
For the first time ever, patients were able to control their diabetes using an artificial pancreas system in a real-life setting, JDRF-funded researchers in Europe announced today at a press conference in Montpellier, France. The study took place in France and Italy. JDRF applauds this major step forward in the field of artificial pancreas research and in diabetes care because of how this work could transform the lives of millions of people with type 1 diabetes (T1D).
In parallel experiments performed at Montpellier University Hospital in France (led by professor Eric Renard and professor Jacques Bringer), and at the Universities of Padova and Pavia in Italy (led by Drs. Claudio Cobelli and Daniela Bruttomesso), two patients with T1D attained near-normal glucose levels after spending one night outside of a hospital while their diabetes was automatically managed by a prototype artificial pancreas system. The patients were able to eat a meal at a restaurant and spend one night at a hotel while using the device.
"This marks a day that has been long awaited by people with type 1 diabetes, and we congratulate the researchers for this important achievement," said Jeffrey Brewer, president and CEO of JDRF. "We are now bounds closer to the realization of the first generation of an artificial pancreas that will truly revolutionize diabetes care."
These studies represent the first outpatient trials using an approach developed by the JDRF-supported International Artificial Pancreas Study Group, an international research consortium including teams from Montpellier University Hospital, the Universities of Padova and Pavia (Italy), and the Universities of Virginia in Charlottesville and of California in Santa Barbara (USA). Eight more patients enrolled in the trial will begin outpatient testing in the coming weeks in Montpellier, France and in Padova, Italy.
The research team used already approved insulin pumps (OmniPod) and continuous glucose monitors (DexCom), which were controlled by a hand-held device created at the University of Virginia by a team led by Dr. Boris Kovatchev and Patrick Keith-Hynes and monitored by the investigators at all times to ensure safety.
People with T1D are burdened with constantly having to determine the right amount of insulin to dose at the right time, multiple times every day. Yet even with diligent monitoring, a significant portion of the day is still spent with either high or low blood sugar, placing them at risk for devastating complications.
"Today, there are no fully-automated insulin delivery systems available on the market, and that's why JDRF has made accelerating the development and delivery of these technologies a priority," said Dr. Aaron Kowalski, assistant vice president of treatment therapies at JDRF. "Today's announcement is incredibly exciting and shows us that the first generation of an artificial pancreas is no longer a dream. Now we need a regulatory pathway that will enable us to make it a reality."
The report coincides with a major effort in the United States to ensure a clear and reasonable regulatory pathway for similar studies, and ultimately for artificial pancreas systems to be approved and made available by the Food & Drug Administration (FDA). The FDA committed to publishing guidance on artificial pancreas systems by December 1, 2011, but the speed with which an artificial pancreas reaches patients in the United States will be determined by whether the agency issues this guidance on time and adopts recommendations from leading clinical experts.
In a letter recently sent to FDA Commissioner Margaret Hamburg and leading members of Congress, the American Association of Clinical Endocrinologists, American Association of Diabetes Educators, American Diabetes Association, and the Endocrine Society told the FDA that the artificial pancreas guidance should adopt recommendations from JDRF, urging the agency to issue guidance that will allow researchers, scientists, and manufacturers to finally move forward with the next phase of outpatient clinical trials.
The advancement of an artificial pancreas is a top priority for the T1D community. A petition already signed by tens of thousands of T1D families and advocates urges the FDA to provide clear and reasonable guidelines for outpatient testing by December 1. The advancement of this life-saving technology relies on the FDA's timely action.
"Today's news is an incredible step forward," said Mr. Brewer. "But to be truly meaningful, people with diabetes must have the opportunity to benefit from research breakthroughs such as these. I hope we will be able to conduct innovative trials like these here in the U.S. soon, and we urge the FDA to demonstrate its commitment to innovative science and provide the opportunity for United States-based researchers who are part of the JDRF Artificial Pancreas Consortium to participate in this important research."
JDRF Applauds Medtronic on FDA Approval of Low-Glucose Suspend (LGS) Device Trial
Medtronic, Inc. today announced FDA approval of its Investigational Device Exemption (IDE) to conduct an in-home clinical trial of the company's MiniMed Paradigm LGS system for its ASPIRE study. The FDA approval of Medtronic's IDE marks the first time that an in-home trial of an artificial pancreas technology is approved in the U.S.
"JDRF and others have been urging FDA to create a more clear and reasonable path for low glucose suspend pumps in the United States," added Kowalski. "While long overdue, we commend Medtronic for their commitment and persistence to our patients in the United Stands and we are pleased that FDA has agreed to let this promising technology move forward into outpatient trials."
JDRF recently submitted comments to the FDA on its draft guidance for the testing and approval of an LGS system. An LGS system is a version of an insulin pump which suspends insulin delivery when a monitor indicates a person with diabetes has or is projected to have dangerously low glucose levels. These systems are the first step toward an artificial pancreas, a device that could transform the lives of individuals with T1D.
"People with diabetes not only need to achieve better glucose control, but they also need to prevent life-threatening complications. Nighttime is a particularly dangerous time for a person with diabetes, because an individual's blood sugar level can drop while they are sleeping, unaware that their levels are too low and unable to do anything about it, leading to seizures, coma, and unfortunately sometimes even death," noted Kowalski.
The in-home trial of LGS systems will be the second phase of the ASPIRE (Automation to Simulate Pancreatic Insulin REsponse) study, following the completion of the in-patient clinical study. ASPIRE is a multi-center, randomized, pivotal in-home study being conducted at multiple investigational centers to determine the safety and efficacy of the Low Glucose Suspend feature in the sensor-augmented MiniMed Paradigm insulin pump.
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JDRF is the leading global organization focused on type 1 diabetes (T1D) research. Driven by passionate, grassroots volunteers connected to children, adolescents, and adults with this disease, JDRF is the largest charitable supporter of T1D research. The goal of JDRF is to improve the lives of every person affected by T1D by accelerating progress on the most promising opportunities for curing, better treating, and preventing T1D. JDRF collaborates with a wide spectrum of partners who share this goal. Since its founding in 1970, JDRF has awarded more than $1.5 billion to T1D research. More than 80 percent of JDRF's expenditures directly support research and research-related education. Past JDRF research efforts have helped to significantly improve the care of people with this disease, and have expanded the critical scientific understanding of T1D. JDRF will not rest until T1D is fully conquered.