A newly launched clinical research study at the Icahn School of Medicine at Mount Sinai is examining whether an artificial pancreas (AP) can prevent too low blood sugar levels or hypoglycemia in patients with type 1 diabetes (T1D) as they sleep. People fast as they sleep and nighttime hypoglycemia can cause seizures, and coma or death in rare cases, among the more than three million Americans with type 1 diabetes.
A collaboration between Mount Sinai, the University of Virginia (UVA) and Mayo Clinic, the outpatient study, the first of its kind in New York, began enrollment in October 2014. The ongoing study is measuring the ability of an automated artificial pancreas (AP) system developed by UVA to normalize nighttime sugar levels in T1D patients. By combining a smart phone app with a unique algorithm for controlling blood sugar levels, a glucose sensor and an insulin pump, the AP system is designed to maintain sugar levels without requiring patients to frequently test their blood sugar levels or inject insulin themselves.
Typically, many patients adjust their insulin delivery based on their glucose readings, but they cannot while they sleep. By automating the process, the UVA AP system has the potential to better control diabetes while significantly reducing the self-care burden.
"The goal is for people with type 1 diabetes using the UVA AP system to show superior glucose control, reduced hypoglycemia overnight, and for significantly longer periods compared to standard therapy," said Carol Levy, MD, Associate Professor of Medicine, Endocrinology, Diabetes and Bone Disease at the Icahn School of Medicine at Mount Sinai and lead investigator. "If these patients can achieve stable glucose levels between 80-140mg/dl during the night, we expect this will lead to improved blood sugar control throughout the next day as well."
According to Dr. Levy, UVA's Artificial Pancreas system, because it regulates levels of a single hormone (insulin), is patient-friendly and likely to be used widely if approved by the U.S. Food and Drug Administration (FDA). Other more complex systems currently in development may take longer to implement, she said.
The current study is part of a larger Mount Sinai's artificial pancreas research program recently launched in partnership with UVA and Rensselaer Polytechnic Institute. The program features latest innovations in biotechnology, systems engineering, and information technology.
Mount Sinai's clinical research study is following ten people with type 1 diabetes for five days, with the UVA AP system providing continuous glucose monitoring and insulin pump therapy through the overnights during the study period. The software algorithm runs on a smart phone that communicates with an insulin pump and glucose sensor to automatically keep each patient's sugar levels in a designated range to avert nighttime hypoglycemia.
"This is the first study of a new and very promising partnership between Mount Sinai and the University of Virginia, which is part of a large collaborative effort involving five research centers in the U.S., three in Europe and one in Israel funded by JDRF, NIH, and the European Commission," said Boris Kovatchev, Ph.D., Director at the Center for Diabetes Technology at the University of Virginia and Professor at the University of Virginia School of Medicine. "Our goal is to embark on a large-scale multi-center pivotal trial of this artificial pancreas system by 2016."
The study is funded by a grant from JDRF, the leading research and advocacy organization funding type 1 diabetes research.
Aaron Kowalski, JDRF Vice President for Artificial Pancreas Research said, "Proving the value of AP systems for better and safer control of the disease during the nighttime will be a major advance in the management of T1D. JDRF is also simultaneously funding other studies through NIH support to evaluate the potential of several AP systems when used in multiple settings to speed these technologies to the marketplace."
"Mount Sinai's study will pave the way to using AP systems by people with type 1 diabetes in an unsupervised environment and ultimately will lead to future studies supporting FDA approval for use in T1D patients," said Yaron Tomer, MD, FACP, FACE, Lillian and Henry M. Stratton Professor of Molecular Medicine and Chief of the Division of Endocrinology, Diabetes and Bone Disease at the Icahn School of Medicine at Mount Sinai. "Our study has the potential to revolutionize the management of type 1 diabetes as it will free the patient from repeatedly testing their sugar by finger sticks and adjusting their insulin regimen which will result in better quality of life and diabetes management."
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