In
a pioneering clinical study, Dr. Carol Levy and colleagues are examining
whether an artificial pancreas (AP) can prevent blood sugar levels that are too
low (hypoglycemia) from occurring in patients with type 1 diabetes (T1D) as
they sleep. Nighttime hypoglycemia can cause seizures and coma or even death in
rare cases, among the more than three million Americans with type 1 diabetes,
making an artificial pancreas system potentially life altering for those living
with diabetes.
This
outpatient AP trial at Mount Sinai is the result of collaboration between Mount
Sinai, the University of Virginia (UVA) and Mayo Clinic, and represents the
first of its kind in New York City. The study began enrollment in October 2014
with a group of ten patients and measures the ability of an automated
artificial pancreas (AP) system, developed by UVA, to normalize nighttime sugar
levels in T1D patients (known as the Diabetes Assistant or DiA). By combining a
smart phone app with a unique algorithm to help control 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.
In
this Mount Sinai clinical research study, investigators are following ten patients
with type 1 diabetes for five days, using the UVA AP system, which provides
continuous glucose monitoring and insulin pump therapy through the overnight
study period. The software algorithm running smart phone communicates with an
insulin pump and glucose sensor to automatically keep each patient’s sugar
levels in a designated range to avert nighttime hypoglycemia.
Typically,
many patients adjust their insulin delivery based on their glucose readings,
but cannot do so while they sleep. By automating this 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,”
says 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.”
“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.”
“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.”
The
AP study recruited, enrolled and completed overnight studies for l ten patients
ahead of its June 2015 deadline. Data was presented at the American Diabetes
Association meeting in June of 2015 showing less hypoglycemia in the AP group
as well as overall time in range for blood glucose levels. The next step
is preparation of an academic paper in the coming months.
New
Studies opening in the near future
RPI
Collaboration: The initial clinical trial is part of a larger
Artificial Pancreas Research Program recently launched in partnership with UVA
and Rensselaer Polytechnic Institute (RPI), featuring the latest innovations in
biotechnology, systems engineering, and information technology. With RPI, Dr. Levy aims
to launch another study to add a new RPI-developed technological platform to
UVA’s Diabetes Assistant system. For this study, 5 patients will wear the
device 24/7 for 3 days and eat meals without ‘announcements’ to test the
technology in a more natural outpatient setting.
Multisite
Study: Dr. Levy and her team completed a grant application to
NIH in early spring 2015 for a multisite study of the Diabetes Assistant
technology designed by UVA who will act as the coordinating site. Funding
notification is expected shortly. This study will likely be the
pivotal study to bring the device to the market. Mount Sinai was invited to
join the team of respected artificial pancreas researchers from sites including
Stanford, Mayo Clinic, Barbara Davis Diabetes Center, Montpelier France,
Amsterdam, and the University of Padova on this multisite study, which is
expected to begin early 2016.
Supporting
Artificial Pancreas Research
To learn more about supporting Dr. Carol Levy and the Artificial
Pancreas Research Program, please contact Pamela
Heller, Director of Development, at 646-605-8722 or pamela.heller@mountsinai.org. or click the link https://www.philanthropy.mountsinai.org/artificialpancreas
