The AP (Artificial Pancreas) system runs an algorithm on a smartphone that communicates with an insulin pump and an implanted glucose sensor.
Research under way at the Icahn School of Medicine at Mount Sinai is revolutionizing the management of type 1 diabetes by using novel technology that serves as an artificial pancreas and automatically enables patients to achieve more stable glucose levels 24 hours a day.
Led by Carol Levy, MD, Associate Professor of Medicine (Endocrinology, Diabetes and Bone Disease), the Icahn School of Medicine is one of nine U.S. and European sites participating in the research, and sharing a $12.7 million grant from the National Institutes of Health. Dr. Levy is one of the study’s lead investigators.
The InControl AP (Artificial Pancreas) system, developed at the University of Virginia, runs a software algorithm on a smartphone that communicates with a standard insulin pump and an implanted glucose sensor that identify and maintain a personalized blood-glucose range for each patient. The system monitors and controls the patient’s blood-glucose levels to avert nighttime hypoglycemia and ensure a goal glucose level in the morning. The application takes into account variables that include meals, physical activity, sleep, and stress.
The 240-patient trial, expected to start this spring, will run for three years and compare the InControl AP system to a control of a standard insulin pump to assess how well blood-sugar levels are controlled and whether the risk of hypoglycemia is reduced. This will be one of the largest long-term clinical trials of an artificial pancreas ever to be done in the home setting.
The new study builds on research conducted at Mount Sinai in 2014-2015. In collaboration with the University of Virginia and the Mayo Clinic, that study followed 10 patients with type 1 diabetes for five days and was the first outpatient study of an AP system in New York State.
“That initial study showed that patients achieved stable glucose levels during the night and that the AP system led to improved blood-sugar control throughout the next day, as well,” says Dr. Levy.
A second study conducted by Dr. Levy’s team in November 2015 was done in partnership with the Rensselaer Polytechnic Institute, Stanford University, and the Barbara Davis Center for Diabetes at the University of Colorado, and observed outpatient participants over three days while they wore the AP system.
Dr. Levy, who has type 1 diabetes herself, says that if the system is approved by the U.S. Food and Drug Administration (FDA), it is likely to be used widely because it is user-friendly and regulates only a single hormone: insulin. Other, more complex systems are currently under development.
“The ultimate goal of this upcoming study is to establish the safety and efficacy of the InControl AP system for FDA approval and accelerate its introduction to the market so patients can start using the system on their own,” says Dr. Levy.