Artificial Pancreas Research Program

The Artificial Pancreas Research Program is a pioneering clinical research program studying the efficacy of artificial pancreas (AP) systems to improve blood glucose control in people with type 1 diabetes (T1D) is underway at the Icahn School of Medicine at Mount Sinai. Under the leadership of Carol Levy, MD, Associate Professor of Medicine, Endocrinology, Diabetes and Bone Disease and Director of the Mount Sinai Diabetes Center and Type 1 Diabetes Clinical Research, the Artificial Pancreas Research Program is studying one of the most promising breakthroughs in type 1 diabetes treatment in decades.

Mount Sinai’s research in this area has the potential to revolutionize the management of type 1 diabetes by paving the way for people with type 1 diabetes to use AP systems at home. Strong initial results have led to more studies supporting FDA approval. “The Artificial Pancreas Program at Mount Sinai holds the promise of freeing the patient from the burdens involved in self-care on a minute to minute basis, including frequent finger stick testing, careful monitoring of glucose sensor data, and regularly making insulin dose adjustments to reduce the risk of both high and low blood sugar levels,” says Dr. Levy. “In short, these devices have the potential to result in better quality of life for people with T1D.”

Diabetes Assistant (DiAs): The initial Artificial Pancreas trial at Mount Sinai began in October of 2014 and was the first of its kind in New York City. A collaboration among Mount Sinai, the University of Virginia (UVA) and Mayo Clinic, this study measured the ability of an automated, smart phone based AP system developed by UVA (known as the Diabetes Assistant or DiAs) to normalize nighttime sugar levels in T1D patients. By combining a smart phone configured to act as a mini computer running 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. This JDRF funded study evaluated patients over five nights in a supervised hotel setting. Data revealed significantly improved overnight and daytime blood glucose control and less hypoglycemia.

RPI Collaboration: A recent study in collaboration with Stanford University and the Barbara Davis Diabetes Center evaluated a new AP system created by Rensselaer Polytechnic Institute (RPI). In this philanthropy funded study, patients wore the device 24/7 for three days, again in a supervised hotel setting. Participants ate meals without announcements and there was minimal patient input overall. Results to be presented at the ADA June 2016

Sensionics, Precise II Study: This study is currently ongoing and evaluates a first in class implanted glucose sensor that stays active for 90 days without being reinserted or reactivated. Current glucose sensors in the US remain active for no more than 7 days before needing to be reinserted and restarted. While this current sensor is active for 90 days, a new version is already planned that will be smaller and active for 180 days. These long-term sensors offer greater freedom to patients and have the potential for use as a part of an artificial pancreas system.

RPI Collaboration Follow-up: The goal of these studies is for patients to take the device home for longer trials and to expand this study to younger adults and adolescents with T1D.

International Diabetes Closed Loop Trial (IDCL): This 10-site international study will trial another artificial pancreas system developed by UVA and refined for clinical use by TypeZero Technologies. Sites include Samsum Clinic, Stanford, Mayo Clinic, Barbara Davis Diabetes Center, Montpelier France, Amsterdam, University of Padova, and Harvard. These studies are expected to provide enough data to submit to the FDA for approval in order to bring the device to market.

Animas Hypoglycemia/Hyperglycemia Minimizer: This trial will evaluate a Johnson & Johnson product that uses a dexcom sensor and UVA based algorithm. This system will run using an insulin pump and a glucose sensor. We anticipate this study will open in the fall.

Future studies: There are several additional studies in development as part of the on-going Artificial Pancreas Research Program. Grants have been submitted and are in process and pending funding. 

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