Artificial Pancreas Study Examines Improving Nighttime Blood Glucose

Commentary by Lead Investigator: Carol Levy, MD

Scientist or tech holds liquid biological sample in gloved handsA clinical trial is examining whether an artificial pancreas improves nighttime blood glucose levels in patients with type 1 diabetes. The study is being conducted by the Icahn School of Medicine at Mount Sinai, New York, NY, and is funded by a grant from JDRF.

The artificial pancreas consists of an insulin pump, glucose sensor, and smart phone application. The application, which is not currently available for purchase or clinical use beyond the research setting, runs an algorithm that communicates with an insulin pump and glucose sensor to automatically keep each patient’s sugar levels in a designated range. The artificial pancreas system was developed by researchers at the University of Virginia (UVA).

“The goal is for people with type 1 diabetes using the UVA artificial pancreas system to show superior glucose control, reduced hypoglycemia overnight, and for significantly longer periods compared to standard therapy,” said lead investigator Carol Levy, MD, Associate Professor of Medicine, Endocrinology, Diabetes and Bone Disease at the Icahn School of Medicine at Mount Sinai. “If these patients can achieve stable glucose levels between 80-140 mg/dL during the night, we expect this will lead to improved blood sugar control throughout the next day as well.”

“Depending what people with diabetes eat for dinner. they may riddled with high blood sugar overnight. If they have a glass of wine, they may be have low blood sugar overnight. This system helps mitigate those changes and keep blood sugar levels stable,” Dr. Levy explained.

“While this is not a cure, the artificial pancreas is a next step technology that can alleviate a lot of worry,” said Alecia Wesner, a patient in the clinical trial and a board member of the JDRF. “I remember the 1970s of diabetes care so this is a tremendous advancement in technology. That something like this exists to regulate and fine-tune your blood sugar levels to a point that surpasses what you can do yourself, especially overnight is amazing,” Ms. Wesner said.

Study Design
The study enrolled 10 adults with type 1 diabetes who were followed during a 5-day control period in which they used their standard diabetes management protocol, including an insulin pump and continuous glucose monitor at home. Next, the participants were studied for 5 days in a research hotel where they were able to eat and exercise as they wished. The smart phone application was turned on from 11 pm until 7 am the next morning to manage blood glucose levels overnight.

“This study was conducted at night based on the belief that the biggest challenge that patients with type 1 diabetes have with glucose management is keeping levels stable overnight,” Dr. Levy explained. The study is testing whether patients who maintain stable glucose levels during the night have more stable glucose levels the next day as well, Dr. Levy said.

“We are waiting on final data from the trial,” Dr. Levy said.

“I watched as the overnight data was downloaded and saw how the system delivered microboluses overnight that kept my blood glucose level in a totally steady even line,” explained Ms. Wesner. “For example, if I received a half unit of insulin over an hour overnight, I could see how the system broke that down. It sometimes gave me less on the front end and more on the back end,” Ms. Wesner said. She added that she would definitely use the device if it were approved for use.

“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 United States, 3 in Europe and 1 in Israel funded by JDRF, NIH, and the European Commission,” said Boris Kovatchev, PhD, 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.”

Another system  that administers both insulin and glucagon is being developed by researchers at Harvard Medical School and Boston University. “Individual patients may find that they derive different benefits from different devices,” explained Dr. Levy. “Proactively adjusting the insulin level alone can often mitigate both high and low glucose levels,” Dr. Levy said.

March 18, 2015

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