Commentary by: Carol Levy, MD
A big challenge for people with type 1 diabetes is managing blood sugar (or glucose) levels when they are asleep. Dips in blood sugar levels overnight may go unrecognized and can lead to serious consequences, including seizures and coma or, in rare cases, death.
Artificial Pancreas System
An artificial pancreas system that uses a smart phone application to continuously monitor blood sugar levels and communicate with an insulin pump to give small doses of insulin when needed is currently being tested for use overnight in a clinical trial by researchers at the Icahn School of Medicine at Mount Sinai, New York, NY. The artificial pancreas system was developed by researchers at the University of Virginia (UVA) and is not currently available for purchase or use beyond the research setting.
About the Study
“The study was done at night based on the belief that the biggest challenge that people with type 1 diabetes have with glucose management is when they can’t focus on it and make their own adjustments,” said lead investigator Carol Levy, MD, Associate Professor of Medicine, Endocrinology, Diabetes and Bone Disease at the Icahn School of Medicine at Mount Sinai. “During the day, people can look at their devices and can make decisions. However, overnight they are asleep, and they can’t manage their glucose levels,” Dr. Levy said.
“In addition, 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 have low blood sugar overnight. This device allows them to wake up with a good blood glucose level in the morning no matter what they ate or drank before they went to bed,” Dr. Levy said. “If these people 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,” Dr. Levy said.
“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.
The study included 10 adults with type 1 diabetes who were followed during a 5-day control period in which they used 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 study was funded by a grant from JDRF. The researchers plan to examine the system in future studies involving larger number of people and at different diabetes centers starting in 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.
Mount Sinai Hospital. Mount Sinai launches artificial pancreas research study. January 21, 2015. http://www.mountsinai.org/about-us/newsroom/press-releases/mount-sinai-launches-artificial-pancreas-research-study. Accessed March 18, 2015.