LAS VEGAS – Advances in developing a so-called bionic pancreas that seamlessly and automatically mimics pancreatic endocrine function in patients with diabetes is far ahead of projections, according to Dr. Jay S. Skyler.
More than 20 groups around the world are working on versions of a bionic pancreas, also known as an artificial pancreas, Dr. Skyler said at the annual meeting of the American Association of Clinical Endocrinologists. These devices combine a continuous glucose monitor, computer algorithms, and an insulin pump (and sometimes also a glucagon pump) to enable tight glucose control.
Dr. Jay S. Skyler
"The progress is moving at dramatic pace," said Dr. Skyler. He and his coauthors recently published a summary of the developments (Ann. N.Y. Acad. Sci. 2014;1311:102-23).
"The prediction when JDRF set up its road map for an artificial pancreas 2 years ago was we would achieve that by 2023. My bet is we achieve it sooner than that: Sometime in the next 3 years or so, we will have available for us to use bionic pancreases to allow excellent glucose control for our patients."
These devices have performed well in studies that have progressively moved them out of the lab and into the real world, according to Dr. Skyler, associate director of the Diabetes Research Institute, chairman of the Type 1 Diabetes TrialNet Clinical Trials Network, and professor of medicine, pediatrics, and psychology at the University of Miami.
One example is the MD-Logic Artificial Pancreas, which improved nocturnal glucose control among adolescents and teenagers at a summer camp (N. Engl. J. Med. 2013;368:824-33). "A lot of people played with these kinds of devices but always in the clinical research center or in the hospital. This was the first outpatient study that was done at a camp," he noted.
And in a study by the Diabetes Wireless Artificial Pancreas Consortium of patients at home,the device maintained glucose levels within a very tight range, with 95% of morning values falling between 110 and 140 mg/dL (Pediatr. Diab. 2013;14:159-167). "That is really a rather impressive achievement," Dr. Skyler said.
The Boston Bionic Pancreas has a receiver that attaches to an iPhone and two pumps, one delivering insulin and the other glucagon. Results in inpatients have shown good glycemic control over the course of the day (Diabetes Care 2012;35:2148-55).
When compared with usual insulin-pump therapy among 20 adult outpatients in the crossover Beacon Hill Study, the bionic pancreas yielded lower mean glucose levels as well as a decrease in the percentage of values falling within the hypoglycemic range (N. Engl. J. Med. 2014 June 15 [doi:10.1056/NEJMoa1314474]). Findings were similar among 32 youth at a summer camp.
The Virginia Closed-Loop Artificial Pancreas interfaces with an Android phone via the Diabetes Information Application and has an insulin pump. This device performed well among outpatients at a summer camp, with the time in range (defined as 70-150 mg/dL) increasing from 55% to 73%, and no excursions below 60 mg/dL (Diab. Technol. Ther. 2014;16 (Suppl 1):A-42)
In an outpatient overnight study, the time in range (defined as 80-150 mg/dL) during early morning hours increased from 39% under open-loop conditions (with user intervention) to 82% under closed-loop conditions (with no user intervention) (Kovatchev B et al. American Diabetes Association, 2013, Abstract 993-P).
The time spent at levels of less than 70 mg/dL fell from 2.0% to 0.6%.
Dr. Skyler disclosed that he was on the board of directors of Minimed (prior to acquisition by Medtronic) at the time of development of the first continuous glucose monitoring systems. He is currently on the board of directors of Dexcom and is an investor in Tandem Diabetes Care.