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View Full Version : 'Bionic Pancreas' Research Brings Device Closer to Real Life



Janis.Y.Chen
Fri 9th October '15, 3:35pm
Miriam E Tucker
May 15, 2015

Nashville, Tennessee — The bihormonal "bionic pancreas" continues to perform well in clinical trials and could reach the US market by 2018.


In the opening plenary session here at the American Association of Clinical Endocrinologists' (AACE) 2015 Annual Scientific and Clinical Congress (http://www.medscape.com/viewcollection/33382), the device's developer, Edward R Damiano, PhD, professor of biomedical engineering at Boston University, Massachusetts, summarized positive results from four recent outpatient clinical trials and described a proposed large, year-long pivotal trial that will be used to seek US Food and Drug Administration (FDA) approval.


"Bionic pancreas" is the name given specifically to the dual-chambered investigational device that comprises two separate pumps for delivering both insulin and glucagon, a continuous glucose monitor (CGM), and a control algorithm built into an iPhone app. Dr Damiano's team is now building a single integrated device that will incorporate all the different components. That device will be the one used in the pivotal trial, he explained during a press briefing.


In all four trials — two of which were presented (http://www.medscape.com/viewarticle/826779) at the American Diabetes Association (ADA) 2014 Scientific Sessions (http://www.medscape.com/viewcollection/33150) and simultaneously published in the New England Journal of Medicine — near-normal blood glucose levels were achieved in children and teens at a summer camp and in adults in real-world settings for 5 to 11 days at a time, with very low rates of hypoglycemia.
"What we're hoping is to bring technology that will not cure diabetes but will eliminate the management challenges to keep people safe, healthy, and out of harm's way until a cure is found," Dr Damiano said during his presentation.


Session moderator and American College of Endocrinology president Yehuda Handelsman, MD, medical director at the Metabolic Institute of America in Tarzana, California, told Medscape Medical News, "The use of glucagon is revolutionizing the whole concept of the artificial pancreas....[Dr Damiano] added the aspect of managing hypoglycemia. I think that's what's giving us a whole new confidence."


Dr Handelsman cautioned, however, that so far "these are very small studies in very willing people," which is why "we are very much anticipating this large phase 3 study."


Former AACE president Paul Jellinger, MD, clinical professor of medicine at the University of Miami, Florida, said, "It's clearly groundbreaking. What it tells me is how important insulin and glucagon are in the control of blood sugar....With these two hormones only, you're able to achieve exquisite control. I think the importance of this is that patients can forget about their disease."

Source: http://www.medscape.com/viewarticle/844749?src=confwrap&uac=180112PN