In the opening plenary session here at the American Association of Clinical Endocrinologists' (AACE) 2015 Annual Scientific and Clinical Congress, 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…
