Bringing autonomous glucose control systems to the hospital and out-patient settings
Speaker: Edward Damiano, Biomedical Engineering, Boston University
Series: MAE Departmental Seminars
Date/Time: Friday, October 12, 2012, 3:30 p.m. - 4:30 p.m.
The holy grail in glucose management of diabetes has been the long sought-after artificial pancreas. Short of a cure, the promise that the artificial pancreas holds for people with type 1 diabetes is to automatically regulate blood glucose levels so as to stave off chronic complications of the disease while at the same time eliminate the ever-present threat of acutely dangerous episodes of hypoglycemia. To meet this challenge, robustly adaptive glucose control algorithms must be integrated with accurate and reliable continuous glucose monitors and portable continuous drug infusion pumps to form an autonomous closed-loop glucose control system. Such a system must be capable of adapting, over time scales ranging from minutes to hours to days, to both sudden and gradual variations in a persons insulin requirement, such as might occur as a result of exercise, intercurrent illness, hormonal changes, puberty, etc. Using commercially available continuous glucose monitors and insulin pumps, we have been testing a bionic endocrine pancreas that is automated by control algorithms of our own design, which regulate blood glucose levels using insulin (a blood-glucose lowering hormone) and glucagon (a blood-glucose raising hormone). In clinical trials at the Massachusetts General Hospital, our system delivers consistent, safe, and effective glycemic control in adolescents and adults with type 1 diabetes under both sedentary conditions, as well as during and after periods of exercise. We have recently deployed our system on a mobile-device platform, in which our control algorithms reside on a smartphone that interconnects a continuous glucose monitor with insulin and glucagon infusion pumps. Our plans for testing our mobile system in the outpatient setting will be presented. In addition to our development efforts to bring this autonomous glucose-control technology to the ambulatory outpatient care market, we will discuss our ongoing efforts to extend this technology into the hospital ward and intensive care environments, in order to manage hospitalized patients with diabetes as well as hyperglycemia of critical illness.
Edward Damiano is an Associate Professor of Biomedical Engineering at Boston University. His expertise and training are in the areas of mechanical and biomedical engineering, applied mechanics, and applied mathematics. His research activities have included mathematical modeling, computational analysis, and experimental investigations across length scales ranging from macromolecular assemblies, cellular mechanics, and microscale biofluidics to cardiovascular fluid mechanics and the biomechanics of vestibular sensory systems. Ever since his 13-year-old son was diagnosed with type 1 diabetes at 11 months of age, he has been committed to creating and integrating closed-loop control technologies with a vision of building a bionic endocrine pancreas. This endeavor began with design and development work on mathematical algorithm strategies for blood glucose control, which he and his group began testing in his laboratory over five years ago in a swine model of type 1 diabetes. Working closely with the FDA, he and his group conducted all necessary animal experiments and performed all required software and hardware validation studies to fully qualify their system for human use in a clinical trial. Their first-generation device became the first academically sponsored investigational device exemption (IDE) ever to receive FDA approval for human testing. Their first-phase clinical trial testing this device in 24-hour experiments in adult subjects with type 1 diabetes was conducted in the Clinical Research Center (CRC) at the Massachusetts General Hospital (MGH), and was completed in 2009. On the strength of their first clinical study, and after additional preclinical studies in diabetic swine, they received IDE approval from the FDA to test their second-generation fully automated device in 48-hour experiments in a second-phase clinical trial, which began in July 2010 in the MGH CRC in children and adults with type 1 diabetes. They have recently built their system to run on a mobile-device platform, which integrates an iPhone with a blood-glucose control algorithm, an insulin pump, and a continuous glucose monitor. Their goal is to begin running five-day experiments testing their mobile-device platform in the out-patient setting this fall.