Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With more than 30,000 students, it is the fourth largest independent university in the U.S. It has 17 colleges and schools and a number of mu
For the past 14 years, Dr. Ed Damiano, a Boston University engineering professor, has been working on the iLet, a compact artificial pancreas system by Beta Bionics now in its third generation of design after three years of investigational human trials.
Recently, Dr. Damiano spoke with Insulin Nation via telephone about the progress being made to bring the device to market.
Dr. Damiano believes the iLet is now nearly poised to commence FDA clinical trialing.
Dr. Damiano expects that additional pediatric trials will be needed, as well.
Dr. Damiano believes that Beta Bionics is the first medical device company to operate as a benefit corporation and to seek crowdsource funding.
Ed Damiano, Aaron Kowalski, and others discuss how soon we are to having an artificial pancreas on the market.
Ed, who now works as an associate professor in the Biomedical Engineering department at Boston University, had a background in applied math and mechanics, but little experience in the field of medicine when David was first diagnosed.
But as David grew older, Ed began to put an idea together that could drastically improve not only David's life, but the lives of Type 1 diabetes sufferers everywhere.
So Ed designed a bionic pancreas that produces both insulin (which lowers your blood sugar) and glucagon (which raises your blood sugar).
said Ed Damiano.
Check out the video below to meet Ed and David and learn more about how the bionic pancreas works:
The AP quoted Ed Damiano, a biomedical engineer at Boston University, as saying "My goal is to have this device done by the time my kid, who has Type 1 diabetes, goes to college" which turns out to be in about three years.
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The Bionic Pancreas is the creation of Ed Damiano, Associate Professor of Biomedical Engineering at Boston University.Dr. Damiano is the father of a teenage son with Juvenile Diabetes.
Dr. Damiano has a distinctive, if not bolder, vision than other researchers.
In fact, to distinguish his device he has branded it the Bionic Pancreas.
Damiano's software currently runs on an iPhone for clinical trials but Ed has plans to develop a separate piece of hardware that will contain the Bionic Pancreas software.
In many respects this is a direct result of Dr. Damiano's dual hormone design.
Because the system has an imbedded "rescue" through glucagon, the administration of insulin therapy can be more aggressive.
Dr. Damiano received FDA approval for a series of more extensive clinical trials using a fully mobile and wireless Bionic Pancreas system during 2013.
The first of these trials began in February and continued for approximately six months.
The patients stayed overnight in a Beacon Hill hotel but were be free to pursue normal day-to-day activities during the daytime.
Each patient's trial will last for approximately two weeks.
During the summer Dr. Damiano ran further clinical trials at a diabetes summer camp, sponsored by the Helmsley Trust.
During 2014, Dr. Damiano will conduct another summer camp study in the pediatric population and a larger multi-center hospital staff study in the adult population.
Ed is working on all of these challenges but each represents a formidable barrier.
No stable, extended-life liquid glucagon exists today.
The current liquid glucagon is usable for less than a day unless refrigerated.
In order for the Bionic Pancreas to work, Dr. Damiano will need a liquid glucagon formulation lasting for at least one week at room temperature.
At least three small companies are working to develop such an extended-life liquid glucagon formulation.
These new glucagon formulations will require clinical trials and FDA approval prior to their incorporation into Dr. Damiano's human clinical trials.
Beta Bionics, a startup created by Boston University biomedical engineer Ed Damiano, hit the benchmark after 775 members of the public put up an average of $1,300 each to back its idea for a new kind of pacemaker for diabetics.
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