From right, researcher Dr. Steven Russell of Massachusetts General Hospital stands with Frank Spesia and Colby Clarizia, participants in a Type I diabetes trial testing an electronic device called a bionic pancreas.
Doctors are one step closer to realizing the holy grail for treatment of Type I diabetes, reporting positive outcomes in adults and youth treated with a "bionic pancreas" that automatically monitors and moderates doses of insulin to keep blood glucose at normal levels during the day and night.
Researchers tested their bionic pancreas technology in a pair of studies examining outcomes in adults living their normal lives around Boston and youth at a camp for children with Type I diabetes. Results showed that those using the device spent less time with dangerously high or low levels of glucose in their blood, especially during the night.
Without a cure for Type I diabetes, where the pancreas creates little or no insulin, patients with the condition must manually monitor their blood glucose levels with multiple daily finger-prick blood tests, using the results to either manually inject insulin or manage an insulin pump that delivers injections. A bionic or artificial pancreas would automate the process, taking regular blood measurements and delivering insulin with minimal patient intervention.
"A cure is always the end goal," senior study author and Boston University biomedical engineering associate professor Ed Damiano said in prepared remarks. "As that goal remains elusive, a truly automated technology, which can consistently and relentlessly keep people healthy and safe from harm of hypoglycemia, would lift an enormous emotional and practical burden from the shoulders of people with Type I diabetes, including my child and so many others."
Damiano’s son, who is now 15 years old, was diagnosed with Type I diabetes at 11 months, according to a study press release.
The researchers allowed study participants to largely manage their own care and live their lives as they normally would without regular finger-prick testing and stringent food monitoring, although adults were limited to moderate alcohol intake during the 5-day study. All participants were instructed to enter their meal data into the app-based interface for the device, although they were only required to enter rough estimates and those over the age of 18 were not reminded if they forgot to enter the information.
The youth arm included 32 participants aged 12-20 years old who followed the same meal and activity schedule as other campers during the 5-day trial, but they were wirelessly monitored closely by researchers and camp staff. The study’s adult arm included 20 participants wore the device for 5 days while living normal lives in Boston.
The results "exceeded our expectations under very challenging real-world conditions," Damiano said. "There’s no current standard-of-care therapy that could match the results we saw."
Patients experienced positive benefits that "almost never go together," co-lead author Dr. Steven Russell, of the diabetes unit at Massachusetts General Hospital, added.
"Participants’ average blood glucose went down while the incidents of low blood sugar also dropped," Russel said. "The fear of hypoglycemia can limit attempts to bring the average blood sugar into the range that dramatically reduces the risk of long-term complications, so it was remarkable that we saw both of these results at once. Both groups had quite good levels in the usual care arms – averages of 159 for both adults and adolescents – but the difference while they were on the bionic pancreas was dramatic, with average blood sugar levels of 133 for the adults and 142 for adolescents"
Researchers are already gearing up for a pair of follow-up studies, one of which aims to be an 22-day "true home study" that requires only that patients stay within 1 hour’s drive of the study site. The 2nd study will evaluate the technology in kids aged 6-11, and is currently enrolling participants, according to a press release.
Some of medtech’s biggest players are also racing to develop the 1st true artificial pancreas systems, considered "the Holy Grail" of diabetes research. Medtronic in September 2013 won FDA pre-market approval for its 1st-generation artificial pancreas device, the MiniMed 530G with Enlite, which features "threshold suspension," a program which monitors and modifies insulin delivery when blood glucose readings hit preset levels, helping reduce the incidence of hypoglycemia without affecting blood sugar
The Juvenile Diabetes Research Foundation and Becton Dickinson & Co. (NYSE:BDX) recently said they’re "accelerating" development of the technology by combining their proprietary diabetes management devices in a 3-year agreement. And Cambridge Consultants and the U.K.’s Institute of Metabolic Science said they’re also researching artificial pancreas technology at Addenbrooke’s Hospital in Cambridge, England.
