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Bionic pancreas superior to insulin pumps in adolescents, adults
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SAN FRANCISCO — New data demonstrate that a wearable, automated bihormonal, bionic pancreas improved glycemic control without increasing hypoglycemia among adolescents, according to a presentation here.
“This system is unique because it uses only the weight of the patient for initialization and then uses three insulin controllers, and one glucagon controller. It has been augmented with adaptive capability so it can adapt to insulin needs across a wide spectrum of patients over a short period of time,” Steven J. Russell, MD, PhD, an assistant professor of medicine at Massachusetts General Hospital, said at the American Diabetes Association’s 74th Scientific Sessions.
Russell and colleagues examined 32 adolescents who participated in the Barton Center Summer Camp Study, consisting of 5 days of glycemic control with the automated bihormonal bionic pancreas and 5 days of control care with an insulin pump. Patients included in the diabetes camp were administered meals without restrictions on diet or exercise.
The researchers derived data from a continuous glucose monitor (CGM) and an autonomously adaptive algorithm via smartphone application to control subcutaneous administration of insulin and glucagon, according to data.
Primary outcomes included differences in the average of scheduled plasma glucose measurements and the percentage of the measurements that were less than 70 mg/dL.
Russell and colleagues found that the mean plasma glucose level was 138 mg/dL (range: 101 mg/dL to 185 mg/dL) on the bionic pancreas, and 157 mg/dL (range: 103 mg/dL to 221 mg/dL) in the control period (P=.004), according to data.
During the time using the bionic pancreas, 6.1% of all scheduled plasma glucose measurements were <70 mg/dL and during the control period, 7.6% of the measurements fell below that threshold (P=.23).
Additional findings established that the bionic pancreas effectively reduced the mean frequency of treatments for hypoglycemia from once per 0.8 days to once per 1.6 days (P<.001); the percentage of time with a glucose level between 70 mg/dL and 180 mg/dL was higher (75.9% vs. 64.5%, P<.001).
The crossover Beacon Hill Study was published simultaneously today in the New England Journal of Medicine and also demonstrated statistically significant results among adults.
“The performance of our system in both adults and adolescents exceeded our expectations under very challenging real-world conditions,” Ed Damiano, PhD, associate professor of biomedical engineering at Boston University, who designed the system for his son with type 1 diabetes, said in a press release.
Damiano added that a cure for diabetes is always the end goal.
“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 1 diabetes, including my child and so many others,” Damiano said in the press release. — by Samantha Costa
Disclosure: Russell reports receiving consulting fees from Medtronic (through Diabetes Technology Management), lecture fees from Tandem Diabetes, Sanofi Aventis, Eli Lilly, Abbott Diabetes Care and Biodel, and loaned equipment and technical assistance from International Biomedical, Abbott Diabetes Care, Medtronic, Insulet, and Hospira and holding a pending patent application for a blood glucose control system (PCT/US 13/870,634), assigned to Partners HealthCare and Massachusetts General Hospital.
For more information:
Russell SJ. Abstract 237-OR. Presented at: American Diabetes Association’s 74th Scientific Sessions; June 13-17, 2014; San Francisco.
Russell SJ. N Engl J Med. 2014; doi: 10.1056/NEJMoa1314474.
Perspective
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Irl B. Hirsch, MD
The hypoglycemic issues in adolescents with diabetes are very different than adults, as I’ve seen in my own clinic. I tend to tell my patients to back off of their insulin because they’re having so much hypoglycemia. The main issue with adults is that we cannot get enough CGM into the environment.
It will be exciting to see where the bionic pancreas goes. The adolescent data were tremendous; I think we need to use the tools that we have better than we are using them right now.
What we’ve learned is that our insulins are not as good as we thought they were when they initially came out with the rapid-acting analogues.
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