NEW ORLEANS — The bionic pancreas could be FDA approved within the next 3 years, which will significantly affect how type 1 diabetes is managed, according to Steven Russell, MD, PhD, of Massachusetts General Hospital Diabetes Research Center in Boston.
Russell, who presented the latest advances on the device at AADE 2015, the annual meeting of the American Association of Diabetes Educators, said remarkable philanthropic support has made it possible to overcome major hurdles and steadily advance the development of the bionic pancreas. Pivotal studies are now scheduled for the next 24 months.
“The bionic pancreas can regulate blood glucose much more effectively than current standard of care for research volunteers with type 1 diabetes, while requiring much less work on the part of the volunteers than their usual diabetes regimen,” said Russell.
“The bionic pancreas achieves mean glucose values that correspond to an HbA1c of less than 7% in nearly all volunteers, while at the same time reducing hypoglycemia dramatically. This technology will dramatically change the way type 1 diabetes is managed within 3 to 4 years.”
The bionic pancreas combines a continuous glucose monitor (CGM), mathematical algorithms and drug delivery pumps to automatically regulate blood glucose levels, according to Russell, who is also an assistant professor of medicine at Harvard Medical School.
He and his colleagues have designed and tested a system that delivers both insulin and glucagon under the control of autonomously adaptive algorithms. These algorithms require no information about the patient other than body weight to start, and the device can quickly adapt to changing insulin needs. No carbohydrate counting is required and qualitative meal announcements are optional, Russell explained.
“The bionic pancreas system automates type 1 diabetes care with little input needed from the patient, thereby reducing the burden of the disease. The system uses both insulin and glucagon, mimicking the normal function of the islets, and enabling it to automatically raise or lower blood glucose without action by the patient,” Russell told Endocrinology Advisor.
“This technology will dramatically change the way type 1 diabetes is managed and will enable a degree of glucose control that could nearly eliminate microvascular complications.”
Russell said the system has achieved superior blood glucose control compared with usual care with minimal hypoglycemia in volunteers with type 1 diabetes ranging aged 6 to 76 years in outpatient settings.
Additionally, at a summer camp study in 2013, the researchers conducted a 5-day experiment in adolescents with type 1 diabetes. The study had a randomized cross-over design (5 days using the bionic pancreas, 5 days using an insulin pump). The study staff and camp staff provided 24-hour coverage and telemetry to monitor glycemia.
The cohort consisted of 16 boys and 16 girls aged 12 to 20 years. Participants were on the bionic pancreas for 160 days in total. A very similar study with children aged 6 to 11 years was completed in 2014.
These studies showed that fully automated control of glycemia is feasible. They demonstrated that a bihormonal bionic pancreas reduces both mean glucose and hypoglycemia compared with usual care in outpatient environments.
A previous study also demonstrated that announcement of meals without carbohydrate counting modestly improves glycemic control. However, it is not necessary, at least for a bihormonal system.
Russell noted that clinicians will greatly appreciate that this fully integrated device drastically reduces the burden of diabetes management by patients. It eliminates the need to count carbohydrates, perform frequent blood glucose checks and administer correction boluses.
He said it also reduces the anxiety felt by patients about hypoglycemic episodes, particularly overnight.
- Russell S. T14 – Artificial Pancreas. Presented at: AADE 2015; Aug. 5-8, 2015; New Orleans.