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The first at-home study to test the efficacy & safety of a fully automated, dual hormone (glucagon and insulin) bionic pancreas was presented at ADA.
The first at-home study to test the efficacy and safety of a fully automated, dual- hormone (glucagon and insulin) bionic pancreas was presented at the ADA Scientific Sessions. The system is designed for adults with type 1 diabetes to use over multiple days in a home setting with no restrictions on diet and exercise.
One of the lead investigators, Edward R. Damiano, PhD, Professor of Biomedical Engineering, Boston University, MA stated that the findings of this trial were consistent with those of previous outpatient studies of children and adults with type 1 diabetes in more controlled settings.1,2
Dr. Damiano noted that while sophisticated technology exists, such as continuous glucose monitoring and insulin delivery systems, “What we have been working on for a little over a decade now is a technology that adds a third component…mathematical dosing algorithms.”
“This device makes a new therapeutic decision every 5 minutes as to how to best dose this insulin. It’s making 288 decisions a day that people with diabetes no longer have to make. This is much more than just lifting a burden, this is making people healthier, preventing the very risky severe hypoglycemia, automating glycemic control, and doing it for everyone. So essentially removing so much of the inter-subject variability with standard care of practice of today.”
For this random-order cross-over study, researchers compared the efficacy of the dual-hormonal bionic pancreas (intervention arm) to the participants’ own insulin pump therapy (control arm). During the study, 39 adults, 33 years and older with a mean duration of type 1 diabetes of 7±10 years, lived at home, performed their normal activities, and followed their usual diet. Their baseline A1c was 7.7±1.2%.
“The device asks only one question as it comes online and begins automatically controlling blood sugar. It asks your body weight, a very objective piece of information,” stated Dr. Damiano. “Then it adapts continuously to your ever-changing insulin needs.” Most patients were not coming in under goal on insulin pumps; 2% to 0.5% experienced hyperglycemia. Variability between patients regarding average blood glucose and hypoglycemia was reduced with the bionic pancreas compared to insulin pump therapy.
Relative to insulin pump therapy, the bionic pancreas was associated with a reduction in mean blood glucose levels (141±10 vs 162±29 mg/dl, P<0.0001). Participants had a three-fold reduction in percentage of time experiencing hypoglycemia, defined as below 60 mg/dl (1.9±1.7 vs 0.6±0.6%, p<0.0001), and had fewer hypoglycemic events per day (0.59±0.56 vs 0.90±0.64 daily events, P=0.023).
“Our goal is to bring this to clinical trials later this year and start the final pivotal trial in the first half of next year…with possible commercial availability in the middle of 2018.” The system can also deliver just insulin or just glucagon.
1. Russel SJ, et al. Outpatient glycemic control with a bionic pancreas in type 1 diabetes. N Engl J Med. 2014;37:313-325.
2. Russel SJ, et al. Day and night glycaemic control with a bionic pancreas versus conventional insulin pump therapy in preadolescent children with type 1 diabetes: a randomised crossover trial. Lancet Diabetes Endocrinol. 2016;4(3):233-243.