‘Bionic Pancreas’ Edges Closer to Market

NASHVILLE, Tenn. — Researchers have now married new phone technology with a “closed-loop,” dual-hormone system and developed a successful “bionic pancreas,” according to a speaker at the American Association of Clinical Endocrinologists (AACE) 24th Annual Scientific and Clinical Congress.

The research, presented by Edward Damiano, PhD, Boston University Professor of Biomedical Engineering, showed the bionic pancreas could mimic the normal function of the pancreas by automatically regulating glycemia in patients with type 1 diabetes through as-needed administration of insulin to lower blood glucose and glucagon to raise blood glucose.

The Technology

The bionic pancreas system consists of a Dexcom continuous glucose monitor (CGM) and two Tandem t:slim infusion pumps, and mathematical algorithms that receive updated CGM readings and make completely automated decisions about insulin and glucagon dosing every 5 minutes.

These mathematical algorithms developed by Damiano’s group run in an iPhone app. The iPhone reads the blood glucose values from the CGM and then uses wireless Bluetooth technology to communicate the insulin and glucagon doses. To keep blood glucose levels within the target range, insulin and glucagon delivery rates are adjusted every 5 minutes, according to a press release.

The ultimate system design, which is currently under development, is a single, compact, integrated unit that houses a dual chamber infusion pump, the CGM and their algorithms, and operates completely independently of a smartphone.

Study Results

During his presentation, Damiano shared the results from four recently completely outpatient trials testing the system. The trials took place between 2013 and 2015 in adults, adolescents and pre-adolescents with type 1 diabetes (age range, 6 to 76 years).

In the first three outpatient studies, patients received therapy with the bionic pancreas for 5 days and therapy with their own insulin pump for 5 days. The fourth outpatient study was a home-use study in which patients received therapy with the bionic pancreas for 11 days and therapy with their own insulin pumps for 11 days at home and in the workplace.

Results from the four studies showed that the bionic pancreas simultaneously reduced mean CGM glucose levels and hypoglycemia, as compared with the patients’ own insulin pumps. Mean CGM glucose levels across the entire cohort were 133 mg/dL for the first adult study, 142 mg/dL for the first adolescent study, 137 mg/dL for the pre-adolescent study and 141 mg/dL for the adult multicenter home-use study.

Additionally, percentage of CGM glucose values below 60 mg/dL were 1.5% in the first adult study, 1.3% in the adolescent study, 1.2% in the pre-adolescent study and 0.6% in the adult multicenter home-use study, according to the data.