Studies show reduction in CGM levels and hypoglycemia compared to insulin-pump therapy…
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Edward Damiano, PhD, the Boston University Professor of Biomedical Engineering leading the team of researchers behind the “bionic” pancreas, presented details of his team’s progress at the American Association of Clinical Endocrinologists’ (AACE) 24th Annual Scientific and Clinical Congress.
Recently tested in real-world outpatient clinical trials at multiple locations throughout the country, Damiano’s technology – a “closed-loop,” dual-hormone system – mimics 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 bionic pancreas system consists of a Dexcom® continuous glucose monitor (CGM), two Tandem t:slim® infusion pumps that pump insulin and recombinant glucagon through the skin, and mathematical algorithms that receive updated CGM readings and make completely automated decisions about insulin and glucagon dosing every five minutes.
The mathematical algorithms that his group have developed run in an app on an iPhone®. The iPhone reads the blood glucose values from the CGM and then uses wireless Bluetooth technology to communicate the insulin and glucagon doses computed by the algorithms to the t:slim pumps. The insulin and glucagon delivery rates are thus adjusted every five minutes to keep blood glucose levels within a target range.
Damiano’s ultimate system design, 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.
During his presentation, Damiano shared the results from four recently completed outpatient trials testing their system, which took place between 2013 and 2015 in adults, adolescents and pre-adolescents with type 1 diabetes. Subjects ranged in age between 6 and 76 years old.
In the first three outpatient studies, patients received therapy with the bionic pancreas for five days and therapy with their own insulin pump for five days. The fourth outpatient study was a home-use study in which subjects received therapy with the bionic pancreas for 11 days and therapy with their own insulin pump for 11 days at home and in the workplace.
The studies, Damiano noted, minimally constrained patients’ behavior but allowed close observation for risk mitigation and high-density data collection. There were no restrictions placed on their activity level, exercise or diets. The system was initialized only with the patient’s weight; no information about the patient’s usual insulin regimen was provided to the algorithm, which automatically adapted insulin and glucagon dosing online.
In the four studies, the bionic pancreas simultaneously reduced mean CGM glucose levels and hypoglycemia, as compared with the patients’ own insulin-pump therapy. The mean CGM glucose level across the entire cohort of the first adult study, the adolescent study, the pre-adolescent study and the adult multi-center home-use study was 133, 142, 137, and 141 mg/dl, respectively, and the percentage of CGM glucose values below 60 mg/dl was 1.5, 1.3, 1.2, and 0.6 percent, respectively.
Based on these results, Damiano explained that the bionic pancreas would deliver mean HbA1c levels of around 6.5 percent in children and adults with type 1 diabetes while significantly and simultaneously reducing hypoglycemia relative to the current standard of care.
Damiano and his team plan to start the final clinical trial in 2016 with the more portable, fully integrated unit, with the goal of bringing the device to market by late 2017 — when Damiano’s son, David, who was diagnosed with type 1 diabetes in 2000, is set to begin college.
- A true bionic pancreas prevents hypo’s and provides better control.
- Is this truly a cure or just another device declaring a cure?
- This device can cost upwards of $9000.
Presented at the AACE 24th Annual Scientific and Clinical Congress. AACE Press Release