After years of research and trials, could the bionic pancreas finally be ready to hit the market?
Diabetes is a perennial area of research in endocrinology, but scientists are now on the precipice of a new era of treatment options. To introduce some of the most revolutionary advances, the Presidential Plenary at ENDO 2016 in Boston is focusing on “Technology and Delivery Breakthroughs in Diabetes.”
This session aims to highlight progress in two particular areas: stem cell-derived beta cells and the bionic pancreas. Both breakthroughs show major promise, but on the device side, the bionic pancreas has been the subject of anticipation for some time.
About two and a half years ago, Endocrine News spoke to Edward Damiano, PhD, Boston University, about his bionic pancreas project, which he was inspired to pursue when his infant son was diagnosed with type 1 diabetes. He had just started outpatient trials at that time — using an iPhone-based prototype that involved a sensor and bihormonal insulin and glucagon delivery system.
Donors and the T1D community converged to help fund and facilitate the next stages of the device. Today, Damiano is ready to present a fully autonomous, dual-chamber bionic pancreas called iLet at the ENDO plenary.
“Profound positive change will be brought about by the bionic pancreas, and its arrival is imminent,” says Damiano.
A Game Changer
He believes that the iLet will redefine the patient–provider interaction with regard to diabetes management. The device was designed with the goal of eliminating the four greatest concerns of type 1 diabetes management: 1) eradicating long-term complications through superior blood sugar management; 2) curtailing hypoglycemia and eliminating severe hypoglycemia; 3) automating blood sugar control; and 4) unburdening people with type 1 diabetes and their families of the emotional hardship and fear that is, for now, part of everyday life.
“A device that solves any one of these concerns would be groundbreaking,” Damiano says. “A device that simultaneously solves all four is without precedent and truly game changing.”
Damiano credits his wife with giving the iLet its name. While they were walking their beagle in Concord, Mass., she announced that it should be dubbed the ‘islet’. Damiano agreed immediately, but did not think he’d be able to trademark the word ‘islet’. He suggested the name to a colleague, who replied that it should be spelled ‘iLet’.
Damiano filed the trademark application with his attorney and thus — in homage to the pancreatic islets of Langerhans — the name iLet was born.
His team has received funding from the NIH to conduct the Bionic Pancreas Bridging Study in the second half of 2016, which will be the first outpatient trial testing the iLet and iLet infusion set, and the penultimate study of the bionic pancreas before the final Bionic Pancreas Pivotal Trial in 2017. With his son now well into his teen years, Damiano and other members of the T1D community are excited to see the device crossing the final hurdles to reaching the market.
Witness a Remarkable Demonstration
During the ENDO plenary, the feature of the iLet will be demonstrated to the audience. The bionic pancreas is unique in that it controls both insulin and glucagon, whereas most artificial pancreases automate only insulin. It does this by using two pumps, which are both fully integrated into the device.
Additionally, the results of the recent outpatient studies with the current version of the bionic pancreas in adults and children will be presented. Participants had no restrictions put on diet and exercise to test its effectiveness in real world conditions.
“It provides a truly turnkey solution for both children and adults with type 1 diabetes, and is able to cope with a wide range of insulin needs across all ages,” says Damiano.
The bionic pancreas is autonomous in determining all dose deliveries, which saves the user from having to figure out basal-rate profiles, correction factors, or carbohydrate-to-insulin ratios. Damiano describes the system as a “pharmacokinetic model of subcutaneously infused insulin absorption in its mathematical dosing algorithm.” This means it accounts for outstanding insulin in both the subcutaneous depot and blood, thereby avoiding any stacking and overdosing of the hormone.
No Smartphone Needed
Although the iLet looks similar to an iPhone with a touch-screen display and handheld design, it does not rely on a smartphone, tablet, or laptop to function. Damiano’s team aimed to create an appealing user interface that combines practical functions with aesthetics. To the layperson, it may even be difficult to identify the iLet as a medical device.
Damiano looks forward to sharing his passion for the iLet with the attendees at the Presidential Plenary. As a biomedical engineer by trade, he finds great inspiration in collaborating with researchers and practitioners from varied backgrounds — which has played a pivotal role in getting the bionic pancreas to its current stage. With the diverse gathering of leaders expected at this year’s ENDO, the sharing of ideas could lead to the next great endocrine innovation.
Mapes is a Washington D.C.-based freelance writer and a regular contributor to Endocrine News. She wrote about the top endocrine discoveries of 2015 in the December issue.
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