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Smartphone System Shown to Control Blood Glucose Levels

Edward Damiano

Edward Damiano, holding an iLet device (Boston University)

21 December 2016. A bionic pancreas system using a smartphone was shown in a clinical trial to control blood glucose levels better than a commercial insulin pump in persons with type 1 diabetes. A team from Boston University that developed the system and Massachusetts General Hospital where the trial was held published its findings in the 19 December issue of the journal The Lancet (paid subscription required).

Type 1 diabetes is an inherited autoimmune disorder where the body does not produce insulin, and is diagnosed primarily in children or young adults. Autoimmune disorders are conditions where the immune system is tricked into attacking healthy cells and tissue as if they were foreign invaders, in this case, insulin-producing beta cells in the pancreas. About 1.25 million people in the U.S. have type 1 diabetes, about 5 percent of people with diabetes of any kind.

Boston University biomedical engineering professor Edward Damiano and researcher Firas El-Khatib developed the device they call a bionic pancreas to provide people having type 1 diabetes control of blood glucose levels with little or no manual intervention. For Damiano, the issue is personal, since his teenage son has type 1 diabetes. The device uses an iPhone connected with Bluetooth to a glucose monitor implanted under the skin, and pumps of insulin and glucagon, a hormone that works in the liver to prevent glucose levels from dropping to dangerously low levels.

Every 5 minutes, the monitor reads blood glucose levels, and algorithms calculate a dose of either insulin or glucagon. People wearing the device can enter information through an app about anticipated meals, but these entries are optional. The device also alerts designated caregivers or medical staff if blood sugar drops to dangerous levels, or if the hormone pumps are disconnected for extended periods.

Damiano and El-Khatib tested earlier versions of the bionic pancreas in a series of clinical studies beginning in 2010. The studies first proved the concept of the device, then showed the system could control blood glucose levels for 5 days in adults, adolescents, and children. In those trials, participants were closely monitored.

The new clinical trial tested the device under more real-life conditions. In the intermediate-stage trial, 39 individuals age 18 and over with type 1 diabetes were randomly assigned to use the bionic pancreas, or their usual glucose monitor or insulin pump for 2 periods of 11 days each. While participants were not closely monitored during the study, they were required to stay with a 30 minute drive of the trial sites: Mass. General, University of Massachusetts Medical Center, Stanford University, and University of North Carolina at Chapel Hill.

The research team looked primarily at average glucose concentration levels in the participants and amount of time with glucose concentrations considered hypoglycemic, or below safe levels. The results show participants with the bionic pancreas reported glucose concentrations of 141 milligrams per deciliter (mg/dl) compared to 162 mg/dl for individuals using their conventional devices, a large enough difference to be statistically reliable.

Bionic pancreas users also reported hypoglycemic blood glucose levels 0.6 percent of the time, while participants with conventional device had hypoglycemic levels 1.9 percent of the time. Few, if any, incidents of symptomatic or severe hypoglycemia were reported by bionic pancreas users, including in overnight periods when the risk of hypoglycemia is high.

“The availability of the bionic pancreas,” says Damiano in a Boston University and Mass. General statement, “would dramatically change the life of people with diabetes by reducing average glucose levels, thereby reducing the risk of diabetes complications, reducing the risk of hypoglycemia, which is a constant fear of patients and their families, and reducing the emotional burden of managing type 1 diabetes.”

Damiano and El-Khatib founded the company Beta Bionics that licensed the technology from Boston University and is developing an iPhone-based system called the iLet similar to the device tested in the clinical trial. Beta Bionics raised $2.5 million in early donations and a $5 million investment from drug maker Eli Lilly and Company. The company is also raising investment capital through equity crowdfunding. Beta Bionics is a certified benefit corporation, meeting social entrepreneurial standards of transparency, accountability, sustainability, and performance.

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