Managing Diabetes with
the Wearable Pancreas


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The idea of finding a cure for diabetes – a disease that affects 360 million people worldwide – has been an elusive challenge for researchers. Until a biological cure comes along, a bionic pancreas being developed by a biomedical engineer could be a bridge to the cure.  

The daily maintenance of Type 1 diabetes is extremely demanding. Today people manage it with either multiple daily insulin injections or the use of an insulin pump and sometimes a continuous glucose monitor. Insulin users have to calculate appropriate doses based on what they eat, their physical activity, blood glucose, and other factors. It’s a complicated self-monitoring dosage regimen based on glucose levels measured through multiple finger sticks. 

Prof. Edward R. Damiano with his son David, who is a Type I diabetic. Image: BU.edu

“The bionic pancreas is a wearable device that makes automated decisions for you and lifts the burden of diabetes management,” says Edward R. Damiano, associate professor of biomedical engineering in the Department of Biomedical Engineering, Boston University. Damiano started working on the device over ten years ago, with an aim to have it on the market before his son, who has type 1 diabetes, goes to college in 2017.  

“When my son goes to college, it will be on him to manage his diabetes. What we want to build is something that will be much safer, be much more effective, and require much less effort,” says Damiano. "It will relieve him from constantly having to think about his glucose levels and free him up to do the things an 18-year old college kid needs to do.” 

Closed-Loop System

The bionic pancreas combines the two valuable tools – insulin pump and glucose monitor – with a third technology to create a completely automated “closed-loop” system. It uses a computer program to calculate how much insulin the pump delivers based on readings from the continuous glucose monitor. “There was a need for a mathematical algorithm to determine what are the appropriate doses of insulin to give in response to a glucose signal that continuously updates every five minutes,” says Damiano. 

Even with continuous insulin infusion, it is almost impossible to completely avoid hyperglycemia (high blood glucose) and hypoglycemia (low blood glucose). “We added another hormone – glucagon – which opposes the insulin infusion as it raises glucose levels. It’s compromised in people with type 1 diabetes, so they really suffer from a dual hormonal insufficiency,” explains Damiano.  

Prof. Damiano’s aim in building a bionic pancreas is to remove the human brain from the equation. Image: Cydney Scott / BU.edu

 

 

The bionic pancreas acts automatically to keep blood glucose levels within a normal range by automatically raising and lowering the blood glucose (just as the pancreas does). The device includes three components: a continuous glucose monitor, control software (smartphone app), and the insulin and glucagon pumps. It gets automated glucose levels every five minutes and the control software makes 288 decisions every day that determine dosage. The smartphone app then directs an insulin pumps clipped to the patient’s belt to inject either insulin or its counterpart, glucagon, as needed. 

“Currently it runs on the iPhone and uses a Bluetooth radio to talk to the pumps,” says Damiano, adding that his team is currently in the process of working with his industrial collaborators to build a new platform – a single handheld unit that will have all of the components built into one device – essentially turning three devices into one.

Prototype to Product

To handover the control to a machine for dosage is a first in the diabetes business, so the bionic pancreas will have to meet stringent regulatory challenges. Damiano and his team of engineers have been conducting extensive clinical trials for over six years and have two-and-a-half more years of studies ahead of them before the device is submitted for FDA approval.  

“We are in the midst of our second outpatient study in adults that we refer to as our Bionic Pancreas Multicenter Study, which is being conducted at four clinical sites across the country,” he says. After the final pivotal study in 2016, data from the clinical trials along with all of the necessary device documentation will be submitted for FDA approval in early 2017. The results have been promising so far and Damiano is optimistic about having an FDA-approved device by the second half of 2017.  

In 2013, the FDA approved Medtronic’s MiniMed 530G, as the first artificial pancreas device system in the FDA’s “threshold-suspend” category. The MiniMed can sense when blood sugar levels drop to a doctor-programmed danger zone and if the wearer doesn’t respond to an audible alert, it automatically shuts off the insulin supply. Their artificial pancreas, however, never increases insulin dosing nor does it add glucagon.  

“Our system completely takes over diabetes management,” reiterates Damiano, who is hopeful the bionic pancreas will be available for use in 3-4 years. In the coming years, even before the device hits the market, he envisions that cloud-based support for medical data is going to become extremely important. “Health metrics like blood glucose data, insulin dosing information, and related data could be available in the cloud and help people manage their diabetes. Access and exchange of this information with a cloud-support system will mark an important change in diabetes management that will be even further exploited by a bionic pancreas in the near future.”

The bionic pancreas is a wearable device that makes automated decisions for you and lifts the burden of diabetes management.

Prof. Edward R. Damiano,
Boston University

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August 2014

by Chitra Sethi, Managing Editor, ASME.org