Steven Russell, M.D., Ph.D., hopes the current approach to type 1 diabetes management soon will seem incredibly old-fashioned. At a plenary session at the AAP National Conference & Exhibition, the Bionic Pancreas Project principal investigator described his team’s goal to bring an automated, wearable system to market by the end of 2018.
The technology combines a continuous glucose monitor, mathematical algorithms and drug delivery pumps to enable a bionic pancreas to regulate blood glucose levels automatically.
Currently, only about 14% of children have A1C test results that meet American Diabetes Association guidelines, and parents face daily challenges in their children’s care.
“These are kids that are asked to do something essentially that we don’t ask of any other patient in medicine. We ask them to do their own testing and make their own decisions about how much of a drug to give,” Dr. Russell said. “And if they make the wrong decision about the dose of the drug, they can become seriously ill or even die of a severe hypoglycemic event.”
Kids with type 1 diabetes face additional challenges such as unpredictable exercise levels and changes in insulin sensitivity (e.g., in post-menarche patients).
The bionic pancreas takes away much of the thinking that goes into current management. The device is managed via an iPhone app. At initialization of the device, only the patient’s weight must be entered, but the patient has the option to tell the device when and how much he or she is about to eat so it can deliver 75% of a dose of insulin that it predicts is needed based on history. The bionic pancreas adapts to individual insulin needs over the following 18 hours and learns over time.
Every five minutes — 288 times a day — the bionic pancreas measures a patient’s insulin levels, implements an algorithm to make decisions and remotely controls the two pump reservoirs that contain insulin and glucagon. When a dose of insulin is needed, the algorithm signals the device to deliver it via an insulin pen cartridge as a subcutaneous infusion. If the patient approaches hypoglycemic range, a small amount of glucagon levels out the blood glucose. The system delivers the same amounts of medication as used with current models of care but with a more steady approach.
“We’re trying to take away a lot of this work that the parent has to do,” he said.
Fears that the child will become hypoglycemic while asleep also are eliminated, because the device enables the child to have a lower mean glucose at night, Dr. Russell said. “Nighttime is actually easier. There’s no meals, there’s no exercise. It’s a perfect time for maintaining a very good mean (blood glucose).”
The bionic pancreas has had success in clinical trials and was tested during a diabetes camp. In 2017, the team begins a pivotal trial and is working with the Food and Drug Administration to provide data on safety and efficacy, as well as a form of glucagon that can remain at room temperature for a longer period of time. Find out more at www.bionicpancreas.org.
“We’d love to be put out of business by a cure for diabetes. Everybody who works with diabetes kids would like that,” said Dr. Russell. “Until that happens, we can reduce the burden of diabetes, we can reduce the fear of diabetes, we can reduce the complications associated with diabetes.”