Stanley Baker can’t remember feeling quite so free in a very long time.
Baker is one of 52 people ages 12 and older with Type 1 diabetes who for five days tested in real-world settings a bionic pancreas, designed to take over the job of providing insulin on a minute-by-minute basis when the body’s real organ fails.
This totally relieves you of managing the diabetes, said Baker, 76, of Ipswich, Massachusetts. It was extremely liberating.
The mechanical device worn outside the body was designed by Edward Damiano, a Boston University engineer who has worked on the technology ever since his 15-year-son was diagnosed with diabetes as an infant. It kept patients at near normal levels in two trials and prevented dangerous blood sugar drops better than standard therapy, according to a report Sunday at the American Diabetes Association meeting in San Francisco.
It is among the first tests of such a system outside of a tightly controlled setting, according to Damiano, who said the investigators are starting a new, larger trial in four cities Monday and plan to have an improved version of the device on the U.S. market by the end of 2017.
The bionic pancreas is composed of five parts connected externally to one another and the body. It includes two pumps attached to the abdomen to deliver hormones, a glucose monitor with a wire that runs just under the skin and a computer program that calculates proper doses in a closed-loop system.
Adults using the device, which checks their blood every five minutes, roamed Boston unfettered, eating and exercising normally, ignoring the condition that typically weighs on their daily activities. Adolescents younger than 20 given the technology were attending a diabetes summer camp. Both groups were closely monitored 24 hours a day.
There’s no current standard-of-care therapy that could match the results we saw, said Damiano. The results were simultaneously published in the New England Journal of Medicine.
About 3 million Americans have Type 1 diabetes, in which the pancreas stops secreting the hormone insulin used to convert food into energy. Patients typically test their blood several times a day to measure glucose levels, then calculate the amount of insulin they need to inject based on their diet and exercise. High blood sugar can lead to organ damage and death, while too little can trigger unconsciousness or a coma.
The device isn’t being tested on people with the more common Type 2 diabetes, which typically develops in adults and is linked to a sedentary lifestyle. People with Type 2 produce insulin, though their bodies don’t use it properly.
The researchers used commercially available equipment, including a glucose monitor from Dexcom and two pumps. They crafted their own computer algorithm and ran it on an iPhone 4 to wirelessly connect the component parts and calculate how much of each hormone the patient needed.
It’s constantly adapting to the patient’s ever-changing insulin needs, said Damiano, who built the device with a colleague.
Other companies, including Medtronic and Johnson & Johnson, are working on similar products.
The bionic pancreas tested by the Boston researchers goes further, by constantly measuring blood-sugar levels and predicting the amount of insulin needed.
It is unique because it also administers glucagon, another hormone that causes the liver to release glucose.