Managing blood sugar is a daily challenge for diabetics and their families. This involves having to check blood repeatedly throughout the day by pricking themselves and injecting insulin manually or through an insulin pump. These devices provide flexibility, but there is still a need to monitor blood sugar levels regularly, and adjust the way the device delivers insulin (bolus or continuous), and by how much, based on readings, diet and physical activity. Too high sugar levels can damage organs and may lead to death, while too little can induce fainting spells or coma.
Conventional devices have made it easier for diabetics to manage their condition. However, many diabetics fail to achieve optimal blood sugar control, and can be prone to life-threatening hypoglycemia. The next step is to eliminate the guesswork and reduce the effort by completely automating blood sugar monitoring and insulin delivery using a single system, so that diabetics can achieve considerable freedom and quality of life.
Researchers at Massachusetts General Hospital and Boston University may have just the solution with their “bionic pancreas.” It has five parts: an iPhone, which is hardwired to a glucose monitor, the iPhone app that calculates doses, and two pumps -- one for insulin and another for glucagon -- which are attached to the abdomen and used to deliver hormones.
In a study published by the New England Journal of Medicine and presented recently at an American Diabetes Association Scientific Sessions in San Francisco, the research team described the results of testing the bionic pancreas system in two separate trials: one in a cohort of 20 adults and another involving 32 adolescents. Both groups suffer from Type 1 diabetes -- the type in which the body cannot produce insulin needed to process sugar into energy.
The experimental device continuously monitored blood sugar levels of the participants and then automatically gave them insulin or sugar-raising glucagon every five minutes or as needed. The researchers said the group of diabetics achieved better glycemic control during the 5-day test compared to when they used standard monitors and insulin pumps. Moreover, the participants said they felt unencumbered by the device, worried less, and appreciated that they needed to exert much less effort in dealing with their condition. They only had to check their blood sugar manually twice a day instead of multiple times, and the device maintained sugar levels consistently.
“The key element with the current version of this device is that it’s wearable, allowing participants to stay in something close to their usual environments, exercise and eat whatever they want,” Steven Russell, MD, PhD, of the Massachusetts General Hospital, and lead co-author of the study, said in a statement.
Another unique feature of the system is it can address low blood sugar levels because of its glucagon pump -- a component missing in other similar experimental devices to treat diabetes.
“In both of these studies this device far exceeded our expectations in terms of its ability to regulate glucose, prevent hypoglycemia and automatically adapt to the very different needs of adults – some of whom were very insulin-sensitive – and adolescents, who typically need higher insulin doses,” Edward Damiano, PhD, associate professor of biomedical engineering at Boston University and senior study author, said in a press release. “There’s no current standard-of-care therapy that could match the results we saw.”
The current system consists of five conventional parts made to work together through a special computer algorithm and a sophisticated app. The researchers hope to get a more advanced version of the device after more trials, and within three years, ultimately get approval from the U.S. Food and Drug Administration.
If approved, it can join the growing market of artificial pancreas devices for diabetics. Large medical device companies such as Medtronic and Johnson & Johnson already have similar devices that aims to help diabetics around the world -- including the millions in the U.S. and the Middle East -- where it is now considered an epidemic.