Bionic Pancreas Provides Dramatic Results in Clinical Trials with Type 1 Diabetics

Medical Design Briefs INSIDER

A team of researchers from Boston University and Massachusetts General Hospital report their study results in a paper published in the New England Journal of Medicine, that reveals that the latest version of a bionic pancreas device was successfully tested in type 1 diabetics in two five-day clinical trials, one in adults, the other in adolescents. They say that the device imposed minimal restrictions on patient activities, and controlled blood sugar in patients using doses of both insulin and the blood sugar-raising hormone glucagon.

“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,” says Edward Damiano, PhD, of theBoston University Department of Biomedical Engineering, principal investigator of the project and senior author of the report. “There’s no current standard-of-care therapy that could match the results we saw,” he claimed.

Along with the software improvements that allowed the device to adapt to widely varied individual dosage needs, the newest version also relies on improved hardware, including a smartphone (iPhone^® 4S) capable of practical wireless communication with two pumps delivering doses of insulin and glucagon. Every five minutes the smartphone receives a blood sugar reading from an attached continuous glucose monitor, which it uses to calculate and administer a dose of either insulin or glucagon. The smartphone includes an application on which the patient enters information immediately before eating. But instead of the complex calculation patients typically do to estimate their carbohydrate intake, this app only asks whether the meal consumed will be breakfast, lunch, or dinner and whether the carbohydrate content will be typical, larger or smaller than usual.

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