Keep Your Fingers Crossed: FDA Approves Artificial Pancreas Outpatient Trial

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The FDA has approved the start of outpatient trials of a smart phone-based monitoring device that functions as an artificial pancreas. If the device, which automatically measures blood glucose levels and adjusts them with insulin, is successful, several million type 1 patients could enjoy a whole new level of convenience.

Trials are expected to begin in early May.

The hand-held device, developed by a research team at the University of Virginia School of Medicine, uses a reconfigured smart phone to automatically monitor blood glucose levels and adjust as necessary with insulin doses. The UVA product is part of a larger collaboration, the Artificial Pancreas Project, that involves several US and international organizations. Among them are the Juvenile Diabetes Research Foundation, the University of California, Santa Barbara, Montpellier University Hospital in France, and the Universities of Padova and Pavia in Italy.

The artificial pancreas is a sort of Holy Grail in diabetes technology. On paper, the concept is simple: Create a device that can continuously measure blood glucose levels and send commands to an insulin pump to inject corrective doses of insulin. A workable device would free insulin users from an often laborious lifelong routine of constant monitoring and adjusting.

However, because of the stakes involved, the requirements for an artificial pancreas are especially high: It must be made of extremely durable and accident-resistant material; its measuring capabilities must be extremely accurate; it must be small enough to allow for user comfort.

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