There are three main parts to what experts call a "closed-loop" artificial pancreas: an insulin pump, a real-time, continuous glucose monitor, and the computer algorithm that calculates the proper dose of insulin. The goal is to deliver insulin with no patient intervention, improving the accuracy of dosages, and thereby "closing the loop." The pump and monitor are each about the size of a pager, and the hope is to one day install software onto a mobile device instead of a laptop.
Animas fully supervised patients for the duration of its study. Future steps include a study in which patients will spend half of their time under hospital care and the other half at home. Ultimately, the unit will be tested on diabetics going about daily life, without supervision.
Animas was acquired in 2006 by pharma giant Johnson & Johnson. It has since partnered with DexCom, Inc., a supplier of continuous glucose monitors, and signed an agreement with the Juvenile Diabetes Research Foundation to create the first commercial closed-loop system.
This year, Animas received a warning letter from the U.S. Food & Drug Administration, in part for late reporting of adverse events among patients using its insulin pumps. A company spokeswoman said one patient who was injured had improperly used the pump, while "errors in our computer system" delayed reports of two more hospitalizations.
Cost is another potential barrier. The company's insulin pump alone retails for $6,343, although insurers are more commonly covering them.
— Meeri Kim