By recently releasing guidelines for premarket approval and investigation device exemption of “artificial pancreas” devices, the FDA set the stage for approval of these systems in the management of type 1 diabetes.
By recently releasing guidelines for premarket approval and investigation device exemption of “artificial pancreas” devices, the FDA set the stage for approval of these systems in the management of type 1 diabetes.
The term “artificial pancreas” derives from the potential ability of devices to artificially replace the functions of healthy pancreases in regulating blood glucose, a function that has been lost in type 1 diabetics. The components of artificial pancreases are principally an insulin pump, a continuous blood glucose monitor and the necessary algorithm or controls to enable feedback from the glucose monitor to regulate insulin infusion rates. Insulin pumps have been on the market for a number of years and sales of approved versions of continuous blood glucose monitors have begun to escalate. Systems combining both pumps and monitors are also on the market but currently not in what is known as “closed loop” systems in which glucose levels are regulated by varying insulin infusion rates directly, without patient intervention. Given the variables impacting blood glucose levels and the potential for inadequately regulated insulin infusion to result in dangerous hypoglycemia, the technology of safely closing the loop of glucose/insulin regulation has been a challenge, at least in terms of meeting FDA approval.
A number of companies are active in the development of closed loop, “artificial pancreas” systems including J&J/Animas Systems, DexCom, Medtronic and others.
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Products, technologies and companies in the field of diabetes are the subject of the MedMarket Diligence report $D510.
