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FDA is playing an important role in accelerating the availability of an artificial pancreas by encouraging independent clinical research and developing a regulatory pathway for new technologies.
Critical Path Dimension: Accelerating the availability of an artificial pancreas
The Problem: Nearly 21 million Americans have diabetes, a complex disorder most often associated with elevated blood glucose levels. It is the leading cause of kidney failure and adult-onset blindness, increases the risk of heart attack deaths by two to four times, and causes more than 80,000 amputations and a million emergency room visits each year. Improving glycemic control can significantly reduce these devastating consequences. However research shows that the majority of diabetics are not able to achieve adequate glycemic control.
The Solution: FDA is collaborating with private organizations, researchers, and other government agencies to accelerate development of new technologies that are needed for an artificial pancreas. The goal of an artificial pancreas is to maintain blood glucose levels within normal ranges, with little to no patient involvement. In other words, it will monitor glucose levels in the body and automatically adjust the delivery of drugs that can either reduce or elevate blood glucose levels. The first generation of an artificial pancreas is likely to consist of three components: (1) an infusion pump to deliver the required drug, many of which are already available; (2) a continuous glucose monitor, several of which have been approved by the FDA for tracking and trending glucose levels; and (3) an algorithm to communicate between the pump(s) and glucose monitor. An algorithm will receive information from the glucose monitor and convert it to instructions for the infusion pump.
The Unique Role of the FDA: FDA is advising independent clinical researchers as they develop new technologies that are needed to make an artificial pancreas a reality and assisting them as they design studies to evaluate their safety and effectiveness. FDA is also collaborating with stakeholders to define a regulatory pathway for these new technologies.
Goals: These efforts will result in improved outcomes for patients by accelerating development of technologies that will revolutionize diabetes care and management.