FDA Issues Draft Guidance for Artificial Pancreas System

Mark Crane

June 21, 2011

June 21, 2011 — The US Food and Drug Administration (FDA) yesterday issued draft guidance to help advance the development and approval of an artificial pancreas system to treat type 1 diabetes in the United States.

An artificial pancreas system is an automated, closed-loop system that combines a continuous glucose monitor, an insulin infusion pump, and a glucose meter for calibrating the monitor. The devices are designed to work together, monitoring the body's glucose levels and automatically pumping appropriate doses of insulin as determined by a computer algorithm, the FDA said.

"There have been tremendous strides made in the research and development of an artificial pancreas system, and there are many research projects underway looking at the feasibility of these device systems in hospital settings," according to the FDA.

The draft guidance addresses an early version of an artificial pancreas system, known as a low-glucose suspend system. It can help reduce or lessen the severity of hypoglycemia by temporarily reducing or stopping the delivery of insulin. However, patients must still manage their glucose levels with a glucose meter and give themselves insulin, if necessary. The draft guidance provides recommendations for those planning to develop and submit an application for a low-glucose suspend system intended for single-patient use in the home environment.

The FDA is seeking input from industry, researchers, the clinical community, and other stakeholders on the draft guidance. Specifically, the agency is interested in the types of clinical studies that should be conducted and what their target outcomes should be to demonstrate safety and effectiveness, which are necessary requirements for FDA approval.

"Our goal is to provide a clear pathway for artificial pancreas development so that people with diabetes can benefit from innovative medical devices," Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, said in a news release. "Getting a safe and effective artificial pancreas system to Americans with type 1 diabetes is an FDA priority."

Diabetes Leaders Applaud Guidance

The draft guidance was applauded by leaders in the diabetes treatment community.

"Development of a safe and effective artificial pancreas has the potential to be life-saving and can dramatically improve the quality of life for hundreds of thousands of individuals with type 1 diabetes," Richard M. Bergenstal, MD, past president of the American Diabetes Association and executive director of the International Diabetes Center at Park Nicollet in Minneapolis, Minnesota, told Medscape Medical News.

"The [American Diabetes Association] is very excited by the positive tone of the FDA guidance and to hear that it is a priority for the FDA to move this research and implementation along as fast as possible," Dr. Bergenstal said.

"Glucose sensing and insulin delivery technology have dramatically improved in the past 5 to 10 years," he added. "It is time to add some brains to the insulin delivery pump so that it knows when to decrease insulin in case of a low glucose or eventually increase insulin delivery in the case of a high glucose."

Howard Wolpert, MD, senior physician at the Joslin Diabetes Center in Boston, Massachusetts, and director of the center's insulin pump program, told Medscape Medical News, "It's important to come up with explicit guidelines so that industry knows what they need for newer technology approval. There is a sense that things had been moving slowly with the FDA in getting new technology improved, so this is an important step.

"There has been a degree of unhappiness that the FDA is slower than regulatory agencies in other countries in approving this technology," said Dr. Wolpert, who is involved in randomized controlled trials to evaluate the potential of real-time continuous glucose monitoring in diabetes management. "What's welcome about the guideline is that it explicitly lays out what the FDA is looking for, focusing on downsides as well as benefits. The target population for the artificial pancreas system may be younger kids. But FDA is right that safety and efficacy should be demonstrated first in adults."

The FDA currently is working on a second draft guidance that will help manufacturers and researchers develop more autonomous artificial pancreas systems. That guidance is expected to be issued by the end of the year.

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