FDA Releases Draft Guidance on “Artificial Pancreas” to Fight Diabetes

June 21, 2011

FDA diabetes artificial pancreas

FDA Guidance for "Artificial Pancreas"

FDA released a draft guidace document for development of an “artificial pancreas,” a highly anticipated step in the fight against diabetes. At one time the onset of type 1 diabetes, where the body stops producing insulin, was always fatal. Then, in 1922, scientists from the University of Toronto gave the first injection of insulin to a 14 year old boy with type 1 diabetes. The experiment was a success and one of the major achievements in the history of medicine. However, this would be the first of many steps in fighting diabetes mellitus. Two of the scientists, Dr. Frederick Banting and Professor John Macleod won the 1923 Nobel Prize for Medicine which they shared with two other members of their team, Charles Best and Bertram Collip. And a new Nobel Prize winner may be working on an artificial pancreas right now.

The concept of an artificial pancreas or a “closed loop” system is that a diabetic could automatically have their blood sugar analyzed and in real time inject insulin to maintain a normal glycemic level.

artificial pancreas FDA

Researchers are Focusing on the "Artificial Pancreas"

Although there have been many advances with insulin pumps and continuous glucose monitors, the devil is in the details on how to regulate the amount of insulin supplied to the diabetic. It is hardly an easy matter.

Most diabetes researchers are looking into the concept of an artificial pancreas as opposed to replacing the islet cells in the diabetic’s pancreas that create insulin. It is the destruction of a diabetic’s islet cells that causes type 1, insulin dependent, diabetes. The Toronto researchers originally called their discovery “isletin.” Type 2 diabetes, once referred to as “adult onset” diabetes, is currently in epidemic proportions in the United States. It impacts the body differently than type 1 diabetes.

The development of an artificial pancreas requires the use of sophisticated medical devices, many of which are already approved. However, it requires the devices to communicate with each other and the development of an algorithm to measure the right amount of insulin to be administered at the right time. No easy task.

FDA guidance artificial pancreas

Draft Guidance Discusses Clinical Trials & Applications for Approval

It is also a difficult issue to regulate. FDA is responsible for ensuring that any artificial pancreas system is safe for the user. The new draft guidance lays out a step-by-step approach for researchers through the regulatory process, for “The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications.” The FDA press release states:

“Our goal is to provide a clear pathway for artificial pancreas development so that people with diabetes can benefit from innovative medical devices,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Getting a safe and effective artificial pancreas system to Americans with type 1 diabetes is an FDA priority.”

The draft guidance is for an “early version of an artificial pancreas system.” There is a 90 day comment period from the date the guidance is issued (22 June 2011). A seperate guidance on more autonomous artificial pancreas systems is expected to be released by FDA by the end of 2011.

FDA Press Release

Draft Guidance…Low Glucose Suspend (LGS) Device Systems

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Top FDA, Health, and Science Blogs

September 8, 2010

FDA health science blogs

Hamlet and Yorick Discuss FDA Compliance, Health,
& Science Blogs

Here are some interesting blogs on the topics of FDA regulated industry, FDA regulations, health and science that regular readers of GxP Perspectives might enjoy while I am on vacation. Everyone should have a vacation now and then and I am going off for almost two weeks!

Acronym Required states they follow science and industry but don’t tell a lot about themselves. Interesting reading.

Applied Clinical Trials: Their blog is one of the best. Take their salary survey.

Chemistry Explained: A good site on a dry topic. Not an actual blog.

Compliance Zen: “Practical FDA compliance insights and intelligence.”

Diabetes Self Management Well organized and informative

Drug Health Supersite An eclectic mix.

Endocrine Today: “Clinical news on diabetes and endocrine disorders.”

Eye on FDA: Not my favorite but an important blog on FDA stuff.

FDA Law Blog: As described

FDA Matters: Feisty blog on FDA from Steven Grossman

GxP Lifeline: A Master Control Newsletter (commercial content and GxP news)

Medical Devices Today: From Elsevier (not feisty)

Partners in Health Blog: News about the health organization’s work in Haiti.

PharmaGossip: We all need a little gossip in our lives. This blog has the longest blogroll I have ever seen (almost). Blogs that everyone has heard of and that no one has heard of.

PharmTech Talk: Pharmaceutical Technology’s excellent blog.

Two Decades and Counting: A GxP professional’s blog that is well worth checking out.

WSJ Health Blog: A good blog from a newspaper that I don’t read.

FDA blog health science

Hamlet Should Have Taken More Vacations

On my return I hope to have a post on the new FDA Guidance: FAQ for IVDs. I also have several Guest Commentaries lined up on the TMF reference model, informed consent, and more! And as for Hamlet and Yorick, Hamlet never said that he knew him well. He did say that Yorick was, “a fellow of infinite jest, of most excellent fancy.” Sounds like a “to be” kind of guy. Unfortunately, the Hamlet of Ashland 2010 left a little to be desired. Oh well.

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Announcement: The 18th and 19th of January 2011 I will be at the conference for Developing CAPAs in the GCP Environment, Arlington, VA.


More on the “artificial pancreas” at Diabetes Technology Conference

December 4, 2009

Here is a link to the Applied Clinical Trials online edition for an article written, by the Blogster, on the diabetes artificial pancreasDiabetes Technology Conference and the “artificial pancreas.” ACT has a new feature on clinical trials for diabetes and other therapeutic areas including podcasts and other high tech features. Read for yourself:


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