December 1, 2011

FDA drafts guidelines for the artificial pancreas

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According to new guidelines set by the FDA for the development of the artificial pancreas – the hope is that the revolutionary device should be arriving faster than previous guidelines permit to give manufacturers ‘maximum flexibility’ in getting it to U.S. patients.

The culmination of patient advocates, medical device makers and researchers  working together created the new guidelines for the artificial pancreas.  To be clear on the device being developed – the artificial pancreas is a complex system of pumps and sensors aimed at automating the blood glucose. To be clear on why the guidelines were drafted – the device manufacturers and researchers need to know how to make it happen yesterday.

The problem in type 1 diabetes is the autoimmune system kills off the insulin-producing cells, or beta cells. Islets work with alpha, beta and delta cells to normalize blood glucose. The artificial pancreas addresses the insulin producing cells and the glucose control issue by regulating the insulin through algorithms sensed by a continuous glucose monitoring system.

A device, known as a low glucose suspend device involves a safety feature built into an insulin pump that shuts off the pump when a diabetic’s blood sugar falls dangerously low. This is a very important feature to include because insulin secretion, in a non-diabetic human, does not happen if blood glucose levels drop below a certain point. If you’re designing an artificial pancreas – why not make it as close to the real thing as possible?  

As with early mobile phones, automobiles, and  computers – don’t look for a discreet, sexy design. The first generation artificial pancreas is set to be an out of body machinery menagerie. It is a collaboration of two medical devices, an insulin pump and a continuous glucose monitor that receives information on glucose levels from a sensor placed under the patient’s skin. The artificiality in this design is the auto-piloting of the devices making sure they play well together to keep your glucose in range.

Once the super computer is successfully created – the FDA guidance document recommends a 3-phase clinical trial progression leading to outpatient clinical trials.

The bottom line for these new guidelines issued by the FDA is that they will help manufacturers and investigators assemble submissions for clinical trials as well as product approval submissions. This, in turn, will bring the safest and most effective artificial pancreas to people living with type 1 diabetes as soon as possible.

To review the full document issued by the FDA for draft guidance for the development of the artificial pancreas, click here.

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