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Artificial Pancreas Awaiting Fda Approval For Clinical Testing


A group of parents of children with diabetes who formed a non-profit foundation in 1970 called the Juvenile Diabetes Research Association (JDRA) has raised almost 1.5 billion for diabetes research, and is close to their goal of developing an artificial pancreas.

In 2006, the JDRA funded a consortium of engineers, mathematicians and diabetes experts to collaborate on computer programs for a possible artificial pancreas. In early 2010, the JDRA hired Animas Corporation, a provider of high tech insulin pumps, to assist in the development of the automated insulin delivery system.

Animas quickly recruited about a dozen "world class" scientists and engineers to work on the project, which it dubbed Project Manya. The collaboration resulted in the development of a first generation wireless insulin delivery system that functions like a human pancreas - the gland which produces chemicals necessary for digestion and blood sugar regulation, including the hormone insulin.

The artificial pancreas is a unique combination of three main closed-loop components:

1) A continuous glucose monitor for ongoing blood sugar levels and patterns

2) A programmable computerized insulin pump

3) An advanced computer algorithm (formula) that can calculate how much insulin the body needs, and when it needs it

Although just the "research and development first step" towards a fully functioning artificial pancreas, the insulin delivery system now awaiting approval for clinical trials is, according to Animas' Chief Medical Officer and director of Project Manya, Dr. Henry Anhalt, "leaps and bounds above technology that is currently available."

Anholt points out that current insulin pumps, which he calls "unintelligent", can monitor blood glucose and dispense insulin, but still require users to input and interpret a lot of data. While some decisions will still have to be made by users until the device is fully automated, Anholt says the new artificial pancreas can "assist the patient and in many ways, take over the decision-making process".

Once perfected, the new technology will have a monumental impact on the quality of life of insulin dependent diabetics. Not only will the new insulin delivery system simplify the constant challenge of controlling blood sugar, accurate insulin dosing and administering insulin injections, the resulting tight blood sugar control will help ward off a host of diabetes complications such as blindness, nerve damage, amputations and kidney and heart disease.