US approval for breakthrough diabetes device

pharmafile | October 29, 2003 | News story | |   

The first integrated glucose meter and insulin pump has been approved by the FDA, bringing the goal of an 'artificial pancreas' one step closer.

Medtronic MiniMed have combined their insulin pump with Becton Dickinson's glucose monitor via a wireless connection to a personal computer.

Bruce Bode, medical director, Diabetes Resource Center of Atlanta, Atlanta Diabetes Associates said the new system was a major breakthrough

"The new pump is so smart it recommends the proper insulin dosage to the patient, after considering a number of variables, such as the amount of insulin previously delivered and still active in the body", he said.

"The system simplifies this critical information process, so patients no longer feel as though they need to be mathematicians in order to keep their blood sugar levels in control".

FDA Commissioner Mark McClellan said the agency was prepared to adapt its resources to the regulatory requirements of new combined devices.

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