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The Food and Drug Administration (FDA) has cleared the first device for diabetics which integrates a glucose meter and an insulin pump with a dose calculator into one device. The new device could be the first step in the development of a fully automated glucose monitoring and insulin delivery system.
The product, made by Medtronic MiniMed, Inc., and Becton Dickinson, combines the Medtronic MiniMed Paradigm insulin pump with a Becton Dickinson glucose monitor and facilitates data interchange between the two. It has additional circuitry and software modifications that allow it to transmit glucose values to the insulin pump and to transfer data between the insulin pump and a personal computer running the appropriate Medtronic MiniMed communications software.
Since the glucose meter calculates and transmits information to the insulin pump automatically, it prevents the errors that sometimes can result when patients input this data manually. In addition, use of the integrated system is expected to make it more convenient for people to manage their diabetes.
"Due to the continuing advances in the ability to provide drug treatments exactly as needed, care for patients with diabetes is evolving," said FDA Commissioner Mark D. McClellan, M.D. Ph.D. "FDA is prepared to meet the new opportunities of combination products by adapting its resources to address these new technologies."
FDA cleared the device for marketing based on the safety and effectiveness of the separately marketed components and on reviews of the new device configuration, the software, and usability studies and electromagnetic interference compatibility testing conducted by the firms.
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Source: FDA News Release # P03-49, July 9, 2003.
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