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Associated Press

FDA Approves Diabetes Monitors
June 13, 2002

WASHINGTON (AP) -- A pair of devices approved Wednesday by the Food and Drug Administration will take a bit of the drudgery out of testing for blood sugar.

The agency approved two devices that combine sugar test meters with the handheld computers known as personal digital assistants.

The devices will allow diabetics to more easily record their blood sugar levels and track them, rather than making notes by hand, the agency said.

Approved were the FreeStyle Tracker Diabetes Management System, made by TheraSense Inc. of Alameda, Calif., and the Accu-Chek Advantage Module, made by Roche Diagnostics Corp. of Indianapolis, Ind.

The companies each combined their glucose meters with a Handspring Visor PDA, providing software to record and track sugar levels.

According to the FDA, the patient inserts a glucose meter module into the handheld computer, then inserts a test strip into the meter, collects a blood sample and places it onto the test strip. The computer reads the glucose levels from the measurement module, displays the results and stores the information in an electronic database.

The test results can also be uploaded onto a personal computer.

Copyright 2002 The Associated Press. All rights reserved.

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