Device Cleared for Week-Long Glucose Monitoring

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The STS-7 Continuous Glucose Monitoring System, a device that measures glucose levels every five minutes for up to seven days in people with diabetes, has received marketing clearance. The additional data pro-vided by continuous monitoring can be used to recognize trends and patterns in glucose levels throughout the week that would not be identified by a fingerstick alone. Diabetics must still rely on the fingerstick test to decide if additional insulin is needed, however. The STS-7 System, manufactured by DexCom, Inc., of San Diego, places a disposable sensor subcutaneously in the abdomen to measure glucose level in the interstitial fluid. Placement of the sensor, which must be replaced weekly, can easily be done by patients and causes minimal discomfort. Approval was based on results of a study conducted by DexCom of 72 patients which demonstrated safety and effectiveness for tracking glucose patterns in adults. A three-day version of the device was approved in March 2006.

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