WASHINGTON, Jun 4, 2007 (UPI via COMTEX) -- The U.S. Food and Drug Administration Monday approved a device that measures glucose levels continuously for up to seven days in people with diabetes.

While a standard fingerstick test records a person's glucose level as a snapshot in time, the STS-7 Continuous Glucose Monitoring System measures glucose levels every five minutes throughout a seven-day period. The FDA said that additional information can be used to track patterns in glucose levels throughout the week that wouldn't be captured by fingerstick measurements.

However, diabetics must still rely on the fingerstick test to decide whether additional insulin is needed, the FDA added.

The STS-7 System, manufactured by DexCom Inc. of San Diego uses a disposable sensor placed just below the skin in the abdomen to measure the level of glucose in the fluid found in the body's tissues. Sensor placement causes minimal discomfort and can easily be done by patients themselves. An alarm can be programmed to sound if a patient's glucose level reaches pre-set lows or pre-set highs.

A three-day version of the device was approved in March 2006.

FDA 批准 7天 葡萄糖 监控设备

华盛顿，2007年6月4日--星期一美国食品药品管理局核准可持续七天监测葡萄糖水平用于人类糖尿病的仪器上市。

标准的手指棒测量法记录了一个患者在某一时点的血糖指标，STS-7连续血糖跟踪系统则是不间断地在一周中每5秒钟监测.食品药品管理局说该系统附加信息可以用于整个一周观测葡萄糖指标而不用手指棒测量法。

然而FDA补充说，糖尿病患者还是要依据手指棒测量结果来决定是否需要额外的胰岛素。

7天系统，由圣迭戈的DexCom公司制造，通过埋置在腹部皮肤下的一个多用途传感器，监测身体的血糖水平。传感器的放置会产生很小的不适感，同时能被患者比较容易操作。如果患者的血糖水平超过设置的上下限值时，报警装置会通过音响提醒。

三天版的装置在2006年3月批准通过。


ps:水平有限，见笑见笑