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【商业翻译】（医师报约稿）FDA Approves Continuou
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FDA Approves Continuous 7-Day Glucose Monitoring System
The U.S. Food and Drug Administration today 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 (STS-7 System) measures glucose levels every five minutes throughout a seven-day period. This additional information can be used to detect trends and track patterns in glucose levels throughout the week that wouldn’t be captured by fingerstick measurements alone. However, diabetics must still rely on the fingerstick test to decide whether additional insulin is needed.
“The STS-7 System supplements standard fingerstick meters and test strips, providing diabetics ages 18 and older with a way to see trends and track patterns,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “It can help detect when glucose levels drop during the overnight hours, show when glucose levels rise between meals and suggest how exercise and diet might affect glucose levels.”
The STS-7 System, manufactured by DexCom Inc. of San Diego, Calif., 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 (interstitial fluid). Sensor placement causes minimal discomfort and can easily be done by patients themselves. The sensor must be replaced weekly. An alarm can be programmed to sound if a patient’s glucose level reaches pre-set lows or pre-set highs.
Diabetes is caused by the body’s inability to produce or use insulin, a hormone that unlocks the cells of the body, allowing glucose (sugar) to enter and fuel them.
An estimated 20.8 million people in the United States—7 percent of the population—have diabetes. Most have type 2 diabetes, a condition in which the body does not properly use insulin. An estimated 5 percent to 10 percent of people with this chronic disease have type 1 diabetes, which results from the body's failure to produce insulin. People with type 1 diabetes must take insulin every day.
Diabetes can lead to wide fluctuations in blood sugar levels. Over time, abnormally high levels of glucose can damage the small and large blood vessels, leading to diabetic blindness, kidney disease, amputations of limbs, stroke, and heart disease.
While there is no known cure, studies have shown that patients who regularly monitor and regulate their blood glucose levels have lower incidences of complications associated with the disease.
FDA’s approval of the STS-7 System was based on results of a study conducted by DexCom of 72 patients with diabetes at five clinical sites in the United States. The study demonstrated that the STS-7 System was safe and effective for detecting trends and tracking patterns in glucose levels in adults. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领 FDA Approves Continuous 7-Day Glucose Monitoring System
FDA批准连续7天的血糖监测系统 请按照翻译须知中的格式编译 编译(中文579字)
FDA批准连续7天的血糖监测系统
美国食品和药品管理局今天批准了一种连续7天监测糖尿病患者血糖水平的装置(STS-7 System), 该系统由加利福尼亚州dexcom公司制造。
据估计美国有2080万人（人口的7%）患有糖尿病，大多数为2型糖尿病，1型糖尿病占5%-10%。糖尿病可导致血糖水平大幅度波动，随着时间推移，异常高水平的血糖能破坏大小血管，导致糖尿病性失明，肾脏疾病，截肢，中风和心脏病。研究显示，定期监测和调节血糖水平的病人，其糖尿病相关并发症发生率较低。
STS-7 系统与传统的标准手指针刺测试相比，该系统能连续监测7天内每5分钟的血糖水平，从而可以探测整个星期内血糖水平的趋势和轨迹模式，这一点传统的手指针刺检测是办不到的。然而 ，糖尿病患者必须依赖手指针刺测试来决定是否需要额外的胰岛素。
FDA中心装置和放射卫生主任，丹尼尔舒尔茨博士说：“STS-7系统补充了标准的手指针刺检测仪和检测试纸，为18岁和18岁以上患者提供了一种观察血糖趋势和轨迹模式的方法，可以帮助探测夜间血糖水平何时下降，两餐之间血糖水平何时上升和运动与饮食如何影响血糖水平。”
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作者:admin@医学,生命科学 2011-02-13 17:11
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