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葡萄糖监测腕表:一种频繁自动且无创的血糖监测仪。

The GlucoWatch biographer: a frequent automatic and noninvasive glucose monitor.

作者信息

Tierney M J, Tamada J A, Potts R O, Eastman R C, Pitzer K, Ackerman N R, Fermi S J

机构信息

Cygnus, Inc, Redwood City, CA 94063, USA.

出版信息

Ann Med. 2000 Dec;32(9):632-41. doi: 10.3109/07853890009002034.

Abstract

The GlucoWatch (Cygnus, Inc, Redwood City, CA, USA) biographer provides automatic, frequent and noninvasive blood glucose measurements for up to 12 h. The device extracts glucose through intact skin where it is measured by an amperometric biosensor. Clinical trials in a variety of environments have shown that the biographer provides accurate and precise glucose measurements when compared with serial fingerstick blood glucose measurements. Mean difference between these measurements was 0.26 mmol/L in the home environment (r = 0.80). Over 94% of biographer readings were in the clinically acceptable A+B region of the Clarke Error Grid. A slight positive bias is observed for the biographer readings at low glucose levels. Biographer precision, as measured by coefficient of variation (CV)%, is approximately 10%. The low glucose alert function of the biographer was able to detect up to 75% of hypoglycaemic episodes with a low false alert level. Skin irritation, characterized by erythema and oedema was either nonexistent or mild in over 87% of subjects and resolved in virtually all subjects without treatment in several days. The GlucoWatch biographer has been shown to be a safe and effective method to track glucose level trends and patterns, which should enable improved glycaemic control for many patients.

摘要

GlucoWatch(美国加利福尼亚州红木城的Cygnus公司)记录器可连续12小时自动、频繁且无创地测量血糖。该设备通过完整皮肤提取葡萄糖,并用安培生物传感器进行测量。在各种环境下进行的临床试验表明,与连续指尖血糖测量相比,记录器能提供准确且精确的血糖测量值。在家庭环境中,这些测量值之间的平均差异为0.26毫摩尔/升(r = 0.80)。超过94%的记录器读数位于克拉克误差网格的临床可接受A + B区域内。在低血糖水平时,记录器读数存在轻微的正偏差。以变异系数(CV)%衡量的记录器精密度约为10%。记录器的低血糖警报功能能够检测到高达75%的低血糖发作,且误报水平较低。以红斑和水肿为特征的皮肤刺激在超过87%的受试者中不存在或很轻微,并且几乎所有受试者在几天内未经治疗就自行消退了。GlucoWatch记录器已被证明是一种安全有效的跟踪血糖水平趋势和模式的方法,这应该能使许多患者改善血糖控制。

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