Tierney M J, Tamada J A, Potts R O, Jovanovic L, Garg S
Cygnus, Inc., 400 Penobscot Drive, 94063, Redwood City, CA 94063, USA.
Biosens Bioelectron. 2001 Dec;16(9-12):621-9. doi: 10.1016/s0956-5663(01)00189-0.
A device providing frequent, automatic, and non-invasive glucose measurements for persons with diabetes has been developed: the GlucoWatch biographer. This device extracts glucose through intact skin via reverse iontophoresis where it is detected by an amperometric biosensor. The biographer can provide glucose readings every 20 min for 12 h. The performance of this device was evaluated in two large clinical studies in a controlled clinical environment (n=231), and the home environment (n=124). Accuracy of the biographer was evaluated by comparing the automatic biographer readings to serial finger-stick blood glucose (BG) measurements. Biographer performance was comparable in both environments. Mean difference between biographer and finger-stick measurements was -0.01 and 0.26 mmol l(-1) for the clinical and home environments, respectively. The mean absolute value of the relative difference was 1.06 and 1.18 mmol l(-1) for the same studies. Correlation coefficient (r) between biographer and finger-stick measurements was 0.85 and 0.80 for the two studies. In both studies, over 94% of the 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 BG levels. Biographer accuracy is relatively constant over all rates of BG changes, except when BG decreases more than 10 mmol l(-1) h(-1), which occurred for only 0.2% of points in the home environment study. Biographer precision, as measured by CV%, is approx. 10%. Skin irritation, characterized by erythema and edema, was either non-existent or mild in >90% of subjects and resolved in virtually all subjects without treatment in several days.
已研发出一种可为糖尿病患者提供频繁、自动且无创血糖测量的设备：GlucoWatch生物记录仪。该设备通过反向离子电渗疗法透过完整皮肤提取葡萄糖，然后由安培生物传感器进行检测。生物记录仪可每20分钟提供一次长达12小时的血糖读数。在受控临床环境（n = 231）和家庭环境（n = 124）中进行的两项大型临床研究对该设备的性能进行了评估。通过将生物记录仪的自动读数与连续指尖血糖（BG）测量值进行比较来评估生物记录仪的准确性。生物记录仪在两种环境中的性能相当。在临床环境和家庭环境中，生物记录仪与指尖测量值之间的平均差异分别为-0.01和0.26 mmol l⁻¹。相同研究中相对差异的平均绝对值分别为1.06和1.18 mmol l⁻¹。两项研究中生物记录仪与指尖测量值之间的相关系数（r）分别为0.85和0.80。在两项研究中，超过94%的生物记录仪读数处于克拉克误差网格中临床可接受的A + B区域。在低BG水平时，观察到生物记录仪读数存在轻微正偏差。除了BG下降超过10 mmol l⁻¹ h⁻¹的情况外，生物记录仪的准确性在所有BG变化率下相对恒定，而这种情况在家庭环境研究中仅占0.2%的测量点。以CV%衡量的生物记录仪精密度约为10%。以红斑和水肿为特征的皮肤刺激在>90%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即可消退。
