Wagner J G, Schmidtke D W, Quinn C P, Fleming T F, Bernacky B, Heller A
Department of Chemical Engineering, The University of Texas, Austin, TX 78712-1062, USA.
Proc Natl Acad Sci U S A. 1998 May 26;95(11):6379-82. doi: 10.1073/pnas.95.11.6379.
The performance of an amperometric biosensor, consisting of a subcutaneously implanted miniature (0.29 mm diameter, 5 x 10(-4) cm2 mass transporting area), 90 s 10-90% rise/decay time glucose electrode, and an on-the-skin electrocardiogram Ag/AgCl electrode was tested in an unconstrained, naturally diabetic, brittle, type I, insulin-dependent chimpanzee. The chimpanzee was trained to wear on her wrist a small electronic package and to present her heel for capillary blood samples. In five sets of measurements, averaging 5 h each, 82 capillary blood samples were assayed, their concentrations ranging from 35 to 400 mg/dl. The current readings were translated to blood glucose concentration by assaying, at t = 1 h, one blood sample for each implanted sensor. The rms error in the correlation between the sensor-measured glucose concentration and that in capillary blood was 17.2%, 4.9% above the intrinsic 12.3% rms error of the Accu-Chek II reference, through which the illness of the chimpanzee was routinely managed. Linear regression analysis of the data points taken at t>1 h yielded the relationship (Accu-Chek) = 0. 98 x (implanted sensor) + 4.2 mg/dl, r2 = 0.94. The capillary blood and the subcutaneous glucose concentrations were statistically indistinguishable when the rate of change was less than 1 mg/(dl. min). However, when the rate of decline exceeded 1.8 mg/(dl.min) after insulin injection, the subcutaneous glucose concentration was transiently higher.
一种电流型生物传感器的性能在一只未受约束、患有自然糖尿病、病情不稳定的I型胰岛素依赖型黑猩猩身上进行了测试。该生物传感器由一个皮下植入的微型传感器(直径0.29毫米,传质面积5×10⁻⁴平方厘米)、一个90秒内10 - 90%上升/下降时间的葡萄糖电极以及一个皮肤表面心电图银/氯化银电极组成。这只黑猩猩经过训练,会在手腕上佩戴一个小型电子设备,并伸出脚跟用于采集毛细血管血样。在五组测量中,每组平均持续5小时,共检测了82份毛细血管血样,其浓度范围为35至400毫克/分升。在t = 1小时时,通过对每个植入传感器的一份血样进行检测,将电流读数转换为血糖浓度。传感器测量的葡萄糖浓度与毛细血管血中葡萄糖浓度之间的相关均方根误差为17.2%,比Accu-Chek II参考值的固有均方根误差12.3%高出4.9%,该黑猩猩的病情常规通过Accu-Chek II进行监测。对t>1小时采集的数据点进行线性回归分析,得到关系(Accu-Chek)= 0.98×(植入传感器)+ 4.2毫克/分升,r² = 0.94。当变化率小于1毫克/(分升·分钟)时,毛细血管血和皮下葡萄糖浓度在统计学上无显著差异。然而,胰岛素注射后,当下降率超过1.8毫克/(分升·分钟)时,皮下葡萄糖浓度会短暂升高。