Diabetes Technol Ther. 2003;5(5):791-800. doi: 10.1089/152091503322526996.
The accuracy of the GlucoWatch G2 Biographer (GW2B; Cygnus, Inc., Redwood City, CA) was assessed in children and adolescents with type 1 diabetes mellitus (T1DM). During a 24-h clinical research center stay, 89 children and adolescents with T1DM (3.5-17.7 years old) wore 174 GW2Bs and had frequent serum glucose determinations during the day and night and during insulin-induced hypoglycemia and meal-induced hyperglycemia, resulting in 3672 GW2B-reference glucose pairs. The median relative absolute difference between the GW2B and reference glucose values was 16% (25th, 75th percentiles = 7%, 29%). The proposed International Organisation for Standardisation criteria were met for 60% of sensor values. Accuracy was better at higher serum glucose levels than low glucose levels. Accuracy degraded slightly as the sensor aged. Time of day, subject age, gender, or body mass index did not impact GW2B accuracy. There were no cases of serious skin reactions. Although the accuracy of this generation of sensor does not approach that of current home glucose meters, the majority of sensor glucose values are within 20% of the serum glucose. This level of accuracy may be sufficient for detecting trends and modifying diabetes management. Further longitudinal outpatient studies are needed to assess the utility of the GW2B as a management tool to improve glycemic control and decrease the incidence of severe hypoglycemia in children with diabetes.
在1型糖尿病（T1DM）儿童和青少年中评估了GlucoWatch G2 Biographer（GW2B；Cygnus公司，加利福尼亚州红木城）的准确性。在临床研究中心停留的24小时期间，89名T1DM儿童和青少年（3.5 - 17.7岁）佩戴了174个GW2B，并在白天和夜间、胰岛素诱导的低血糖和进餐诱导的高血糖期间频繁测定血清葡萄糖，共得到3672对GW2B - 参考葡萄糖值。GW2B与参考葡萄糖值之间的相对绝对差异中位数为16%（第25、75百分位数分别为7%、29%）。60%的传感器值符合国际标准化组织提议的标准。血清葡萄糖水平较高时的准确性优于低水平时。随着传感器使用时间延长，准确性略有下降。一天中的时间、受试者年龄、性别或体重指数均不影响GW2B的准确性。未出现严重皮肤反应的病例。尽管这一代传感器的准确性未达到当前家用血糖仪的水平，但大多数传感器葡萄糖值与血清葡萄糖值相差在20%以内。这种准确性水平可能足以检测血糖趋势并调整糖尿病管理。需要进一步进行纵向门诊研究，以评估GW2B作为一种管理工具在改善糖尿病儿童血糖控制和降低严重低血糖发生率方面的效用。
