Tansey Michael J, Beck Roy W, Buckingham Bruce A, Mauras Nelly, Fiallo-Scharer Rosanna, Xing Dongyuan, Killman Craig, Tamborlane William V, Ruedy Katrina J
DirecNet Coordinating Center, Jaeb Center for Health Research, Tampa, FL 33647, USA.
Diabetes Technol Ther. 2005 Feb;7(1):109-14. doi: 10.1089/dia.2005.7.109.
We previously reported the results of an inpatient accuracy study in children with type 1 diabetes using the Continuous Glucose Monitoring System (CGMS, Medtronic MiniMed, Northridge, CA). During the course of that study, a new process was implemented for manufacturing the CGMS sensor. Accuracy from the resulting modified sensor used by only 14 children was significantly better than the original version [median relative absolute difference (RAD), 11% vs. 19%; P < 0.001]. Baseline data from a subsequent outpatient study provide an opportunity to further assess the accuracy of the modified sensor in a much larger sample of children with type 1 diabetes.
As part of a randomized trial to assess the utility of the GlucoWatch G2 Biographer (Cygnus, Inc., Redwood City, CA), 200 children with type 1 diabetes were instructed to wear a CGMS for 48-72 h in an outpatient setting at baseline. Glucose measurements from a OneTouch UltraSmart (Lifescan, Inc., Milpitas, CA) home glucose meter were downloaded and used as reference values to calculate accuracy measures.
The overall median RAD was 12%. Accuracy was better during hyperglycemia than during hypoglycemia (median RAD, 10% vs. 20%; P < 0.001) and on optimal versus non-optimal days but did not vary significantly by the number of calibrations entered.
These data confirm the improved accuracy previously reported for the modified version of the CGMS sensor.
我们之前报告了一项针对1型糖尿病儿童的住院准确性研究结果，该研究使用了连续血糖监测系统（CGMS，美敦力MiniMed公司，加利福尼亚州诺斯里奇）。在该研究过程中，实施了一种新的CGMS传感器制造工艺。仅14名儿童使用的改良后传感器的准确性显著优于原始版本[中位相对绝对差（RAD），11%对19%；P<0.001]。后续门诊研究的基线数据提供了一个机会，可在更大样本的1型糖尿病儿童中进一步评估改良后传感器的准确性。
作为评估GlucoWatch G2生物记录器（Cygnus公司，加利福尼亚州红木城）效用的随机试验的一部分，200名1型糖尿病儿童在基线时被指示在门诊环境中佩戴CGMS 48 - 72小时。下载来自OneTouch UltraSmart（Lifescan公司，加利福尼亚州米尔皮塔斯）家用血糖仪的血糖测量值，并将其用作参考值来计算准确性指标。
总体中位RAD为12%。高血糖期间的准确性优于低血糖期间（中位RAD，10%对20%；P<0.001），最佳日与非最佳日的准确性也有差异，但准确性并未因输入的校准次数而有显著变化。
这些数据证实了之前报道的CGMS传感器改良版本准确性有所提高。
