Wong Lisa J, Buckingham Bruce A, Kunselman Betsy, Istoc Emil, Leach Jacob, Purvis Richard
Stanford University School of Medicine, Stanford, California 94305-5208, USA.
Diabetes Technol Ther. 2006 Apr;8(2):139-45. doi: 10.1089/dia.2006.8.139.
A new continuous glucose monitoring system (CGMS Datalogger, Medtronic MiniMed, Northridge, CA) potentiates extended sensor use by eliminating the cable connection to a monitor and by being waterproof. We evaluated the performance, safety, and patient tolerance of using the CGMS for 7 continuous days in children with type 1 diabetes mellitus who were encouraged to participate fully in their usual sports and activities in their home environment.
Twenty pediatric subjects (12.2 +/- 4.6 years old [mean +/- SD] and glycosylated hemoglobin of 8.06 +/- 1.22%) wore two CGMS devices simultaneously for 7 days. Sensor function was assessed by paired sensor-meter values obtained from the CGMS and their Paradigm Link (Medtronic Minimed) home glucose meter and a daily patient log of sensor and Datalogger sites.
Subjects were wearing 90% of the sensors at the end of 7 days. The devices were well tolerated except for pruritus at the adhesive sites in 29% of subjects, and one sensor site (3%) became infected. Once a correction was made to the connection between the cable and Datalogger, 89% of the 18 sensors that initialized were functional at the end of 5 days [r = 0.91; percent mean absolute relative difference (%MARD) = 12.4%], and 78% were functioning at the end of 7 days (r = 0.91; %MARD s 15.4%). Patient comfort while wearing the device decreased after 5 days of sensor wear.
This study demonstrates that the life of the glucose sensor can be extended well beyond the current labeling of 72 h. Once the cable connection was corrected, there was no statistically significant change in sensor performance over 7 days. Patients preferred to wear the device for a maximum of 5-6 days.
一种新型的连续血糖监测系统（CGMS数据记录器，美敦力MiniMed公司，加利福尼亚州诺斯里奇）通过消除与监测仪的电缆连接以及具备防水功能，增强了传感器的使用时长。我们评估了在1型糖尿病患儿中连续7天使用CGMS的性能、安全性及患者耐受性，这些患儿在家庭环境中被鼓励充分参与其日常运动和活动。
20名儿科受试者（平均年龄12.2±4.6岁[均值±标准差]，糖化血红蛋白为8.06±1.22%）同时佩戴两个CGMS设备7天。通过从CGMS及其Paradigm Link（美敦力MiniMed）家用血糖仪获取的配对传感器-血糖仪数值以及患者每日记录的传感器和数据记录器部位，评估传感器功能。
7天结束时，受试者佩戴着90%的传感器。除29%的受试者在粘贴部位出现瘙痒外，该设备耐受性良好，且有一个传感器部位（3%）发生感染。对电缆与数据记录器之间的连接进行校正后，18个初始化的传感器中有89%在5天结束时仍能正常工作[r = 0.91；平均绝对相对差异百分比（%MARD）= 12.4%]，78%在7天结束时仍能正常工作（r = 0.91；%MARD = 15.4%）。佩戴传感器5天后，患者佩戴该设备时的舒适度下降。
本研究表明，血糖传感器的使用寿命可以远超目前标注的72小时。校正电缆连接后，7天内传感器性能无统计学显著变化。患者最多愿意佩戴该设备5至6天。
