Retrospective Analysis of 3-Month Real-World Glucose Data After the MiniMed 670G System Commercial Launch
Retrospective Analysis of 3-Month Real-World Glucose Data After the MiniMed 670G System Commercial Launch
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DOI：
10.1089/dia.2018.0202
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发表时间：
2018-10-01
影响因子：
5.4
通讯作者：
Kaufman, Francine R.
中科院分区：
文献类型：
--
作者：
Stone, Michael P.;Agrawal, Pratik;Kaufman, Francine R.
在MiniMed 670G系统商业发布期间，首批3141名患者完成了3个月的SmartGuard Auto mode启用MiniMed 670G系统的实际数据。在2017年3月17日至2017年12月31日的商业发布中，对现实世界患者上传的CareLink系统数据进行识别和分析。比较总体和夜间（10:00 PM-07:00 AM）在基线手动模式和闭环自动模式期间低于、低于和高于目标血糖范围（TIR） （70-180mg/dL）的时间。从2015年6月2日至2016年3月7日，124名完成了为期3个月的MiniMed 670G系统关键试验（NCT 2463097）的患者（14-75岁）的数据进行了评估。真实世界的患者使用自动模式的时间中位数为80.8%（一天中的19小时和24分钟）。在基线手动模式下，TIR的总平均时间为66.0%，而在自动模式下为73.3%
Real-world data from the first 3141 patients who completed 3 months of SmartGuard Auto Mode-enabled MiniMed 670G system use during the MiniMed 670G System Commercial Launch are reported. CareLink system data uploaded by real-world patients in the Commercial Launch from March 17, 2017 to December 31, 2017 were deidentified and analyzed. Comparisons of overall and night (10:00 PM-07:00 AM) time spent below, within, and above target glucose range (TIR) (70-180mg/dL) between the baseline Manual Mode and closed-loop Auto Mode periods were made. These were evaluated alongside data from the 124 patients (aged 14-75 years) who completed the 3-month MiniMed 670G system pivotal trial (NCT 2463097), from June 2, 2015 to March 7, 2016. Real-world patients used Auto Mode a median 80.8% of the time (19h and 24min of the day). The overall mean of time spent in TIR was 66.0% during baseline Manual Mode versus 73.3% during Auto Mode (P