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对传感器增强型胰岛素泵阈值暂停功能实际应用的回顾性分析。

Retrospective analysis of the real-world use of the threshold suspend feature of sensor-augmented insulin pumps.

作者信息

Agrawal Pratik, Zhong Alex, Welsh John B, Shah Rajiv, Kaufman Francine R

机构信息

Medtronic, Inc. , Northridge, California.

出版信息

Diabetes Technol Ther. 2015 May;17(5):316-9. doi: 10.1089/dia.2014.0257. Epub 2015 Jan 22.

Abstract

BACKGROUND

The automatic Threshold Suspend (TS) feature of the MiniMed 530G system (Medtronic MiniMed, Inc., Northridge, CA), when enabled, suspends insulin delivery for up to 2 h when the sensor glucose (SG) value reaches a preset threshold.

MATERIALS AND METHODS

SG data from 20,973 patients who enabled the TS feature at their discretion and uploaded pump and sensor data to CareLink(®) (Medtronic MiniMed, Inc.) from October 15, 2013 to July 21, 2014 were analyzed. Comparisons between 758,382 patient-days wherein the TS feature was enabled at any time and 166,791 patient-days in which it was not enabled were made. Further comparisons were made between data collected during daytime (8:00 a.m. to 10:00 p.m.) and nighttime (10:00 p.m. to 8:00 a.m.) hours. Data from subsets of patients who enabled the TS feature all of the time (n=14,673) versus those who never enabled the TS feature (n=2,249) were also compared. Recovery from hypoglycemia during and after 2-h pump suspension events was also assessed.

RESULTS

The TS feature was enabled on 82% of patient-days. Patient-days in which the TS feature was enabled, compared with patient-days in which it was not, had 69% fewer SG values ≤50 mg/dL (0.64% vs. 2.09%, respectively; P<0.001). The reduction in hypoglycemia seen on TS-enabled days was more pronounced during nighttime than during daytime hours. SG data from full-time users of the TS feature reflected a 62% reduction in values ≤50 mg/dL and a 5.6% reduction in values ≥300 mg/dL compared with data from nonusers (P<0.001 for each). The median SG value at the start of 2-h suspensions was 60 (interquartile range [IQR], 57-66) mg/dL, immediately after was 87 (IQR, 63-123) mg/dL, and 4 h later was 164 (IQR, 117-220) mg/dL.

CONCLUSIONS

The TS feature, when enabled consistently, reduced hypoglycemic exposure, and for those who had it enabled 100% of the time, hyperglycemia was also reduced.

摘要

背景

美敦力530G系统(美敦力迷你迈德公司,加利福尼亚州诺斯里奇)的自动阈值暂停(TS)功能启用后,当传感器葡萄糖(SG)值达到预设阈值时,胰岛素输送将暂停长达2小时。

材料与方法

分析了20973例自行启用TS功能并于2013年10月15日至2014年7月21日将泵和传感器数据上传至CareLink®(美敦力迷你迈德公司)的患者的SG数据。对随时启用TS功能的758382个患者日与未启用该功能的166791个患者日进行了比较。还对白天(上午8:00至晚上10:00)和夜间(晚上10:00至上午8:00)收集的数据进行了进一步比较。还比较了一直启用TS功能的患者子集(n = 14673)与从未启用TS功能的患者子集(n = 2249)的数据。还评估了2小时泵暂停事件期间及之后的低血糖恢复情况。

结果

82%的患者日启用了TS功能。启用TS功能的患者日与未启用该功能的患者日相比,SG值≤50mg/dL的情况减少了69%(分别为0.64%和2.09%;P<0.001)。启用TS功能的日子里低血糖的减少在夜间比白天更明显。与未使用者的数据相比,TS功能全职使用者的SG数据显示,≤50mg/dL的值减少了62%,≥300mg/dL的值减少了5.6%(每项P<0.001)。2小时暂停开始时的SG中位数为60(四分位间距[IQR],57 - 66)mg/dL,暂停后立即为87(IQR,63 - 123)mg/dL,4小时后为164(IQR,117 - 220)mg/dL。

结论

持续启用TS功能可减少低血糖暴露,对于100%时间启用该功能的患者,高血糖情况也有所减少。

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