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真实生活中使用具有预测性低血糖管理的胰岛素泵 3 个月的效果:日本中心治疗患者的分析。

Effect of real-life insulin pump with predictive low-glucose management use for 3 months: Analysis of the patients treated in a Japanese center.

机构信息

Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.

Department of Nursing, Juntendo University Hospital, Tokyo, Japan.

出版信息

J Diabetes Investig. 2020 Nov;11(6):1564-1569. doi: 10.1111/jdi.13288. Epub 2020 Jun 10.

DOI:10.1111/jdi.13288
PMID:32374513
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7610121/
Abstract

AIMS/INTRODUCTION: In Japan, an insulin pump with predictive low-glucose management (PLGM) was launched in 2018. It automatically suspends insulin delivery when the sensor detects or predicts low glucose values. The aim of this study was to analyze the safety and efficacy of PLGM in patients treated in a Japanese center.

MATERIALS AND METHODS

We carried out a retrospective observational analysis of 16 patients with type 1 diabetes mellitus and one patient after pancreatectomy. They switched from the MiniMed 620G device to the 640G device with PLGM. The primary outcome was the change in the percentage of time in hypoglycemia. The secondary outcome was the change in HbA1c (%) over a period of 3 months. We also explored the presence of "post-suspend hyperglycemia" with the 640G device.

RESULTS

After changing to the 640G device, the percentage of time in hypoglycemia (glucose <50 mg/dL) significantly decreased from 0.39% (0-1.51%) to 0% (0-0.44%; P = 0.0407). The percentage of time in hyperglycemia (glucose >180 mg/dL) significantly increased from 25.53% (15.78-44.14%) to 32.9% (24.71-45.49%; P = 0.0373). HbA1c significantly increased from 7.6 ± 1.0% to 7.8 ± 1.1% (P = 0.0161). From 1.5 to 4.5 h after the resumption of insulin delivery, the percentage of time in hyperglycemia was 32.23% (24.2-53.75%), but it was significantly lower, 2.78% (0-21.6%), when patients manually restarted the pump within 30 min compared with automatic resumption 31.2% (20-61.66%; P = 0.0063).

CONCLUSIONS

Predictive low-glucose management is an effective tool for reducing hypoglycemia, but possibly elicits "post-suspend hyperglycemia." This information is useful for achieving better blood glucose control in the patients treated with PLGM.

摘要

目的/引言:在日本,一种具有预测性低血糖管理(PLGM)功能的胰岛素泵于 2018 年推出。当传感器检测到或预测到低血糖值时,它会自动暂停胰岛素输送。本研究的目的是分析该设备在日本中心治疗的患者中的安全性和疗效。

材料和方法

我们对 16 名 1 型糖尿病患者和 1 名胰腺切除术后患者进行了回顾性观察性分析。他们从 MiniMed 620G 装置切换到具有 PLGM 的 640G 装置。主要结局是低血糖时间百分比的变化。次要结局是在 3 个月内 HbA1c(%)的变化。我们还探索了使用 640G 装置时是否存在“暂停后高血糖”。

结果

改用 640G 装置后,低血糖时间百分比(血糖 <50mg/dL)从 0.39%(0-1.51%)显著下降至 0%(0-0.44%;P=0.0407)。高血糖时间百分比(血糖 >180mg/dL)从 25.53%(15.78-44.14%)显著增加至 32.9%(24.71-45.49%;P=0.0373)。HbA1c 从 7.6±1.0%显著增加至 7.8±1.1%(P=0.0161)。在胰岛素输送恢复后 1.5 至 4.5 小时期间,高血糖时间百分比为 32.23%(24.2-53.75%),但当患者在 30 分钟内手动重新启动泵时,该百分比显著降低至 2.78%(0-21.6%),与自动恢复 31.2%(20-61.66%;P=0.0063)相比。

结论

预测性低血糖管理是减少低血糖的有效工具,但可能会引发“暂停后高血糖”。这些信息有助于在接受 PLGM 治疗的患者中实现更好的血糖控制。

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Diabetes Technol Ther. 2019 Sep;21(9):478-484. doi: 10.1089/dia.2019.0190. Epub 2019 Aug 1.
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Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc): protocol for a group randomised controlled trial of a novel intervention addressing cognitions.1 型糖尿病患者低血糖意识恢复方案(HARPdoc):一项针对认知问题的新型干预措施的群组随机对照试验方案
BMJ Open. 2019 Jun 16;9(6):e030356. doi: 10.1136/bmjopen-2019-030356.
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Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range.临床连续血糖监测数据解读目标:时间范围国际共识推荐意见。
Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.
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Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial.在低血糖倾向的 1 型糖尿病成人中应用暂停前低胰岛素泵技术的疗效和安全性(SMILE):一项开放标签随机对照试验。
Lancet Diabetes Endocrinol. 2019 Jun;7(6):462-472. doi: 10.1016/S2213-8587(19)30150-0. Epub 2019 Apr 29.
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