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使用预测性低血糖管理的传感器增强型泵治疗的 1 型糖尿病患者中与临床显著低血糖相关的因素:一项关于伊比利亚美洲的多中心研究。

Factors associated with clinically significant hypoglycemia in patients with type 1 diabetes using sensor-augmented pump therapy with predictive low-glucose management: A multicentric study on iberoamerica.

机构信息

Pontificia Universidad Javeriana, Carrera 7 No. 40-62, Bogotá, Colombia; Hospital Universitario San Ignacio, Endocrinology Unit, Carrera 7 No. 40-62, Bogotá, Colombia.

Universidad EAN, Calle 79 No. 11-45, Bogotá, Colombia.

出版信息

Diabetes Metab Syndr. 2021 Jan-Feb;15(1):267-272. doi: 10.1016/j.dsx.2021.01.002. Epub 2021 Jan 11.

DOI:10.1016/j.dsx.2021.01.002
PMID:33477103
Abstract

BACKGROUND AND AIMS

Despite using sensor-augmented pump therapy (SAPT) with predictive low-glucose management (PLGM), hypoglycemia is still an issue in patients with type 1 Diabetes (T1D). Our aim was to determine factors associated with clinically significant hypoglycemia (<54 mg/dl) in persons with T1D treated with PLGM-SAPT.

METHOD

ology: This is a multicentric prospective real-life study performed in Colombia, Chile and Spain. Patients with T1D treated with PLGM-SAPT, using sensor ≥70% of time, were included. Data regarding pump and sensor use patterns and carbohydrate intake from 28 consecutive days were collected. A bivariate and multivariate Poisson regression analysis was carried out, to evaluate the association between the number of events of <54 mg/dl with the clinical variables and patterns of sensor and pump use.

RESULTS

188 subjects were included (41 ± 13.8 years-old, 23 ± 12 years disease duration, A1c 7.2% ± 0.9). The median of events <54 mg/dl was four events/patient/month (IQR 1-10), 77% of these events occurred during day time. Multivariate analysis showed that the number of events of hypoglycemia were higher in patients with previous severe hypoglycemia (IRR1.38; 95% CI 1.19-1.61; p < 0.001), high glycemic variability defined as Coefficient of Variation (CV%) > 36% (IRR 2.09; 95%CI 1.79-2.45; p < 0.001) and hypoglycemia unawareness. A protector effect was identified for adequate sensor calibration (IRR 0.77; 95%CI 0.66-0.90; p:0.001), and the use of bolus wizard >60% (IRR 0.74; 95%CI 0.58-0.95; p:0.017).

CONCLUSION

In spite of using advanced SAPT, clinically significant hypoglycemia is still a non-negligible risk. Only the identification and intervention of modifiable factors could help to prevent and reduce hypoglycemia in clinical practice.

摘要

背景与目的

尽管使用了带有预测性低血糖管理(PLGM)的传感器增强型泵治疗(SAPT),1 型糖尿病(T1D)患者仍会发生低血糖。我们的目的是确定使用 PLGM-SAPT 治疗的 T1D 患者中与临床显著低血糖(<54mg/dl)相关的因素。

方法

这是一项在哥伦比亚、智利和西班牙进行的多中心前瞻性真实世界研究。纳入使用 PLGM-SAPT 治疗、传感器使用率≥70%的 T1D 患者。收集 28 天连续的泵和传感器使用模式以及碳水化合物摄入量的数据。进行了双变量和多变量泊松回归分析,以评估<54mg/dl 事件次数与临床变量以及传感器和泵使用模式之间的关联。

结果

共纳入 188 名受试者(41±13.8 岁,23±12 岁疾病病程,A1c 7.2%±0.9)。每月每名患者发生<54mg/dl 的事件中位数为 4 次(IQR 1-10),其中 77%的事件发生在白天。多变量分析显示,有既往严重低血糖史的患者低血糖事件次数更高(IRR1.38;95%CI 1.19-1.61;p<0.001)、血糖变异性高(定义为变异系数(CV%)>36%)(IRR 2.09;95%CI 1.79-2.45;p<0.001)和无症状性低血糖。适当的传感器校准(IRR 0.77;95%CI 0.66-0.90;p:0.001)和使用>60%的推注向导(IRR 0.74;95%CI 0.58-0.95;p:0.017)被认为是保护因素。

结论

尽管使用了先进的 SAPT,但临床显著的低血糖仍然是一个不可忽视的风险。只有识别和干预可改变的因素,才能帮助预防和减少临床实践中的低血糖。

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