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联合连续血糖监测和皮下胰岛素输注与优化多次注射的自我血糖监测在 1 型糖尿病患者中的比较:一项随机交叉试验。

Combined continuous glucose monitoring and subcutaneous insulin infusion versus self-monitoring of blood glucose with optimized multiple injections in people with type 1 diabetes: A randomized crossover trial.

机构信息

Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy.

Diabetes Unit, Careggi Teaching Hospital, Florence, Italy.

出版信息

Diabetes Obes Metab. 2020 Aug;22(8):1286-1291. doi: 10.1111/dom.14028. Epub 2020 Apr 8.

Abstract

AIM

To investigate the efficacy of a combination of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII) versus an optimized degludec-based multiple daily injections (MDI) regimen + self-monitoring of blood glucose (SMBG) in people with type 1 diabetes with regard to optimizing glucose control.

MATERIAL AND METHODS

The trial included 28 individuals who underwent a 4-week run-in phase, and were then randomized 1:1 to: (a) CSII + CGM followed by MDI + SMBG or (b) an MDI basal-bolus regimen followed by CSII + CGM.

RESULTS

In patients randomized to the CSII + CGM → MDI + SMBG arm, a significant reduction in glycated haemoglobin (HbA1c) versus baseline was found at the end of the first phase (CSII + CGM) without significant variation in the following MDI + SMBG phase. In the arm randomized to the MDI + SMBG → CSII + CGM sequence, a significant improvement in HbA1c was observed in the first phase (MDI + SMBG), together with a further decrease in the following CSII + CGM phase. In the comparison of the two treatments using a mixed linear model, CSII + CGM was superior to MDI + SMBG with respect to change in HbA1c (P = 0.001).

CONCLUSIONS

This study suggests that CSII + CGM improves glycaemic control without relevant safety issues in type 1 diabetes, in comparison with MDI + SMBG.

摘要

目的

旨在比较连续血糖监测(CGM)联合持续皮下胰岛素输注(CSII)与优化的基于德谷胰岛素的多次皮下注射(MDI)方案+自我血糖监测(SMBG)在 1 型糖尿病患者中优化血糖控制的疗效。

材料和方法

该试验纳入了 28 名参与者,他们首先进行了 4 周的导入期,然后随机分为 1:1 组:(a)CSII+CGM 后接 MDI+SMBG 或(b)MDI 基础-餐时胰岛素方案后接 CSII+CGM。

结果

在随机分配至 CSII+CGM→MDI+SMBG 组的患者中,在第一阶段(CSII+CGM)结束时发现糖化血红蛋白(HbA1c)与基线相比显著降低,而在随后的 MDI+SMBG 阶段则没有显著变化。在随机分配至 MDI+SMBG→CSII+CGM 组的患者中,在第一阶段(MDI+SMBG)中观察到 HbA1c 显著改善,随后在 CSII+CGM 阶段进一步降低。在使用混合线性模型比较两种治疗方法时,CSII+CGM 在 HbA1c 变化方面优于 MDI+SMBG(P=0.001)。

结论

与 MDI+SMBG 相比,CSII+CGM 可改善 1 型糖尿病患者的血糖控制,且无明显安全性问题。

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