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空腹血糖6.1毫摩尔/升作为使用甘精胰岛素的2型糖尿病患者的可能最佳目标:一项随机临床试验

Fasting Glucose of 6.1 mmol/L as a Possible Optimal Target for Type 2 Diabetic Patients with Insulin Glargine: A Randomized Clinical Trial.

作者信息

Yuan Lu, Li Fengfei, Zhou Yue, Sun Rui, Gao Gu, Zhang Qing, Tang Yajuan, Dai Lu, Wu Jindan, Ma Jianhua

机构信息

Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.

Department of Endocrinology, The First People's Hospital of Huaian, Huaian, China.

出版信息

J Diabetes Res. 2021 Jul 14;2021:5524313. doi: 10.1155/2021/5524313. eCollection 2021.

Abstract

To observe whether different insulin glargine titration algorithms based on fasting blood glucose (FBG) levels lead to different glycaemic variations (GVs) in type 2 diabetes (T2D) patients, a prospective, randomized, single-centre, comparative, three-arm parallel-group, open-label, treat-to-target, 24-week study was performed. A total of 71 uncontrolled T2D patients were recruited and randomized 1 : 3 : 3 into Groups 1, 2, and 3 (insulin titration goals of FBG ≤ 5.6, ≤6.1, and ≤7.0) for this study. The initiated insulin glargine dose was recommended at 0.2 U/kg/day and was then titrated following the FBG target. Patients were subjected to two 3-day continuous glucose monitoring (CGM) at baseline and the endpoint, wherein the CGM data were analysed, and the study's primary endpoint was the difference in 24 hrs mean amplitude of glycaemic excursion (MAGE) among the three groups. We observed that patients in the three groups had similar MAGE levels at the endpoint; however, Group 2 achieved a significant decrease in the MAGE level from baseline to the endpoint as compared to Groups 1 and 3 (all < 0.05). We also observed that these patients had significant glycated haemoglobin A1c (HbA1c) value improvements as compared to the other two groups (all < 0.05). Therefore, choosing an FBG level of 6.1 mmol/L as an insulin titration target provided significant GVs and HbA1c value improvements in T2D patients. Moreover, our data indicated that an FBG of 6.1 mmol/L could possibly be an insulin glargine titration target in T2D patients.

摘要

为观察基于空腹血糖(FBG)水平的不同甘精胰岛素滴定算法是否会导致2型糖尿病(T2D)患者出现不同的血糖波动(GVs),开展了一项前瞻性、随机、单中心、比较性、三臂平行组、开放标签、达标治疗的24周研究。本研究共招募了71例血糖控制不佳的T2D患者,并按1∶3∶3随机分为第1、2和3组(FBG胰岛素滴定目标分别为≤5.6、≤6.1和≤7.0)。起始甘精胰岛素剂量建议为0.2 U/kg/天,然后根据FBG目标进行滴定。患者在基线和终点接受两次为期3天的连续血糖监测(CGM),对CGM数据进行分析,研究的主要终点是三组之间24小时血糖波动平均幅度(MAGE)的差异。我们观察到,三组患者在终点时的MAGE水平相似;然而,与第1组和第3组相比,第2组从基线到终点的MAGE水平显著降低(均P<0.05)。我们还观察到,与其他两组相比,这些患者的糖化血红蛋白A1c(HbA1c)值有显著改善(均P<0.05)。因此,选择6.1 mmol/L的FBG水平作为胰岛素滴定目标可使T2D患者的GVs和HbA1c值得到显著改善。此外,我们的数据表明,6.1 mmol/L的FBG可能是T2D患者的甘精胰岛素滴定目标。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0507/8294995/4399c292900b/JDR2021-5524313.001.jpg

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