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住院糖尿病患者的连续血糖监测指导下的胰岛素给药:一项随机临床试验。

Continuous Glucose Monitoring-Guided Insulin Administration in Hospitalized Patients With Diabetes: A Randomized Clinical Trial.

机构信息

University of Maryland Medical Center, Baltimore, MD.

Baltimore VA Medical Center, Baltimore, MD.

出版信息

Diabetes Care. 2022 Oct 1;45(10):2369-2375. doi: 10.2337/dc22-0716.

Abstract

OBJECTIVE

The efficacy and safety of continuous glucose monitoring (CGM) in adjusting inpatient insulin therapy have not been evaluated.

RESEARCH DESIGN AND METHODS

This randomized trial included 185 general medicine and surgery patients with type 1 and type 2 diabetes treated with a basal-bolus insulin regimen. All subjects underwent point-of-care (POC) capillary glucose testing before meals and bedtime. Patients in the standard of care (POC group) wore a blinded Dexcom G6 CGM with insulin dose adjusted based on POC results, while in the CGM group, insulin adjustment was based on daily CGM profile. Primary end points were differences in time in range (TIR; 70-180 mg/dL) and hypoglycemia (<70 mg/dL and <54 mg/dL).

RESULTS

There were no significant differences in TIR (54.51% ± 27.72 vs. 48.64% ± 24.25; P = 0.14), mean daily glucose (183.2 ± 40 vs. 186.8 ± 39 mg/dL; P = 0.36), or percent of patients with CGM values <70 mg/dL (36% vs. 39%; P = 0.68) or <54 mg/dL (14 vs. 24%; P = 0.12) between the CGM-guided and POC groups. Among patients with one or more hypoglycemic events, compared with POC, the CGM group experienced a significant reduction in hypoglycemia reoccurrence (1.80 ± 1.54 vs. 2.94 ± 2.76 events/patient; P = 0.03), lower percentage of time below range <70 mg/dL (1.89% ± 3.27 vs. 5.47% ± 8.49; P = 0.02), and lower incidence rate ratio <70 mg/dL (0.53 [95% CI 0.31-0.92]) and <54 mg/dL (0.37 [95% CI 0.17-0.83]).

CONCLUSIONS

The inpatient use of real-time Dexcom G6 CGM is safe and effective in guiding insulin therapy, resulting in a similar improvement in glycemic control and a significant reduction of recurrent hypoglycemic events compared with POC-guided insulin adjustment.

摘要

目的

尚未评估连续血糖监测(CGM)在调整住院胰岛素治疗中的疗效和安全性。

研究设计和方法

本随机试验纳入了 185 名接受基础-餐时胰岛素方案治疗的 1 型和 2 型糖尿病的内科和外科患者。所有患者在餐前和睡前进行即时血糖仪(POC)毛细血管血糖检测。接受标准护理(POC 组)的患者佩戴 Dexcom G6 CGM 血糖仪,但胰岛素剂量根据 POC 结果进行调整,而 CGM 组则根据日常 CGM 图谱进行胰岛素调整。主要终点是血糖达标时间(TIR;70-180mg/dL)和低血糖(<70mg/dL 和 <54mg/dL)的差异。

结果

CGM 指导组与 POC 组之间 TIR(54.51%±27.72 与 48.64%±24.25;P=0.14)、平均日血糖(183.2±40 与 186.8±39mg/dL;P=0.36)或 CGM 值<70mg/dL(36%与 39%;P=0.68)或<54mg/dL(14%与 24%;P=0.12)的患者比例均无显著差异。与 POC 相比,在有一次或多次低血糖事件的患者中,CGM 组低血糖再发率显著降低(1.80±1.54 与 2.94±2.76 次/患者;P=0.03),<70mg/dL 以下时间百分比更低(1.89%±3.27 与 5.47%±8.49;P=0.02),且<70mg/dL 和<54mg/dL 的发生率比值更低(0.53[95%CI 0.31-0.92]和 0.37[95%CI 0.17-0.83])。

结论

实时 Dexcom G6 CGM 在住院患者中的应用是安全有效的,可指导胰岛素治疗,与 POC 指导的胰岛素调整相比,血糖控制得到相似改善,且低血糖事件再发率显著降低。

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