在糖尿病自我管理教育的背景下，对于未使用餐前胰岛素的 2 型糖尿病患者，间歇性扫描连续血糖监测并未优于结构化的自我血糖监测：新加坡血糖监测计划（GLiMPSE）。

Intermittently scanned continuous glucose monitoring provides no benefit over structured self-monitoring of blood glucose in type 2 diabetes not on prandial insulin, in the context of diabetes self-management education: GLucose monitoring programme SingaporE (GLiMPSE).

机构信息

Department of Endocrinology, Singapore General Hospital, Singapore; Duke-NUS Medical School, Singapore.

Singapore Clinical Research Institute, Biostatistics, Singapore; National University of Singapore and National University Health System, Saw Swee Hock School of Public Health, Singapore.

出版信息

Diabetes Res Clin Pract. 2024 May;211:111678. doi: 10.1016/j.diabres.2024.111678. Epub 2024 Apr 18.

DOI:10.1016/j.diabres.2024.111678

PMID:38642860

Abstract

OBJECTIVE

We evaluated the impact of intermittently scanned continuous glucose monitoring(is-CGM)over self-monitoring of blood glucose(SMBG) in the context of diabetes self-management education (DSME) in sub-optimally controlled type 2 diabetes(T2D) in a multi-ethnicsetting.

RESEARCH DESIGN AND METHOD

Randomized-controlled, open-label trial (NCT04564911), of T2D with HbA1c ≥ 7.5-≤10 %, on oral agents with/without basal insulin was carried out. Intervention arm received 6 weeks(w) continuous is-CGM, followed by one is-CGM/month till 24w. Control arm was advised to perform 4 SMBG/day. Educationwas delivered at weeks 0, 2, 8, 16.

PRIMARY OUTCOME

Change in HbA1c from baseline at 24w. Modified intention-to-treat (mITT) analysis with linear mixed-effect model for repeated measurementswas performed.

RESULTS

176 subjects, age 55 ± 10.7 years(y), DM duration 11 ± 7.3y, BMI 27.8 ± 5.9 kg/m, 58 % Male, 29.5 % basal insulin users were analysed. Within each arm,from baseline to 24w, mean HbA1c decreasedby -0.6 % (-6.6.mmol/mol, p-value < 0.01)and weight decreased(isCGM: -1.44 kg; SMBG: -1.25 kg, both p < 0.01). These changes were sustained to one year. However, there wasno significant difference in these parameters between arms (p-value > 0.05).

CONCLUSION

In the context of DSME, use of either SMBG or is-CGM led to improved glycaemia and reduced weight over a period of 24 weeks, sustained to one year.

摘要

目的

我们评估了在多民族环境中，在糖尿病自我管理教育（DSME）背景下，间歇性扫描连续血糖监测（is-CGM）对血糖自我监测（SMBG）的影响，该研究纳入了血糖控制不佳的 2 型糖尿病（T2D）患者。

研究设计和方法

这是一项随机对照、开放性试验（NCT04564911），纳入了糖化血红蛋白（HbA1c）≥7.5-≤10%、接受口服药物治疗且/或基础胰岛素治疗的 T2D 患者。干预组接受 6 周（w）连续 is-CGM，之后每月 1 次 is-CGM，共 24w。对照组建议进行 4 次/d 的 SMBG。在第 0、2、8、16 周进行教育。

主要结局

24w 时 HbA1c 自基线的变化。采用重复测量线性混合效应模型进行意向治疗（mITT）分析。

结果

共纳入 176 例年龄 55±10.7 岁、糖尿病病程 11±7.3 年、体重指数 27.8±5.9kg/m2、男性 58%、基础胰岛素使用者 29.5%的患者进行分析。在每个治疗组中，从基线到 24w，HbA1c 平均下降 0.6%（-6.6mmol/mol，p 值<0.01），体重下降（isCGM：-1.44kg；SMBG：-1.25kg，均 p<0.01）。这些变化持续到 1 年。然而，两组间这些参数无显著差异（p 值>0.05）。