多针胰岛素注射治疗的 2 型糖尿病成人患者的连续血糖监测与结构化教育：一项多中心随机对照试验。
Continuous glucose monitoring with structured education in adults with type 2 diabetes managed by multiple daily insulin injections: a multicentre randomised controlled trial.
机构信息
Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Diabetes Education Unit, Diabetes Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
出版信息
Diabetologia. 2024 Jul;67(7):1223-1234. doi: 10.1007/s00125-024-06152-1. Epub 2024 Apr 19.
AIMS/HYPOTHESIS: The aim of this study was to compare the effectiveness of stand-alone intermittently scanned continuous glucose monitoring (isCGM) with or without a structured education programme and blood glucose monitoring (BGM) in adults with type 2 diabetes on multiple daily insulin injections (MDI).
METHODS
In this 24 week randomised open-label multicentre trial, adults with type 2 diabetes on intensive insulin therapy with HbA levels of 58-108 mmol/mol (7.5-12.0%) were randomly assigned in a 1:1:1 ratio to isCGM with a structured education programme on adjusting insulin dose and timing according to graphical patterns in CGM (intervention group), isCGM with conventional education (control group 1) or BGM with conventional education (control group 2). Block randomisation was conducted by an independent statistician. Due to the nature of the intervention, blinding of participants and investigators was not possible. The primary outcome was change in HbA from baseline at 24 weeks, assessed using ANCOVA with the baseline value as a covariate.
RESULTS
A total of 159 individuals were randomised (n=53 for each group); 148 were included in the full analysis set, with 52 in the intervention group, 49 in control group 1 and 47 in control group 2. The mean (± SD) HbA level at baseline was 68.19±10.94 mmol/mol (8.39±1.00%). The least squares mean change (± SEM) from baseline HbA at 24 weeks was -10.96±1.35 mmol/mol (-1.00±0.12%) in the intervention group, -6.87±1.39 mmol/mol (-0.63±0.13%) in control group 1 (p=0.0367 vs intervention group) and -6.32±1.42 mmol/mol (-0.58±0.13%) in control group 2 (p=0.0193 vs intervention group). Adverse events occurred in 28.85% (15/52) of individuals in the intervention group, 26.42% (14/53) in control group 1 and 48.08% (25/52) in control group 2.
CONCLUSIONS/INTERPRETATION: Stand-alone isCGM offers a greater reduction in HbA in adults with type 2 diabetes on MDI when education on the interpretation of graphical patterns in CGM is provided.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04926623.
FUNDING
This study was supported by Daewoong Pharmaceutical Co., Ltd.
目的/假设：本研究旨在比较单独使用间歇性扫描连续血糖监测（isCGM）与使用或不使用结构化教育方案和血糖监测（BGM）在接受多次每日胰岛素注射（MDI）的 2 型糖尿病成人中的疗效。
方法
在这项 24 周的随机开放标签多中心试验中，HbA 水平为 58-108mmol/mol（7.5-12.0%）的接受强化胰岛素治疗的 2 型糖尿病成人按照 1:1:1 的比例随机分配，接受根据 CGM 中的图形模式调整胰岛素剂量和时间的 isCGM 加结构化教育方案（干预组）、接受常规教育的 isCGM（对照组 1）或接受常规教育的 BGM（对照组 2）。采用独立的统计学家进行区组随机化。由于干预的性质，参与者和研究人员无法被蒙蔽。主要结局是 24 周时 HbA 自基线的变化，采用协方差分析（以基线值为协变量）进行评估。
结果
共随机分配 159 名参与者（每组 53 名）；148 名被纳入全分析集，其中干预组 52 名，对照组 1 49 名，对照组 2 47 名。基线时的平均（±SD）HbA 水平为 68.19±10.94mmol/mol（8.39±1.00%）。24 周时，HbA 自基线的最小二乘均值变化（±SEM）在干预组为-10.96±1.35mmol/mol（-1.00±0.12%），对照组 1 为-6.87±1.39mmol/mol（-0.63±0.13%）（p=0.0367 与干预组相比），对照组 2 为-6.32±1.42mmol/mol（-0.58±0.13%）（p=0.0193 与干预组相比）。干预组有 28.85%（15/52）的患者发生不良事件，对照组 1 有 26.42%（14/53），对照组 2 有 48.08%（25/52）。
结论/解释：在接受多次每日胰岛素注射的 2 型糖尿病成人中，当提供关于 CGM 图形模式解释的教育时，单独使用 isCGM 可更大程度地降低 HbA。
试验注册
ClinicalTrials.gov NCT04926623。
资金来源
本研究由大宇制药有限公司资助。
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