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_1c 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_1c 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_1c level at baseline was 68.19±10.94 mmol/mol (8.39±1.00%). The least squares mean change (± SEM) from baseline HbA_1c 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_1c 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.

Graphical Abstract

中文翻译：

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通过每日多次胰岛素注射对成人 2 型糖尿病患者进行持续血糖监测和结构化教育：一项多中心随机对照试验

目标/假设

本研究的目的是比较独立间歇扫描连续血糖监测 (isCGM)（有或没有结构化教育计划）和血糖监测 (BGM) 对每日多次胰岛素注射 (MDI) 的 2 型糖尿病成人的有效性。

方法

在这项为期 24 周的随机开放标签多中心试验中，接受强化胰岛素治疗且 HbA _1c水平为 58-108 mmol/mol (7.5-12.0%) 的 2 型糖尿病成人患者以 1:1:1 的比例随机分配至 isCGM根据 CGM（干预组）、isCGM 常规教育（对照组 1）或 BGM 常规教育（对照组 2）中的图形模式调整胰岛素剂量和时间的结构化教育计划。分组随机化由独立统计学家进行。由于干预的性质，不可能对参与者和研究人员实施盲法。主要结局是 24 周时 HbA _1c相对于基线的变化，使用 ANCOVA 进行评估，并以基线值作为协变量。

结果

总共 159 名个体被随机分配（每组n = 53）；完整分析集中包括 148 名患者，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 _1c水平为 68.19±10.94 mmol/mol (8.39±1.00 %）。24 周时，干预组相对于基线 HbA _1c的最小二乘平均变化 (± SEM)为 -10.96±1.35 mmol/mol (-1.00±0.12%)，为 -6.87±1.39 mmol/mol (-0.63±0.13%)对照组1（与干预组相比， p = 0.0367）和对照组2（与干预组相比， p = 0.0193）为-6.32±1.42 mmol/mol（-0.58±0.13%）。干预组中 28.85% (15/52) 的个体、对照组 1 中的 26.42% (14/53) 和对照组 2 中的 48.08% (25/52) 个体发生不良事件。

结论/解释

当提供 CGM 图形模式解释教育时，独立 isCGM 可以使接受 MDI 的 2 型糖尿病成人患者的 HbA _{1c更大程度降低。}

试用注册

ClinicalTrials.gov NCT04926623。

资金

这项研究得到了大熊制药有限公司的支持。

图形概要