Continuous glucose monitoring with structured education in adults with type 2 diabetes managed by multiple daily insulin injections: a multicentre randomised controlled trial

期刊论文
发表日期：

2024年4月19日

查看全文

Ji Yoon Kim,
Sang-Man Jin,
Kang Hee Sim,
Bo-Yeon Kim,
Jae Hyoung Cho,
Jun Sung Moon,
Soo Lim,
Eun Seok Kang,
Cheol-Young Park,
Sin Gon Kim,
Jae Hyeon Kim

摘要

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