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

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

doi:10.1007/s00125-024-06152-1

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

Diabetologia. 2024 Apr 19. doi: 10.1007/s00125-024-06152-1. Online ahead of print.

Authors

Ji Yoon Kim^#¹, Sang-Man Jin^#¹, Kang Hee Sim², Bo-Yeon Kim³, Jae Hyoung Cho⁴, Jun Sung Moon⁵, Soo Lim⁶, Eun Seok Kang⁷, Cheol-Young Park⁸, Sin Gon Kim⁹, Jae Hyeon Kim¹⁰

Affiliations

¹ Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
² Diabetes Education Unit, Diabetes Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
³ Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea.
⁴ Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
⁵ Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Republic of Korea.
⁶ Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.
⁷ Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.
⁸ Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
⁹ Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
¹⁰ Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. jaehyeon@skku.edu.

^# Contributed equally.

PMID: 38639876
DOI: 10.1007/s00125-024-06152-1

Abstract

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.

Keywords: Continuous glucose monitoring; Diabetes education; Flash sensor glucose technology; Insulin; Type 2 diabetes.

Associated data

ClinicalTrials.gov/NCT04926623