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

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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 HbA1c 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 HbA1c 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) HbA1c level at baseline was 68.19±10.94 mmol/mol (8.39±1.00%). The least squares mean change (± SEM) from baseline HbA1c 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 HbA1c 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

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Abbreviations

BGM:

Blood glucose monitoring

CGM:

Continuous glucose monitoring

DTSQ:

Diabetes Treatment Satisfaction Questionnaire

FA:

Full analysis

FreEdoM-2:

Freestyle Libre-based Education on MDI in type 2 diabetes

isCGM:

Intermittently scanned CGM

LS:

Least squares

MDI:

Multiple daily insulin injections

TAR:

Time above range

TBR:

Time below range

TIR:

Time in range

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Author information

Author notes

  1. Ji Yoon Kim and Sang-Man Jin contributed equally to this study as the first authors.

Authors and Affiliations

  1. Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

    Ji Yoon Kim, Sang-Man Jin & Jae Hyeon Kim

  2. Diabetes Education Unit, Diabetes Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

    Kang Hee Sim

  3. Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea

    Bo-Yeon Kim

  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

    Jae Hyoung Cho

  5. Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Republic of Korea

    Jun Sung Moon

  6. Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea

    Soo Lim

  7. Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea

    Eun Seok Kang

  8. Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

    Cheol-Young Park

  9. Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea

    Sin Gon Kim

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Corresponding author

Correspondence to Jae Hyeon Kim.

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Acknowledgements

The authors thank all the healthcare professionals at each centre who provided education, including J. H. Kim of The Catholic Smart Healthcare Center, Seoul St Mary’s Hospital, The Catholic University of Korea (Seoul, Republic of Korea), S. Park of Seoul National University Bundang Hospital, Seoul National University College of Medicine (Seongnam, Republic of Korea), H. Ju and Y. Hyun of Diabetes Center, Severance Hospital, Yonsei University College of Medicine (Seoul, Republic of Korea), J. M. Kim of Diabetes Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine (Seoul, Republic of Korea) and M. Yoon, H. Kim and K. Kim of Diabetes Center, Korea University Anam Hospital, Korea University College of Medicine (Seoul, Republic of Korea).

Data availability

Data are available from the corresponding author on reasonable request.

Funding

This study was supported by Daewoong Pharmaceutical Co., Ltd. The funding sources had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; or decision to submit the manuscript for publication.

Author’s relationships and activities

The authors declare that there are no relationships or activities that might bias, or be perceived to bias, their work.

Contribution statement

S-MJ and JHK contributed to the conception and design of the study. JYK, S-MJ, KHS, B-YK, JHC, JSM, SL, ESK, C-YP, SGK and JHK conducted data collection. JYK, S-MJ and JHK interpreted the results. JYK and S-MJ wrote the initial draft of the manuscript. JYK, S-MJ, KHS, B-YK, JHC, JSM, SL, ESK, C-YP, SGK and JHK contributed to reviewing the work critically for important intellectual content. All authors approved the final version to be published. JHK is the guarantor of this work.

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Kim, J.Y., Jin, SM., Sim, K.H. et al. 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). https://doi.org/10.1007/s00125-024-06152-1

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