Continuous glucose monitoring with structured education in adults with type 2 diabetes managed by multiple daily insulin injections: a multicentre randomised controlled trial
Open accessAbstract
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.
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Previous studies examining the use of CGM in patients with T2D over a 6-month period, without midpoint CGM measurements, found only a modest reduction in HbA1c.
“Similarly, previous studies examining the use of CGM in patients with T2D over a 6-month period, without midpoint CGM measurements, found only a modest reduction in HbA1c [10, 16].”
From Sequential use of continuous glucose monitoring, with or without exercise trackers, significantly improves glycemic control in patients with type 2 diabetes (2025) · cites this paper as [16]
The Study outcomes section describes a 24-week trial in adults with type 2 diabetes, and Table 2 reports HbA1c reductions at week 24. But the claim that it lacked midpoint CGM measurements is not supported: the Change in CGM metrics section reports measurements at week 12, and the Study design and participants section says CGM was used throughout the 24 weeks in both CGM groups. The structured-education group’s HbA1c reduction was 1.00 percentage point, so describing the study’s reductions collectively as only modest also obscures that result (page numbers unavailable). (LLM, conf=0.88)
Experimental — accuracy not yet measuredCGM with or without structured education is superior in reducing HbA1c in patients with T2D.
“Furthermore, Kim et al. [16] demonstrated the superiority of CGM with or without structured education in reducing HbA1c in patients with T2D.”
From Sequential use of continuous glucose monitoring, with or without exercise trackers, significantly improves glycemic control in patients with type 2 diabetes (2025) · cites this paper as [16]
The Discussion reports that CGM with structured education was superior to both blood glucose monitoring and CGM with conventional education for reducing HbA1c. Table 2 shows HbA1c fell with conventional-education CGM, but its reduction was similar to that with blood glucose monitoring; the paper does not establish superiority without structured education. The trial was also limited to adults with type 2 diabetes using multiple daily insulin injections. Page numbers were not supplied. (LLM, conf=0.90)
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Advances in Continuous Glucose Monitoring: Clinical Applications
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“The importance of education has been recently highlighted by demonstrating superior glycemia in MDI-treated individuals with T2D when CGM was combined with education on the interpretation of glucose patterns [74].”
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“10 Second, the differences in the educational content between studies, particularly our comprehensive approach to educating CGM users, likely contributed to the different outcomes.”
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“…been calculated to provide at least 80% power to demonstrate the superiority of the stage 5 CIP over the tracking insulin pen, assuming a between-group difference in HbA1c of –0.41%, a standard deviation of 0.85%, and a one-sided significance level of 2.5% based on data from a previous trial [16].”
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“Furthermore, Kim et al. [16] demonstrated the superiority of CGM with or without structured education in reducing HbA1c in patients with T2D.”
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Primary Care and Diabetes Technologies and Treatments
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“It is likely that we will see more studies, like a recent one by Kim et al., showing that CGM use with added healthcare professional support and shared decision-making resulted in signi fi cantly more HbA1c reduction than just prescribing the use of CGM (11).”
Simultaneous transcatheter aortic and mitral valve-in-valve replacement: A case report
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“…3-phase prehabilitation was implemented preoperatively, [14] including cognitive-behavioral interventions [15] combined with structured education, [16] individualized low-intensity aerobic combined with inspiratory muscle training, and daily protein intake of ≥ 1.2 g/kg. postoperative…”
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“After any single study among Kim (2024), Haak (2017), Lau (2024), Wada (2020), or Lind (2024) was sequentially omitted, the recalculated pooled effect sizes (SMD) varied between 1.41 and 3.04.”
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Diabetes Technology: Continuous Glucose Monitoring and Insulin Delivery
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- Authors
- Kim, J. Y., Jin, S.-M., Sim, K. H., Kim, B.-Y., Cho, J. H., Moon, J. S., Lim, S., Kang, E. S., Park, C.-Y., Kim, S. G., & Kim, J. H.
- Affiliations
- Samsung Medical Center (KR)
- The Catholic University of Korea Seoul St. Mary's Hospital (KR)
- Yeungnam University College (KR)
- Seoul National University (KR)
- Yonsei University (KR)
- Kangbuk Samsung Hospital (KR)
- Korea University (KR)
- Corresponding author
- Kim, Jae Hyeon
- ORCID
- Venue
- Diabetologia
- Published
- 2024-04-19
- Volume
- 67
- Issue
- 7
- Pages
- 1223-1234
- ISSN
- 0012-186X (ISSN-L)
- 1432-0428
- OpenAlex
- W4394962327
- Cited by
- 36
- References
- 36
- Citations by year
- 2026: 15 · 2025: 19 · 2024: 2
- FWCI
- 11.86
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Diabetologia (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Daewoong Pharmaceutical Company
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Keywords
- continuous glucose monitoring, flash glucose monitoring, type 2 diabetes, multiple daily insulin injections, intensive insulin therapy, glycemic control, HbA1c, blood glucose monitoring, insulin dose adjustment, diabetes self-management education, adverse events, hypoglycemia, glycemic variability, glycemic variability index, glycemic variability index 2, glycemic variability index 3
- MeSH terms
- Continuous Glucose Monitoring, Adult, Aged, Blood Glucose, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Male, Middle Aged, Patient Education as Topic, Blood Glucose Self-Monitoring
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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