The effect of continuous glucose monitoring-guided glycemic control on progression of coronary atherosclerosis in type 2 diabetic patients with coronary artery disease: The OPTIMAL randomized clinical trial.

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  • Additional Information
    • Source:
      Publisher: Elsevier Science Pub. Co Country of Publication: United States NLM ID: 9204583 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-460X (Electronic) Linking ISSN: 10568727 NLM ISO Abbreviation: J Diabetes Complications Subsets: MEDLINE
    • Publication Information:
      Original Publication: New York, NY : Elsevier Science Pub. Co., c1992-
    • Subject Terms:
      Diabetes Mellitus, Type 2*/complications ; Diabetes Mellitus, Type 2*/drug therapy ; Coronary Artery Disease*/complications ; Diabetes Mellitus, Type 1* ; Hypoglycemia*/chemically induced ; Hypoglycemia*/prevention & control ; Plaque, Atherosclerotic*; Humans ; Blood Glucose ; Glycated Hemoglobin ; Blood Glucose Self-Monitoring/methods ; Prospective Studies ; Glycemic Control ; Hypoglycemic Agents/therapeutic use ; Insulin
    • Abstract:
      Background: Continuous glucose monitoring (CGM) improves glycemic fluctuation and reduces hypoglycemic risk. Whether CGM-guided glycemic control favorably modulates coronary atherosclerosis in patients with type 2 diabetes (T2DM) remains unknown.
      Methods: The OPTIMAL trial was a prospective, randomized, single-center trial in which 94 T2DM patients with CAD were randomized to CGM- or HbA1c-guided glycemic control for 48 weeks (jRCT1052180152). The primary endpoint was the nominal change in total atheroma volume (TAV) measured by serial IVUS. The secondary efficacy measure was the nominal change in maxLCBI 4mm on near-infrared spectroscopy imaging.
      Results: Among the 94 randomized patients, 82 had evaluable images at 48 weeks. Compared to HbA1c-guided glycemic control, CGM-guided control achieved a greater reduction in %coefficient of variation [-0.1 % (-1.8 to 1.6) vs. -3.3 % (-5.1 to -1.5), p = 0.01] and a greater increase in the duration with glucose between 70 and 180 mg/dL [-1.5 % (-6.0 to 2.9) vs. 6.7 % (1.9 to 11.5), p = 0.02]. TAV increased by 0.11 ± 1.9 mm 3 in the HbA1c-guided group and decreased by -3.29 ± 2.00 mm 3 in the CGM-guided group [difference = -3.4 mm 3 (95%CI: -8.9 to 2.0 mm 3 ), p = 0.22]. MaxLCBI 4mm , increased by 90.1 ± 25.6 in the HbA1c-guided group and by 50.6 ± 25.6 in the CGM-guided group (difference = -45.6 (95%CI: -118.1 to 26.7) p = 0.21]. A post-hoc exploratory analysis showed a greater regression of maxLCBI 4mm in the CGM-guided group [difference = 20.4 % (95%CI:1.3 to 39.5 %), p = 0.03].
      Conclusions: CGM-guided control for 48 weeks did not slow disease progression in T2DM patients with CAD. A greater regression of lipidic plaque under CGM-guided glycemic control in the post-hoc analysis requires further investigation.
      Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Yu Kataoka has received research support from Kowa, Nipro and Abbott, and honoraria from Nipro, Abbott, Kowa, Amgen, Sanofi, Astellas, Takeda and Daiichi-Sankyo. Stephen J. Nicholls is a recipient of a Principal Research Fellowship from the National Health and Medical Research Council of Australia and has received research support from AstraZeneca, Amgen, Anthera, CSL Behring, Cerenis, Eli Lilly, Esperion, Resverlogix, Novartis, InfraReDx and Sanofi-Regeneron and is a consultant for Amgen, Akcea, AstraZeneca, Boehringer Ingelheim, CSL Behring, Eli Lilly, Esperion, Kowa, Merck, Takeda, Pfizer, Sanofi-Regeneron and Novo Nordisk. Other authors have nothing to disclose.
      (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)
    • Contributed Indexing:
      Keywords: Continuous glucose monitoring; Coronary atherosclerosis; Glycated hemoglobin; Intravascular ultrasound; Near-infrared spectroscopy; Type 2 diabetes mellitus
    • Molecular Sequence:
      JPRN jRCT1052180152
    • Accession Number:
      0 (Blood Glucose)
      0 (Glycated Hemoglobin)
      0 (Hypoglycemic Agents)
      0 (Insulin)
    • Publication Date:
      Date Created: 20230923 Date Completed: 20231010 Latest Revision: 20231018
    • Publication Date:
      20240628
    • Accession Number:
      10.1016/j.jdiacomp.2023.108592
    • Accession Number:
      37741088