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  • Flash glucose monitoring helps achieve better glycemic control than conventional self-monitoring of blood glucose in non-insulin-treated type 2 diabetes: a randomized controlled trial

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Emerging Technologies, Pharmacology and Therapeutics
Flash glucose monitoring helps achieve better glycemic control than conventional self-monitoring of blood glucose in non-insulin-treated type 2 diabetes: a randomized controlled trial
  1. Eri Wada1,
  2. Takeshi Onoue1,
  3. Tomoko Kobayashi1,
  4. Tomoko Handa1,
  5. Ayaka Hayase1,
  6. Masaaki Ito1,
  7. Mariko Furukawa1,
  8. Takayuki Okuji1,
  9. Norio Okada1,
  10. Shintaro Iwama1,
  11. Mariko Sugiyama1,
  12. Taku Tsunekawa1,
  13. Hiroshi Takagi1,
  14. Daisuke Hagiwara1,
  15. Yoshihiro Ito1,2,
  16. Hidetaka Suga1,
  17. Ryoichi Banno1,3,
  18. Yachiyo Kuwatsuka4,
  19. Masahiko Ando4,
  20. Motomitsu Goto1,
  21. Hiroshi Arima1
  1. 1Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan
  2. 2Department of CKD Initiatives Internal Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan
  3. 3Research Center of Health, Physical Fitness and Sports, Nagoya University, Nagoya, Japan
  4. 4Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan
  1. Correspondence to Dr Takeshi Onoue; t-onoue{at}med.nagoya-u.ac.jp; Dr Hiroshi Arima; arima105{at}med.nagoya-u.ac.jp

Abstract

Introduction The present study aimed to evaluate the effects of flash glucose monitoring (FGM) and conventional self-monitoring of blood glucose (SMBG) on glycemic control in patients with non-insulin-treated type 2 diabetes.

Research design and methods In this 24-week, multicenter, open-label, randomized (1:1), parallel-group study, patients with non-insulin-treated type 2 diabetes at five hospitals in Japan were randomly assigned to the FGM (n=49) or SMBG (n=51) groups and were provided each device for 12 weeks. The primary outcome was change in glycated hemoglobin (HbA1c) level, and was compared using analysis of covariance model that included baseline values and group as covariates.

Results Forty-eight participants in the FGM group and 45 in the SMBG group completed the study. The mean HbA1c levels were 7.83% (62.1 mmol/mol) in the FGM group and 7.84% (62.2 mmol/mol) in the SMBG group at baseline, and the values were reduced in both FGM (−0.43% (−4.7 mmol/mol), p<0.001) and SMBG groups (−0.30% (−3.3 mmol/mol), p=0.001) at 12 weeks. On the other hand, HbA1c was significantly decreased from baseline values in the FGM group, but not in the SMBG group at 24 weeks (FGM: −0.46% (−5.0 mmol/mol), p<0.001; SMBG: −0.17% (−1.8 mmol/mol), p=0.124); a significant between-group difference was also observed (difference −0.29% (−3.2 mmol/mol), p=0.022). Diabetes Treatment Satisfaction Questionnaire score was significantly improved, and the mean glucose levels, SD of glucose, mean amplitude of glycemic excursions and time in hyperglycemia were significantly decreased in the FGM group compared with the SMBG group.

Conclusions Glycemic control was better with FGM than with SMBG after cessation of glucose monitoring in patients with non-insulin-treated type 2 diabetes.

Trial registration number UMIN000026452, jRCTs041180082.

  • clinical trial(s)
  • education and behavioral interventions
  • glucose monitoring
  • HbA1c
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjdrc-2019-001115

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    Footnotes

    • Contributors TOn, TK, MG and HA designed the study. EW, TK, TH, AH, MI, MF, TOk, NO, TK, SI, MS, TT, HT, DH, YI, HS and RB acquired data. YK and MA analyzed data. EW, TOn, MG and HA interpreted data. EW and TOn wrote the first draft of the manuscript and together with all the coauthors worked collaboratively to write, discuss and review this manuscript which was revised and edited by HA. All authors have read and approved the final manuscript. TOn is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

    • Funding This study was supported by the Nagoya University Hospital Funding for Clinical Development.

    • Disclaimer The funder of the study had no role in the study design, data collection, data analysis, data interpretation or writing of the report.

    • Competing interests HA reports grants and speaker honoraria from Abbott Japan outside the submitted work.

    • Patient consent for publication Not required.

    • Ethics approval The study protocol was approved by the Ethical Committee of the Nagoya University Graduate School of Medicine (No. 2017–0091). This study was performed in accordance with the ethical principles of the Declaration of Helsinki and the Ethical Guidelines for Medical and Health Research Involving Human Subjects in Japan.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information.