Abstract

Background and aims: Flash glucose monitoring (FGM) is a novel system with which glucose levels are monitored and has been reported to improve glucose variability and glycemic control in type 1 and type 2 diabetes patients treated with insulin. The present study aimed to evaluate the effects of FGM and conventional self-monitoring of blood glucose (SMBG) on glycemic control in patients with non-insulin-treated type 2 diabetes. Reseach design and Methods: In this 24-week, multicenter, open-label, randomized (1:1), parallel group study, non-insulin-treated type 2 diabetic patients at 5 hospitals in Japan were randomly assigned to the FGM (n = 49) or SMBG (n = 51) groups and were provided FGM or SMBG devices for 12 weeks. The primary outcome was change in glycated hemoglobin (HbA1c) level. This trial is registered with UMIN-CTR (UMIN000026452). Results: Forty-eight participants in the FGM group and 45 in the SMBG group completed the study. The mean HbA1c levels were 7·83% (SD 0·25) in the FGM group and 7·84% (SD 0·27) in the SMBG group at baseline, and the values were reduced in both FGM (−0·43%; 95% confidence interval [CI], −0·57 to −0·28; p < 0·0001) and SMBG groups (−0·30%; 95% CI −0·48 to −0·13; 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%, 95% CI −0·59 to −0·32, p < 0·0001; SMBG: −0·17%, 95% CI −0·05 to 0·11, p = 0·124); a significant between-group difference was also observed (difference −0·29%, 95% CI −0·54 to −0·05; p = 0·022). Diabetes Treatment Satisfaction Questionnaire score was significantly improved, and the mean glucose levels, standard deviation of glucose, mean amplitude of glycemic excursions, and duration of 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 non-insulin-treated type 2 diabetic patients.

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