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

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.

Keywords: HbA1c; clinical trial(s); education and behavioral interventions; glucose monitoring.

Figure 1

Schematic illustration of the study design. One-hundred participants were randomly assigned to the flash glucose monitoring (FGM) (n=49) or self-monitoring of blood glucose (SMBG) (n=51) group. Forty-eight participants in the FGM group and 45 participants in the SMBG group completed the study.

Figure 2

Change in glycated hemoglobin (HbA1c). HbA1c was reduced from baseline level in both groups at 12 weeks (flash glucose monitoring (FGM): −0.43% (−4.7 mmol/mol), 95% CI −0.57 to −0.28, p<0.001; self-monitoring of blood glucose (SMBG): −0.30% (−3.3 mmol/mol), 95% CI −0.48 to −0.013 p=0.001); there were no significant between-group differences in this respect in the analysis of covariance (ANCOVA) model (difference −0.13% (−1.4 mmol/mol), 95% CI −0.35 to 0.09; p=0.241). HbA1c was significantly decreased in the FGM group compared with the SMBG group at 24 weeks in the ANCOVA model (FGM: −0.46% (−5.0 mmol/mol), 95% CI −0.59 to −0.32, p<0.001; SMBG: −0.17% (−1.8 mmol/mol), 95% CI −0.05 to 0.11, p=0.124; difference −0.29% (−3.2 mmol/mol), 95% CI −0.54 to −0.05; p=0.022). Change in HbA1c throughout the 24 weeks analyzed using a linear mixed model showed significant improvement in the FGM group compared with the SMBG group (−0.29% (−3.2 mmol/mol), 95% CI −0.53 to −0.06; p=0.014). Data are expressed as mean (95% CI). *Significant difference between groups, p<0.05. †p<0.05 vs baseline.