Abstract
INTRODUCTION: Frequent self-monitoring of blood glucose (SMBG) is usually required in patients with type 1 diabetes (T1D). However, the fear of self-testing, hygiene, and social obstacles may deter some patients from SMBG. Flash glucose monitoring (FGM), a less-invasive glucose monitoring method, was launched in Japan in September 2017. The aim of this study was to evaluate patient satisfaction and the clinical efficacy of FGM in Japanese patients with T1D. METHODS: Patient satisfaction with FGM was assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Diabetes Therapy-Related Quality of Life (DTR-QOL) questionnaire before (baseline) and 4 and 12 weeks after initiating FGM use in 20 Japanese patients with T1D. Clinical parameters related to glucose metabolism, such as glycated hemoglobin (HbA1c) levels, were assessed, and glucose fluctuations were evaluated using the FGM data. Values at 4 and 12 weeks after initiating FGM were compared with baseline data using the Wilcoxon signed-rank test. The mean absolute relative difference (MARD) between glucose values detected using the FGM device and by SMBG was also calculated. RESULTS: The DTSQ scores significantly improved 12 weeks after initiating FGM (P < 0.001). The DTR-QOL scores related to "burden in social activities" and "treatment satisfaction" also significantly improved 12 weeks after initiating FGM (P = 0.024 and 0.007, respectively). The HbA1c values and the percentage of time within the target glucose range (3.9-7.8 mmol/L) at the 12-week time point also improved, from 58 ± 5 (baseline) to 54 ± 4 mmol/mol (P = 0.002) and from 36% (interquartile range [IQR] 25-44.5%) (baseline) to 43% (IQR 39-50%) (P = 0.016), respectively. The MARD between glucose values detected using FGM and those detected using SMBG was 12.2% throughout the study period. CONCLUSIONS: Flash glucose monitoring contributed to improved patient satisfaction and the adjustment of blood glucose levels in patients with T1D. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR): UMIN000029673.