Background. Self-monitoring of blood glucose (SMBG) has been widely prescribed in Japan for patients with diabetes who receive insulin and/or glucagon-like peptide-1 receptor agonist injection(s) to achieve ideal glycemic control and reduce hypoglycemia risk. Although it is frequently noted that many patients experience the finger prick as tedious or painful and fall into non-adherence, a large-scale survey of mental distress and health-related quality of life (QOL) among patients using SMBG has not been conducted in Japan. 
Aim. To explore the impact of views of patients with diabetes using SMBG and their doctors against SMBG to encourage the patients to improve their self-management skills.   
Materials and Methods. This multi-center, cross-sectional survey was conducted in patients with type 1 (T1D), type 2 (T2D) or other diabetes (OD) using SMBG ≥3 months, recruited from 42 Japanese medical institutions (Clinical trial registration number: UMIN000026761). To evaluate mood status and health-related QOL, POMS2 and DTR-QOL questionnaires were used in addition to our original SMBG questionnaire developed in this study, which asks four questions using a 5-point Likert scale with responses ranging from “very unlikely” (1) to “very likely” (5): Q1) “How important is SMBG to you?”; Q2) “How painful is SMBG to you?”; Q3) “How confident are you to enter SMBG results correctly on your notes?” and Q4) “Would you like to share your SMBG results with your physician?”. Each value represents mean ± SD. Another original questionnaire for doctors asking four questions: QD1) “How do you have credit with readings of SMBG?”; QD2) “How much do you think readings of SMBG reflect the patients’ self-management behavior?”; QD3) “How much do you think patients report diary SMBG correctly?”; QD4) “How are you sure to check patients’ diary SMBG every time in clinic?”.  The protocol was approved by the Ethical Committees of the Japan Association for Diabetes Education and Care and those of each participating institution. Results. Valid responses were obtained from 2,136 patients (T1D 491/T2D 1560/OD 50/Unknown 35). Among T1D patients (Male 46.0%; Age 51.6±15.4 years; Duration 15.2±10.7 years), patients answering “very likely” or “likely” (Group A) in Q2 of our SMBG questionnaire (45.5% of all T1D) showed significantly higher POMS2 total mood disturbance (TMD) score, lower DTR-QOL score and higher HbA1c compared to those answering “very unlikely” or “unlikely” (Group B, 40.9% of all T1D): POMS2 TMD 49.7±9.4 versus (vs) 46.3±8.7, p<0.01; DTR-QOL 0.53±0.15 vs 0.68±0.15, p<0.01; HbA1c (%) 7.9±1.2 vs 7.6±1.1, p<0.05. The number of daily SMBG checks did not differ significantly between the groups (3.6±1.8 and 2.6±1.5, p=0.07). Among T2D patients (Male 59.5%; Age 64.0±11.7 years; Duration 16.6±9.9 years), similar trends were observed in those answering “very likely” or “likely” (Group C) compared to those answering “very unlikely” or “unlikely” (Group D): POMS2 TMD 49.0±8.6 vs 45.8±7.8, p<0.01; DTR-QOL 0.63±0.15 vs 0.72±0.14, p<0.01; HbA1c (%) 7.6±1.1 vs 7.4±1.0, p<0.01; daily SMBG checks (times) 2.5±1.6 vs 2.4±1.6, p=0.79. Importantly, Groups A and C showed lower scores in Q1 of our SMBG questionnaire than Groups B and D (Group A vs B, 4.7±0.6 vs 4.8±0.6, p<0.05; Group C vs D, 4.5±0.7 vs 4.6±0.8, p<0.01. Together, these results suggest that patient education on the importance of SMBG may serve to alleviate SMBG-associated discomfort. Another questionnaire for doctors was collected from 142 doctors registered in this survey. In QD4, 98.6% of the doctors answered that they are “likely” or “very likely” sure for checking their patients’ diary SMBG every time. In facility-settings, the average score for QD4 was associated with the average score of Q1(r = 0.311, p<0.05) and Q3(r = 0.344, p<0.05). Conclusion. T1D and T2D patients experiencing SMBG-associated discomfort have more mental distress, lower health-related QOL and higher HbA1c, regardless of the number of daily SMBG checks. SMBG education can reduce SMBG-related discomfort and mental distress and increase health-related QOL for patients. Furthermore, doctors’ check of diary SMBG may lead the patients facilitate the importance of SMBG and share SMBG results with their doctors.
Financial support: This study is financially supported by Terumo Corporation.

Mental distress and health-related QOL among patients with diabetes using SMBG in Japan: a large-scale survey