BACKGROUND: We conducted a clinical research study to determine the effect of self-monitoring of blood glucose (SMBG) on glycaemic control and the value of a putatively less painful blood sampling technique on SMBG in oral hypoglycaemic agent-treated type 2 diabetes patients; SMBG has not been broadly applied in non-insulin-treated patients in Japan. METHODS:One hundred thirty-seven subjects were recruited for the 24-week, prospective, comparison study and randomized into three groups: 46, no SMBG group; 46, fingertip group; and 45, palm group. The primary endpoint was change in HbA(1c). The secondary endpoints were SMBG compliance, dropout rate, treatment changes, and patient's and physician's satisfaction. RESULTS: Six subjects in the fingertip group (13.2%) and one subject in the palm group (2.2%) were dropped because of pain. A(1C) level of all subjects at 24-week was decreased more in the fingertip (-0.23%) and palm (-0.16%) groups than that in the no SMBG group (+0.31%) (p < 0.05). SMBG compliance was higher in the fingertip group (2.17 times/day) than that in the palm group (1.65 times/day) (p < 0.05). A(1C) level of treatment-unchanged subjects was decreased more in the fingertip (-0.25%) and palm (-0.21%) groups than that in the no SMBG group (+0.30%) (p < 0.05). SMBG compliance was higher in the fingertip group (2.24 times/day) than that in the palm group (1.65 times/day) (p < 0.05). Patient's questionnaire showed that 84.1% of the fingertip group and 90.2% of the palm group were satisfied with SMBG. Physician's satisfaction was higher in the palm group (94.0%) than that in the fingertip group (80.0%) (p < 0.05). CONCLUSION:SMBG is beneficial for glycaemic control, and palm blood sampling is a useful procedure for oral hypoglycaemic agent-treated type 2 diabetes.
RCT Entities:
BACKGROUND: We conducted a clinical research study to determine the effect of self-monitoring of blood glucose (SMBG) on glycaemic control and the value of a putatively less painful blood sampling technique on SMBG in oral hypoglycaemic agent-treated type 2 diabetespatients; SMBG has not been broadly applied in non-insulin-treated patients in Japan. METHODS: One hundred thirty-seven subjects were recruited for the 24-week, prospective, comparison study and randomized into three groups: 46, no SMBG group; 46, fingertip group; and 45, palm group. The primary endpoint was change in HbA(1c). The secondary endpoints were SMBG compliance, dropout rate, treatment changes, and patient's and physician's satisfaction. RESULTS: Six subjects in the fingertip group (13.2%) and one subject in the palm group (2.2%) were dropped because of pain. A(1C) level of all subjects at 24-week was decreased more in the fingertip (-0.23%) and palm (-0.16%) groups than that in the no SMBG group (+0.31%) (p < 0.05). SMBG compliance was higher in the fingertip group (2.17 times/day) than that in the palm group (1.65 times/day) (p < 0.05). A(1C) level of treatment-unchanged subjects was decreased more in the fingertip (-0.25%) and palm (-0.21%) groups than that in the no SMBG group (+0.30%) (p < 0.05). SMBG compliance was higher in the fingertip group (2.24 times/day) than that in the palm group (1.65 times/day) (p < 0.05). Patient's questionnaire showed that 84.1% of the fingertip group and 90.2% of the palm group were satisfied with SMBG. Physician's satisfaction was higher in the palm group (94.0%) than that in the fingertip group (80.0%) (p < 0.05). CONCLUSION: SMBG is beneficial for glycaemic control, and palm blood sampling is a useful procedure for oral hypoglycaemic agent-treated type 2 diabetes.