Aims: To investigate the effects of self-monitoring of glucose in blood or urine, on diabetes-specific distress and self-efficacy, compared with usual care in people with non-insulin-treated Type 2 diabetes mellitus.
Methods: One hundred and eighty-one participants with non-insulin-treated Type 2 diabetes mellitus [diabetes duration ≥ 1 year, age 45-75 years, HbA1c ≥ 53.0 mmol/mol (7.0%), self-monitoring frequency < 3 times in the previous year] were randomly assigned to blood self-monitoring (n = 60), urine self-monitoring (n = 59) or usual care (n = 62). Primary outcomes were between-group differences in diabetes-specific distress [Problem Areas in Diabetes scale (PAID)] and self-efficacy [Confidence in Diabetes Self-Care questionnaire (CIDS-2)] after 12 months. Secondary outcomes included changes in HbA1c , treatment satisfaction and depressive symptoms.
Results: There were no statistically significant between-group differences in changes in PAID and CIDS-2 after 12 months. Mean difference in PAID between blood monitoring and control was -2.2 [95% confidence interval (CI) -7.1 to 2.7], between urine monitoring and control was -0.9 (95% CI -4.4 to 2.5) and between blood monitoring and urine monitoring was -2.0 (95% CI -4.1 to 0.1). Mean difference in CIDS-2 between blood monitoring and control was 0.6 [95% CI (-2.0 to 2.1), between urine monitoring and control was 2.8 (95% CI -2.3 to 7.9)] and between blood monitoring and urine monitoring was -3.3 (95% CI -7.9 to 1.3). No statistically significant between-group differences in change in any of the secondary outcome measures were found.
Conclusions: This study did not find statistical or clinical evidence for a long-term effect of self-monitoring of glucose in blood or urine on diabetes-specific distress and self-efficacy in people with moderately controlled non-insulin-treated Type 2 diabetes mellitus. (Current Controlled Trials ISRCTN84568563).
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