Effect of structured self‐monitoring of blood glucose, with and without additional TeleCare support, on overall glycaemic control in non‐insulin treated Type 2 diabetes: the SMBG Study, a 12‐month randomized controlled trial

AIM: To examine the impact of structured self‐monitoring of blood glucose, with or without TeleCare support, on glycaemic control in people with sub‐optimally controlled Type 2 diabetes. METHODS: We conducted a 12‐month, multicentre, randomized controlled trial in people with established (>1 year) Type 2 diabetes not on insulin therapy, with sub‐optimal glycaemic control [HbA(1c) ≥58 to ≤119 mmol/mol (≥7.5% to ≤13%)]. A total of 446 participants were randomized to a control group (n =151) receiving usual diabetes care, a group using structured self‐monitoring of blood glucose alone (n =147) or a group using structured self‐monitoring of blood glucose with additional monthly ‘TeleCare’ support (n =148). The primary outcome was HbA(1c) at 12 months. RESULTS: A total of 323 participants (72%) completed the study; 116 (77%) in the control group, 99 (67%) in the self‐monitoring of blood glucose alone group and 108 (73%) in the self‐monitoring of blood glucose plus TeleCare group. Compared to baseline, the mean HbA(1c) was lower in all groups at 12 months, with reductions of 3.3 mmol/mol (95% CI –5.71 to –0.78) or 0.3% (95% CI –0.52 to –0.07; P=0.01) in the control group, 11.4 mmol/mol (95% CI –14.11 to –8.76) or 1.1% (–1.29 to –0.81; P<0.0001) in the group using self‐monitoring of blood glucose alone and 12.8 mmol/mol (95% CI –15.34 to –10.31) or 1.2% (95% CI –1.40 to ‐0.94; P<0.0001) in the group using self‐monitoring of blood glucose plus TeleCare. This represents a reduction in HbA(1c) of 8.9 mmol/mol (95% CI –11.97 to –5.84) or 0.8% (95% CI –1.10 to ‐0.54; P≤0.0001) with structured self‐monitoring of blood glucose compared to the control group. Participants with lower baseline HbA(1c), shorter duration of diabetes and higher educational achievement were more likely to achieve HbA(1c) ≤53 mmol/mol (7.0%). CONCLUSIONS: Structured self‐monitoring of blood glucose provides clinical and statistical improvements in glycaemic control in Type 2 diabetes. No additional benefit, over and above the use of structured self‐monitoring of blood glucose, was observed in glycaemic control with the addition of once‐monthly TeleCare support. (Clinical trial registration no.: ISRCTN21390608)