Effect of introduction of intermittently scanned continuous glucose monitoring on glycaemic control in individuals living with type 2 diabetes mellitus treated with non-insulin therapies-A randomised controlled trial.

Abstract

This pilot randomised controlled trial aimed to evaluate the effect of introducing isCGM on glycaemic control and diabetes distress in individuals with T2DM receiving non-insulin therapies. Forty adults with T2DM were randomised to either receive FreeStyle Libre 2 (Libre 2), an isCGM system, or FreeStyle Libre Pro iQ (Libre Pro) also known as 'blinded' CGM. Participants were followed for 12 weeks. The primary outcome was a fall in haemoglobin A1c (HbA1c) of ≥5.5 mmol/mol. Diabetes distress was assessed using the two-item diabetes distress scale (DDS2). The median age was 59.5 years; 57.5% were male. Of the Libre 2 users, 53% achieved a ≥5.5 mmol/mol reduction in HbA1c compared to 35% in the Libre pro group (p = 0.34). Compared to Libre Pro, the use of Libre 2 was associated with an improved time in range at 12 weeks of 18 percentage points (confidence interval 2-35, p = 0.028). Participants in the Libre 2 group exhibited a non-significant reduction in HbA1c levels of 8 mmol/mol compared to the Libre Pro group after 12 weeks. However, no significant differences were observed in other CGM metrics or diabetes distress between the study groups. The use of isCGM in individuals living with T2DM on non-insulin therapy showed promise in improving glycaemic control, as evidenced by increased TIR, albeit without a significant reduction in HbA1c or impact on diabetes distress, suggesting this could be potentially beneficial in individuals with T2DM.