Aims: 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.
Materials and methods: 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).
Results: 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.
Conclusions: 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.
Keywords: clinical trial; continuous glucose monitoring (CGM); glycaemic control; type 2 diabetes.
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