• Diab Vasc Dis Res · Jul 2019

    Randomized Controlled Trial Multicenter Study

    Reduction in HbA1c using professional flash glucose monitoring in insulin-treated type 2 diabetes patients managed in primary and secondary care settings: A pilot, multicentre, randomised controlled trial.

    • Ramzi A Ajjan, Neil Jackson, and Scott A Thomson.
    • 1 St James's University Hospital, Leeds Teaching Hospitals NHS Trust and LIGHT Laboratories: Leeds Institute of Cardiovascular and Metabolic Research, University of Leeds, Leeds, UK.
    • Diab Vasc Dis Res. 2019 Jul 1; 16 (4): 385-395.

    AimAnalyse the effects of professional flash glucose monitoring system (FreeStyle Libre Pro™) on glycaemic control in insulin-treated type 2 diabetes.MethodsPrimary (n = 17) and secondary care centres (n = 5) randomised 148 type 2 diabetes patients into three groups: (A) self-monitoring of blood glucose (n = 52), (B) self-monitoring of blood glucose and two Libre Pro sensor wears (n = 46) or (C) self-monitoring of blood glucose and four sensor wears (n = 50). Primary endpoint was time in range (glucose 3.9-10 mmol/L) within group C comparing baseline with days 172-187. Predefined secondary endpoints included HbA1c, hypoglycaemia and quality of life measures analysed within and between groups (clinicaltrials.gov, NCT02434315).ResultsIn group C, time in range in the first 14 days (baseline) and days 172-187 was similar at 15.0 ± 5.0 and 14.1 ± 4.7 h/day (mean ± SD), respectively, (p = 0.1589). In contrast, HbA1c reduced from baseline to study end within group C by 4.9 ± 8.8 mmol/mol (0.44% ± 0.81%; p = 0.0003). HbA1c was also lower in group C compared with A at study end by 5.4 ± 1.79 mmol/mol (0.48% ± 0.16%; p = 0.0041, adjusted mean ± SE), without increased time in hypoglycaemia (p = 0.1795). Treatment satisfaction scores improved in group C compared with A (p = 0.0225) and no device-related serious adverse events were reported.ConclusionsLibre Pro can improve HbA1c and treatment satisfaction without increasing hypoglycaemic exposure in insulin-treated type 2 diabetes individuals managed in primary/secondary care centres.

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