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

摘要

Aim: Analyse the effects of professional flash glucose monitoring system (FreeStyle Libre Pro (TM)) on glycaemic control in insulin-treated type 2 diabetes. Methods: Primary (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). Results: In 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. Conclusions: Libre Pro can improve HbA1c and treatment satisfaction without increasing hypoglycaemic exposure in insulin-treated type 2 diabetes individuals managed in primary/secondary care centres.