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.

ABSTRACT: AIM:Analyse the effects of professional flash glucose monitoring system (FreeStyle Libre Pro™) 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.

SUBMITTER: Ajjan RA 

PROVIDER: S-EPMC6613178 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature