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.

Keywords: Continuous glucose monitoring; HbA1c; flash glucose monitoring; glycaemic variability; hyperglycaemia; hypoglycaemia.

Conflict of interest statement

Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: RA Ajjan has received honoraria and research support from Abbott Diabetes Care. N Jackson reports grants from Abbott Diabetes Care during the conduct of the study. SA Thomson reports personal fees from Abbott Diabetes Care during the conduct of the study, personal fees from Sanofi and personal fees from the Clinical Research Practice Datalink (CPRD) outside the submitted work.

Figures

Figure 1.

Trial design. Following consent, screening and enrolment, all participants had a professional flash sensor applied to the upper arm for the 14-day baseline period. Participants with baseline sensor data of ⩾500 sensor glucose readings were randomised to one of the three study groups as shown.

Figure 2.

Trial profile demonstrating withdrawal rate.

Figure 3.

Time in (a) glucose range 3.9–10 mmol/L and (b) HbA1c, during the baseline and treatment phases.

Figure 4.

Time in (a) hypoglycaemia 10 mmol/L and (c) hyperglycemia >13.3 mmol/L, during the baseline and treatment phases.

Figure 5.

Scores from the DTSQ Questionnaire for (a) total treatment satisfaction score and (b) perceived frequency of hyperglycaemia and hypoglycaemia.