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.

Effect of the FreeStyle Libre™ flash glucose monitoring system on glycemic control in individuals with type 2 diabetes treated with basal–bolus insulin therapy: An open label, prospective, multicenter trial in Japan

“…Improvement of HbA1c without increased hypoglycemia was also observed with other flash glucose monitoring studies in white people 5,7 . The current results, along with existing data, show the benefits of utilizing flash glucose monitoring technology 5,7,8,31–35 or real‐time CGM in type 2 diabetes patients treated with insulin 4,6 .…”

“…Improvement of HbA1c without increased hypoglycemia was also observed with other flash glucose monitoring studies in white people 5,7 . The current results, along with existing data, show the benefits of utilizing flash glucose monitoring technology 5,7,8,[31][32][33][34][35] or real-time CGM in type 2 diabetes patients treated with insulin 4,6 . In Japan, insulin dose titration for type 2 diabetes is generally physician-led, and poor patient concordance with insulin regimens is acknowledged as an issue 20 .…”

Making sense of glucose metrics in diabetes: linkage between postprandial glucose (PPG), time in range (TIR) & hemoglobin A1c (A1C)

“…Overall, realtime CGM use can improve dietary insights, A1C values, and decrease hypoglycemia in individuals with T2D using insulin [55,56] and non-insulin therapies [57,58]. Although patients need to be more proactive to retrieve glucose data and potentiate the mitigation of hypoglycemic events, FGM can provide similar improvements as real-time CGM [59][60][61]. Despite the many benefits that CGM can provide, the cost of a CGM system can be limiting for some patients.…”

A Systematic Review of Collective Evidences Investigating the Effect of Diabetes Monitoring Systems and Their Application in Health Care

“…The other important outcome, Time in Glycemic Range (70–180 mg/dl), is reported to increase with isCGM (intermittently scanned) among well-controlled patients with Type 1 diabetes ( 33 ). Whereas, the results are controversial among adult patients with uncontrolled T2DM using insulin ( 62 ).…”