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

Abstract

Aims/Introduction: We investigated the effect of FreeStyle Libre TM on glycemic control in Japanese type 2 diabetes patients treated with basal-bolus insulin therapy. Materials and Methods: This prospective, 90-day single-arm study enrolled 94 adults with type 2 diabetes treated with insulin. A 14-day masked baseline phase was followed by an 11-week treatment phase during which participants used the device to monitor glucose levels. The primary end-point was time spent in hypoglycemia (<70 mg/dL) for baseline versus study end (days 76-90). Secondary end-points included other measures of glycemic control, along with patient satisfaction using the Japanese Diabetes Treatment and Satisfaction Questionnaire. Results: Time spent in hypoglycemia was low at baseline (0.51-0.93 h/day) and did not significantly decrease at study end (0.47-0.63 h/day, P = 0.6354). Time in range, time in hyperglycemia and estimated A1c all improved versus baseline (by +1.7-3.0 h/day,-1.6-.4 h/day and-0.4-0.8%, respectively, P < 0.0001 in each). Finger stick tests fell from 2.9-1.3 to 1.9-1.4/day, and mean scanning frequency during the intervention phase was 11.3/day. The mean treatment satisfaction score increased by 11.8-5.3 (P < 0.0001). Two severe hypoglycemia-related adverse events were reported; one of which was possibly related to the device. Three participants reported mild device-related skin trauma, site discomfort or subcutaneous bleeding. Conclusions: Use of FreeStyle Libre by Japanese type 2 patients diabetes treated with basal-bolus insulin therapy showed a low baseline of hypoglycemia, and enabled improved glycemic control and treatment satisfaction.

The Impact of the FreeStyle Libre&lt;sup&gt;TM&lt;/sup&gt; Flash Glucose Monitoring System on Glycemic Control in Patients with Diabetes; Observational Multicenter 15-Months Study

“…The decreasing number of hypoglycemic events supports this over time (9.54 ± 1.73 3 -6 months before using the flash glucose monitoring system to 0.52 ± 0.50 last six months of the study). These results are consistent with current literature suggesting that the flash glucose monitoring system decreases the incidence of hypoglycemic events [20] [21] [22] [23] [24].…”

Association between Flash Glucose Monitors and A1C: A Retrospective Pre-Post Analysis

“…These results are consistent with current literature suggesting that the use of flash glucose monitoring systems decrease the incidence of hypoglycemic events. [12][13][14][15] This study is not without limitations. First, this was a singlecenter study and may not be generalizable to other settings.…”

“…Current studies show that flash glucose monitors positively impact the risk of hypoglycemia, treatment satisfaction, and quality of life in various diabetes populations. 7,8,[12][13][14][15] However, the impact of flash glucose monitors on A1C reduction is not as wellestablished, particularly in broader diabetes populations with varying insulin requirements. This ambiguity in treatment effect makes it difficult for clinicians to evaluate the costs and benefits when considering flash glucose monitors for their patients.…”

Use of Continuous Glucose Monitoring (CGM) Technology in the Management of Type 2 Diabetes Mellitus in the Primary Care Setting: A Case Report

“…There is so far one prospective trial in Japan that demonstrated the effectiveness of Freestyle Libre TM CGM at improving glycaemic control in Japanese type 2 diabetes treated with insulin. 1 Indices of glycaemic control, including time in range, mean glucose and time in hyperglycaemia, were significantly improved. However, the mean total daily dose of insulin was unchanged at the study end.…”