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
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
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DOI：
10.1177/1479164119827456
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发表时间：
2019-07-01
影响因子：
2.4
通讯作者：
Thomson, Scott A.
中科院分区：
文献类型：
--
作者：
Ajjan, Ramzi A.;Jackson, Neil;Thomson, Scott A.
目的：分析FreeStyle Libre Pro（TM）专业快速血糖监测系统对胰岛素治疗的2型糖尿病患者血糖控制的影响。方法：初级（n = 17）和二级护理中心（n = 5）将148例2型糖尿病患者随机分为三组：（A）自我血糖监测（n = 52），（B）自我血糖监测和两个Libre Pro传感器佩戴（n = 46）或（C）自我血糖监测和四个传感器佩戴（n = 50）。主要终点是C组内将基线与第172-187天进行比较的范围内时间（葡萄糖3.9-10 mmol/L）。预定义的次要终点包括组内和组间分析的HbA 1c、低血糖和生活质量指标（clinicaltrials.gov，NCT 02434315）。结果如下：在C组中，前14天（基线）和第172-187天范围内的时间相似，分别为15.0 +/- 5.0和14.1 +/- 4.7 h/d（平均值+/- SD）（p = 0.1589）。相比之下，C组中HbA 1c从基线至研究结束降低4.9 +/- 8.8 mmol/mol（0.44% +/- 0.81%; p = 0.0003）。在研究结束时，C组的HbA 1c也比A组低5.4 +/- 1.79 mmol/mol（0.48% +/- 0.16%; p = 0.0041，校正均值+/- SE），低血糖时间未延长（p = 0.1795）。与A组相比，C组的治疗满意度评分有所改善（p = 0.0225），未报告器械相关严重不良事件。结论：Libre Pro可以改善在初级/二级保健中心接受胰岛素治疗的2型糖尿病患者的HbA 1c和治疗满意度，而不会增加低血糖暴露。
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.