OBJECTIVE In 2016, nationwide reimbursement of intermittently scanned continuous glucose monitoring (isCGM) for people living with type 1 diabetes treated in specialist diabetes centers was introduced in Belgium. We undertook a 12-month prospective observational multicenter real-world study to investigate impact of isCGM on quality of life and glycemic control. RESEARCH DESIGN AND METHODS Between July 2016 and July 2018, 1,913 adults with type 1 diabetes were consecutively recruited in three specialist diabetes centers. Demographic, metabolic, and quality of life data were collected at baseline, 6 months, and 12 months of standardized clinical follow-up. The primary end point was evolution of quality of life from baseline to 12 months. Secondary outcome measures were, among others, change in HbA1c, time spent in different glycemic ranges, occurrence of acute diabetes complications, and work absenteeism. RESULTS General and diabetes-specific quality of life was high at baseline and remained stable, whereas treatment satisfaction improved (P < 0.0001). Admissions for severe hypoglycemia and/or ketoacidosis were rare in the year before study (n = 63 out of 1,913; 3.3%), but decreased further to 2.2% (n = 37 out of 1,711; P = 0.031). During the study, fewer people reported severe hypoglycemic events (n = 280 out of 1,913 [14.6%] vs. n = 134 out of 1,711 [7.8%]; P < 0.0001) or hypoglycemic comas (n = 52 out of 1,913 [2.7%] vs. n = 18 out of 1,711 [1.1%]; P = 0.001) while maintaining HbA1c levels. Fewer people were absent from work (n = 111 out of 1,913 [5.8%] vs. n = 49 out of 1,711 [2.9%]; P < 0.0001). Time spent in hypoglycemia significantly decreased in parallel with less time in range and more time in hyperglycemia. Eleven percent (n = 210) of participants experienced skin reactions, leading to stopping of isCGM in 22 participants (1%). CONCLUSIONS Nationwide unrestricted reimbursement of isCGM in people with type 1 diabetes treated in specialist diabetes centers results in higher treatment satisfaction, less severe hypoglycemia, and less work absenteeism, while maintaining quality of life and HbA1c.

中文翻译：

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在1型糖尿病的成年人中，进行间歇性扫描连续血糖监测的全国性报销1年后的生活质量和血糖控制（一项未来研究）：一项前瞻性观察性现实世界队列研究。

目标2016年，比利时实行了在全国范围内对在专科糖尿病中心接受治疗的1型糖尿病患者进行间歇性扫描连续血糖监测（isCGM）的补偿。我们进行了为期12个月的前瞻性观察性多中心现实世界研究，以调查isCGM对生活质量和血糖控制的影响。研究设计与方法2016年7月至2018年7月，在三个专业糖尿病中心连续招募了1,913名1型糖尿病成年人。在基线，6个月和12个月的标准化临床随访中收集人口统计学，代谢和生活质量数据。主要终点是生活质量从基线到12个月的演变。次要结果指标包括HbA1c的变化，在不同血糖范围内花费的时间，发生急性糖尿病并发症，并缺勤。结果总体和特定于糖尿病的生活质量在基线时很高，并且保持稳定，而治疗满意度得到了改善（P <0.0001）。在研究前的一年中，严重低血糖和/或酮症酸中毒的入院率极低（在1,913名患者中，n = 63； 3.3％），但进一步下降到2.2％（在1,711名患者中，n = 37； P = 0.031）。在研究过程中，报告严重降血糖事件的人数有所减少（n = 1,913中有280人[14.6％]，而1,711人中的n = 134人[7.8％]； P <0.0001）或低血糖昏迷（1,913人中有52人[2.7]保持HbA1c水平的同时，在1,711个[1.1％； P = 0.001]中，％= n = 18。缺勤的人更少（1,913人中的n = 111 [5.8％]与1,711人中的n = 49 [2.9％]； P <0.0001）。在低血糖症中花费的时间显着减少，同时在范围内的时间更少，而在高血糖症中的时间更多。11％（n = 210）的参与者发生了皮肤反应，导致22名参与者（1％）停止了isCGM。结论在专业糖尿病中心接受治疗的1型糖尿病患者中，isCGM在全国范围内的无限制报销可提高治疗满意度，降低严重的低血糖症和减少旷工，同时保持生活质量和HbA1c。