Quality of Life and Glucose Control After 1 Year of Nationwide Reimbursement of Intermittently Scanned Continuous Glucose Monitoring in Adults Living With Type 1 Diabetes (FUTURE): A Prospective Observational Real-World Cohort Study
Quality of Life and Glucose Control After 1 Year of Nationwide Reimbursement of Intermittently Scanned Continuous Glucose Monitoring in Adults Living With Type 1 Diabetes (FUTURE): A Prospective Observational Real-World Cohort Study
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DOI：
10.2337/dc19-1610
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发表时间：
2020-02-01
期刊：
影响因子：
16.2
通讯作者：
Gillard, Pieter
中科院分区：
文献类型：
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作者：
Charleer, Sara;De Block, Christophe;Gillard, Pieter
2016年，比利时引入了在专科糖尿病中心治疗的1型糖尿病患者间歇性扫描连续血糖监测（isCGM）的全国报销。我们进行了一项为期12个月的前瞻性观察性多中心现实研究，以调查isCGM对生活质量和血糖控制的影响。研究设计和方法在2016年7月至2018年7月期间，在三个专业糖尿病中心连续招募了1913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。次要指标包括HbA（1c）的变化、在不同血糖范围内停留的时间、急性糖尿病并发症的发生和旷工。结果：总体生活质量和糖尿病特异性生活质量在基线时较高并保持稳定，而治疗满意度提高（P < 0.0001）。在研究前一年，因严重低血糖和/或酮症酸中毒入院的患者很少见（n = 63 / 1913; 3.3%），但进一步下降至2.2% （n = 37 / 1711; P = 0.031）。在研究期间，在维持HbA（1c）水平的情况下，报告严重低血糖事件的人数较少（1913例中n = 280例[14.6%]vs. 1711例中n = 134例[7.8%];P < 0.0001）或低血糖昏迷（1913例中n = 52例[2.7%]vs. 1711例中n = 18例[1.1%];P = 0.001）。缺勤人数减少（n = 111 / 1913 [5.8%] vs. n = 49 / 1711 [2.9%]; P < 0.0001）。低血糖期的时间显著减少，血糖持续时间减少，高血糖期持续时间增加。11% （n = 210）的参与者出现皮肤反应，导致22名参与者（1%）停止使用isCGM。结论：在专科糖尿病中心治疗的1型糖尿病患者，在全国范围内无限制地报销isCGM，可提高治疗满意度，减少严重低血糖，减少旷工，同时保持生活质量和HbA（1c）。
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 HbA(1c), 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 HbA(1c) 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 HbA(1c).