Introduction The FreeStyle Libre (FSL) is a flash glucose monitoring (FGM) system. The Flash Monitor Register in the Netherlands (FLARE-NL-4) study previously demonstrated the positive effects of FSL-FGM use during 1 year on glycemic control, quality of life and disease burden among persons with diabetes mellitus (DM). The present follow-up study assesses the effects of FSL-FGM after 2 years. Research design and methods Patients included in the FLARE-NL-4 study who continued FSL-FGM during the 1-year study period were invited to participate (n=687). Data were collected using questionnaires (the 12-Item Short Form Health Survey version 2 (SF-12v2) and the EuroQol 5-Dimension 3-Level (EQ-5D-3L) for quality of life), including self-reported hemoglobin A1c (HbA1c). Results A total of 342 patients agreed to participate: mean age 48.0 (±15.6) years, 52% men and 79.5% with type 1 DM. HbA1c decreased from 60.7 (95% CI 59.1 to 62.3) mmol/mol before use of FSL-FGM to 57.3 (95% CI 55.8 to 58.8) mmol/mol after 1 year and 57.8 (95% CI 56.0 to 59.5) mmol/mol after 2 years. At the end of the 2-year follow-up period, 260 (76%) persons were still using the FSL-FGM and 82 (24%) had stopped. The main reason for stopping FSL-FGM was financial constraints (55%). Concerning the whole 2-year period, there was a significant decrease in HbA1c among persons who continued use of FSL-FGM (−3.5 mmol/mol, 95% CI −6.4 to –0.7), while HbA1c was unaltered compared with baseline among persons who stopped FSL-FGM (−2.4 mmol/mol, 95% CI −7.5 to 2.7): difference between groups 2.2 (95% CI −1.3 to 5.8) mmol/mol. After 2 years, persons who continued use of FSL-FGM had higher SF-12 mental component score and higher EQ-5D Dutch tariff score and felt less often anxious or depressed compared with persons who discontinued FSL-FGM. Conclusions Although the considerable number of non-responders limits generalizability, this study suggests that persons who continue to use FSL-FGM for 2 years may experience sustained improvement in glycemic control and quality of life. Data are available upon reasonable request.

中文翻译：

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使用两年快速血糖监测与血糖控制和生活质量的持续改善有关 (FLARE-NL-6)

简介 FreeStyle Libre (FSL) 是一种快速血糖监测 (FGM) 系统。荷兰的 Flash Monitor Register (FLARE-NL-4) 研究先前表明，在 1 年内使用 FSL-FGM 对糖尿病 (DM) 患者的血糖控制、生活质量和疾病负担有积极影响。目前的后续研究评估了 2 年后 FSL-FGM 的影响。研究设计和方法 FLARE-NL-4 研究中包括在 1 年研究期间继续 FSL-FGM 的患者被邀请参与 (n=687)。使用问卷（12 项简表健康调查第 2 版（SF-12v2）和用于生活质量的 EuroQol 5 维 3 级（EQ-5D-3L））收集数据，包括自我报告的血红蛋白 A1c（糖化血红蛋白）。结果 共有 342 名患者同意参与：平均年龄 48.0 (±15.6) 岁，52% 的男性和 79.5% 的 1 型糖尿病患者。HbA1c 从使用 FSL-FGM 前的 60.7（95% CI 59.1 至 62.3）mmol/mol 降至 1 年后的 57.3（95% CI 55.8 至 58.8）mmol/mol 和 57.8（95% CI 56.0 至 59.5）mmol/mol 2年后。在 2 年随访期结束时，260 (76%) 人仍在使用 FSL-FGM，82 (24%) 人已停止使用。停止 FSL-FGM 的主要原因是财务限制（55%）。在整个 2 年期间，继续使用 FSL-FGM 的人的 HbA1c 显着降低（-3.5 mmol/mol，95% CI -6.4 至 –0.7），而 HbA1c 与基线相比未改变谁停止 FSL-FGM (-2.4 mmol/mol, 95% CI -7.5 to 2.7): 组间差异 2.2 (95% CI -1.3 to 5.8) mmol/mol。2年后，与停止 FSL-FGM 的人相比，继续使用 FSL-FGM 的人具有更高的 SF-12 精神成分评分和更高的 EQ-5D 荷兰关税评分，并且焦虑或抑郁的频率更低。结论 尽管相当多的无反应者限制了普遍性，但这项研究表明，继续使用 FSL-FGM 2 年的人可能会在血糖控制和生活质量方面获得持续改善。可应合理要求提供数据。