Department of Endocrinology, the First Affiliated Hospital of USTC, Division of Life Science and Medicine, University of Science and Technology of China, Hefei, China.
Department of Endocrinology and Metabolism, Third Affiliated Hospital of Sun Yat-sen University;Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.
BMJ Open. 2020 Dec 4;10(12):e039400. doi: 10.1136/bmjopen-2020-039400.
Optimal glycaemic control is beneficial to prevent and delay microvascular complications in patients with type 1 diabetes mellitus (T1DM). The benefits of flash glucose monitoring (FGM) have been proved among well-controlled adults with T1DM, but evidence for FGM in adults with T1DM who have suboptimal glycaemic control is limited. This study aims to evaluate the effect of FGM in suboptimally controlled adult patients with T1DM .
This open-label, multicentre, randomised trial will be conducted at eight tertiary hospitals and recruit 104 adult participants (≥18 years old) with T1DM diagnosed for at least 1 year and with suboptimal glycaemic control (glycated haemoglobin (HbA1c) ranging from 7.0% to 10.0%). After a run-in period (baseline, 0-2 weeks), eligible participants will be randomised 1:1 to either use FGM or self-monitoring of blood glucose alone consequently for the next 24 weeks. At baseline, 12-14 weeks and 24-26 weeks, retrospective continuous glucose monitoring (CGM) systems will be used in both groups for device-related data collection. Biological metrics, including HbA1c, blood routine, lipid profiles, liver enzymes, questionnaires and adverse events, will be assessed at baseline, week 14 and week 26. All analyses will be conducted on the intent-to-treat population. Efficacy endpoint analyses will also be repeated on the per-protocol population. The primary outcome is the change of HbA1c from baseline to week 26. The secondary outcomes are the changes of CGM metrics, including time spent in range, time spent in target, time spent below range, time spent above range, SD, coefficient of variation, mean amplitude of glucose excursions, high or low blood glucose index, mean of daily differences, percentage of HbA1c in target (<7%), frequency of FGM use, total daily insulin dose and the scores of questionnaires including Diabetes Distress Scale, Hypoglycemia Fear Scale and European Quality of Life Scale.
This study was approved by the Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University in January 2017. Ethical approval has been obtained at all centres. All participants will be provided with oral and written information about the trial. The study will be disseminated by peer-review publications and conference presentations.
NCT03522870.
对于 1 型糖尿病（T1DM）患者来说，控制血糖有益于预防和延缓微血管并发症。在血糖控制良好的 T1DM 成年患者中，已证实闪光血糖监测（FGM）的益处，但在血糖控制不佳的 T1DM 成年患者中，FGM 的证据有限。本研究旨在评估 FGM 在血糖控制不佳的 T1DM 成年患者中的效果。
本开放标签、多中心、随机试验将在 8 家三级医院进行，招募 104 名年龄在 18 岁及以上的 T1DM 成年患者（确诊至少 1 年，血糖控制不佳（糖化血红蛋白（HbA1c）范围为 7.0%至 10.0%）。在导入期（基线，0-2 周）后，符合条件的参与者将按 1:1 比例随机分为使用 FGM 或单独自我血糖监测组，随后进行 24 周的治疗。在基线、12-14 周和 24-26 周时，两组均使用回顾性连续血糖监测（CGM）系统收集设备相关数据。在基线、14 周和 26 周时评估生物指标，包括 HbA1c、血常规、血脂谱、肝酶、问卷和不良事件。所有分析均基于意向治疗人群进行。主要疗效终点也将在符合方案人群中重复分析。主要结局是从基线到 26 周时 HbA1c 的变化。次要结局是 CGM 指标的变化，包括血糖达标时间、血糖目标范围内时间、血糖低于目标时间、血糖高于目标时间、标准差、变异系数、血糖波动幅度、高低血糖指数、平均血糖差值、HbA1c 达标率（＜7%）、FGM 使用频率、总日胰岛素剂量和包括糖尿病困扰量表、低血糖恐惧量表和欧洲生活质量量表在内的问卷评分。
本研究于 2017 年 1 月获得中山大学附属第三医院伦理委员会批准。所有中心均已获得伦理批准。所有参与者将获得关于试验的口头和书面信息。研究结果将通过同行评议出版物和会议报告进行传播。
NCT03522870。
