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导航未来:在糖尿病试验中使用持续葡萄糖监测的考虑因素
Anna Kettermann1, Gauri Dandi2,3, Jennifer Clark2
1Center for Drug Evaluation and Research, Office of Translational Science, Office of Biostatistics, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993-0002, USA. anna.kettermann@fda.hhs.gov.
Therapeutic innovation & regulatory science
|November 7, 2025
概括
持续血糖监测 (CGM) 数据质量对于糖尿病管理至关重要. 准确记录缺失的数据事件,如传感器变化,对于数字健康技术的可靠研究和监管分析至关重要.
科学领域:
- 糖尿病管理 糖尿病管理
- 数字卫生技术 (DHT) 是指数字卫生技术.
- 临床试验数据分析
背景情况:
- 持续血糖监测 (CGM) 系统是糖尿病管理中至关重要的数字健康技术 (DHT).
- 评估CGM数据质量对于可靠的临床试验结果至关重要.
- 这项研究追溯评估了1型糖尿病患者的CGM数据质量.
研究的目的:
- 追溯评估持续血糖监测 (CGM) 数据的质量.
- 分析CGM数据丢失的模式及其原因.
- 研究CGM指标与血糖控制 (HbA1c) 之间的关系.
主要方法:
- 分析了16周的第3期试验中461名1型糖尿病患者的CGM数据.
- 使用数据可视化技术来检查缺失的数据模式和CGM指标.
- 研究了缺少数据的原因 (非磨损,用户/设备问题) 以及它们与HbA1c的联系.
主要成果:
- 在研究期间,4.7-6%的CGM观测缺失.
- 在传感器更换的日子里,缺少16%的每日值.
- 高葡萄糖变化与低时间在范围 (TIR) 和HbA1c>7%相关;低变化与更高的TIR相关.
结论:
- 需要对患者和设备相关事件 (例如传感器变化) 进行充分的记录,以解决缺少的CGM数据.
- 在研究和监管用途的统计分析之前,了解缺失数据的原因至关重要.
- 对基线后事件的准确记录是制定DHT数据标准的关键.
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