视觉方法的比较,以重新分析来自随机对照临床试验的挑性测试数据,用于新发或最近发病的1型糖尿病
Brenda Orozco1, Kurt J Griffin1
1University of South Dakota Sanford School of Medicine.
概括
在混合饮食耐受性测试 (MMTT) 之前的高血糖可能会影响1型糖尿病试验结果. 对MMTT数据的新图形分析可以完善在测试期间更好地控制血糖的协议.
科学领域:
- 免疫学 免疫学 免疫学
- 内分泌学 在内分泌学.
- 临床试验 临床试验
背景情况:
- 免疫耐受性网络 (ITN) 已经研究了1型糖尿病 (T1D) 自免疫力13年.
- 在T1D试验中的主要终点通常涉及C-的产量,通过混合性食耐受性测试 (MMTT) 在2-3年内测量.
- 目前的协议允许在MMTT之前使用快速起作用的胰岛素,这可能导致一夜之间高血糖,这可能会影响结果.
研究的目的:
- 研究一夜间或禁食高血糖对1型糖尿病MMTT结局的影响.
- 假设测试前的高血糖会耗尽胰岛素,影响第一阶段胰岛素分泌和曲线下的C-区域 (AUC).
主要方法:
- 利用来自ITN TrialShare的公开可用,无标识的主体级数据.
- 开发了新的图形分析来重新检查MMTT结果,包括葡萄糖和C-反应曲线.
- 采用了中心体的分析和葡萄糖/C-外游的比率.
主要成果:
- 在8项ITN研究中应用图形分析,对来自245名受试者的1161个MMTT进行分析.
- 随着时间的推移,在MMTT结果中观察到C-的预期下降和血糖的增加.
- 图形分析显示,中心点向上和向左移动,反映了这些变化.
结论:
- 通过使用新的图形方法成功分析了MMTT数据.
- 准备好通过将MMTT前的血糖水平与预测的变化相关联来测试假设.
- 在挑性测试之前,有可能改进未来的临床试验协议,以便在挑性测试之前更严格地调节血糖.
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