Trajectories in Insulin Sensitivity Across Menstrual Cycles in Women With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Identify clusters in trajectories across the menstrual cycle
研究概览
简要总结
Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements, glucose variability, nutritional information, and menstrual cycle information) to identify categories of cycle trajectories.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Identify clusters in trajectories across the menstrual cycle
时间窗: 6 months
1. Insulin sensitivity across the menstrual cycle/menstrual cycle phases (see Table 1 for definitions relevant to the clinical endpoints). 2. Glycemia measures across the menstrual cycle/menstrual cycle phases: * Percentage in Time In Range (TIR), Rime In Tight Range (TITR), Time Below Range (TBR), Time Above Range (TAR), Coefficient of Variation (CV) * Mean glucose and mean fasted glucose * High and Low Blood Glucose Index (HBGI and LBGI) and Glucose Management Indicator (GMI) 3. Insulin administration measures across the menstrual cycle/menstrual cycle phases: * Basal and bolus insulin dosage * Total daily dose (TDD) * Basal/bolus ratio
次要结局
- To quantify and classify the techniques used for manual insulin adjustments, comparing their utilization and effectiveness.(6 months)
- To identify predictive factors that correlate individual participants and menstrual cycles with specific insulin sensitivity and clinical endpoints.(6 months)
- To quantify differences in clusters in insulin sensitivity, glycemic metrics and insulin administration across different phases of the menstrual cycle(6 months)