Glucose monitoring by Freestyle Libre in patients with Type 2 diabetes mellitus from India A pooled analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,200
- 试验地点
- 10
- 主要终点
- Estimate the average TIR across 12-15 centres in patients with Diabetes in India with the help of cross sectional data available
研究概览
简要总结
This study aims to evaluate the average Time in Range (TIR) in Type 2 Diabetes Mellitus (T2DM) patients using the FreeStyle Libre system across 12 centres in India. The secondary objectives include assessing the percentage of patients achieving recommended TIR targets and exploring variations in TIR based on factors such as age, gender, BMI, medication type, and comorbidities. Data from approximately 1500 patients will be analyzed, focusing on key metrics like Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), and glucose variability. Statistical analysis will include Spearman’s coefficient and linear regression to determine relationships between various patient characteristics and glycaemic control.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged above 18 years with a diagnosis of T2D using Libre for glucose monitoring will be included in the study.
排除标准
- •Patients below 18 years as well as patients using continuous glucose monitoring instrument other than Libre will be excluded.
- •Patients having difficulty in handling device and are non-compliant will be excluded.
结局指标
主要结局
Estimate the average TIR across 12-15 centres in patients with Diabetes in India with the help of cross sectional data available
时间窗: Baseline, 4 weeks
次要结局
- •Estimate % of patients with diabetes in India achieving recommended TIR targets (in line with customized targets based on comorbidities/ type of diabetes)(•Estimate average TIR among different patient profiles with T2DM based on 1) comorbidities 2) Age groups 3) Form of pharmacotherapy (Non Insulin, Basal Insulin, MDI) 4) Duration of diabetes)
研究者
Rohit Bhandari
Indegene Private Limited