Efficacy of continuous glucose monitoring for glycaemic control over standard treatment and monitoring in individuals with uncontrolled type 2 diabetes in Khordha district: A randomized control trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- attainment of glycemic control (HbA1c less than 7)
研究概览
简要总结
This study is a randomized, parallel-group, two-arm controlled trial to assess the efficacy of Continuous Glucose Monitoring (CGM) in control of glycaemic status among uncontrolled type 2 diabetes patients of Khordha district, Odisha. The study will be conducted in the Non-Communicable Diseases (NCD) Prevention Clinicand Endocrinology OPD at AIIMS Bhubaneswar, a tertiary care hospital in the eastern part of India. The eligible participants will be randomized into intervention and control arm using****Computer-generated random sequences, and the intervention arm will be provided with a Continuous Glucose Monitoring ( CGM**)** device (Abbott Freestyle Libre) for 14 days. The subcutaneous sensor will be applied on the back of the arm, along with standard treatment. The individuals in the control arm will be receiving standard antidiabetic treatment **as per the guidelines.**The primary outcome will be the number of individuals who attained glycaemic control and the meanreduction in the HbA1clevels after 3 months and 6 months of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals with type 2 diabetes on 3 or more oral antidiabetic agents with or without insulin HbA1C more than 7%.
排除标准
- •Individuals with type 1 diabetes Gestational diabetes mellitus Individuals with diabetic complications (acute or chronic) Individuals with a history of bleeding disorder Individuals with a recent history of steroid use.
结局指标
主要结局
attainment of glycemic control (HbA1c less than 7)
时间窗: 3months | 6months
Mean reduction in HbA1c level
时间窗: 3months | 6months
次要结局
未报告次要终点
研究者
Priyamadhaba Behera
AIIMS Bhubaneswar