The Management of Glucose Control and Hypoglycemic Prevention Using Continuous Glucose Monitoring System in Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The change of glycated hemoglobin (HbA1c) level
研究概览
简要总结
This study was designed to evaluate the glucose control and hypoglycemic prevention effect of using continuous glucose monitoring system(CGMS) in patients with type 1 diabetes. This is a prospective randomized controlled, single-center clinical study. Patients will randomized 1:1 to either CGMS or conventional self-monitoring of blood glucose (SMBG) group. After 12 weeks of applying the CGMS sensors, the improvement of parameters collected from the CGMS will be estimated in comparison with data collected from the SMBG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ages >= 20 years
- •Patients diagnosed with type 1 diabetes.
- •Patients with glycated hemoglobin (HbA1c) > 8.0% within 6 months before screening
- •Patients who agree to perform self blood glucose monitoring responsibly during the study period
- •Patients diagnosed with type 1 diabetes minimum 3 months prior to recruitment
排除标准
- •Patients diagnosed with type 2 diabetes.
- •Patients with chronic disease (Excluding thyroid disorders in which thyroid function is controlled in the normal range), or psychiatric disease
- •Patients who cannot use the device properly such as an illiterate person or foreigners
- •Patients incapable of making decisions based on their own judgement and will
- •A person who may not participate in the study according to investigator's judgement
结局指标
主要结局
The change of glycated hemoglobin (HbA1c) level
时间窗: 12 weeks after applying continuous glucose monitoring system
The HbA1c levels in this study will analyzed twice during the study, once at the baseline and after the CGMS testing was initiated. The improvement of HbA1c level in CGMS group will be estimated and compare it with the change in HbA1c level in the SMBG group.
次要结局
- The number of participants with improved clinical glycometabolic parameters(12 weeks after applying continuous glucose monitoring system)