NCT06542627招募中不适用
Continuous Glucose Monitoring for Glucose and Weight Management in Prediabetes and Non-severe Type 2 Diabetes
Kangbuk Samsung Hospital2 个研究点 分布在 2 个国家目标入组 420 人开始时间: 2023年5月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
This study aimed to evaluate the effectiveness of use of Continuous Glucose Monitoring (CGM), combined with personalized dietary education and use of smartphone applications in improving glucose control and weight management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects over the age of 19
- •Patients with type 2 diabetes
- •Fasting blood glucose ≥ 126 mg/dL or
- •HbA1c ≥ 6.5% or
- •Type 2 diabetes by clinical history and treated with antidiabetic medications or lifestyle Modifications
- •Patients with prediabetes
- •Fasting blood glucose 100-125 mg/dL
- •HbA1c 5.7-6.4%
- •Willing to participate in the study
排除标准
- •Subjects less than 19 years old
- •Patients with type 1 diabetes
- •Pregnant at the time of screening or planning to become pregnant during the study
- •Severe chronic diseases such as cancer, stroke, proliferative retinopathy, myocardial infarction, chronic renal disease, or amputation of a diabetic foot
- •Diagnosed with or treated for myocardial infarction, stroke, end-stage renal disease, liver failure, or chronic lung disease within the past year
- •Severe liver disease (e.g., cancer, liver cirrhosis, hepatitis B, hepatitis C)
- •Diseases of the biliary tract, thyroid disorders, autoimmune disorders, or acute infections
- •Planning to be admitted to a hospital within 2 months
- •Unable to participate in the mobile intervention study as determined by the investigator
结局指标
主要结局
HbA1c
时间窗: 8weeks after intervention
HbA1c assessed by blood test after 2-week use of CGM and dietary education
次要结局
- Fasting blood glucose(8weeks after intervention)
- Pre- and post-intervention questionnaire: Diabetes Treatment Satisfaction Questionnaire (DTSQ)(8weeks after intervention)
- Pre- and post-intervention questionnaire: Summary of Diabetes Self-Care Activities Questionnaire (SDSCAS).(8weeks after intervention)
- Body weight(8weeks after intervention)
- Lipid profiles(8weeks after intervention)
研究者
Cheol-Young Park
Professor, MD. PhD
Kangbuk Samsung Hospital
研究点 (2)
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