NCT05149625招募中不适用
Comparison of the Efficacy and Satisfaction of Blood Glucose Management Between Continuous Glucose Monitoring Versus Traditional Self-blood Glucose Measurement in Diabetic Patients After Pancreatectomy : A Randomized Controlled Open Labeled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c (HbA1c)
研究概览
简要总结
This study aims to compare the efficacy and satisfaction of blood glucose management between continuous glucose monitoring versus traditional self blood glucose measurement in diabetic patients after pancreatectomy.
详细描述
Patients will be enrolled after the 75g oral glucose tolerance test performed 7 days after pancreatectomy. Patients will be divided into two groups by randomization (continuous glucose measurement method vs. traditional self blood glucose measurement method), and 3months after surgery, HbA1c, hypoglycemic events, and satisfaction would be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Patients over 19 years of age
- •Preoperative diabetes history
- •Patients who underwent subtotal or total pancreatectomy
- •Patients who were diagnosed with diabetes mellitus in the evaluation of endocrine function test on the 7th day after pancreaticoduodenectomy, central pancreatectomy, or distal pancreatectomy
排除标准
- •Patients who have used continuous blood glucose measurement device more than once before.
- •Elderly patients who are not accustomed to using the smartphone applications
- •Serious systemic diseases that can affect diabetes (chronic kidney disease, heart failure, decompensated liver cirrhosis, etc.)
- •Steroid user during the study period
- •Major medical or psychiatric condition that will affect response to treatment
结局指标
主要结局
Hemoglobin A1c (HbA1c)
时间窗: postoperative 3months
次要结局
- Hypoglycemic events(postoperative 3months)
- satisfaction survey(postoperative 3months)
- Fasting, postprandial plasma glucose(postoperative 3months)
研究者
Jin-Young Jang
Dr
Seoul National University Hospital
研究点 (2)
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