A Study on the Effect of CGM Alone on Glycemic Metrics in Type 2 Diabetes Patients Not Using Insulin, Without Additional Interventions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in Percentage of Time in Range (TIR) 70-180 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)
研究概览
简要总结
This study evaluates the effect of using a real-time continuous glucose monitoring (CGM) system on blood sugar control in people with type 2 diabetes who do not use insulin.
Participants will wear a CGM device (CareSens Air) for a total of two weeks. During the first week, the device will be set to "blinded mode," meaning participants cannot see their glucose readings. During the second week, the device will be switched to "unblinded mode," allowing participants to view their glucose levels and trends in real-time.
The study aims to determine if simply seeing real-time glucose data can help patients improve their blood sugar control (such as increasing the time their blood sugar is in the target range) without receiving additional structured education on diet or exercise. Researchers will compare the glucose data collected during the blinded week with the data from the unblinded week.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type 2 Diabetes Mellitus (HbA1c ≥ 6.5%, fasting plasma glucose ≥ 126 mg/dL, 2-hour plasma glucose ≥ 200 mg/dL during 75g OGTT, or random plasma glucose ≥ 200 mg/dL with classic symptoms)
- •No medication changes in the past 3 months, and receiving treatment with lifestyle modification or oral antidiabetic drugs or GLP-1 receptor agonists
- •Ages 19 - 80 years old
- •Patients who have voluntarily signed the informed consent form
排除标准
- •Type 1 diabetes patients
- •Insulin users
- •Patients who have changed oral hypoglycemic agents within the past 3 months
- •Patients scheduled for hospitalization within 2 weeks
- •Pregnant women or those planning pregnancy within 1 month
- •Those who do not agree to the program
- •Those deemed unsuitable for participation in this clinical trial by the investigator
结局指标
主要结局
Change in Percentage of Time in Range (TIR) 70-180 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)
时间窗: Week 1 and Week 2
Percentage of time glucose readings are within the target range of 70-180 mg/dL.
次要结局
- Change in Percentage of Time in Tight Range (TITR) 70-140 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)(Week 1 and Week 2)
- Change in Percentage of Time Below Range (TBR) <70 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)(Week 1 and Week 2)
- Change in Percentage of Time Below Range (TBR) <54 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)(Week 1 and Week 2)
- Change in Percentage of Time Above Range (TAR) >140 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)(Week 1 and Week 2)
- Change in Percentage of Time Above Range (TAR) >180 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)(Week 1 and Week 2)
- Change in Percentage of Time Above Range (TAR) >250 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)(Week 1 and Week 2)
- Change in Mean Glucose Concentration From Week 1 (Blinded) to Week 2 (Unblinded)(Week 1 and Week 2)
- Change in Glucose Standard Deviation (SD) From Week 1 (Blinded) to Week 2 (Unblinded)(Week 1 and Week 2)
- Change in Glucose Coefficient of Variation (CV) From Week 1 (Blinded) to Week 2 (Unblinded)(Week 1 and Week 2)
- Change in Glucose Management Indicator (GMI) From Week 1 (Blinded) to Week 2 (Unblinded)(Week 1 and Week 2)
研究者
Sun Joon, Moon
Assistant Professor
Kangbuk Samsung Hospital