NCT05824286招募中不适用
Efficacy and Safety of HbA1c Prediction Model Based on Self-monitoring Blood Glucose in Patients With Type 2 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in measured HbA1c from baseline to 24 weeks
研究概览
简要总结
Patients with type 2 diabetes who have poor blood glucose control are enrolled to evaluate the efficacy and safety of the HbA1c prediction model for adjust the hypoglycemic treatment regimen, compared with the conventional treatment using self-monitoring blood glucose or glycated albumin.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old;
- •Diagnosed with type 2 diabetes mellitus, and the hypoglycemic treatment was not limited; The study physicians judged that the hypoglycemic treatment regimen was stable in nearly 8 weeks;
- •Have HbA1c results within 4 weeks, and the range was 7.5-11%;
- •Willing and able to conduct self-glucose monitoring;
- •Have not participated in any other research program in the past 4 weeks.
排除标准
- •Type 1 diabetes mellitus;
- •Severe hypoglycemia ≥1 time or fasting C-peptide ≤0.80 ng/mL in the past 6 months;
- •Diabetic ketosis in the last 1 week;
- •Oral or inhaled corticosteroids for more than 14 days within the last 8 weeks;
- •Anemia, recent blood transfusion, hemoglobinopathy (hemoglobinosis and thalassemia), use of erythropoietic drugs, undergoing dialysis;
- •Pregnancy or breastfeeding;
- •Receiving chemotherapy or radiation therapy;
- •Have a severe mental illness and cannot complete the trial.
结局指标
主要结局
Change in measured HbA1c from baseline to 24 weeks
时间窗: 24 weeks
次要结局
- Change in measured HbA1c from baseline to 12 weeks(12 weeks)
- The percentages of participants with HbA1c less than 7.0% at 12 weeks(12 weeks)
- Change in weight from baseline to 24 weeks(24 weeks)
- The percentages of participants with HbA1c less than 7.0% at 24 weeks(24 weeks)
- The rate of severe hypoglycemic events and confirmed hypoglycemic events during the 24 weeks of the study(24 weeks)
研究者
Xianghai Zhou
Prof.
Peking University People's Hospital
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Effectiveness of a High-risk Diabetic Patients ProgramDiabetes Mellitus, Type 2NCT01051245Hospital Italiano de Buenos Aires223
已完成
不适用
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)Diabetes Mellitus, Type 2NCT03620357DexCom, Inc.72
已完成
不适用
Accuracy of Hemoglobin A1C to Predict Glycemia in HIVHIVDiabetesHyperglycemiaNCT00433628National Institute of Allergy and Infectious Diseases (NIAID)175
Unknown
不适用
Predictability of Preoperative Hemoglobin A1c in Diabetic Patients Underwent Off-Pump Coronary Artery Bypass Surgery: A Retrospective Study.Coronary Artery Disease, DiabetesNCT03543449Yonsei University703
已完成
不适用
Glooko mHealth Advantage StudyDiabetes Mellitus, Type 2NCT02974816Glooko197