Efficacy and Safety of HbA1c Prediction Model Based on Self-monitoring Blood Glucose in Patients With Type 2 Diabetes
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.
研究组 & 干预措施
HbA1c prediction model group
HbA1c was predicted every month based on self-monitoring blood glucose for patients in HbA1c prediction model group. Study physicians adjusted patients' hypoglycemic therapy based on self-monitoring blood glucose records/glycated albumin and predicted HbA1c every month.
干预措施: HbA1c prediction (Other)
Conventional treatment group
Study physicians adjusted patients' hypoglycemic therapy based on self-monitoring blood glucose records/glycated albumin, without predicted HbA1c.
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