A Prospective, Randomized, Controlled Study on Self-monitoring of Blood Glucose (SMBG) Protocols in Predicting Glucose Levels in Senior Patients With Type 2 Diabetes Mellitus (T2DM) and Coronary Artery Disease (CAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS)
研究概览
简要总结
Self-monitoring of blood glucose (SMBG) is a common way to assess glycemic control in diabetes management. Multiple times of blood glucose measurements by fingerstick in the same day are of tough challenge to it. The changes and variations of glucose excursion in senior diabetics with Coronary Artery Disease (CAD)involve a safety issue besides glycated hemoglobin (GHb) value. The goal of this study is to explore modified SMBG protocols for precisely monitoring and predicting glycemic excursion, variability in senior type 2 diabetics with CAD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 2 diabetes
- •Clinical diagnosis of coronary artery disease
- •Age ≥65 years
- •The blood glucose is controlled by diets and (or) oral hypoglycemic drugs
- •BMI≤28 kg/m²
- •Being able to monitor and record capillary glucose value by themselves at home
排除标准
- •Diabetic ketoacidosis (DKA)
- •Acute cardiovascular events
- •Insulin treatment
- •Incapable to perform SMBG at home
研究组 & 干预措施
Control Group
Patients will receive conventional care and keep on their usual SMBG(Self-monitoring of blood glucose) methods. Additionally, each patient will also wear a CGMS(continous glucose monitoring system) device for 72h in the first week and the last week, respectively.
干预措施: SMBG (Behavioral)
Control Group
Patients will receive conventional care and keep on their usual SMBG(Self-monitoring of blood glucose) methods. Additionally, each patient will also wear a CGMS(continous glucose monitoring system) device for 72h in the first week and the last week, respectively.
干预措施: CGMS (Other)
SMBG-4 Group
Capillary glucose level is measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient will also wear a CGMS device for 72h in the first week and the last week, respectively.
干预措施: SMBG (Behavioral)
SMBG-4 Group
Capillary glucose level is measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient will also wear a CGMS device for 72h in the first week and the last week, respectively.
干预措施: CGMS (Other)
SMBG-7 Group
Capillary glucose level is measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient will also wear a CGMS device for 72h in the first week and the last week, respectively.
干预措施: SMBG (Behavioral)
SMBG-7 Group
Capillary glucose level is measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient will also wear a CGMS device for 72h in the first week and the last week, respectively.
干预措施: CGMS (Other)
结局指标
主要结局
Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS)
时间窗: 12 weeks
The peak value:\>16.7mmol/L(which may precipitate ketosis),nadir:≤2.8mmol/L(Severe hypoglycemia).
次要结局
- Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS(12 weeks)
- HbA1c(%) at Endpoint(12 weeks)
- The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS(12 weeks)
研究者
Yingsheng Zhou, MD; PhD
Director of Endocrinology and Metabolism Department of Capital Medical University Affiliated Beijing Anzhen Hospital
Beijing Anzhen Hospital