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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Beijing Anzhen Hospital
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Yingsheng Zhou, MD; PhD
Director of Endocrinology and Metabolism Department of Capital Medical University Affiliated Beijing Anzhen Hospital
Beijing Anzhen Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Diabetic ketoacidosis (DKA)
- •Acute cardiovascular events
- •Insulin treatment
- •Incapable to perform SMBG at home
Outcomes
Primary Outcomes
Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS)
Time Frame: 12 weeks
The peak value:\>16.7mmol/L(which may precipitate ketosis),nadir:≤2.8mmol/L(Severe hypoglycemia).
Secondary Outcomes
- 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)