SMBG Protocols Predicting Glucose Levels in Senior Diabetes Mellitus With CAD

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Coronary Artery Disease

• Registration Number: NCT01954771
• Lead Sponsor: Beijing Anzhen Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-29
• Study First Posted: 2013-10-07
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2016-08-31
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-27
• Last Update Submitted: 2017-06-27
• Results First Posted: 2017-07-27
• Last Update Posted: 2017-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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
• Anemia
• Insulin treatment
• Incapable to perform SMBG at home

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS)	12 weeks	The peak value:\>16.7mmol/L(which may precipitate ketosis),nadir:≤2.8mmol/L(Severe hypoglycemia).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS	12 weeks	Severe hypoglycemia is defined as glucose concentration of ≤2.8mmol/L (50 mg/dL).
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	A correlation coefficient of 0.5 is defined as large effect size.(Cohen Jacob.Statistical power analysis for the the behavioral sciences.2nd edition.Lawrence Erlbaum Associates.1988:80)

Trial Locations

Locations (1)

Capital Medical University Affiliated Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China