SMBG Protocols Predicting Glucose Levels in Senior Diabetics With CAD

Coronary Artery Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01954771
• Other study ID #: Z131100004013044
• Status: Recruiting
• Phase: N/A
• First received: September 2, 2013
• Last updated: April 1, 2015
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2015
• Source: Beijing Anzhen Hospital
• Contact: Yingsheng Zhou, MD; PhD
• Phone: 0086-10-64456185
• Email: zhouys01[@]sina.cn
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Myocardial Ischemia

Intervention

Behavioral:
• SMBG

Other:
• CGMS
In this study, according to the protocol, all the patients will follow their prespecified SMBG methods and periodically visit doctor, but therapies will not be adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.

Locations

Country	Name	City	State
China	Capital Medical University Affiliated Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of peak and nadir glucose profiles from SMBG protocols and continuous glucose monitoring system (CGMS)		12 weeks	No
Secondary	The correlation study between GHb and glycemic profiles of MBG (mean blood glucose) or AUC (area under the curve) from SMBG protocols and CGMS		12 weeks	No
Secondary	Events of hypoglycemia (=50mg/dL or 2.8mmol/L) captured by SMBG method and CGMS		12 weeks	Yes