SMBG Protocols Predicting Glucose Levels in Senior Diabetes Mellitus With CAD

Not Applicable

Completed

Conditions: Diabetes Mellitus, Type 2
Coronary Artery Disease

Interventions: Behavioral: SMBG
Other: CGMS

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

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

Arm && Interventions

Group	Intervention	Description
Control Group	SMBG	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.
Control Group	CGMS	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.
SMBG-4 Group	CGMS	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.
SMBG-7 Group	SMBG	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.
SMBG-4 Group	SMBG	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.
SMBG-7 Group	CGMS	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.

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)