SMBG Protocols Predicting Glucose Levels in Senior Diabetes Mellitus With CAD

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Diabetes Mellitus, Type 2, Coronary Artery Disease

Intervention / Treatment
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* Behavioral: SMBG
* Other: CGMS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>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. | Behavioral: SMBG<br>* Control Group Patients will receive conventional care and keep on their usual SMBG methods. Additionally, each patient will also wear a CGMS device for 72h in the first week and the last week, respectively. 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. 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.<br>Other: CGMS<br>* 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.<br>|
| Active Comparator: SMBG-4 Group<br>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. | Behavioral: SMBG<br>* Control Group Patients will receive conventional care and keep on their usual SMBG methods. Additionally, each patient will also wear a CGMS device for 72h in the first week and the last week, respectively. 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. 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.<br>Other: CGMS<br>* 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.<br>|
| Active Comparator: SMBG-7 Group<br>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. | Behavioral: SMBG<br>* Control Group Patients will receive conventional care and keep on their usual SMBG methods. Additionally, each patient will also wear a CGMS device for 72h in the first week and the last week, respectively. 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. 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.<br>Other: CGMS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS | 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) | 12 weeks | 
| Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS | Severe hypoglycemia is defined as glucose concentration of ≤2.8mmol/L (50 mg/dL). | 12 weeks | 
| HbA1c(%) at Endpoint |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, Coronary artery disease, SMBG, Elderly