Coronary Artery Disease, Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes mellitus, Coronary artery disease, SMBG, Elderly
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.
Interventions
BEHAVIORALSMBG
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.
OTHERCGMS
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.
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 | — |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks. | 29 |
| SMBG-4 Group Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks. | 32 |
| SMBG-7 Group Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks. | 28 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Missing CGMS of end-point | 1 | 1 | 0 |
| Overall Study | Missing HbA1c and CGMS of end-point | 5 | 1 | 3 |
| Overall Study | Missing HbA1c of end-point | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | SMBG-4 Group | Total | Control Group | SMBG-7 Group |
|---|---|---|---|---|
| Age, Continuous | 70.5 years | 69.0 years | 71.0 years | 67.0 years |
| Blood urea nitrogen（Normal values range from 2.8-7.2 mmol/L） | 6.2 mmol/L STANDARD_DEVIATION 1.4 | 5.9 mmol/L STANDARD_DEVIATION 1.4 | 5.6 mmol/L STANDARD_DEVIATION 1.4 | 6.0 mmol/L STANDARD_DEVIATION 1.4 |
| Body mass index | 26.1 kg/m² | 26.1 kg/m² | 26.1 kg/m² | 26.3 kg/m² |
| CKD-EPI -eGFR | 80.32 ml/min/1.73m² | 80.81 ml/min/1.73m² | 72.72 ml/min/1.73m² | 87.15 ml/min/1.73m² |
| C-peptid(Normal values range from 0.78-5.19 ng/ml) | 2.00 ng/ml | 1.97 ng/ml | 1.94 ng/ml | 1.87 ng/ml |
| Creatinine（Normal values range from 59-104 mmol/L for male,45-84 mmol/L for female） | 81.65 mmol/L STANDARD_DEVIATION 16.49 | 80.32 mmol/L STANDARD_DEVIATION 16.91 | 82.71 mmol/L STANDARD_DEVIATION 15.2 | 76.33 mmol/L STANDARD_DEVIATION 18.87 |
| Diastolic blood pressure | 65.5 mmHg | 67.0 mmHg | 68.0 mmHg | 68.0 mmHg |
| Fasting glucose(Normal values range from 3.9-6.1 mmol/L) | 6.5 mmol/L | 7.4 mmol/L | 7.6 mmol/L | 7.5 mmol/L |
| Glycated hemoglobin(Normal values range from 4-6 percent) | 6.8 percent | 6.8 percent | 7.0 percent | 6.8 percent |
| Heart rate | 72.0 beats per minute | 67.0 beats per minute | 66.0 beats per minute | 66.0 beats per minute |
| Hemoglobin(Normal values range from 130-175 g/L) | 139.5 g/L | 141.0 g/L | 139.0 g/L | 143.0 g/L |
| High density lipoprotein cholesterol(Normal values range from 1.04-1.55 mmol/L) | 1.13 mmol/L | 1.11 mmol/L | 1.09 mmol/L | 1.12 mmol/L |
| Insulin(Normal values range from 2.08-10.9 μU/ml) | 9.2 μU/ml | 9.0 μU/ml | 8.8 μU/ml | 8.1 μU/ml |
| Insulin secretagogues no | 19 participants | 48 participants | 17 participants | 12 participants |
| Insulin secretagogues yes | 13 participants | 41 participants | 12 participants | 16 participants |
| LDL-C (1.27-3.12 for normal; <2.59 at high risk factors; <1.80 at very high risk factors) | 2.17 mmol/L | 2.02 mmol/L | 2.22 mmol/L | 1.85 mmol/L |
| MDRD-eGFR | 89.66 ml/min/1.73m² | 89.72 ml/min/1.73m² | 79.39 ml/min/1.73m² | 93.86 ml/min/1.73m² |
| Other Oral Anti-diabetic Drugs no | 5 participants | 13 participants | 5 participants | 3 participants |
| Other Oral Anti-diabetic Drugs yes | 27 participants | 76 participants | 24 participants | 25 participants |
| Sex: Female, Male Female | 10 Participants | 31 Participants | 11 Participants | 10 Participants |
| Sex: Female, Male Male | 22 Participants | 58 Participants | 18 Participants | 18 Participants |
| Statins no | 6 participants | 11 participants | 2 participants | 3 participants |
| Statins yes | 26 participants | 78 participants | 27 participants | 25 participants |
| Systolic blood pressure | 129.0 mmHg | 128.0 mmHg | 125.0 mmHg | 127.0 mmHg |
| Total cholesterol(Normal values range from 3.1-5.2 mmol/L) | 4.01 mmol/L | 3.85 mmol/L | 3.88 mmol/L | 3.46 mmol/L |
| Triglyceride(Normal values range from 0-1.7 mmol/L) | 1.15 mmol/L | 1.24 mmol/L | 1.35 mmol/L | 1.12 mmol/L |
| Urinary albumin ratio(Normal values range from 0-30 mg/g) | 9.09 mg/g | 8.62 mg/g | 7.59 mg/g | 8.62 mg/g |
| β-blocker no | 15 participants | 35 participants | 9 participants | 11 participants |
| β-blocker yes | 17 participants | 54 participants | 20 participants | 17 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 16 / 29 | 20 / 32 | 19 / 28 |
| serious Total, serious adverse events | 7 / 29 | 4 / 32 | 7 / 28 |
Outcome results
Primary
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).
Time frame: 12 weeks
Population: 13 patients did not followed the study protocol.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control Group | Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS) | Peak at endpoint | 8.74 mmol/L |
| Control Group | Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS) | Nadir at endpoint | 6.32 mmol/L |
| Control Group | Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS) | Peak at baseline | 8.86 mmol/L |
| Control Group | Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS) | Nadir at baseline | 6.87 mmol/L |
| SMBG-4 Group | Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS) | Peak at endpoint | 8.00 mmol/L |
| SMBG-4 Group | Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS) | Nadir at baseline | 6.05 mmol/L |
| SMBG-4 Group | Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS) | Nadir at endpoint | 6.55 mmol/L |
| SMBG-4 Group | Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS) | Peak at baseline | 8.72 mmol/L |
| SMBG-7 Group | Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS) | Nadir at endpoint | 6.44 mmol/L |
| SMBG-7 Group | Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS) | Peak at baseline | 8.80 mmol/L |
| SMBG-7 Group | Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS) | Nadir at baseline | 6.15 mmol/L |
| SMBG-7 Group | Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS) | Peak at endpoint | 8.68 mmol/L |
Secondary
HbA1c(%) at Endpoint
Time frame: 12 weeks
Population: 13 patients did not followed the study protocol.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group | HbA1c(%) at Endpoint | 6.9 percentage |
| SMBG-4 Group | HbA1c(%) at Endpoint | 6.7 percentage |
| SMBG-7 Group | HbA1c(%) at Endpoint | 6.6 percentage |
Secondary
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).
Time frame: 12 weeks
Population: 13 patients did not followed the study protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS | End-point CGMS | 3 participants |
| Control Group | Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS | Baseline CGMS | 4 participants |
| Control Group | Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS | SMBG | 1 participants |
| SMBG-4 Group | Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS | End-point CGMS | 1 participants |
| SMBG-4 Group | Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS | Baseline CGMS | 3 participants |
| SMBG-4 Group | Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS | SMBG | 0 participants |
| SMBG-7 Group | Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS | Baseline CGMS | 7 participants |
| SMBG-7 Group | Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS | SMBG | 1 participants |
| SMBG-7 Group | Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS | End-point CGMS | 3 participants |
Secondary
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)
Time frame: 12 weeks
Population: 13 patients did not followed the study protocol.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control Group | The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS | MBG from SMBG | 7.92 mmol/L |
| Control Group | The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS | MBG from CGMS at endpoint | 7.62 mmol/L |
| SMBG-4 Group | The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS | MBG from SMBG | 8.00 mmol/L |
| SMBG-4 Group | The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS | MBG from CGMS at endpoint | 7.24 mmol/L |
| SMBG-7 Group | The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS | MBG from SMBG | 7.81 mmol/L |
| SMBG-7 Group | The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS | MBG from CGMS at endpoint | 7.76 mmol/L |
Comparison: The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.p-value: <0.001Correlation analysis
Comparison: The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.p-value: 0.004Correlation analysis
Comparison: The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.p-value: <0.001Correlation analysis
Comparison: The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.p-value: 0.011Correlation analysis
Comparison: The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.p-value: 0.009Correlation analysis
Comparison: The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.p-value: <0.001Correlation analysis