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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | 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 | Active Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMBG | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yingsheng Zhou, MD; PhD | Capital Medical University Affiliated Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University Affiliated Beijing Anzhen Hospital | Beijing | Beijing Municipality | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18784090 | Background | Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. doi: 10.1056/NEJMoa0806470. Epub 2008 Sep 10. | |
| 19092168 | Background | Skyler JS, Bergenstal R, Bonow RO, Buse J, Deedwania P, Gale EA, Howard BV, Kirkman MS, Kosiborod M, Reaven P, Sherwin RS; American Diabetes Association; American College of Cardiology Foundation; American Heart Association. Intensive glycemic control and the prevention of cardiovascular events: implications of the ACCORD, ADVANCE, and VA diabetes trials: a position statement of the American Diabetes Association and a scientific statement of the American College of Cardiology Foundation and the American Heart Association. Diabetes Care. 2009 Jan;32(1):187-92. doi: 10.2337/dc08-9026. Epub 2008 Dec 17. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 13 patients did not followed the study protocol. | Posted | Median | Inter-Quartile Range | mmol/L | 12 weeks |
|
12 weeks
Events reported according to description in study protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe hypoglycemia (≤2.8mmol/L) | Endocrine disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage | Skin and subcutaneous tissue disorders | Systematic Assessment |
This clinical trial population may not be representative of all patients. Because patients missed clinic visits in three months by reason of vacation tour, or complained about frequent blood samplings, 14.6% of all did not follow the study protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Yingsheng Zhou | Beijing Anzhen Hospital | 0086-010-64456185 | zys626@aliyun.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003324 | Coronary Artery Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| CGMS | Other | 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. |
|
| 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 |
| 18227477 | Background | Monnier L, Colette C. Glycemic variability: should we and can we prevent it? Diabetes Care. 2008 Feb;31 Suppl 2:S150-4. doi: 10.2337/dc08-s241. |
| 20886203 | Background | Borg R, Kuenen JC, Carstensen B, Zheng H, Nathan DM, Heine RJ, Nerup J, Borch-Johnsen K, Witte DR; ADAG Study Group. HbA(1)(c) and mean blood glucose show stronger associations with cardiovascular disease risk factors than do postprandial glycaemia or glucose variability in persons with diabetes: the A1C-Derived Average Glucose (ADAG) study. Diabetologia. 2011 Jan;54(1):69-72. doi: 10.1007/s00125-010-1918-2. Epub 2010 Oct 1. |
| 26954412 | Background | Lipska KJ, Krumholz H, Soones T, Lee SJ. Polypharmacy in the Aging Patient: A Review of Glycemic Control in Older Adults With Type 2 Diabetes. JAMA. 2016 Mar 8;315(10):1034-45. doi: 10.1001/jama.2016.0299. |
| 26392171 | Background | Wang P, Huang R, Lu S, Xia W, Sun H, Sun J, Cai R, Wang S. HbA1c below 7% as the goal of glucose control fails to maximize the cardiovascular benefits: a meta-analysis. Cardiovasc Diabetol. 2015 Sep 22;14:124. doi: 10.1186/s12933-015-0285-1. |
| 26272739 | Background | Munshi MN, Segal AR, Slyne C, Samur AA, Brooks KM, Horton ES. Shortfalls of the use of HbA1C-derived eAG in older adults with diabetes. Diabetes Res Clin Pract. 2015 Oct;110(1):60-65. doi: 10.1016/j.diabres.2015.07.012. Epub 2015 Aug 3. |
| 12351471 | Background | Hoffman RM, Shah JH, Wendel CS, Duckworth WC, Adam KD, Bokhari SU, Dalton C, Murata GH; Diabetes Outcome in Veterans Study. Evaluating once- and twice-daily self-monitored blood glucose testing strategies for stable insulin-treated patients with type 2 diabetes : the diabetes outcomes in veterans study. Diabetes Care. 2002 Oct;25(10):1744-8. doi: 10.2337/diacare.25.10.1744. |
| Missing HbA1c and CGMS of end-point |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Insulin secretagogues | include sulfonylureas and glinides | Number | participants |
|
| Other Oral Anti-diabetic Drugs | Number | participants |
|
| Statins | Number | participants |
|
| β-blocker | Number | participants |
|
| Systolic blood pressure | Median | Inter-Quartile Range | mmHg |
|
| Diastolic blood pressure | Median | Inter-Quartile Range | mmHg |
|
| Heart rate | Median | Inter-Quartile Range | beats per minute |
|
| Body mass index | Median | Inter-Quartile Range | kg/m² |
|
| Glycated hemoglobin(Normal values range from 4-6 percent) | Median | Inter-Quartile Range | percent |
|
| Hemoglobin(Normal values range from 130-175 g/L) | Median | Inter-Quartile Range | g/L |
|
| Fasting glucose(Normal values range from 3.9-6.1 mmol/L) | Median | Inter-Quartile Range | mmol/L |
|
| C-peptid(Normal values range from 0.78-5.19 ng/ml) | Median | Inter-Quartile Range | ng/ml |
|
| Insulin(Normal values range from 2.08-10.9 μU/ml) | Median | Inter-Quartile Range | μU/ml |
|
| Triglyceride(Normal values range from 0-1.7 mmol/L) | Median | Inter-Quartile Range | mmol/L |
|
| Total cholesterol(Normal values range from 3.1-5.2 mmol/L) | Median | Inter-Quartile Range | mmol/L |
|
| High density lipoprotein cholesterol(Normal values range from 1.04-1.55 mmol/L) | Median | Inter-Quartile Range | mmol/L |
|
| LDL-C (1.27-3.12 for normal; <2.59 at high risk factors; <1.80 at very high risk factors) | Median | Inter-Quartile Range | mmol/L |
|
| Blood urea nitrogen（Normal values range from 2.8-7.2 mmol/L） | Mean | Standard Deviation | mmol/L |
|
| Creatinine（Normal values range from 59-104 mmol/L for male,45-84 mmol/L for female） | Mean | Standard Deviation | mmol/L |
|
| Urinary albumin ratio(Normal values range from 0-30 mg/g) | Median | Inter-Quartile Range | mg/g |
|
| CKD-EPI -eGFR | Chronic Kidney Disease Epidemiology Collaboration - Estimate glomerular filtration rate (CKD-EPI -eGFR) | Median | Inter-Quartile Range | ml/min/1.73m² |
|
| MDRD-eGFR | Modification of Diet in Renal Disease - Estimate glomerular filtration rate (MDRD -eGFR) | Median | Inter-Quartile Range | ml/min/1.73m² |
|
| OG001 |
| SMBG-4 Group |
SMBG: 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. 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. |
| OG002 | SMBG-7 Group | SMBG: 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. 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. |
|
|
| 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) | 13 patients did not followed the study protocol. | Posted | Median | Inter-Quartile Range | mmol/L | 12 weeks |
|
|
|
|
| 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). | 13 patients did not followed the study protocol. | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | HbA1c(%) at Endpoint | 13 patients did not followed the study protocol. | Posted | Median | Inter-Quartile Range | percentage | 12 weeks |
|
|
|
| 7 |
| 29 |
| 16 |
| 29 |
| EG001 | 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. | 4 | 32 | 20 | 32 |
| EG002 | 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. | 7 | 28 | 19 | 28 |
| Hypoglycemia (≤3.9mmol/L) | Endocrine disorders | Systematic Assessment |
|
| Pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| MBG from CGMS at endpoint |
|
|
| Correlation analysis |
| 0.004 |
| Correlation coefficient |
| 0.522 |
| 2-Sided |
| Superiority or Other |
| The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements. | Correlation analysis | <0.001 | Correlation Coefficient | 0.784 | 2-Sided | Superiority or Other |
| The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements. | Correlation analysis | 0.011 | Correlation Coefficient | 0.533 | 2-Sided | Superiority or Other |
| The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements. | Correlation analysis | 0.009 | Correlation Coefficient | 0.479 | 2-Sided | Superiority or Other |
| The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements. | Correlation analysis | <0.001 | Correlation Coefficient | 0.801 | 2-Sided | Superiority or Other |
| End-point CGMS |
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| SMBG |
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|