SMBG Protocols Predicting Glucose Levels in Senior Diabetes Mellitus With CAD
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)
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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-
Beijing
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Beijing, Beijing, Čína, 100029
- Capital Medical University Affiliated Beijing Anzhen Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Control Group
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.
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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.
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.
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Aktivní komparátor: 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.
|
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.
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.
|
|
Aktivní komparátor: 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.
|
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.
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS)
Časové okno: 12 weeks
|
The peak value:>16.7mmol/L(which
may precipitate ketosis),nadir:≤2.8mmol/L(Severe
hypoglycemia).
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12 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS
Časové okno: 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)
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12 weeks
|
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Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS
Časové okno: 12 weeks
|
Severe hypoglycemia is defined as glucose concentration of ≤2.8mmol/L (50 mg/dL).
|
12 weeks
|
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HbA1c(%) at Endpoint
Časové okno: 12 weeks
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12 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Yingsheng Zhou, MD; PhD, Capital Medical University Affiliated Beijing Anzhen Hospital
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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. Erratum In: Diabetes Care. 2009 Apr;32(4):754.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Více informací
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