SMBG Protocols Predicting Glucose Levels in Senior Diabetes Mellitus With CAD
27 de junio de 2017 actualizado por: Yingsheng Zhou, MD; PhD, Beijing Anzhen Hospital
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)
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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
89
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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Beijing
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Beijing, Beijing, Porcelana, 100029
- Capital Medical University Affiliated Beijing Anzhen Hospital
-
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
65 años y mayores (Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
|
|
Comparador activo: 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.
|
|
Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS)
Periodo de tiempo: 12 weeks
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The peak value:>16.7mmol/L(which
may precipitate ketosis),nadir:≤2.8mmol/L(Severe
hypoglycemia).
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12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS
Periodo de tiempo: 12 weeks
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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
Periodo de tiempo: 12 weeks
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Severe hypoglycemia is defined as glucose concentration of ≤2.8mmol/L (50 mg/dL).
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12 weeks
|
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HbA1c(%) at Endpoint
Periodo de tiempo: 12 weeks
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12 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Yingsheng Zhou, MD; PhD, Capital Medical University Affiliated Beijing Anzhen Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2013
Finalización primaria (Actual)
1 de junio de 2016
Finalización del estudio (Actual)
1 de junio de 2016
Fechas de registro del estudio
Enviado por primera vez
2 de septiembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
29 de septiembre de 2013
Publicado por primera vez (Estimar)
7 de octubre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de julio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
27 de junio de 2017
Última verificación
1 de junio de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedades del sistema endocrino
- Enfermedad de la arteria coronaria
- Isquemia miocardica
- Enfermedad coronaria
- Diabetes mellitus
- Diabetes Mellitus, Tipo 2
Otros números de identificación del estudio
- Z131100004013044
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre SMBG
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HealthPartners InstituteAbbott Diabetes Care; International Diabetes Center at Park NicolletTerminadoDiabetes tipo 2Estados Unidos
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DexCom, Inc.TerminadoDiabetes Mellitus, Tipo 2Estados Unidos, Canadá
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Pusan National University HospitalDesconocidoObesidad | Estado prediabético | Monitoreo Continuo de GlucosaCorea, república de
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Medtronic DiabetesTerminadoDiabetes mellitusFrancia, Alemania, Israel, Italia, Eslovenia, Suecia, Reino Unido
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Chinese University of Hong KongDesconocidoDiabetes con enfermedad renal crónica diabética (diagnóstico)Hong Kong
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Abbott Diabetes CareTerminadoDiabetes mellitusEstados Unidos
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Abbott Diabetes CareTerminadoDiabetes mellitusReino Unido
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Kangbuk Samsung HospitalDexCom, Inc.ReclutamientoDiabetes mellitus | Prediabetes | Enfermedad cardiacaCorea, república de
-
Consorzio Mario Negri SudLifeScanTerminado