Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System (ISO/FDA Study)
29 de enero de 2016 actualizado por: Ascensia Diabetes Care
User Performance of the Karajishi Contour Blood Glucose Monitoring System (ISO/FDA Study)
The purpose of this study was to determine if untrained persons with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid blood glucose results.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
372
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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California
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Escondido, California, Estados Unidos, 92026
- AMCR Institute
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Washington
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Renton, Washington, Estados Unidos, 98057
- Rainier Clinical Research Center
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Males and females, 18 years of age and older
- Able to speak, read, and understand English
- Willing to complete all study procedures
Exclusion Criteria:
- Hemophilia or any other bleeding disorder
- Pregnancy
- Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM
- Previously participated in a BG monitor study using the Karajishi Contour BGMS (or used a Bayer Contour meter)
- Work for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
- Work for a competitive medical device company, or having an immediate family member who works for such a company
- A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk
General enrollment guidelines:
- Most subjects will be persons with type 1 or type 2 diabetes
- At least 10% of subjects with diabetes will have type 1 diabetes
- Approximately 10% of subjects will be persons without diabetes
- At least 60% of subjects will be younger than age 65
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: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Persons With Diabetes
Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
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Untrained subjects WITH diabetes use the Karajishi Contour BGMS (Blood Glucose Monitoring System).
Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS.
All BG results were compared to reference method results obtained with subject capillary plasma.
Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.
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Experimental: Persons With and Without Diabetes
Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
|
Untrained subjects WITH and WITHOUT diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS.
All BG results were compared to reference method results obtained with subject capillary plasma.
Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
Periodo de tiempo: 1 hour
|
Untrained subjects WITH diabetes (329) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS).
BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).
|
1 hour
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
Periodo de tiempo: 1 hour
|
Study staff tested venous blood of subjects WITH diabetes (329) using an investigational Blood Glucose Monitoring System (BGMS).
Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI Analyzer venous plasma BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma).
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1 hour
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Number of Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff
Periodo de tiempo: 1 hour
|
Study staff obtained and tested subject (329 WITH diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS).
BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI capillary plasma results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).
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1 hour
|
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Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements
Periodo de tiempo: 1 hour
|
Staff obtained responses from persons WITH diabetes (329) using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS.
Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree.'
|
1 hour
|
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Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range
Periodo de tiempo: 1 hour
|
Untrained subjects WITH diabetes (329) and WITHOUT diabetes (43) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS).
BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15% of the laboratory method across the entire tested YSI glucose range.
|
1 hour
|
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Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range
Periodo de tiempo: 1 hour
|
Untrained subjects WITH diabetes (329) and WITHOUT diabetes (43) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS).
BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI Analyzer BG results were used to calculate the number of BGMS results within +/-20% of the laboratory method across the entire tested YSI glucose range.
|
1 hour
|
|
Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Obtained and Tested by Study Staff
Periodo de tiempo: 1 hour
|
Study staff obtained and tested subject (WITH and WITHOUT diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS).
BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI capillary plasma results were used to calculate the number of BGMS results within +/-15% across the tested YSI glucose range.
|
1 hour
|
|
Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Obtained and Tested by Study Staff
Periodo de tiempo: 1 hour
|
Study staff obtained and tested subject (WITH and WITHOUT diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS).
BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI capillary plasma results were used to calculate the number of BGMS results within +/-20% across the tested YSI glucose range.
|
1 hour
|
|
Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements
Periodo de tiempo: 1 hour
|
Staff obtained responses from subjects WITH and WITHOUT diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS.
Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree.'
|
1 hour
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Leslie J Klaff, MD, Rainier Clinical Research Center
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 2014
Finalización primaria (Actual)
1 de junio de 2014
Finalización del estudio (Actual)
1 de junio de 2014
Fechas de registro del estudio
Enviado por primera vez
27 de mayo de 2014
Primero enviado que cumplió con los criterios de control de calidad
27 de mayo de 2014
Publicado por primera vez (Estimar)
29 de mayo de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
29 de febrero de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
29 de enero de 2016
Última verificación
1 de junio de 2015
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- GCA-2014-002-01
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. .