Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System
Evaluation of Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System
Glucose metabolism is impaired in many critically ill patients and is often aggravated by parenteral feeding, infections and/or pre-existent diabetes.Therefore insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented on most critical care units. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. Several barriers to the implementation of glycemic control have been identified. Most importantly, there is concern about increased frequency of severe hypoglycemic episodes. To overcome these problems Space GlucoseControl was developed as a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges (4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l).
The objective of this non-interventional study is to gain additional information on the performance of the Space GlucoseControl system for glycaemic control in ICU patients when used in routine clinical practice.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Augsburg, Alemania
- Klinikum
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Leipzig, Alemania
- Universitatsklinikum Leipzig
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Copenhagen, Dinamarca
- Rigshospitalet Copenhagen
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Vejle, Dinamarca
- Vejle Sygehus
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Madrid, España
- Hospital Sur,
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Tartu, Estonia
- Tartu University Hospital
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Legnano, Italia
- Investigational Site
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Siena, Italia
- Investigational Site
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Wroclaw, Polonia
- Wroclaw Medical University
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Bury St Edmonds, Reino Unido
- West Suffolk Hospital
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Truro, Reino Unido
- Royal Cornwall Hospital
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Hradec Kralove, República Checa
- Investigational Site
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Plzen, República Checa
- Investigational Site
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Prague, República Checa
- Investigational Sites
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Jönköping, Suecia
- Investigational Site
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Stockholm, Suecia
- Investigational Site
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Södertälje, Suecia
- Investigational Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion:
- Intensive care patients who require blood glucose control by intravenous application of insulin
Exclusion:
- All contraindication of intravenous insulin therapy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Blood glucose values: Percentage of time within the chosen glucose target range of 4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l
Periodo de tiempo: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
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From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Frequency of hypoglycaemic episodes
Periodo de tiempo: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
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From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
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Adherence to the advice of the Space GlucoseControl system
Periodo de tiempo: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
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From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
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Blood glucose measurement interval
Periodo de tiempo: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
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From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- HC-O-H-1102
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