Diabetes Multicenter Observational Study (DIAMOND-1-) (DIAMOND-1)
8 de junio de 2011 actualizado por: Medtronic Hellas Medical Devices ΑEE
Prospective, Multicenter, Non-interventional Post Market Release Study , to Examine Whether Pump Treatment Combined With the Use of Continuous Glucose Monitoring System is a Mean to Normalize Glycaemic Control.
The purpose of this study is to examine whether pump treatment combined with the use of continuous glucose monitoring system is a mena to normalize glycaemic control.
Descripción general del estudio
Estado
Desconocido
Condiciones
Descripción detallada
In this study, 100 subjects, users of Paradigm 522/722 Infusion Pump and Self- Monitoring Blood Glucose finger sticks for the control of their glucose levels for at least 3 months prior enrollment will participate.
Moreover the subjects won't have achieved the best blood glucose control, with an average HbA1c above 7% and should meet all the inclusion and none of the exclusion criteria.
The HbA1c value for screening purposes can be taken from the medical chart, while in the enrollment visit according to current medical practice of each investigational center, the sample taken for HbA1c measurement will be analyzed centrally by HPLC, in a lab in Germany.
In all enrolled patients a continuous glucose monitoring system will be provided.
Since this is an observational study, the provision of the glucose monitoring system will be based on medical justification and will not be done per protocol requirement.
All subjects will be followed for 3 months according to the current medical practice of each investigational center.
All other visits, e.g.
patient comes into the hospital because of symptoms, will also be recorded as unscheduled visits.
These visits are usually linked to Adverse Events.
Tipo de estudio
De observación
Inscripción (Anticipado)
100
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
12 años a 45 años (Niño, Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
This is an observational pilot study that does not have a statistically powered primary hypothesis.
The data collected during this study are for the purpose of accumulating information that may generate research ideas and lead to publications.
For this reason a sample size of 100 subjects has been defined.
The statistical analysis will be descriptive statistics and will be described in a separate statistical analysis plan.
Moreover any enrolled patient that has a sensor usage % in the end of the study that is less than 65% will be excluded from the analysis.
Descripción
Inclusion Criteria:
- Subjects and/or their legal representative must sign the Patient Data Release Form (PDRF).
- Subjects must be aged between 12 and 45 years old.
- Subjects must be pump and Self- Monitoring Blood Glucose fingersticks users for at least 3 months and no more than 9 months.
- HbA1c >7.0% with a measurement no older than three months prior to enrollment.
- Diagnosed T1D at least 1 year before study entry.
- Subjects must be able to understand how to use the Paradigm REAL-Time System and how to adjust and administer corrective treatment.
- Subjects should not have used the sensor in the past.
Exclusion Criteria:
- Hearing or vision impairment so that alarms can not be recognized.
- Alcohol or drug abuse other than nicotine.
- Subjects suffering from severe chronic disease or genetic disorder other than T1D. (i.e. Down syndrome etc.)
- Subjects suffering from allergy.
- Subjects in pregnancy or with desire to conceive during study.
- Subjects participating in other device or drug studies.
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
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The levels of HbA1c will be investigated on patients combining the pump therapy with continuous glucose monitoring over a period of three months.
Periodo de tiempo: 2 years
|
2 years
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
To evaluate the impact of continuous sensing on the variability of glucose
Periodo de tiempo: 2 years
|
2 years
|
|
To examine the frequency of hypoglycemic events.
Periodo de tiempo: 2 years
|
2 years
|
|
To examine the frequency of ketoacidosis events
Periodo de tiempo: 2 years
|
2 years
|
|
To examine the frequency of Emergency Department visits
Periodo de tiempo: 2 years
|
2 years
|
|
To examine the frequency of hospitalizations
Periodo de tiempo: 2 years
|
2 years
|
|
To examine the duration of hospitalizations
Periodo de tiempo: 2 years
|
2 years
|
|
To evaluate the daily insulin requirements
Periodo de tiempo: 2 years
|
2 years
|
|
To evaluate the % sensor usage
Periodo de tiempo: 2 years
|
2 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Charalampos Vasilopoulos, Dr., General Hospital of Athens "Evaggelismos"
- Investigador principal: Christos Zoupas, Dr., Diagnostic and Therapeutic Center of Athens "Hygeia"
- Investigador principal: Marriana Benroubi, Dr., General Hospital of Athens "POLICLINIC"
- Investigador principal: Christina Kanaka, Dr., Children General Hospital " Agia Sofia"
- Investigador principal: Nikolaos Tentolouris, Dr., General Hospital of Athens "LAIKO"
- Investigador principal: Maria Alevizaki, Assoc. Prof., General Hospital of Athens "ALEXANDRA"
- Investigador principal: Andrianni Gerasimidi, Dr., Children Hospital "Aglaia Kiriakou"
- Investigador principal: Andreas Melidonis, Dr., General Hospital of Peiraeus "TZANEIO"
- Investigador principal: Dimitrios Mamoulakis, Dr., University Hospital of Heraklion
- Investigador principal: Angelos Pappas, Dr., "Venizeleio - Pananeio" General Hospital of Heraklion
- Investigador principal: Triantafillos Didaggelos, Lecturer, University Hospital of Thessalonica " AXEPA",Α' Propedeutic Pathology Clinic
- Investigador principal: Ioannis Giovos, Assoc. Prof., University Hospital of Thessalonica " AXEPA" ,Α' Pathology Clinic
- Investigador principal: Emmanouil Pagkalos, Dr., General University Hospital of Thessalonica "PAPAGEORGIOU",Α' Pathology Clinic
- Investigador principal: Asimina Galli, Ass. Prof., General University Hospital of Thessalonica "PAPAGEORGIOU",D' Pediatric Clinic
- Investigador principal: Christos Manes, Dr., General University Hospital of Thessalonica "PAPAGEORGIOU",Β' Pathology Clinic
- Investigador principal: Agathoklis Tsatsoulis, Prof., General University Hospital of Ioannina
- Investigador principal: Ioannis Chabeos, Lecturer, General University Hospital of Rio- Patra
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 2009
Finalización del estudio (Anticipado)
1 de diciembre de 2011
Fechas de registro del estudio
Enviado por primera vez
7 de junio de 2011
Primero enviado que cumplió con los criterios de control de calidad
8 de junio de 2011
Publicado por primera vez (Estimar)
9 de junio de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
9 de junio de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
8 de junio de 2011
Última verificación
1 de junio de 2011
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Version 1.0 - 12/Sep/2008
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. .