User Evaluation of the MiniMed 640G Insulin Pump
A User Evaluation of the MiniMed® 640G Insulin Pump and Guardian® Link Transmitter
This four center international study will include two United Kingdom National Health Service centers, and two centers in Melbourne, Australia. The objective of the study is to evaluate subject acceptance of a new insulin pump and transmitter together with the accompanying training materials. Descriptive data from participant questionnaires and device uploads will be evaluated.
Pediatric subjects between the ages of 7 - 18 years and adults from the age of 19 years of age upwards, who currently use an insulin pump in the management of their type 1 or type 2 diabetes, will be invited to participate. Each subject will be trained on the study device and then use it for approximately four weeks. During this time there will be three in-clinic visits and four follow-up phone calls, scheduled at the subjects' convenience. At the end of this period, they will revert back to their original insulin pump and complete a questionnaire on the study pump training materials, features and usability.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Fitzroy, Australia, 3050
- St Vincent Hospital and The University of Melbourne
-
Patkville, Australia, 3050
- The Royal Melbourne Hospital
-
-
-
-
-
London, Reino Unido, NW1 2PG
- University College Hospital
-
London, Reino Unido, SE5 9NU
- King's College London
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Criteria for Inclusion: A subject is eligible for the user evaluation study if all of the following criteria are met:
- Subject is 7 years or older at time of screening
- Subject is current insulin pump user for at least 3 months
Subject has the following CGM experience as determined by the Investigator:
- Has experience and is able to insert/change sensor by herself/himself and
- Has experience and can recharge the transmitter and
- Has experience and can read sensor data in real-time on her/his pump screen
- Subject/legal representative has signed a Patient Informed Consent and is willing to comply with the study procedures;
- Subject is willing to complete study questionnaires throughout the study
- Must have the following clinical diagnosis:
1. Type 1 diabetes, for a minimum of 6 months prior to enrollment
Criteria for Exclusion: A subject is excluded from the user evaluation if any of the following criteria are met:
- Female subject has a positive urine pregnancy screening test.
- Female subject who plans to become pregnant during the course of study. If a woman becomes pregnant during participation, she will be withdrawn
- Subject has any condition that, in the opinion of the Investigator or qualified Investigational Centre staff, may preclude him/her from participating in the study and completing study related procedures.
- Subject has impaired vision or hearing problems that could compromise the handling of the device as determined by Investigator or qualified Investigational Centre staff
- Subject is unable to tolerate tape adhesive in the area of sensor placement
- Subject has any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection)
- Subject has travel plans which would make it difficult for the subject to attend on-site study visits as scheduled
- Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks (CEP267 User Evaluation is not included in this exclusion criteria).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Diabetic participants with study devices
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
User Acceptance of the New MiniMed 640G Insulin Pump and Guardian Link Transmitter
Periodo de tiempo: Four weeks of pump wear
|
Descriptive summary will be used to characterize the results of the study questionnaires.
The questionnaire will use a Likert scale (rating of 1 to 7) to assess subject acceptance of the MiniMed 640G, Guardian Link Transmitter, and the training materials.
A response of 4 or greater will be considered positive on a Likert scale for training materials and product acceptance.
|
Four weeks of pump wear
|
Colaboradores e Investigadores
Patrocinador
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CEP284
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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. .