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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05251506
The Evaluation of Laser Lancing Devices in Adult Type 2 Diabetes Patients
The Evaluation of Laser Lancing Devices in Constructing Self-management Systems for Chronic Diseases in Adult Diabetes Patients
Self monitoring of blood glucose level is crucial in diabetes management, but currently available methods, lancet, have shown low compliance of self monitoring of blood glucose because of pain, keratinization of finger tip, secondary infection. The purpose of this study is evaluating laser lancing device which cause much less pain than lancet to increase compliance of blood sugar checking, and to establish self monitoring system for patients of chronic diseases.
The investigators recruit total of 80 type 2 diabetes patients who visit Korea University Medical center Guro and Ansan hospital. HbA1c level of subject is more than 6.5% and less than 8.5%, and their age is above 20 years and under 80 years. Subjects are randomly distributed in group A or B. Group A subjects use laser device to check blood glucose for 2 months, then take a month for wash out period. After wash out period, participants use lancet for following 2 months. Group B perform the process vice versa. The investigators evaluate the number of blood glucose measurement, HbA1c, diabetes distress scale, average pain score, average satisfaction score from each group.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Self monitoring of blood glucose level is crucial in diabetes management, so it is important to increase compliance of blood glucose checking. Lancet which is currently available methods have shown low compliance of self monitoring of blood glucose, since it causes pain, keratinization of finger tip, secondary infection. The purpose of this study is evaluating laser lancing device which cause much less pain than lancet to increase compliance of blood sugar checking, and to establish self monitoring system for patients of chronic diseases.
The investigators recruit total of 80 subjects who visit Korea University Medical center Guro and Ansan hospital. Study subject are type 2 diabetes whose glycated hemoglobin level is more than 6.5% and less than 8.5%, and whose age is more than 20 years and under 80 years. Subjects are randomly distributed in group A or B. Group A subjects use laser device to check blood glucose for 2 months, then take a month for wash out period. After wash out period, participants use lancet for following 2 months. Group B subjects use lancet first, then have a month for wash out period, after then, switch to laser device afterwards. During washout period, participants use usual glucose checking method which subjects had used. The investigators evaluate the number of blood glucose measurement, glycated hemoglobin, diabetes distress scale, average pain score, average satisfaction score from each group. Also the investigators compare blood glucose, liver function test, lipid level between values from one hand measured by lancet, and values from the other hand measured by laser lancing device.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Min Jeong Park
- Número de teléfono: +82-10-7271-3805
- Correo electrónico: minjeong87@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Hye Jin Yoo
- Número de teléfono: +82-10-8951-9451
- Correo electrónico: deisy21@naver.com
Ubicaciones de estudio
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Seoul, Corea, república de, 08308
- Reclutamiento
- Korea University Medical Center
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Contacto:
- Min Jeong Park, M.D.
- Número de teléfono: +82-10-7271-3805
- Correo electrónico: minjeong87@gmail.com
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Contacto:
- Hye Jin Yoo, M.D. Ph.D
- Número de teléfono: +82-10-8951-9451
- Correo electrónico: deisy21@naver.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Type 2 diabetes patients who visit Korea University medical center, Guro hospital, Ansan hospital
- Patients with Hba1c more than 6.5% and less than 8.5%
- Adults who are able to measure blood glucose level by themselves
- Adults who are able to lance their same finger from both hands
- Adults who comprehend risk of participating in the clinical research, who are able to communicate each other, who are able to follow rules of clinical research
- Subjects who decide to participate in the clinical research voluntarily and sign in the consent format after being informed purposes, methods, expectations of the clinical research
Exclusion Criteria:
- Subject whose age is younger than 19 or older than 80
- students of research institutes
- Pregnant and lactating women
- Subjects who are not able to make decision
- Subjects who are in emergency or being hospitalized
- Subjects who cannot lance sane finger from both hands
- Subjects who are infected by HIV in hospital records
- Subjects who have thrombocytopenia, coagulation disorder or haemophilia
- Subjects who are incompatible for clinical research as researcher evaluated
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: laser lancing device (LMT-1000) first user
Subjects measure blood glucose using laser lancing device (LMT-1000) for first 2 months, then take a month for wash out period, after that do using lancet for following 2 months.
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Subjects measure blood glucose level using laser lancing device (LMT-1000) and lancet for 2 months each.
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Comparador activo: lancet first user
Subjects measure blood glucose using lancet for first 2 months, , then take a month for wash out period, after that do using laser lancing device (LMT-1000) for following 2 months.
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Subjects measure blood glucose level using laser lancing device (LMT-1000) and lancet for 2 months each.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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average number of checking blood glucose per week
Periodo de tiempo: two months after using the device
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Study subject is going to be surveyed about 'average number of checking blood glucose per week' at 2 month after using lancet device, and 2 month after using laser lancing device (LMT-1000)
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two months after using the device
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glycated hemoglobin level
Periodo de tiempo: two months after using the device
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Study subject is going to be checked glycated hemoglobin level at 2 month after using lancet device, and 2 month after using laser lancing device (LMT-1000).
Data will be shown in percent (%).
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two months after using the device
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
average satisfaction score
Periodo de tiempo: two months after using the device
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Study subject is going to be surveyed about 'average satisfaction score' at 2 month after using lancet device, and 2 month after using laser lancing device (LMT-1000)
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two months after using the device
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average pain scale
Periodo de tiempo: two months after using the device
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Study subject is going to be surveyed about 'average pain scale' at 2 month after using lancet device, and 2 month after using laser lancing device (LMT-1000)
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two months after using the device
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Diabetes Distress Scale
Periodo de tiempo: two months after using the device
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Study subject is going to be surveyed about 'Diabetes Distress Scale' at 2 month after using lancet device, and 2 month after using laser lancing device (LMT-1000)
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two months after using the device
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Diabetes Fear of Self-injecting
Periodo de tiempo: two months after using the device
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Study subject is going to be surveyed about 'Diabetes Fear of Self injecting' at 2 month after using lancet device, and 2 month after using laser lancing device (LMT-1000)
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two months after using the device
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success rate of measurement of blood glucose by laser lancing device
Periodo de tiempo: two months after using the device
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Study subject is going to be surveyed about 'success rate of measurement of blood glucose by laser lancing device' at 2 month after using lancet device, and 2 month after using laser lancing device (LMT-1000)
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two months after using the device
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- K2021-1520-002
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.
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. .
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