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The Evaluation of Laser Lancing Devices in Adult Type 2 Diabetes Patients

13 de febrero de 2022 actualizado por: Hye Jin Yoo, Korea University Guro Hospital

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

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

Intervencionista

Inscripción (Anticipado)

80

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.

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

      • Seoul, Corea, república de, 08308
        • Reclutamiento
        • Korea University Medical Center
        • Contacto:
          • Min Jeong Park, M.D.
          • Número de teléfono: +82-10-7271-3805
          • Correo electrónico: minjeong87@gmail.com
        • Contacto:
          • Hye Jin Yoo, M.D. Ph.D
          • Número de teléfono: +82-10-8951-9451
          • Correo electrónico: deisy21@naver.com

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

20 años a 79 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

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

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Subjects measure blood glucose level using laser lancing device (LMT-1000) and lancet for 2 months each.
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.
Subjects measure blood glucose level using laser lancing device (LMT-1000) and lancet for 2 months each.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
average number of checking blood glucose per week
Periodo de tiempo: two months after using the device
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)
two months after using the device
glycated hemoglobin level
Periodo de tiempo: two months after using the device
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 (%).
two months after using the device

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
average satisfaction score
Periodo de tiempo: two months after using the device
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)
two months after using the device
average pain scale
Periodo de tiempo: two months after using the device
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)
two months after using the device
Diabetes Distress Scale
Periodo de tiempo: two months after using the device
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)
two months after using the device
Diabetes Fear of Self-injecting
Periodo de tiempo: two months after using the device
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)
two months after using the device
success rate of measurement of blood glucose by laser lancing device
Periodo de tiempo: two months after using the device
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)
two months after using the device

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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 (Actual)

10 de agosto de 2021

Finalización primaria (Anticipado)

31 de marzo de 2022

Finalización del estudio (Anticipado)

31 de diciembre de 2022

Fechas de registro del estudio

Enviado por primera vez

2 de septiembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

13 de febrero de 2022

Publicado por primera vez (Actual)

22 de febrero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de febrero de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

13 de febrero de 2022

Última verificación

1 de febrero de 2022

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

Ensayos clínicos sobre Diabetes tipo 2

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