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- Ensayo clínico NCT03112343
Information and Communication Technology Based Centralized Clinical Trial Monitoring System for Insulin Dose Adjustment (ICT)
An Information and Communication Technology-based Centralized Clinical Trial to Determine the Efficacy and Safety of Insulin Dose Adjustment Education Based on a Smartphone Personal Health Record Application
This is a 24-week, open-label, randomized, multi-center trial conducted in three tertiary hospitals. There are three follow-up measures; at baseline, post-intervention at Week 12, and Week 24. Subjects are diagnosed as type 1 DM, type 2 DM, and/or post-transplant DM, and initiate or currently use insulin therapy. After the given education on insulin dose titration and prevention for hypoglycemia and 1 week of run-in period, subjects are randomized in a 1:1 ratio to either the ICT-based intervention group or the conventional intervention group. Subjects in conventional intervention group will save and send their health information to the server via the PHR app, whereas those in ICT-based intervention group have additional algorithm-based feedback messages. The health information includes levels of blood glucose, insulin dose, details on hypoglycemia, food diary, and number of steps. The primary outcome will be the proportion of patients who reach an optimal insulin dose within 12 weeks of enrolling in the study without severe hypoglycemia or unscheduled clinic visits.
This study is based upon work supported by the Ministry of Trade, Industry & Energy (MOTIE, Korea) under Industrial Technology Innovation Program (No. 10059066, 'Establishment of ICT Clinical Trial System and Foundation for Industrialization.")
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Seoul, Corea, república de, 135-710
- Samsung Medical Center
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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
- age between 18-69 years
- diagnosis of T1DM, T2DM, and/or post-transplant DM (Post-transplant DM includes both diagnosed T1DM or T2DM before organ transplantation and first diagnosed DM after organ transplantation)
- initiation or current use of insulin therapy including once-daily basal insulin (including basal insulin only or basal insulin plus rapid-acting insulin), premixed insulin, or NPH)
- most recent hemoglobin A1c (HbA1c) ≥7.0% based on the National Glycohemoglobin Standardization Program (NGSP) at least 3 months prior to participation (recent HbA1c values measured <3 months prior to screening are permitted.)
- available to use smartphone and wireless internet
- Voluntarily write consent to participate in the trial
Exclusion criteria
- on insulin pump
- history of alcohol or drug abuse 1 year prior to participation
- history of psychological disorder (e.g., schizophrenia, depression, or bipolar disorder)
- history of severe visual or hearing impairment
- pregnant
- any condition, in the investigator's opinion, not suitable for enrollment eligibility.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: ICT-based intervention
Subjects in the ICT-based intervention group have algorithm-based feedback messages in addition to conventional intervention
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ICT-based intervention group have algorithm-based feedback messages in addition to conventional intervention
Subjects will save and send their health information to the server via the personal health record app
|
Comparador de placebos: Conventional intervention group
Subjects in the conventional intervention group will only save and send their health information to the server via the personal health record app
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Subjects will save and send their health information to the server via the personal health record app
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
the proportion of patients who reach his/her optimal insulin dose within 12 weeks of enrolling in the study without severe hypoglycemia or unscheduled clinic visits.
Periodo de tiempo: Week 12
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Reaching optimal insulin dose: A.For a patient who uses basal insulin only or basal insulin with pre-meal rapid-acting insulin once per day,1)3 or more fasting blood glucose(FBG) values in the morning within the target range(80-130mg/dL or 100-140 mg/dL) during Week12,2)no nocturnal(11pm-7am) or pre-breakfast hypoglycemia(<70mg/dL) during Week12,3)variation of basal insulin dose (the difference between the highest and lowest basal insulin dose) of <10% of mean total basal insulin dose during Week12.
B.For a patient who uses MDI at least twice per day, the criteria A plus 4)3 or more days in which correction dose premeal insulin is required less than 3times per day during the Week12,5) no daytime(7am-11pm) hypoglycemia during Week12.
C.For a patient who uses premixed insulin or NPH,1)3 or more FBG values in the morning and evening within the target range during Week 12,2) no nocturnal or pre-breakfast hypoglycemia during Week12
|
Week 12
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 24
Periodo de tiempo: Week 24
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the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 24
|
Week 24
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the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 12
Periodo de tiempo: Week 12
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the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 12
|
Week 12
|
mean fasting blood glucose values for three consecutive days prior to Week 12 and Week 24
Periodo de tiempo: Week 12 and 24
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mean fasting blood glucose values for three consecutive days prior to Week 12 and Week 24
|
Week 12 and 24
|
levels of HbA1c at Week 12 and Week 24
Periodo de tiempo: Week 12 and Week 24
|
levels of HbA1c at Week 12 and Week 24
|
Week 12 and Week 24
|
lipid profile at Week 12 and Week 24
Periodo de tiempo: Week 12 and 24
|
lipid profile at Week 12 and Week 24
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Week 12 and 24
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the proportion of patients having hypoglycemia (total, asymptomatic, daytime, nighttime, severe hypoglycemia, and coma/convulsions) at Week 12 and Week 24
Periodo de tiempo: Week 12 and Week 24
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the proportion of patients having hypoglycemia (total, asymptomatic, daytime, nighttime, severe hypoglycemia, and coma/convulsions) at Week 12 and Week 24
|
Week 12 and Week 24
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the number of steps during Week 1-12 and Week 13-24
Periodo de tiempo: Week 12 and Week 24
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the number of steps during Week 1-12 and Week 13-24
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Week 12 and Week 24
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recorded exchange unit by food group
Periodo de tiempo: Week 12 and 24
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recorded exchange unit by food group (grains, meats and protein, fruits, vegetables, dairy, and fats and oils) in each breakfast, lunch, and dinner on 3-day food diary at Week 12 and 24
|
Week 12 and 24
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daily insulin dose
Periodo de tiempo: Week 12 and Week 24
|
daily insulin dose at Week 12 and Week 24
|
Week 12 and Week 24
|
blood pressure
Periodo de tiempo: Week 12 and Week 24
|
blood pressure at Week 12 and Week 24
|
Week 12 and Week 24
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body weight
Periodo de tiempo: Week 12 and Week 24
|
body weight at Week 12 and Week 24
|
Week 12 and Week 24
|
lean body mass
Periodo de tiempo: Week 12 and 24
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lean body mass at Week 12 and Week 24
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Week 12 and 24
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fat mass
Periodo de tiempo: Week 12 and 24
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fat mass at Week 12 and Week 24
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Week 12 and 24
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Satisfaction evaluation by questionnaire for ICT-based centralized clinical trial monitoring
Periodo de tiempo: Week 12 and 24
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Satisfaction evaluation by questionnaire for ICT-based centralized clinical trial monitoring at Week 12 and 24
|
Week 12 and 24
|
Satisfaction evaluation by DTSQ
Periodo de tiempo: Week 12 and 24
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Satisfaction evaluation by DTSQ at Week 12 and 24
|
Week 12 and 24
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the number of telephone counselling by diabetes educators
Periodo de tiempo: Week 12 and 24
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the number of telephone counselling by diabetes educators
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Week 12 and 24
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the number of self-monitoring blood glucose measurements
Periodo de tiempo: Week 12 and 24
|
the number of self-monitoring blood glucose measurements
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Week 12 and 24
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Sang-Man Jin, MD PhD, Samsung Medical Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2016-08-006-001
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.
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