- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.")
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Seoul, Republica da Coréia, 135-710
- Samsung Medical Center
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: ICT-based intervention
Subjects in the ICT-based intervention group have algorithm-based feedback messages in addition to conventional intervention
|
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 Placebo: 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
|
Subjects will save and send their health information to the server via the personal health record app
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
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.
Prazo: Week 12
|
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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 24
Prazo: Week 24
|
the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 24
|
Week 24
|
the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 12
Prazo: Week 12
|
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
Prazo: Week 12 and 24
|
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
Prazo: 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
Prazo: Week 12 and 24
|
lipid profile at Week 12 and Week 24
|
Week 12 and 24
|
the proportion of patients having hypoglycemia (total, asymptomatic, daytime, nighttime, severe hypoglycemia, and coma/convulsions) at Week 12 and Week 24
Prazo: Week 12 and Week 24
|
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
|
the number of steps during Week 1-12 and Week 13-24
Prazo: Week 12 and Week 24
|
the number of steps during Week 1-12 and Week 13-24
|
Week 12 and Week 24
|
recorded exchange unit by food group
Prazo: Week 12 and 24
|
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
|
daily insulin dose
Prazo: Week 12 and Week 24
|
daily insulin dose at Week 12 and Week 24
|
Week 12 and Week 24
|
blood pressure
Prazo: Week 12 and Week 24
|
blood pressure at Week 12 and Week 24
|
Week 12 and Week 24
|
body weight
Prazo: Week 12 and Week 24
|
body weight at Week 12 and Week 24
|
Week 12 and Week 24
|
lean body mass
Prazo: Week 12 and 24
|
lean body mass at Week 12 and Week 24
|
Week 12 and 24
|
fat mass
Prazo: Week 12 and 24
|
fat mass at Week 12 and Week 24
|
Week 12 and 24
|
Satisfaction evaluation by questionnaire for ICT-based centralized clinical trial monitoring
Prazo: Week 12 and 24
|
Satisfaction evaluation by questionnaire for ICT-based centralized clinical trial monitoring at Week 12 and 24
|
Week 12 and 24
|
Satisfaction evaluation by DTSQ
Prazo: Week 12 and 24
|
Satisfaction evaluation by DTSQ at Week 12 and 24
|
Week 12 and 24
|
the number of telephone counselling by diabetes educators
Prazo: Week 12 and 24
|
the number of telephone counselling by diabetes educators
|
Week 12 and 24
|
the number of self-monitoring blood glucose measurements
Prazo: Week 12 and 24
|
the number of self-monitoring blood glucose measurements
|
Week 12 and 24
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Sang-Man Jin, MD PhD, Samsung Medical Center
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2016-08-006-001
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