- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.")
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
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Seoul, Korejská republika, 135-710
- Samsung Medical Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Aktivní komparátor: 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
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Komparátor placeba: 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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
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.
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 24
Časové okno: 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
Časové okno: 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
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mean fasting blood glucose values for three consecutive days prior to Week 12 and Week 24
Časové okno: Week 12 and 24
|
mean fasting blood glucose values for three consecutive days prior to Week 12 and Week 24
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Week 12 and 24
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levels of HbA1c at Week 12 and Week 24
Časové okno: Week 12 and Week 24
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levels of HbA1c at Week 12 and Week 24
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Week 12 and Week 24
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lipid profile at Week 12 and Week 24
Časové okno: Week 12 and 24
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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
Časové okno: 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
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Week 12 and Week 24
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the number of steps during Week 1-12 and Week 13-24
Časové okno: 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
Časové okno: 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
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Week 12 and 24
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daily insulin dose
Časové okno: Week 12 and Week 24
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daily insulin dose at Week 12 and Week 24
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Week 12 and Week 24
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blood pressure
Časové okno: Week 12 and Week 24
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blood pressure at Week 12 and Week 24
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Week 12 and Week 24
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body weight
Časové okno: Week 12 and Week 24
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body weight at Week 12 and Week 24
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Week 12 and Week 24
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lean body mass
Časové okno: 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
Časové okno: 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
Časové okno: Week 12 and 24
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Satisfaction evaluation by questionnaire for ICT-based centralized clinical trial monitoring at Week 12 and 24
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Week 12 and 24
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Satisfaction evaluation by DTSQ
Časové okno: Week 12 and 24
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Satisfaction evaluation by DTSQ at Week 12 and 24
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Week 12 and 24
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the number of telephone counselling by diabetes educators
Časové okno: 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
Časové okno: Week 12 and 24
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the number of self-monitoring blood glucose measurements
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Week 12 and 24
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Sang-Man Jin, MD PhD, Samsung Medical Center
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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