- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.")
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Seoul, Corea, Repubblica di, 135-710
- Samsung Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: 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
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Comparatore 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
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Subjects will save and send their health information to the server via the personal health record app
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
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.
Lasso di tempo: 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
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Week 12
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 24
Lasso di tempo: 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
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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
Lasso di tempo: 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
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Week 12
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mean fasting blood glucose values for three consecutive days prior to Week 12 and Week 24
Lasso di tempo: Week 12 and 24
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
blood pressure
Lasso di tempo: Week 12 and Week 24
|
blood pressure at Week 12 and Week 24
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Week 12 and Week 24
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body weight
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Sang-Man Jin, MD PhD, Samsung Medical Center
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2016-08-006-001
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Informazioni su farmaci e dispositivi, documenti di studio
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Prove cliniche su Algorithm-based feedback messages
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