Study procedure | Screening | Baseline | 12 weeks | 24 weeks | 36 weeks | 48 weeks | Early termination |
---|---|---|---|---|---|---|---|
Visit | 1 | 2 | 3 | 4 | 5 | 6 | EDV |
Visit window | −28 ~ 0 day | 0 | ±14 days | ±14 days | ±14 days | ±14 days | |
Informed consent | ● | ||||||
Demographic information and medical history | ● | ||||||
Inclusion/exclusion criteria | ● | ||||||
Physical examination | ● | ||||||
Randomization | ● | ||||||
Digital integrated healthcare platform application (Groups B, C) | ● | ● | ● | ● | ● | ● | |
Continuous glucose monitoring system application (Group C) | ● | ● | ● | ● | ● | ● | |
Continuous glucose monitoring system data collection (Group C) | ● | ● | ● | ● | ● | ● | |
Vital signs | ● | ● | ● | ● | ● | ● | ● |
Laboratory tests | ● | ● | ● | ● | ● | ● | ● |
Evaluation of hypoglycemia/severe hyperglycemia | ● | ● | ● | ● | ● | ||
Satisfaction questionnaire (DTSQ) | ● | ● | ● | ● | ● | ● | |
Digital integrated healthcare platform data collection (Group B, C) | ● | ● | ● | ● | ● | ● | |
Monitoring and intervention (Group C) | ● | ● | ● | ● | ● | ● | |
Adverse event report | ● | ● | ● | ● | ● | ● | |
Concomitant drugs | ● | ● | ● | ● | ● | ● | ● |