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Table 1 Study schedule

From: Validation of the effectiveness of a digital integrated healthcare platform utilizing an AI-based dietary management solution and a real-time continuous glucose monitoring system for diabetes management: a randomized controlled trial

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