Visit Number V-2 Pre-screening -3 weeks V-1 Qualification -2weeks V0 Randomization Baseline V1 3 months V2 6 months V3 12 months Follow up
Eligibility criteria x x        
Demographic data     x      
Informed consent x          
Medical History     x      
Current therapies x   x x x x
Body weight     x x x x
Height     x      
StandardizeHbA1c* x     x x x
Blood glucose values and notes stored in glucose meters x   x x x x
Type and insulin dose adjustments     x x x x
Quality of life questionnaires     x   x x
Patient satisfaction     x   x x
Episodes of hypoglycemia     x x x x
Adverse Events     x x x x
Table 1: Flow Chart