| 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 |
