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 |