Evaluation | Observational Phase | |||
---|---|---|---|---|
Month | M0 | M6 (± 1 M) | M12 (± 2 M) | M24 (± 2 M) |
Demographics & Co-morbidity | Â | Â | Â | Â |
   Inclusion/Exclusion Criteria | X |  |  |  |
   Patient Identification | X | X | X | X |
   Date of visit | X | X | X | X |
   Date of consent | X |  |  |  |
   Demographics | X |  |  |  |
   Physical examination | X | X | X | X |
   Diabetes history | X |  |  |  |
   Diabetic complications and co-morbidity | X | X | X | X |
Pharmacotherapy | X | X | X | X |
Laboratory values: | Â | Â | Â | Â |
   TC, TG, HDL-C, LDL-C | X | X | X | X |
   Serum-Creatinine, Micro-, Macroalbuminuria | X | X | X | X |
   CRP | X | X | X | X |
   HbA1c, FPG, PPG | X | X | X | X |
Non-drug intervention | X | X | X | X |
Hypoglycaemic events | X | X | X | X |
Body Weight | Â | Â | Â | Â |
   Body weight and height | X | X | X | X |
   Hip and waist circumference | X | X | X | X |
EQ-5D, DTSQ | X | Â | X | X |
Hypoglycemia Awareness Questionnaire | X | X | X | X |
WHO-5 | X | Â | X | X |