Table 3.

Schedule of Events (quantitative)

Protocol Activities	VISIT 1 Screening - Day 1	VISIT 2 Month 12 ± 28 days	VISIT 3 Month 24± 28 days
BASELINE DOCUMENTATION
Informed consent No activity should be performed before obtaining signed and dated informed consent	×
Review of inclusion and exclusion criteria	×
Disease history Assess diabetes history, diabetes-related medications and complications, co-morbidities, ongoing drugs, smoking habits.	×	×	×
Physical assessment Height (at screening only), weight, abdominal circumference, presence of insulin lipodystrophy, BMI, blood pressure and pulse rate	×	×	×
LABORATORY STUDIES
HbA1c (mmol and %)	×	×	×
Lipid profileTotal Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides	×	×	×
Renal and Liver profile Creatinine, estimated GFR, ALT, AST, GGT	×	×	×
QUESTIONNAIRES
Short Form 12 (SF-12)	×	×	×
Self-Care of Diabetes Inventory (SCODI)	×	×	×
Quality of Life (EQ-5D-5L)	×	×	×
Problem Areas in Diabetes Questionnaire Short Form (PAID-5)	×	×	×
Pittsburgh Sleep Quality Index (PSQI)	×	×	×
OTHER ASSESSMENT
Events Any referral or unplanned diabetes visit, request for home care assistance, hospitalization, access to emergency care, death, received diabetes education in the last year.	×	×	×