Table 1 Outcome measurements according to periods of follow-up and type of collection
Time | Outcome measurements | |
|---|---|---|
Outcomes measured on patients | ||
M0, M3, M6, M12, M18, M24 (F to F) | Demographic data, health history, history of DM, DM health status, current medications, risk factors for complications of poorly controlled DM | |
Laboratory measurements | ||
M0, M12, M24 (CT) | HbA1c; fasting glucose; total cholesterol; HDL, LDL, and non-HDL cholesterol; triglycerides; serum creatinine; albumin/creatinine ratio; and glomerular filtration rate | |
M3, M18 (CT) | HbA1c, fasting glucose | |
M6 (CT) | HbA1c, fasting glucose, total cholesterol, HDL, LDL cholesterol, and triglycerides | |
Anthropometric measurements | ||
M0, M3, M6, M12, M18, M24 (F to F) | BMI, waist/hip ratio, systolic and diastolic blood pressure, heart rate | |
Macro and microvascular complications | ||
M0, M12, M24 (F to F, ECR) | Incidence of new ischemic heart events, hospitalization for congestive heart failure, peripheral artery disease, carotid stenosis fulfilling criteria for endarterectomy or confirmed ischemic or hemorrhagic stroke, incidence or progression of diabetic retinopathy, incidence or progression of diabetic nephropathy | |
Eye examination | ||
M3, M24 (CT) | Retinography and macular examination by OCT | |
Instruments used for self-reported outcomes measures | ||
M0, M12, M24 | (SRI) | ADDQoL-19, BDI-II, DES-SF, DDS2, DIATEK, IPAQ, MEDAS, STAI-S, INDICA-LSQ |
(F to F) | EQ-5D-5 L, MMAS | |
M6, M18 | (SRI) | ADDQoL-19, IPAQ, MEDAS |
(F to F) | EQ-5D-5 L, MMAS | |
Healthcare utilization | ||
M0, M3, M6, M12, M18, M24 (F to F, ECR) | Visits to primary care services, nurses, specialists; hospital admissions, emergency room visits, laboratory procedures, and other diagnostic tests; medication | |
Satisfaction | ||
M24 (SRI) | INDICA-SATP | |
Outcomes measured on physicians and nurses | ||
M0 (F to F) | Demographic data, years in practice, practice descriptors | |
M0, T3 (SRI) | INDICA-KNOW, LATCon | |
M24 (SRI) | INDICA-SATC | |