| Outcome Measures: |
Primary: MACE + HHF, Calculate the incidence of cardiovascular events (MACE+HF) to determine whether a multifactorial intervention is superior to standard care with respect to MACE+HHF (composite of time to first non-fatal myocardial infarction, first non-fatal stroke, cardiovascular death or first hospitalization for heart failure)., 5 years | Secondary: All-cause mortality, Calculate the incidence of all-cause mortality to determine whether a multifactorial intervention is superior to standard care with respect to all-cause mortality., 5 years|Renal function, Calculate the incidence of ESKD to determine whether a multifactorial intervention is superior to standard care with respect to renal function (end-stage kidney disease (ESKD) (dialysis, renal death, transplantation) or \>50% sustained decline in eGFR) compared to standard of care., 5 years|Diabetic ketoacidosis, safety, Calculate the incidence of DKA to determine whether a multifactorial intervention including the use of SGLT2i and GLP-1RA leads to a change in the frequency of diabetic ketoacidosis compared to standard care., 5 years | Other: Indivudual components of the primary endpoint, To determine whether a multifactorial intervention is superior to standard care with respect to the individual components of the primary endpoint., 5 years|Lower extremity amputations, Calculate the incidence of lower extremity amputations to determine whether a multifactorial intervention is superior to standard of care in reducing the total number of lower extremity amputations., 5 years|Progression of retinopathy, Calculate the incidence of progression to retinopathy to determine whether a multifactorial intervention is superior to standard of care in reducing progression of retinopathy., 5 years|Reduction in kidney function, Calculate the reduction in eGFR (ml/min/1.73m2) to determine whether a multifactorial intervention is superior to standard care with respect to sustained reduction in kidney function (\>30% decline in eGFR as well as \>40% decline in eGFR)., 5 years|EQ5D questionnaire, To determine whether a multifactorial intervention is superior to standard care with respect to quality of life as measured with the EQ5D questionnaire., 5 years|5- and 10-year cardiovascular risk as assessed using the Steno T1 Risk Engine, To calculate the 5- and 10 year risk of cardiovascular disease at baseline and after 3 and 5 years by the use of the Steno T1 Risk engine to determine whether a multifactorial intervention reduces estimated 5- and 10-year cardiovascular risk compared to standard of care., 5 years|Urinary albumin to creatinine ratio (UACR), Measurement of urinary albumin to creatinine raio (UACR) mg/g at baseline and after 3 and 5 years to determine whether a multifactorial intervention reduces urinary albumin to creatinine ratio (UACR) compared to standard of care., 5 years|Decline in eGFR, Measure eGFR (ml/min/1.72 m2) at baseline and after 3 and 5 years to determine whether a multifactorial intervention reduces decline in eGFR compared to standard of care., 5 years|HbA1c, Measure HbA1c (mmol/mol) at baseline and after 3 and 5 years to determine whether a multifactorial intervention reduces HbA1c levels compared to standard of care., 5 years|LDL cholesteerol, Measure LDL-cholesterol (mmol/L) at baseline and after 3 and 5 years to determine whether a multifactorial intervention reduces LDL cholesterol levels compared to standard of care., 5 years|BMI, Measure height (cm) and weight (kg) at baseline and after 3 and 5 years to calculate BMI (kg/m2) to determine whether a multifactorial intervention reduces BMI compared to standard of care., 5 years|Biothesiometry, Measure biothesiometry (V) at baseline and efter 3 and years to determine whether a multifactorial intervention reduces biothesiometry score compared to standard of care., 5 years|Diabetic ketoacidosis (DKA), Calculate events of DKA at baeline and after 3 and 5 years to calculate the incidence of DKA to compare incidence of diabetic ketoacidosis between the groups., 5 years|Long term risk of CVD events, Calculate the incidence of cardiovascular events (MACE+HHF) at 5 and 10 years to compare in both groups, 10 years|Survival, Calculate mortality rates after 5 and 10 years to compare overall survival between the groups, 10 years|Long term risk of ESKD, Calculate rates of ESKD after 5 and 10 years to compare number of individuals developing ESKD in both groups., 10 years|Long term risk of lower extremity amputations, Calculate numbers of lower extremity amputations after 5 and 10 years to compare between the groups., 10 years|Long term risk of DKA, Calculate the incidence of DKA after 5 and 10 years to compare between the groups., 10 years
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