Table 1 Study timeline, variables and procedures

Data collected

Source

Assessment

Source

0

3

12

Month 0 & Month 12

Inclusion/Exclusion criteria

1 + 2

1 + 2

1 + 2

e-CRF

§

SIDIAP

Sociodemographic variables and comorbidities:

1. Age, height, gender, weight, BMI, duration of T2DM, medication (active component and dose), etc....

2. Pluripathology, clinical risk group

1 + 2

1

1 + 2

eCAP

§

SIDIAP

Main variable: HbA1c

1 + 2

1

1 + 2

e-CRF

eCAP

§

SIDIAP

Lipid profile and other laboratory variables:

Total cholesterol, HDL, LDL, triglycerides, non-HDL, urea, creatinine, glomerular filtration rate, urine albumin, AST, ALT, FA, GGT.

Systolic and diastolic blood pressure

1 + 2

1

1 + 2

eCAP

e-CRF

§

SIDIAP

Smoking habit

1 + 2

1

1 + 2

eCAP

e-CRF

§

SIDIAP

Sedentary lifestyle

1 + 2

1 + 2

1 + 2

e-CRF

Detection of macrovascular complications

Ischaemic heart disease, stroke, peripheral artery disease, heart failure

1 + 2

1

1 + 2

eCAP

e-CRF

§

SIDIAP

Chronic microvascular complications detection

Diabetic retinopathy, diabetic nephropathy (albuminuria, renal failure), diabetic neuropathy.

1 + 2

1

1 + 2

eCAP

e-CRF

§

SIDIAP

Costs:

Cost of medication, laboratory tests, additional tests, cost of staff (visits), referrals, IT

1 + 2

1 + 2

eCAP

e-CRF

§

SIDIAP

Costs:

Urgent care, outpatient and hospital admissions

1 + 2

1 + 2

e-CRF

Satisfaction and quality of life of patients DTSQ / ESDQoL

1 + 2

1 + 2

e-CRF

Professional Satisfaction

Specific Questionnaire

1 + 2

e-CRF

intensification/treatment adherence

1 + 2

1 + 2

e-CRF

Occurrence of severe hypoglycaemia episodes

1 + 2

1

1 + 2

e-CRF

SIDIAP

“Patient Activation Measure” questionnaire (instrument for disease self-evaluation)

1 + 2

1 + 2

1 + 2

e-CRF