Table 2.

Required baseline data and measurements.

(i) Demographic data including type of DM (type 1 DM, type 2 DM, latent autoimmune diabetes, maturity-onset diabetes of the young, and others)

(ii) Indication for participation

(iii) HbA1c levels of preceding year (last four measurements), to be reported by the health professional

(iv) Absence or presence of neuropathy, retinopathy, nephropathy, or macrovascular disease

(v) Frequency of SBGM

(vi) Scores of EQ-6D and SF-12v2 questionnaires

(vii) Self-reported number of diabetes-related hospitalizations in the previous year

(viii) Self-reported estimated/measured hypoglycemias 3 months before the device is used; specific categorization for severe (grade III) hypoglycemia (grade I (mild) symptoms with blood glucose <70 mg/dL, grade II (minor) symptoms with blood glucose <56 mg/dL, and grade III (severe) symptoms with glucose <40 mg/dL, requiring third-party assistance)

(ix) Self-reported levels of working day losses or reduced functioning (including sports performance) due to glucose variability

(x) DVN questionnaire