Introduction
Methods
Study Design and Population
Compliance with Ethics Guidelines
Inclusion and Exclusion Criteria
Inclusion criteria |
Subjects in this study must fulfill all of the following criteria: 1. Provide written informed consent for study participation 2. Female or male aged 20 years or over 3. Diagnosed with type 2 diabetes mellitus 4. Initiating a second oral or parenteral antidiabetic therapy added to oral antidiabetic monotherapy or switching from the monotherapy to another monotherapy with a different drug class |
Exclusion criteria |
Patients will not be eligible to participate if any of the following exclusion criteria are present: 1. Diagnosis of type 1 diabetes mellitus 2. Current pregnancy 3. Current treatment for any cancer 4. Current dialysis treatment or renal transplantation 5. Current treatment with any oral steroids 6. Participation in any randomized control trials 7. Presence of any condition/circumstance that, in the opinion of the investigator, could significantly limit the complete follow-up of the patient (e.g., tourist, non-native speaker who does not understand the local language where an interpreter is not available, psychiatric disturbances, alcohol or drug abuse). |
Data Collection
Data collection | Enrollment | Year 1 | Year 2 | Year 3 | |
---|---|---|---|---|---|
Visit number | 1 | 2 | 3 | 4 | 5 |
Study month | Day 0 | 6 | 12 | 24 | 36 |
Written informed consent | Xa
| ||||
Site and physician characteristics | X | ||||
Demographicsb
| X | ||||
Risk factors (smoking status, etc.) | X | ||||
Changes in demographics and risk factors | X | X | |||
Diabetes medical and treatment history | X | ||||
Medical history (comorbidities) | X | ||||
Concomitant medications | X | ||||
New comorbidities, concomitant medications, and interventions (including chemotherapy, steroids, dialysis) | X | X | X | X | |
Physical examination (including height, weight, waist circumference, heart rate, blood pressure, etc.) | X | X | X | X | X |
Laboratory testsc
| X | X | X | X | X |
HbA1c and glucose at the time of diabetes treatment change | X | X | X | X | X |
Diabetes medication changes from baseline | X | X | X | X | |
QOL questionnaires (SF-36, DTSQ) | X | X | X | X | X |
BDHQ | X | X | X | X | |
Physical activity questionnaires (IPAQ-SV) | X | X | X | X | X |
Minor hypoglycemic events in last 1 month | X | X | X | X | X |
Major hypoglycemic events in last 12 months/last visit | X | X | X | X | X |
Hyperglycemia hospitalization since the last visit | X | X | X | X | X |
Incidence and progression of microvascular complications since last visit | X | X | X | X | |
Incidence of macrovascular complications since last visit | X | X | X | X |