Table 2.
Study plan
| 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 | |
BDHQ Brief-Type Self-Administration Diet History Questionnaire, DTSQ Diabetes Treatment Satisfaction Questionnaire, HbA1c glycated hemoglobin, IPAQ-SV International Physical Activity Questionnaire Short Version, SF-36 36-Item Short-Form Health Survey
aInformed consent must be obtained before data collection is started
bDemographics: gender, date of birth, race, living arrangement status (living alone, living with someone, etc.), education level (no education or primary school, etc.), employment status (full-time worker, part-time worker, etc.), smoking status, alcohol intake, family history of diabetes, bed time (day or night), average sleeping hours per day in usual week, menstrual status (women only)
cLaboratory tests: aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltranspeptidase (γ-GTP), alkaline phosphatase (ALP), serum creatinine, serum albumin, fasting serum insulin (IRI), hematocrit, white blood cell, hemoglobin, platelet, serum C-peptide, high-sensitivity C-reactive protein (CRP), serum amylase, serum ketone body, serum uric acid, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, urinary test data (if routine urinary test data are available). Urinary test data include: urinary glucose (qualitative), urine protein (qualitative), urine protein (quantitative), urine albumin (quantitative), urinary ketone (qualitative), urinary ketone (quantitative), urinary albumin to creatinine ratio, urine protein to creatinine ratio