Table 1.
Items and schedule
| Registration | Treatment period (weeks) | ||||||
|---|---|---|---|---|---|---|---|
| Baseline | 52 weeks | 104 weeks | 156 weeks | 208 weeks | 260 weeks | ||
| Informed consent | ○ | ||||||
| Patient characteristics | ○ | ||||||
| Continuous glucose monitoring | ○ | △ | |||||
| Outcomes | ○ | ○ | ○ | ○ | ○ | ○ | |
| Body weight | ○ | ○ | ○ | ○ | ○ | ○ | |
| Blood pressure | ○ | ○ | ○ | ○ | ○ | ○ | |
| Blood chemistry* | ○ | ○ | ○ | ○ | ○ | ○ | |
| Urinary albumin excretion | ○ | ○ | ○ | ○ | ○ | ○ | |
| Carotid arterial echography | △ | △ | △ | ||||
| baPWV and ABI | △ | △ | △ | ||||
| Electrocardiogram | △ | △ | △ | ||||
| Diabetes Therapy-Related Quality of Life questionnaire | △ | △ | △ | ||||
| Pittsburgh Sleep Quality Index questionnaire | △ | △ | △ | ||||
| Cardiovascular events | |||||||
baPWV brachial-ankle pulse wave velocity, ABI ankle brachial blood pressure index, △ optional examination
*Including red blood cells, white blood cells, hemoglobin, hematocrit, blood platelet count, aspartate aminotransferase, alanine aminotransferase, γ-glutamyl transpeptidase, creatinine, estimated glomerular filtration rate, uric acid, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, fasting plasma glucose, HbA1c