Table 1.
Baseline characteristics of patients grouped by low, medium and high day‐to‐day fasting SMBG variability tertiles
| Characteristics | Patients with T1D | Patients with T2D | ||||
|---|---|---|---|---|---|---|
| Low day‐to‐day fasting SMBG variability tertile | Medium day‐to‐day fasting SMBG variability tertile | High day‐to‐day fasting SMBG variability tertile | Low day‐to‐day fasting SMBG variability tertile | Medium day‐to‐day fasting SMBG variability tertile | High day‐to‐day fasting SMBG variability tertile | |
| Number of patients | 189 | 217 | 199 | 288 | 325 | 292 |
| Number of combinations of patient and treatment, n (%) | 285 (100.0) | 287 (100.0) | 285 (100.0) | 424 (100.0) | 424 (100.0) | 424 (100.0) |
| Male, n (%) | 169 (59.3) | 156 (54.4) | 139 (48.8) | 241 (56.8) | 213 (50.2) | 219 (51.7) |
| Race, n (%) | ||||||
| White | 270 (94.7) | 258 (89.9) | 266 (93.3) | 344 (81.1) | 340 (80.2) | 342 (80.7) |
| Black | 13 (4.6) | 23 (8.0) | 16 (5.6) | 55 (13.0) | 60 (14.2) | 69 (16.3) |
| Asian | 2 (0.7) | 1 (0.3) | 1 (0.4) | 19 (4.5) | 16 (3.8) | 3 (0.7) |
| Other | 0 (0.0) | 5 (1.7) | 2 (0.7) | 6 (1.3) | 8 (1.8) | 10 (2.4) |
| Ethnicity: Hispanic or Latino, n (%) | 35 (12.3) | 22 (7.7) | 28 (9.8) | 212 (50.0) | 136 (32.1) | 107 (25.2) |
| Mean age, years | 49.4 | 45.5 | 43.0 | 59.7 | 62.3 | 62.3 |
| Age group | ||||||
| 18 to 64 years, n (%) | 233 (81.8) | 265 (92.3) | 273 (95.8) | 294 (69.3) | 259 (61.1) | 247 (58.3) |
| 65 to 84 years, n (%) | 52 (18.2) | 22 (7.7) | 12 (4.2) | 126 (29.7) | 163 (38.4) | 177 (41.7) |
| >84 years, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (0.9) | 2 (0.5) | 0 (0.0) |
| Body weight, kg | 81.8 | 81.7 | 78.3 | 93.1 | 92.0 | 90.4 |
| BMI, kg/m2 | 27.8 | 27.8 | 26.7 | 32.5 | 32.3 | 31.9 |
| Duration of diabetes, years | 21.0 | 22.9 | 25.3 | 12.7 | 13.8 | 15.6 |
| HbA1c, % | 7.2 | 7.6 | 7.8 | 7.4 | 7.5 | 7.8 |
| HbA1c, mmol/mol | 55.7 | 59.5 | 62.2 | 57.9 | 58.0 | 61.6 |
| FPG, mmol/L | 9.3 | 9.5 | 9.5 | 7.9 | 7.4 | 7.4 |
| FPG, mg/dL | 166.7 | 170.7 | 170.5 | 141.9 | 133.2 | 133.2 |
| eGFR, mL/min/1.73 m2 | 87.2 | 90.8 | 91.8 | 80.8 | 78.2 | 75.5 |
| Insulin treatment at screening | ||||||
| CSII | 41 (14.4) | 59 (20.6) | 62 (21.8) | – | – | – |
| Basal | 244 (85.6) | 228 (79.4) | 223 (78.2) | 424 (100.0) | 424 (100.0) | 424 (100.0) |
| IDet, n (%) | 185 (64.9) | 172 (59.9) | 171 (60.0) | 111 (26.2) | 92 (21.7) | 83 (19.6) |
| NPH, n (%) | 58 (20.4) | 55 (19.2) | 52 (18.2) | 47 (11.1) | 31 (7.3) | 26 (6.1) |
| Glargine U100, n (%) | 1 (0.4) | 1 (0.3) | 0 (0.0) | 266 (62.7) | 301 (71.0) | 315 (74.3) |
Abbreviations: BMI, body mass index; CSII, continuous subcutaneous insulin infusion; eGFR, estimated glomerular filtration rate; FPG, fasting plasma glucose; IDet, insulin detemir; n, number of combinations of patient and treatment; NPH, neutral protamine Hagedorn; SMBG, self‐monitored blood glucose; T1D, type 1 diabetes; T2D, type 2 diabetes.
Data were summarized for the full analysis set. Baseline characteristics data were pooled for two treatment arms and two maintenance periods, and only patient and treatment combinations with two or more fasting SMBG measurements available within one week at least once during the maintenance periods were included in the baseline data. C‐peptide levels were not available to determine baseline endogenous insulin production. Data are given as mean values.