Table 1.
Baseline Demographics and Patient Characteristics (Randomized Population).
| Device-supported titration n = 75 |
Routine titration n = 76 |
All N = 151 |
|
|---|---|---|---|
| Age, years, mean (SD) | 61.2 (9.5) | 62.9 (9.4) | 62.1 (9.5) |
| Age group, years, n (%) | |||
| <65 | 43 (57.3) | 42 (55.3) | 85 (56.3) |
| 65-75 | 29 (38.7) | 24 (31.6) | 53 (35.1) |
| ≥75 | 3 (4.0) | 10 (13.2) | 13 (8.6) |
| Sex, n (%) | |||
| Male | 48 (64.0) | 56 (73.7) | 104 (68.9) |
| Female | 27 (36.0) | 20 (26.3) | 47 (31.1) |
| Race, Caucasian, n (%) | 75 (100) | 76 (100) | 151 (100) |
| Body Weight, kg, mean (SD) | 96.9 (24.0) | 100.0 (23.8) | 98.5 (23.8) |
| BMI, kg/m2, mean (SD) | 33.2 (6.9) | 33.3 (7.0) | 33.2 (6.9) |
| BMI categories, kg/m2, n (%) | |||
| <25 | 5 (6.7) | 5 (6.6) | 10 (6.6) |
| 25-30 | 24 (32.0) | 20 (26.3) | 44 (29.1) |
| 30-40 | 35 (46.7) | 37 (48.7) | 72 (47.7) |
| ≥40 | 11 (14.7) | 14 (18.4) | 25 (16.6) |
| Estimated GFR, L/min/1.73m2, mean (SD) | 82.02 (27.60) | 84.04 (24.02) | 83.04 (25.80) |
| Estimated GFR categories, n (%) | |||
| ≥90 | 22 (29.3) | 33 (43.4) | 55 (36.4) |
| 60-90 | 40 (53.3) | 30 (39.5) | 70 (46.4) |
| 30-60 | 13 (17.3) | 13 (17.1) | 26 (17.2) |
| Randomization stratuma (previous insulin use) | |||
| Insulin-naïve | 30 (40.0) | 30 (39.5) | 60 (39.7) |
| Insulin-pretreated | 45 (60.0) | 46 (60.5) | 91 (60.3) |
a
Due to stratification errors, 4 insulin pretreated participants were randomized as insulin-naïve and 1 insulin-naïve participant was randomized as insulin pretreated.