Table 3.
Glycemic Outcomes by Study Phases (Baseline, Supervised Hotel and Home)
| Overall | ||||||
|---|---|---|---|---|---|---|
| |
Mean ± SD or median (quartiles) |
P |
||||
| Glycemic outcomes | Baseline (B) | SH | Home (H) | SH vs. B | H vs. B | H vs. SH |
| Percent <50 mg/dL (%) | 0.2 (0%–0.9%) | 0.2 (0.1%–0.4%) | 0 (0%–0.3%) | 0.922 | 0.148 | 0.055 |
| Percent <54 mg/dL (%) | 0.6 (0.1%–1.6%) | 0.6 (0.4%–0.8%) | 0.1 (0%–0.7%) | 0.966 | 0.074 | 0.024 |
| Percent <60 mg/dL (%) | 1.6 (0.3%–2.8%) | 1.4 (1%–1.8%) | 0.2 (0%–1.2%) | 0.898 | 0.042 | 0.024 |
| Percent <70 mg/dL (%) | 3.7 (1.5%–6.4%) | 5 (3.3%–5.7%) | 1.5 (0.4%–2.9%) | 0.233 | 0.052 | 0.002 |
| Percent 70–140 mg/dL (%) | 41.8 ± 15.9 | 58.8 ± 17 | 46.8 ± 12.5 | 0.007 | 0.319 | 0.006 |
| Percent 70–180 mg/dL (%) | 61.7 ± 16.1 | 76.5 ± 15.5 | 68 ± 12.4 | 0.001 | 0.125 | 0.021 |
| Percent >180 mg/dL (%) | 34.1 ± 17.3 | 18.6 ± 14.9 | 30.1 ± 12.2 | 0.001 | 0.343 | 0.003 |
| percent >250 mg/dL (%) | 12.1 ± 9.4 | 3.6 ± 5.1 | 8.8 ± 8.7 | 0.003 | 0.153 | 0.004 |
| Percent >300 mg/dL (%) | 3.4 (0.6%–5.4%) | 0 (0%–0%) | 0.9 (0%–2.3%) | 0.004 | 0.027 | 0.074 |
| Mean CGM (mg/dL) | 161.1 ± 28.1 | 134 ± 20.5 | 155.2 ± 18.3 | 0.001 | 0.42 | <0.001 |
| Glucose variability (CV, %) | 39.1 ± 5.9 | 34.6 ± 4.6 | 35.5 ± 4.2 | 0.0498 | 0.047 | 0.53 |
| Total insulin [U/(kg·day)] | 0.67 ± 0.15 | 0.63 ± 0.18 | 0.74 ± 0.15 | 0.232 | <0.001 | 0.009 |
| Total CHO (g/day) | 106.5 ± 31.4 | 123.6 ± 53.8 | 129.8 ± 40.5 | 0.297 | 0.002 | 0.447 |
| Number of hypoglycemic events | 2.13 ± 1.36 | 2.76 ± 0.85 | 1.19 ± 1.06 | 0.134 | <0.001 | 0.100 |
| Percent time in closed loop (%) | — | 98.7 (93.4%–99.5%) | 97.4 (95%–98.7%) | — | — | 0.614 |
| Daytime (7 am–11 pm) | ||||||
| Baseline (B) | SH | Home (H) | SH vs. B | H vs. B | H vs. SH | |
| Percent <50 mg/dL (%) | 0 (0%–0.9%) | 0.3 (0%–0.4%) | 0 (0%–0.4%) | 0.375 | 0.820 | 0.469 |
| Percent <54 mg/dL (%) | 0.3 (0.1%–1.4%) | 0.7 (0%–1.1%) | 0.1 (0%–1%) | 0.898 | 0.098 | 0.160 |
| Percent <60 mg/dL (%) | 0.7 (0.4%–3.6%) | 1.7 (0.6%–2.4%) | 0.3 (0%–1.8%) | 0.831 | 0.054 | 0.064 |
| Percent <70 mg/dL (%) | 3.6 (1.5%–7.2%) | 6.2 (4.3%–8.4%) | 1.9 (0.6%–3.5%) | 0.092 | 0.077 | 0.001 |
| Percent 70–140 mg/dL (%) | 42.8 ± 15 | 58.8 ± 17.1 | 44.1 ± 11.9 | 0.006 | 0.750 | 0.001 |
| Percent 70–180 mg/dL (%) | 63.7 ± 15.1 | 75.5 ± 14.9 | 65.1 ± 12.9 | 0.007 | 0.667 | 0.007 |
| Percent >180 mg/dL (%) | 31.5 ± 16.5 | 18.4 ± 14.9 | 32.6 ± 13 | 0.004 | 0.788 | 0.001 |
| Percent >250 mg/dL (%) | 10 ± 9.3 | 3.8 ± 5.3 | 9 ± 8.6 | 0.012 | 0.663 | 0.002 |
| Percent >300 mg/dL (%) | 2.1 (0%–5.5%) | 0 (0%–0.1%) | 0.6 (0%–3.3%) | 0.008 | <0.001 | 0.078 |
| Mean CGM (mg/dL) | 157.1 ± 28.4 | 132.7 ± 21.7 | 157.2 ± 18.9 | 0.002 | 0.984 | <0.001 |
| Glucose variability (CV, %) | 38.7 ± 6.3 | 35.7 ± 4.7 | 35.7 ± 4.8 | 0.188 | 0.100 | 0.978 |
| Total Insulin [U/(kg·day)] | 0.55 ± 0.12 | 0.51 ± 0.15 | 0.61 ± 0.13 | 0.317 | <0.001 | 0.013 |
| Total CHO (g/day) | 103.5 ± 29.6 | 120.8 ± 53.8 | 126.6 ± 40.5 | 0.308 | 0.006 | 0.546 |
| Number of hypoglycemic events | 1.71 ± 1.18 | 2.42 ± 0.9 | 1.03 ± 0.93 | 0.084 | 0.001 | 0.122 |
| Night (11 pm–7 am) | ||||||
| Baseline (B) | SH | Home (H) | SH vs. B | H vs. B | H vs. SH | |
| Percent <50 mg/dL (%) | 0 (0%–0%) | 0 (0%–1.2%) | 0 (0%–0%) | 0.500 | 0.563 | 0.125 |
| Percent <54 mg/dL (%) | 0 (0%–1%) | 0 (0%–1.3%) | 0 (0%–0%) | 0.594 | 0.375 | 0.063 |
| Percent <60 mg/dL (%) | 0.7 (0%–2.2%) | 0 (0%–2.4% | 0 (0%–0% | 0.945 | 0.098 | 0.063 |
| Percent <70 mg/dL (%) | 2.1 (1.4%–4.9% | 1.8 (0%–4.8% | 0 (0%–1.3% | 0.413 | 0.105 | 0.371 |
| Percent 70–140 mg/dL (%) | 39.8 ± 19.9 | 58.8 ± 21.9 | 53.1 ± 24.5 | 0.028 | 0.113 | 0.476 |
| Percent 70–180 mg/dL (%) | 57.8 ± 19.7 | 78.6 ± 21.4 | 74.5 ± 18.8 | 0.003 | 0.019 | 0.531 |
| Percent >180 mg/dL (%) | 38.9 ± 21.1 | 18.9 ± 19 | 24.4 ± 18.7 | 0.003 | 0.042 | 0.376 |
| Percent >250 mg/dL (%) | 15.9 ± 14 | 3.2 ± 5.1 | 8.3 ± 10.7 | 0.007 | 0.100 | 0.044 |
| Percent >300 mg/dL (%) | 2.1 (0%–6.2% | 0 (0%–0% | 0 (0%–0.1% | 0.078 | <0.001 | 0.625 |
| Mean CGM (mg/dL) | 168.3 ± 33.8 | 136.3 ± 23.1 | 150.4 ± 27.2 | 0.008 | 0.102 | 0.087 |
| Glucose variability (CV, %) | 37.2 ± 5.8 | 29.6 ± 8 | 30.8 ± 7.3 | 0.031 | 0.024 | 0.619 |
| Total Insulin [U/(kg·day)] | 0.13 ± 0.04 | 0.12 ± 0.05 | 0.12 ± 0.03 | 0.612 | 0.782 | 0.879 |
| Total CHO (g/day) | 3 ± 6.8 | 2.9 ± 6.9 | 3.2 ± 5.2 | 0.878 | 0.311 | 0.394 |
| Number of hypoglycemic events | 0.48 ± 0.36 | 0.39 ± 0.32 | 0.19 ± 0.32 | 0.615 | 0.200 | 0.175 |
P values in bold are statistically significant (P < 0.05)
SH, outpatient supervised hotel.