Table 2.
Baseline and estimated change in glycemic parameters after at least 12 months
| Glycemic parameters, estimated mean (95% CI) | Baseline period (n = 34) | Follow-up at quarter ≥ 5 (≥ 12 months; n = 21) |
Mean change from baseline |
p value |
|---|---|---|---|---|
| Glucosea levels, mg/dL | 176.00 (164.50, 187.50) | 181.02 (169.34, 192.70) | 5.03 (− 3.38, 13.48) | 0.24 |
| %CV | 38.72 (36.47, 40.98) | 37.51 (35.23, 39.79) | − 1.21 (− 2.54, 0.12) | 0.074 |
| TIR, per day | 11.70 h (10.58, 12.81) | 11.26 h (10.13, 12.39) | − 0.44 h (− 1.15, 0.26) | 0.22 |
| 51.83% (46.97, 56.69) | 50.06% (45.14, 54.98) | − 1.77%-points (− 4.89, 1.36) | 0.27 | |
| TBR L1, per day | 0.94 h (0.76, 1.12) | 0.79 h (0.61, 0.98) | − 0.15 h (− 0.33, 0.04) | 0.12 |
| 4.27% (3.49, 5.06) | 3.58% (2.77, 4.38) | − 0.70%-points (− 1.50, 0.10) | 0.087 | |
| TBR L2, per day | 0.64 h (0.45, 0.83) | 0.50 h (0.30, 0.69) | − 0.14 h (− 0.27, − 0.02) | 0.029 |
| 2.82% (2.01, 3.64) | 2.18% (1.35, 3.02) | − 0.64%-points (− 1.19, − 0.08) | 0.025 | |
| TAR, per day | 9.13 h (8.05, 10.22) | 9.85 h (8.75, 10.95) | 0.71 h (− 0.11, 1.53) | 0.089 |
| 41.15% (36.18, 46.12) | 44.00% (38.95, 49.05) | 2.85%-points (− 0.87, 6.57) | 0.13 | |
| Events, estimated mean (95% CI) | ||||
| Total hypoglycemic events, n per day | 0.36 (0.26, 0.51) | 0.25 (0.18, 0.35) | − 31.4% (− 44.2, − 15.7) | 0.00035 |
| Nocturnal hypoglycemic events, n | 0.086 (0.056, 0.131) | 0.065 (0.042, 0.101) | − 24.4% (− 42.3, − 0.9) | 0.043 |
| Hyperglycemic events, n per day | 2.88 (2.64, 3.15) | 3.07 (2.81, 3.35) | 6.3% (− 0.2, 13.1) | 0.058 |
| Dosing, estimated mean (95% CI) | Baseline period (n = 30) | Follow-up at quarter ≥ 5 (≥ 12 months; n = 14) |
Mean percentage change from baseline |
p value |
|---|---|---|---|---|
| Bolus dose, n per dayb | 4.98 (4.48, 5.54) | 4.84 (4.32, 5.43) | − 2.8% (− 9.4, 4.2) | 0.42 |
| Bolus dose, U per dayb | 30.5 (26.3, 35.5) | 29.8 (25.2, 35.3) | − 2.4% (− 14.6, 11.5) | 0.71 |
| Dosing, estimated mean (95% CI) | Baseline period (n = 23) | Follow-up at quarter ≥ 5 (≥ 12 months; n = 10) |
Mean percentage change from baseline |
p value |
|---|---|---|---|---|
| Basal dose, U per dayc | 26.7 (22.5, 31.8) | 29.9 (25.0, 35.7) | 11.8% (3.1, 21.2) | 0.0075 |
%CV coefficient of variability, CI confidence interval, CGM continuous glucose monitoring, TAR time above range (> 180 mg/dL [> 10 mmol/L]), TBR L1 time below range level 1 (54 to < 70 mg/dL [3.0 to < 3.9 mmol/L]), TBR L2 time below range level 2 (< 54 mg/dL [< 3.0 mmol/L]), TIR time in range (70–180 mg/dL [3.9–10.0 mmol/L])
aMean CGM glucose
bFor days with ≥ 1 bolus dose
cFor days with ≥ 1 basal dose