Table 3.
Overall (n = 157) |
Adolescents (n = 39) |
Adults (n = 118) |
|||||||
---|---|---|---|---|---|---|---|---|---|
Run-ina | Studyb | P | Run-ina | Studyb | P | Run-ina | Studyb | P | |
24-h day | |||||||||
SG, mg/dL | 153 ± 16 | 148 ± 10 | <0.001d | 162 ± 16 | 150 ± 8 | <0.001 | 151 ± 15 | 147 ± 11 | <0.001 |
CV of SG, % | 35.0 ± 5.0 | 34.2 ± 4.1 | 0.003 | 36.5 ± 4.8 | 35.7 ± 4.1 | 0.202 | 34.5 ± 5.0 | 33.7 ± 3.9 | 0.008 |
Total insulin, units | 54.9 ± 25.8 | 56.7 ± 28.4 | 0.002d | 60.0 ± 16.3 | 63.1 ± 17.3 | 0.007 | 53.2 ± 28.1 | 54.6 ± 31.0 | 0.103d |
Total basal insulin, units | 25.1 ± 13.6 | 23.6 ± 13.2 | <0.001d | 25.2 ± 8.7 | 24.4 ± 8.4 | 0.265 | 25.1 ± 14.9 | 23.3 ± 14.5 | <0.001d |
Total bolus insulin, units | 29.8 ± 14.8 | 33.1 ± 16.8 | <0.001d | 34.8 ± 10.9 | 38.7 ± 10.1 | 0.002 | 28.1 ± 15.5 | 31.3 ± 18.2 | <0.001d |
Auto Correction, units | 0.0 ± 0.4 | 7.5 ± 6.1 | <0.001d | 0.0 ± 0.2 | 8.3 ± 3.3 | <0.001 | 0.0 ± 0.5 | 7.3 ± 6.7 | <0.001d |
Auto Correction, %c | 0.2 ± 1.4 | 22.0 ± 9.3 | <0.001d | 0.1 ± 0.5 | 21.6 ± 7.0 | <0.001 | 0.2 ± 1.6 | 22.1 ± 10.0 | <0.001d |
Daytime (6 AM–12 AM) | |||||||||
SG, mg/dL | 155 ± 17 | 151 ± 12 | <0.001d | 164 ± 17 | 154 ± 10 | <0.001d | 151 ± 16 | 150 ± 12 | 0.113 |
CV of SG, % | 35.0 ± 5.1 | 34.5 ± 4.0 | 0.157d | 36.7 ± 4.9 | 36.0 ± 4.1 | 0.261 | 34.5 ± 5.1 | 34.0 ± 3.8 | 0.129 |
Total insulin, units | 46.4 ± 21.7 | 47.5 ± 23.6 | 0.024d | 51.4 ± 13.7 | 53.4 ± 14.2 | 0.061 | 44.7 ± 23.6 | 45.6 ± 25.7 | 0.250d |
Total basal insulin, units | 18.7 ± 10.1 | 17.2 ± 9.8 | <0.001d | 18.6 ± 6.6 | 17.7 ± 6.1 | 0.092 | 18.7 ± 11.0 | 17.0 ± 10.8 | <0.001d |
Total bolus insulin, units | 27.6 ± 13.8 | 30.3 ± 15.3 | <0.001d | 32.7 ± 10.1 | 35.7 ± 9.3 | 0.017 | 26.0 ± 14.5 | 28.5 ± 16.5 | <0.001d |
Auto Correction, units | 0.0 ± 0.4 | 5.9 ± 4.8 | <0.001d | 0.0 ± 0.2 | 6.5 ± 2.7 | <0.001d | 0.0 ± 0.4 | 5.7 ± 5.4 | <0.001d |
Auto Correction, %c | 0.2 ± 1.3 | 18.8 ± 8.7 | <0.001d | 0.1 ± 0.5 | 18.5 ± 6.6 | <0.001d | 0.2 ± 1.5 | 18.9 ± 9.2 | <0.001d |
Nighttime (12 AM–6 AM) | |||||||||
SG, mg/dL | 150 ± 19 | 140 ± 13 | <0.001 | 156 ± 19 | 140 ± 12 | <0.001 | 148 ± 19 | 140 ± 14 | <0.001 |
CV of SG, % | 33.1 ± 6.1 | 30.6 ± 5.2 | <0.001d | 34.1 ± 5.9 | 32.0 ± 5.0 | 0.008 | 32.7 ± 6.1 | 30.1 ± 5.2 | <0.001d |
Total insulin, units | 8.6 ± 4.8 | 9.3 ± 5.5 | <0.001d | 8.7 ± 3.5 | 9.8 ± 3.8 | <0.001d | 8.5 ± 5.1 | 9.1 ± 5.9 | <0.001d |
Total basal insulin, units | 6.5 ± 3.7 | 6.4 ± 3.7 | 0.990d | 6.6 ± 2.3 | 6.7 ± 2.3 | 0.593 | 6.4 ± 4.0 | 6.4 ± 4.0 | 0.672d |
Total bolus insulin, units | 2.1 ± 2.1 | 2.8 ± 2.5 | <0.001d | 2.1 ± 2.1 | 3.1 ± 2.2 | <0.001 | 2.1 ± 2.0 | 2.8 ± 2.6 | <0.001d |
Auto Correction, units | 0.0 ± 0.1 | 1.7 ± 1.5 | <0.001d | 0.0 ± 0.0 | 1.8 ± 0.9 | <0.001d | 0.0 ± 0.1 | 1.6 ± 1.6 | <0.001d |
Auto Correction, %c | 0.5 ± 3.6 | 66.1 ± 22.4 | <0.001d | 0.3 ± 1.3 | 69.9 ± 20.6 | <0.001d | 0.5 ± 4.1 | 64.9 ± 22.9 | <0.001d |
All values are shown as mean ± SD.
Run-in CGM was ∼14 days and study phase was ∼90 days.
During baseline run-in period, Auto Correction bolus was inadvertently delivered on six systems.
Sensor-augmented/integrated pump, PLGM, or Auto Basal use.
Auto Basal+Auto Correction use.
Factored as a percentage of total bolus insulin.
Wilcoxon signed-rank test.
CV, coefficient of variation; SG, sensor glucose.