Table 2.
Glycemic Outcomes During the Run-in Period and Study Phase
| Overall (n = 157) |
Adolescents (n = 39) |
Adults (n = 118) |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Run-ina | Studyb | P | Run-ina | Studyb | P | Run-ina | Studyb | P | |
| A1C, %c | 7.5 ± 0.8 | 7.0 ± 0.5 | <0.001d | 7.6 ± 0.8 | 7.1 ± 0.6 | <0.001d | 7.5 ± 0.9 | 7.0 ± 0.5 | <0.001d |
| 24-h day | |||||||||
| Time in closed loop, % | — | 94.9 ± 5.4 | — | — | 93.8 ± 5.7 | — | — | 95.2 ± 5.2 | — |
| TBR <50 mg/dL | 0.5 ± 0.7 | 0.3 ± 0.4 | 0.003d | 0.6 ± 0.7 | 0.4 ± 0.5 | 0.252d | 0.5 ± 0.7 | 0.3 ± 0.4 | 0.006d |
| TBR <54 mg/dL | 0.8 ± 1.1 | 0.5 ± 0.6 | 0.001d | 0.9 ± 1.0 | 0.6 ± 0.6 | 0.106d | 0.8 ± 1.1 | 0.5 ± 0.6 | 0.005d |
| TBR <70 mg/dL | 3.3 ± 2.9 | 2.3 ± 1.7 | <0.001d | 3.3 ± 2.7 | 2.4 ± 1.8 | 0.021 | 3.4 ± 3.0 | 2.3 ± 1.7 | <0.001d |
| TIR 70–180 mg/dL | 68.8 ± 10.5 | 74.5 ± 6.9 | <0.001d | 62.4 ± 9.9 | 72.7 ± 5.6 | <0.001 | 70.9 ± 9.8 | 75.1 ± 7.3 | <0.001 |
| TAR >180 mg/dL | 27.9 ± 11.0 | 23.1 ± 7.2 | <0.001d | 34.3 ± 10.7 | 24.9 ± 5.7 | <0.001 | 25.7 ± 10.2 | 22.6 ± 7.5 | <0.001 |
| TAR >250 mg/dL | 6.2 ± 4.7 | 4.6 ± 3.0 | <0.001d | 9.1 ± 5.4 | 5.6 ± 2.7 | <0.001 | 5.3 ± 4.1 | 4.3 ± 3.0 | <0.001d |
| TAR >300 mg/dL | 1.7 ± 1.9 | 1.2 ± 1.1 | <0.001d | 2.6 ± 2.4 | 1.5 ± 1.1 | <0.001d | 1.4 ± 1.5 | 1.1 ± 1.1 | 0.047d |
| Daytime (6 AM–12 AM) | |||||||||
| Time in closed loop, % | — | 94.8 ± 5.4 | — | — | 93.8 ± 5.9 | — | — | 95.2 ± 5.2 | — |
| TBR <50 mg/dL | 0.5 ± 0.7 | 0.3 ± 0.5 | 0.042d | 0.5 ± 0.7 | 0.4 ± 0.5 | 0.342d | 0.5 ± 0.7 | 0.3 ± 0.5 | 0.073d |
| TBR <54 mg/dL | 0.8 ± 1.0 | 0.5 ± 0.6 | 0.007d | 0.8 ± 1.0 | 0.6 ± 0.7 | 0.175d | 0.8 ± 1.1 | 0.5 ± 0.6 | 0.020d |
| TBR <70 mg/dL | 3.4 ± 3.0 | 2.4 ± 1.9 | <0.001d | 3.2 ± 2.7 | 2.5 ± 1.8 | 0.041 | 3.4 ± 3.1 | 2.4 ± 1.9 | <0.001d |
| TIR 70–180 mg/dL | 68.0 ± 10.8 | 72.1 ± 7.7 | <0.001d | 60.9 ± 10.4 | 69.8 ± 6.3 | <0.001d | 70.3 ± 9.9 | 72.9 ± 8.0 | <0.001 |
| TAR >180 mg/dL | 28.6 ± 11.5 | 25.4 ± 8.1 | <0.001d | 35.8 ± 11.5 | 27.7 ± 6.8 | <0.001 | 26.2 ± 10.5 | 24.6 ± 8.4 | 0.006 |
| TAR >250 mg/dL | 6.6 ± 5.2 | 5.3 ± 3.6 | <0.001d | 10.0 ± 6.0 | 6.4 ± 3.3 | <0.001d | 5.5 ± 4.4 | 4.9 ± 3.6 | 0.073d |
| TAR >300 mg/dL | 1.8 ± 2.1 | 1.4 ± 1.4 | 0.002d | 2.9 ± 2.7 | 1.7 ± 1.3 | <0.001d | 1.5 ± 1.8 | 1.3 ± 1.4 | 0.242d |
| Nighttime (12 AM–6 AM) | |||||||||
| Time in closed loop, % | — | 94.9 ± 5.4 | — | — | 94.1 ± 5.5 | — | — | 95.1 ± 5.4 | — |
| TBR <50 mg/dL | 0.6 ± 1.0 | 0.3 ± 0.5 | 0.017d | 0.7 ± 0.9 | 0.4 ± 0.6 | 0.195d | 0.5 ± 1.0 | 0.3 ± 0.4 | 0.050d |
| TBR <54 mg/dL | 0.9 ± 1.4 | 0.5 ± 0.7 | 0.006d | 1.0 ± 1.4 | 0.6 ± 0.8 | 0.194d | 0.8 ± 1.4 | 0.5 ± 0.6 | 0.017d |
| TBR <70 mg/dL | 3.2 ± 3.5 | 2.0 ± 2.0 | <0.001d | 3.4 ± 3.7 | 2.2 ± 2.3 | 0.032 | 3.2 ± 3.5 | 2.0 ± 1.8 | <0.001d |
| TIR 70–180 mg/dL | 71.2 ± 13.6 | 81.5 ± 9.5 | <0.001d | 66.8 ± 12.8 | 81.1 ± 9.1 | <0.001 | 72.6 ± 13.6 | 81.7 ± 9.7 | <0.001 |
| TAR >180 mg/dL | 25.6 ± 13.6 | 16.4 ± 9.2 | <0.001d | 29.9 ± 13.0 | 16.7 ± 8.4 | <0.001 | 24.2 ± 13.6 | 16.4 ± 9.5 | <0.001 |
| TAR >250 mg/dL | 5.1 ± 5.1 | 2.6 ± 2.6 | <0.001d | 6.5 ± 5.4 | 3.2 ± 2.9 | <0.001d | 4.7 ± 4.9 | 2.5 ± 2.4 | <0.001d |
| TAR >300 mg/dL | 1.2 ± 2.0 | 0.7 ± 0.8 | 0.003d | 1.7 ± 2.6 | 0.8 ± 1.0 | 0.114d | 1.1 ± 1.7 | 0.6 ± 0.8 | 0.012d |
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.
a
Sensor-augmented/integrated pump, PLGM, or Auto Basal use.
b
Auto Basal+Auto Correction use.
c
Number of participants whose data comprised A1C analysis: N = 155 for overall, n = 38 for adolescents, and n = 117 for adults.
d
Wilcoxon signed-rank test.
CGM, continuous glucose monitoring; PLGM, predictive low glucose management; TAR, time spent above target glucose range; TBR, time spent below target glucose range; TIR, time spent in target glucose range.