Table 2.
24-h Glucose Control During OL and CL Periods in Patients Exhibiting ≥ 5% of Time in Low Glucose.
WP7 (n = 9) | WP8 (n = 28) | WP9 (n = 8) | Total (n = 45) | ||||
---|---|---|---|---|---|---|---|
OL | CL | OL | CL | OL | CL | OL | CL |
Diff CL-OL P value size effect |
Diff CL-OL P value size effect |
Diff CL-OL P value size effect |
Diff CL-OL P value size effect |
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Time in low glucose (54 to <70 mg/dL) (%) | |||||||
8.3 ± 2.3 | 3.3 ± 1.6 | 7.9 ± 2.5 | 3.1 ± 1.7 | 7.4 ± 2.1 | 3.5 ± 1.7 | 7.9 ± 2.4 | 3.2 ± 1.6 |
−5.9 [−6.8, −3.1] 0.0003 2.1 |
−4.9 [−5.6, −4.0] <10−4 2.1 |
−4.0 [−5.3, −2.7] 0.0002 1.7 |
−4.7 [−5.3, −4.1] <10−4 2.2 |
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Time in very low glucose (<54 mg/dL) (%) | |||||||
2.1 ± 1.1 | 0.8 ± 0.5 | 1.9 ± 1.5 | 0.7 ± 0.8 | 1.6 ± 0.9 | 0.9 ± 0.6 | 1.9 ± 1.3 | 0.8 ± 0.7 |
−1.3 [−2.1, −0.5] 0.0044 1.3 |
−0.9 [−1.6, −0.8] <10-4 0.9 |
−0.6 [−1.1, −0.3] 0.0047 0.8 |
−0.9 [−1.4, −0.8] <10−4 1.0 |
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Time in range (70-180 mg/dL) (%) | |||||||
65.4 ± 9.4 | 72.0 ± 10.6 | 62.5 ± 10.3 | 67.4 ± 8.2 | 63.6 ± 6.8 | 66.8 ± 3.8 | 63.3 ± 9.5 | 68.2 ± 8.2 |
6 [2.4, 10.7] 0.0066 0.5 |
4.7 [1.8, 8.0] 0.0028 0.5 |
0.2 [−0.7, 7.1] 0.0944 0.5 |
5.1 [2.9, 7.0] <10−4 0.5 |
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Time in high glucose (>180 mg/dL) (%) | |||||||
26.3 ± 10.1 | 24.7 ± 10.8 | 29.6 ± 10.6 | 29.5 ± 7.9 | 29 ± 7.7 | 29.8 ± 3.6 | 28.8 ± 9.9 | 28.6 ± 8.1 |
0.4 [−5.8, 2.7] 0.417 0.1 |
−0.3 [−3.2, 3] 0.955 0.0 |
0.5 [−4.2, 5.7] 0.773 0.1 |
−0.2 [−2.4, 1.9] 0.827 0.0 |
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Time in very high glucose (>250 mg/dL) (%) | |||||||
7.7 ± 5 | 6.3 ± 4.8 | 9.7 ± 5.9 | 8.5 ± 4.6 | 10.5 ± 5.2 | 8.4 ± 3.1 | 9.4 ± 5.6 | 8 ± 4.4 |
−1.2 [−3.6, 0.9] 0.196 0.2 |
−0.7 [−3, 0.7] 0.204 0.2 |
−2.7 [−5.2, 1.1] 0.161 0.4 |
−1.1[−2.6, −0.1] 0.035 0.3 |
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Glycemia Risk Index | |||||||
48.8 ±10.9 | 33.7 ± 12.5 | 52.0 ± 13.9 | 38.8 ± 11.4 | 50.8 ± 9.0 | 39.9 ± 6.7 | 51.2 ± 12.4 | 38.0 ± 12.9 |
−15.3 [−21.0, −9.1] 0.0003 1.1 |
−12.6 [−17.3, −9.2] <10−4 1.0 |
−11.0 [−15.4, −6.5] 0.0007 1.1 |
−13.1 [−16.0, −10.4] <10−4 1.1 |
Data are given as mean (SD). Differences are shown as median [95% CI]. Paired t-test and Cohen’s d test are provided.
Abbreviation: OL, open loop; CL, closed loop; CI, confidence interval.