Table 3.
Extension Study Results for Adolescents and Adults (Ages 14–70 Years)
| Parameter | Standard therapy phase | Pivotal study | Extension study | Change from ST to pivotal study | P-valuea ST versus pivotal | Change from ST to extension study | P-valuea ST versus extension | Change from pivotal to extension | P-valuea pivotal versus extension |
|---|---|---|---|---|---|---|---|---|---|
| N | 114 | 114 | 114 | 114 | 114 | 114 | |||
| Phase duration | 14 days | 3 months | 17.6 ± 4.2 months | ||||||
| Percentage time 70–180 mg/dL, % | 63.6 ± 16.5, 65.4 (50.5, 77.0) | 73.8 ± 10.8, 75.6 (68.0, 80.7) | 72.9 ± 11.3, 73.7 (66.2, 81.4) | 10.2 ± 11.9, 8.7 (2.4, 17.0) | <0.0001†† | 9.2 ± 11.6, 8.1 (1.4, 16.6) | <0.0001†† | −0.9 ± 5.4, −0.8 (−3.5, 1.8) | 0.0411†† |
| Mean sensor glucose, mg/dL | 163 ± 28, 158 (139, 180) | 154 ± 16, 151 (144, 163) | 155 ± 18, 152 (143, 164) | −9 ± 20, −7 (−18, 6) | <0.0001†† | −8 ± 20, −6 (−19, 5) | <0.0001†† | 1 ± 9, 1 (−4, 4) | 0.2690†† |
| SD of sensor glucose, mg/dL | 58 ± 14, 56 (48, 67) | 49 ± 11, 48 (42, 55) | 51 ± 12, 51 (42, 57) | −8 ± 9, −8 (−14, −2) | <0.0001† | −7 ± 9, −6 (−12, 1) | <0.0001†† | 2 ± 5, 1 (−1, 4) | 0.0011†† |
| Coefficient of variation of sensor glucose, %‡ | 35.3 ± 5.9, 35.1 (30.6, 38.6) | 31.8 ± 4.8, 32.2 (28.5, 34.8) | 32.6 ± 5.0, 32.6 (29.8, 35.6) | −3.5 ± 4.5, −3.7 (−6.0, 0.0) | <0.0001† | −2.7 ± 4.9, −2.0 (−5.7, 0.7) | <0.0001† | 0.9 ± 2.1, 0.7 (−0.6, 2.2) | <0.0001† |
| Percentage time in glucose range, % | |||||||||
| <54 mg/dL | 0.65 ± 1.30, 0.28 (0.00, 0.77) | 0.23 ± 0.28, 0.18 (0.06, 0.29) | 0.29 ± 0.36, 0.18 (0.08, 0.38) | −0.42 ± 1.21, −0.11 (−0.44, 0.04) | <0.0001†† | −0.36 ± 1.21, −0.03 (−0.41, 0.07) | 0.0008†† | 0.06 ± 0.21, 0.03 (−0.02, 0.11) | 0.0001†† |
| <70 mg/dL | 2.93 ± 3.19, 2.05 (0.60, 4.10) | 1.34 ± 1.11, 1.09 (0.46, 1.80) | 1.52 ± 1.36, 1.23 (0.62, 1.93) | −1.59 ± 2.64, −0.89 (−2.27, 0.02) | <0.0001†† | −1.41 ± 2.70, −0.86 (−2.11, 0.17) | <0.0001†† | 0.18 ± 0.76, 0.09 (−0.12, 0.36) | 0.0070†† |
| >180 mg/dL | 33.4 ± 17.1, 30.1 (20.7, 46.8) | 24.9 ± 11.1, 23.2 (17.0, 31.4) | 25.6 ± 11.7, 24.9 (17.6, 32.8) | −8.6 ± 12.2, −7.1 (−16.1, 0.6) | <0.0001†† | −7.8 ± 12.0, −6.9 (−14.1, 1.1) | <0.0001†† | 0.7 ± 5.6, 0.7 (−1.6, 3.5) | 0.1141†† |
| ≥250 mg/dL | 10.5 ± 10.5, 6.7 (2.7, 16.2) | 5.8 ± 5.3, 3.9 (2.3, 7.8) | 6.5 ± 5.9, 5.0 (2.3, 9.0) | −4.7 ± 7.9, −2.5 (−8.1, 0.1) | <0.0001†† | −4.0 ± 7.8, −1.6 (−6.6, 0.6) | <0.0001†† | 0.7 ± 3.1, 0.4 (−0.5, 1.7) | 0.0036†† |
| ≥300 mg/dL | 3.8 ± 5.5, 1.8 (0.3, 5.1) | 1.7 ± 2.4, 0.9 (0.3, 2.2) | 2.1 ± 3.1, 1.2 (0.3, 2.8) | −2.1 ± 4.4, −0.6 (−3.0, 0.1) | <0.0001†† | −1.7 ± 4.2, −0.3 (−2.4, 0.4) | 0.0001†† | 0.4 ± 1.8, 0.1 (−0.1, 0.6) | 0.0012†† |
Data are mean ± SD, median (IQR). To convert the values for glucose to millimoles per liter, multiply by 0.05551.
a
p-value determined using †unadjusted two-sided paired t-tests or ††two-sided Wilcoxon signed rank test.
b
Coefficient of variation of sensor glucose is SD divided by the mean.
IQR, interquartile range; SD, standard deviation; ST, standard therapy.