Table 2.
Extension Study Results for Children (Ages 6–13.9 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 | 110 | 110 | 110 | 110 | 110 | 110 | |||
| Phase duration | 14 days | 3 months | 19.2 ± 1.0 months | ||||||
| Percentage time 70–180 mg/dL, % | 52.4 ± 15.6, 52.8 (39.3, 63.1) | 67.9 ± 8.0, 68.2 (63.3, 73.3) | 65.9 ± 8.9, 66.1 (60.0, 72.4) | 15.5 ± 11.6, 15.0 (7.9, 24.6) | <0.0001† | 13.5 ± 12.0, 12.8 (5.6, 20.6) | <0.0001† | −2.0 ± 5.1, −1.7 (−5.2, 1.2) | <0.0001† |
| Mean sensor glucose, mg/dL | 184 ± 31, 181 (163, 205) | 161 ± 15, 159 (150, 171) | 164 ± 18, 165 (153, 176) | −23 ± 23, −21 (−36, −8) | <0.0001†† | −19 ± 24, −16 (−32, −3) | <0.0001†† | 4 ± 10, 3 (−3, 10) | <0.0001†† |
| SD of sensor glucose, mg/dL | 68 ± 13, 68 (59, 77) | 60 ± 9, 59 (52, 65) | 63 ± 12, 62 (54, 69) | −9 ± 8, −8 (−14, −3) | <0.0001† | −6 ± 9, −6 (−12, 0) | <0.0001† | 3 ± 6, 3 (−2, 6) | <0.0001† |
| Coefficient of variation of sensor glucose, %b | 37.4 ± 5.1, 36.9 (33.7, 40.9) | 37.0 ± 3.9, 37.6 (34.3, 39.8) | 37.8 ± 4.1, 37.5 (35.4, 40.5) | −0.3 ± 4.2, −0.6 (−3.5, 2.5) | 0.4060† | 0.5 ± 4.4,0.4 (−2.6, 3.3) | 0.2673† | 0.8 ± 2.1, 0.7 (−0.6, 2.2) | 0.0001† |
| Percentage time in glucose range, % | |||||||||
| <54 mg/dL | 0.40 ± 0.83, 0.10 (0.00, 0.38) | 0.32 ± 0.33, 0.22 (0.07, 0.41) | 0.37 ± 0.39, 0.27 (0.11, 0.44) | −0.08 ± 0.67, 0.04 (−0.08, 0.21) | 0.0551†† | −0.03 ± 0.66, 0.07 (−0.06, 0.26) | 0.0049†† | 0.05 ± 0.20, 0.03 (−0.05, 0.12) | 0.0223†† |
| <70 mg/dL | 2.15 ± 2.63, 1.33 (0.41, 2.65) | 1.77 ± 1.38, 1.46 (0.64, 2.21) | 1.80 ± 1.40, 1.55 (0.75, 2.22) | −0.38 ± 1.97, 0.10 (−0.65, 0.69) | 0.9752†† | −0.35 ± 2.12, 0.14 (−0.86, 0.83) | 0.9186†† | 0.04 ± 0.71, −0.02 (−0.25, 0.28) | 0.8975†† |
| >180 mg/dL | 45.5 ± 16.6, 44.8 (35.3, 59.2) | 30.3 ± 8.6, 29.7 (24.2, 35.5) | 32.3 ± 9.5, 32.5 (25.7, 38.8) | −15.2 ± 12.2, −14.3 (−24.2, −7.0) | <0.0001† | −13.1 ± 12.7, −12.0 (−21.3, −4.8) | <0.0001† | 2.0 ± 5.4, 1.9 (−1.5, 5.3) | 0.0002† |
| ≥250 mg/dL | 19.1 ± 13.0, 15.9 (10.2, 26.3) | 9.7 ± 5.4, 8.9 (5.7, 12.5) | 11.3 ± 6.7, 10.3 (6.0, 15.3) | −9.4 ± 9.8, −6.1 (−14.1, −2.1) | <0.0001†† | −7.8 ± 10.1, −5.2 (−12.8, −1.2) | <0.0001†† | 1.6 ± 3.9, 0.8 (−0.5, 3.7) | <0.0001†† |
| ≥300 mg/dL | 8.5 ± 8.9, 5.8 (2.5, 11.0) | 3.5 ± 2.9, 2.7 (1.4, 4.7) | 4.6 ± 4.2, 3.4 (1.5, 6.1) | −5.0 ± 7.1, −2.6 (−7.5, −0.4) | <0.0001†† | −4.0 ± 7.1, −2.3 (−6.1, 0.3) | <0.0001†† | 1.1 ± 2.7, 0.5 (−0.3, 2.1) | <0.0001†† |
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.