Table 2.
Glucose Control, Variability, HbA1c, Insulin Delivered, and Weight from the Run-in Phase to Study Phase
| Adolescents | Adults | |||||
|---|---|---|---|---|---|---|
| Run-in | Study | P | Run-in | Study | P | |
| Sensor glucose, mg/dL | 163.1 ± 19.2 (158.6, 153.5–173.5) | 158.5 ± 11.8 (160.3, 152.1–166.1) | 0.13284a | 146.1 ± 22.3 (143.9, 130.0–158.0) | 148.3 ± 13.5 (148.1, 139.5–156.3) | 0.04203a |
| Percent of sensor glucose values in range | ||||||
| ≤50 mg/dL | 0.7 ± 0.6 (0.5, 0.1–1.2) | 0.5 ± 0.5 (0.4, 0.2–0.6) | 0.14654 | 1.1 ± 1.2 (0.6, 0.3–1.3) | 0.6 ± 0.6 (0.4, 0.2–0.9) | <0.001a |
| ≤70 mg/dL | 4.3 ± 2.9 (4.4, 1.8–5.4) | 2.8 ± 1.3 (2.5, 1.7–3.2) | 0.00928 | 6.4 ± 4.3 (5.7, 3.2–8.2) | 3.4 ± 2.1 (3.0, 1.5–4.4) | <0.001a |
| 71–180 mg/dL | 60.4 ± 10.9 (60.9, 53.1–68.1) | 67.2 ± 8.2 (66.4, 59.8–72.3) | <0.001 | 68.8 ± 11.9 (70.1, 62.6–77.6) | 73.8 ± 8.4 (74.9, 70.0–79.1) | <0.001 |
| >180 mg/dL | 35.3 ± 11.4 (33.6, 28.8–42.2) | 30.0 ± 8.0 (31.4, 25.9–37.0) | <0.001a | 24.9 ± 13.5 (22.9, 14.8–32.6) | 22.8 ± 8.9 (21.8, 16.6–27.4) | 0.01045 |
| >300 mg/dL | 3.8 ± 4.3 (2.7, 1.4–4.5) | 2.8 ± 2.0 (2.3, 1.4–3.8) | 0.25429a | 1.8 ± 4.1 (0.7, 0.1–1.9) | 1.3 ± 1.7 (0.7, 0.4–1.6) | 0.38836a |
| Within-day SD of glucose, mg/dL | 56.4 ± 10.8 (57.4, 50.7–61.7) | 51.4 ± 7.7 (50.3, 48.9–55.0) | <0.001 | 48.1 ± 8.8 (46.8, 42.4–52.7) | 45.2 ± 6.6 (44.3, 41.0–48.1) | <0.001 |
| Within-day CV of glucose, % | 34.8 ± 4.7 (34.2, 32.3–37.7) | 32.2 ± 3.0 (32.1, 30.7–33.8) | 0.00118 | 33.1 ± 4.1 (32.9, 30.3–35.7) | 30.3 ± 3.2 (30.1, 27.7–32.2) | <0.001 |
| HbA1c, % | 7.7 ± 0.8 (7.8, 7.1–8.4) | 7.1 ± 0.6 (7.2, 6.6–7.4) | <0.001 | 7.3 ± 0.9 (7.2, 6.7–7.8) | 6.8 ± 0.6 (6.7, 6.4–7.1) | <0.001a |
| TDD, U | 55.6 ± 17.1 (53.2, 42.0–72.5) | 60.2 ± 19.8 (56.3, 42.5–72.2) | 0.00146 | 44.9 ± 23.7 (40.1, 30.1–51.8) | 47.9 ± 28.0 (41.3, 30.8–53.3) | <0.001a |
| Basal insulin as % of TDD | 49.7 ± 12.1 (47.5, 40.2–59.1) | 46.4 ± 8.5 (45.3, 39.2–51.9) | 0.02271 | 54.1 ± 10.9 (52.7, 46.8–60.9) | 46.8 ± 9.4 (46.4, 39.7–54.3) | <0.001 |
| Weight, kg | 67.4 ± 13.0 (66.9, 57.6–74.6) | 68.4 ± 12.5 (68.5, 57.9–76.7) | 0.06516 | 79.9 ± 18.2 (76.6, 67.7–86.4) | 81.3 ± 16.0 (78.1, 68.6–89.5) | <0.001a |
The run-in phase duration was 2 weeks and the study phase duration was 3 months. Values are shown as mean ± SD (median, IQR). For HbA1c, the end of study mean included N = 30 adolescents and N = 93 adults. For weight, the end of study mean included N = 30 adolescents and N = 75 adults.
a
Wilcoxon signed-rank test.
CV, coefficient of variation.