CGM-measured outcomes by treatment group
| CGM group | Control group | P* | ||||||
|---|---|---|---|---|---|---|---|---|
| Baseline | 13 weeks | 26 weeks† | Baseline | 13 weeks | 26 weeks‡ | 26 weeks | 13 and 26 weeks combined | |
| n | 67 | 67 | 66 | 62 | 58 | 60 | ||
| Glucose level (min/day) | ||||||||
| ≤70 mg/dl | 91 (40–147) | 61 (24–118) | 54 (28–108) | 96 (37–225) | 89 (33–198) | 91 (27–188) | 0.16/0.04/0.06 | 0.05/0.03/0.03 |
| ≤60 mg/dl | 40 (9–73) | 21 (3–52) | 18 (5–40) | 40 (9–130) | 37 (12–100) | 35 (7–116) | 0.05/0.02/0.02 | 0.01/0.007/0.008 |
| ≤50 mg/dl | 7 (0–38) | 3 (0–18) | 4 (0–15) | 9 (0–45) | 7 (0–51) | 8 (0–55) | 0.12/0.05/0.04 | 0.05/0.03/0.01 |
| 71–180 mg/dl | 1,063 (921–1,174) | 1,092 (947–1,200) | 1,063 (948–1,185) | 972 (809–1,089) | 951 (778–1,079) | 949 (784–1,106) | 0.003/0.002/0.004 | <0.001/<0.001/0.001 |
| >180 mg/dl | 255 (151–420) | 268 (179–410) | 283 (173–423) | 331 (206–489) | 362 (221–527) | 341 (232–502) | 0.10/0.09/0.13 | 0.03/0.03/0.04 |
| >250 mg/dl | 40 (10–101) | 42 (8–77) | 48 (11–103) | 63 (27–118) | 76 (29–173) | 82 (22–149) | 0.12/0.05/0.10 | 0.005/0.003/0.006 |
| Area under the curve (70 mg/dl) | 0.64 (0.19–1.24) | 0.32 (0.09–0.80) | 0.26 (0.11–0.64) | 0.60 (0.18–1.88) | 0.48 (0.17–1.80) | 0.49 (0.13–1.73) | 0.09/0.02/0.02 | 0.03/0.01/0.008 |
| SD of values | 48 (42–58) | 49 (40–58) | 50 (41–63) | 56 (48–67) | 58 (48–69) | 60 (46–67) | 0.17/0.13/0.21 | 0.008/0.02/0.03 |
| MAGE | 93 (80–110) | 95 (82–111) | 96 (84–113) | 106 (84–130) | 103 (90–129) | 108 (86–126) | 0.77/0.78/0.87 | 0.26/0.27/0.31 |
| Absolute rate of change (mg/dl per min) | 0.60 (0.50–0.71) | 0.65 (0.50–0.73) | 0.66 (0.53–0.76) | 0.65 (0.56–0.80) | 0.63 (0.54–0.79) | 0.66 (0.54–0.87) | 0.35/0.51/0.51 | 0.39/0.63/0.57 |
Data are medians (interquartile range). CGM glucose data were obtained after completion of the 13- and 26-week visits with the CGM group using an unblinded device and the control group using a blinded device.
↵*P values were from three methods described in research design and methods: ANCOVA model based on van der Waerden scores, ANCOVA model with truncation of outliers, and ANCOVA model with square root transformation.
↵†One subject in the CGM group was missing sensor data.
↵‡Two subjects in the control group dropped out before the 26-week visit. MAGE, mean amplitude of glycemic excursion.