Table 2

CGM-measured outcomes by treatment group

CGM group
Control group
P*
Baseline13 weeks26 weeksBaseline13 weeks26 weeks26 weeks13 and 26 weeks combined
n676766625860
Glucose level (min/day)
≤70 mg/dl91 (40–147)61 (24–118)54 (28–108)96 (37–225)89 (33–198)91 (27–188)0.16/0.04/0.060.05/0.03/0.03
≤60 mg/dl40 (9–73)21 (3–52)18 (5–40)40 (9–130)37 (12–100)35 (7–116)0.05/0.02/0.020.01/0.007/0.008
≤50 mg/dl7 (0–38)3 (0–18)4 (0–15)9 (0–45)7 (0–51)8 (0–55)0.12/0.05/0.040.05/0.03/0.01
71–180 mg/dl1,063 (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/dl255 (151–420)268 (179–410)283 (173–423)331 (206–489)362 (221–527)341 (232–502)0.10/0.09/0.130.03/0.03/0.04
>250 mg/dl40 (10–101)42 (8–77)48 (11–103)63 (27–118)76 (29–173)82 (22–149)0.12/0.05/0.100.005/0.003/0.006
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)0.09/0.02/0.020.03/0.01/0.008
SD of values48 (42–58)49 (40–58)50 (41–63)56 (48–67)58 (48–69)60 (46–67)0.17/0.13/0.210.008/0.02/0.03
MAGE93 (80–110)95 (82–111)96 (84–113)106 (84–130)103 (90–129)108 (86–126)0.77/0.78/0.870.26/0.27/0.31
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)0.35/0.51/0.510.39/0.63/0.57
  • 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.