Table 3

Blinded CGM data£

Case subjectsControl subjects
n = 101n = 100P value*
Overall
 Mean glucose (mg/dL)174.9 ± 31.6175.4 ± 33.80.57
 Percentage of time <70 mg/dL (%)6.9 (3.4, 12)5.3 (2.4, 9.3)0.09
  Min/day <70 mg/dL99 (49, 173)76 (34, 134)
 Percentage of time <60 mg/dL (%)4.5 (1.7, 8.2)3.0 (1.2, 5.7)0.04
  Min/day <60 mg/dL65 (24, 117)43 (18, 83)
 Percentage of time <50 mg/dL (%)2.7 (0.7, 5.0)1.6 (0.6, 3.7)0.05
  Min/day <50 mg/dL39 (11, 73)23 (8, 54)
 Percentage of time >180 mg/dL (%)41.6 (28.2, 53.1)40.3 (26.9, 58.1)0.67
  Min/day >180 mg/dL600 (406, 765)581 (387, 836)
 Percentage of time in target range (70–180 mg/dL) (%)50.9 (40.6, 62.8)51.7 (39.1, 61.7)0.26
  Min/day in target range733 (585, 905)745 (563, 888)
 Glucose variability≠ (%CV)46.4 (38.8, 50.2)41.9 (37.0, 45.7)0.008
 Percentage of days with ≥1 hypoglycemic event¥ (%)46.2 (26.7, 61.5)33.3 (20.0, 53.3)0.10
Daytime (6 a.m. to 12 midnight)
 Mean glucose (mg/dL)177.4 ± 32.3178.8 ± 33.80.66
 Percentage of time <70 mg/dL (%)7.0 (3.7, 10.6)4.7 (2.4, 8.0)0.01
 Percentage of time <60 mg/dL (%)4.6 (1.8, 7.4)2.6 (1.2, 4.8)0.01
 Percentage of time <50 mg/dL (%)2.4 (0.8, 4.2)1.3 (0.4, 2.7)0.02
 Percentage of time >180 mg/dL (%)44.3 (30.3, 54.0)42.0 (30.1, 55.5)0.82
 Percentage of time in range (70–180 mg/dL) (%)49.2 (39.6, 60.0)51.0 (39.7, 62.2)0.30
 Glucose variability≠ (%CV)44.9 (38.9, 48.8)41.2 (36.8, 45.4)0.004
NighttimeΩ (12 midnight to 6 a.m.)
 Mean glucose (mg/dL)164.9 ± 37.8164.2 ± 42.60.50
 Percentage of time <70 mg/dL (%)7.7 (1.6, 15.2)6.3 (0.9, 14.6)0.51
 Percentage of time <60 mg/dL (%)4.1 (0.7, 11.5)2.5 (0.0, 9.4)0.32
 Percentage of time <50 mg/dL (%)2.2 (0.3, 7.0)1.2 (0.0, 5.9)0.19
 Percentage of time >180 mg/dL (%)34.4 (20.6, 49.3)33.8 (19.3, 50.5)0.80
 Percentage of time in range (70–180 mg/dL) (%)54.6 (42.6, 65.6)55.6 (40.9, 65.0)0.78
 Glucose variability≠ (%CV)42.2 (35.6, 51.8)39.9 (33.2, 46.1)0.03
  • Values are shown as mean ± SD or median (25th, 75th percentile).

  • £CGM data missing for 1 control subject and excluded for 1 case subject due to continual acetaminophen use throughout wear, which affects CGM accuracy; blinded CGM data from subsets of day and night presented in Supplementary Table 3.

  • *P value adjusted for age and SMBG; rank scores used to obtain P value.

  • ≠Coefficient of variation (CV) of glucose variability [(SD/mean of glucose) × 100].

  • ¥Event defined as at least 20 min <60 mg/dL; additional CGM data missing for 3 case subjects due to not having the minimum requirement of at least 7 days of data (at least 6 full h/day).

  • ΩAdditional CGM data missing for 4 case and 2 control subjects due to less than 24 h of nighttime CGM readings available.