Table 2

QOL outcomes by study arm from baseline to 24-week follow-up

CGM groupControl groupModel 1Model 2
Baseline24 weeksBaseline24 weeksMean difference in change between arms95% CIP valueMean difference in change between arms95% CIP valueEffect size (d)
WHO-571.28 ± 14.7170.47 ± 16.6869.06 ± 14.8967.32 ± 16.86−1.26−5.42 to 2.910.62−1.63−5.88 to 2.610.500.12
EQ-5D-5L0.90 ± 0.110.89 ± 0.100.89 ± 0.110.88 ± 0.100.00−0.03 to 0.030.860.00−0.03 to 0.030.920.00
Diabetes distress (DDS)
 Total1.78 ± 0.651.61 ± 0.481.69 ± 0.621.78 ± 0.650.220.08 to 0.360.0090.230.09 to 0.360.030.44
 Regimen2.09 ± 0.871.81 ± 0.682.08 ± 0.992.05 ± 0.870.250.05 to 0.460.040.260.05 to 0.470.040.31
 Emotional burden2.06 ± 0.901.93 ± 0.801.91 ± 0.832.03 ± 0.950.210.01 to 0.410.080.210.00 to 0.410.090.33
 Interpersonal1.54 ± 0.811.43 ± 0.611.45 ± 0.701.73 ± 1.040.370.16 to 0.560.0090.370.16 to 0.580.010.51
 Physician1.19 ± 0.631.09 ± 0.251.12 ± 0.251.18 ± 0.690.10−0.04 to 0.250.210.12−0.03 to 0.270.150.18
Hypoglycemic confidence (HCS)3.27 ± 0.573.47 ± 0.553.15 ± 0.573.18 ± 0.630.230.06 to 0.400.030.230.05 to 0.410.030.40
Hypoglycemia fear (worry subscale of HFS-II)15.75 ± 12.3013.48 ± 10.6317.30 ± 13.2217.73 ± 14.923.170.19 to 6.140.072.46−0.58 to 5.510.150.25
  • Data are unadjusted mean ± SD by group unless otherwise indicated. Model 1 values resulted from mixed linear regression models adjusted for baseline levels of the outcome and clinical site as a random effect. Model 2 values are further adjusted for the participant demographic factors of age, sex, and number of years since diagnosis. P values are adjusted for multiple comparisons by using the Benjamini-Hochberg procedure.