Table 2 Changes in IQ scores from baseline to 6 months and intention-to-treat (ITT) effects on these changes (all estimated based on mixed-effects modeling)

From: A Pilot randomized trial to examine effects of a hybrid closed-loop insulin delivery system on neurodevelopmental and cognitive outcomes in adolescents with type 1 diabetes

 

Standard care

Closed loop

Group difference in change

 

Baseline

6 months

Change

95% CI

Effect size*

P value

Baseline

6 months

Change

95% CI

Effect size*

P value

Change

95% CI

Effect size*

P value

Perceptual Reasoning Index

109.29

111.33

2.05

−0.17, 4.27

0.57

0.070

108.05

114.14

6.10

4.05, 8.14

1.82

0.000

4.05

1.03, 7.07

0.82

0.009

Verbal Comprehension Index

112.38

112.67

0.29

−2.89, 3.47

0.05

0.860

110.24

111.71

1.48

−0.87, 3.82

0.39

0.217

1.19

−2.76, 5.14

0.18

0.555

Full-Scale IQ

111.81

113.76

1.95

−0.22, 4.13

0.55

0.078

110.19

114.24

4.05

1.98, 6.11

1.20

0.000

2.10

−0.90, 5.09

0.43

0.171

  1. CI confidence interval.
  2. *Effect sizes (in Cohen d) were approximately calculated as two times t value divided by the square root of (sample size − 1), where t values were calculated as point estimates of the group difference from mixed-effects modeling divided by their robust maximum likelihood standard errors.
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