Table 3. Results of the intention-to-treat analysis for general and behavioural development.

	Control rate		Insulin effect		Total rate		Control rate		Insulin effect
	All ages		All ages		All ages		Age >36 months		Age >36 months
	C	P-value	C	P-value	C	95% CI	C	P-value	C	P-value
B: cognition	0.40	0.30	0.57	0.11	0.97	(0.36; 1.58)	0.19	0.64	0.75	0.046
B: receptive language	1.02	0.02	0.63	0.13	1.64	(1.04; 2.25)	0.87	0.05	0.60	0.14
B: expressive language	1.35	0.002	0.05	0.92	1.39	(0.85; 1.94)	1.09	0.02	0.29	0.54
B: fine motor function	0.47	0.18	0.41	0.26	0.87	(0.38; 1.37)	0.30	0.44	0.56	0.15
B: gross motor functiona	1.82	0.01	−0.07	0.92	1.75	(1.12; 2.38)	1.82	0.004	−0.01	0.99
V: communication skillsb	0.11	0.80	0.57	0.19	0.68	(0.004; 1.35)	0.14	0.76	0.56	0.32
V: social skills	−0.12	0.88	1.41	0.06	1.29	(0.11; 2.47)	−0.45	0.57	1.54	0.042
V: daily skills	0.14	0.78	0.84	0.14	0.97	(0.33; 1.61)	0.04	0.94	1.10	0.07
V: motor skills	0.30	0.64	1.21	0.09	1.51	(0.62; 2.40)	0.07	0.91	1.28	0.10
E: social developmenta	2.39	0.13	0.56	0.76	2.96	(1.08; 4.83)	2.31	0.18	0.93	0.64
E: emotional developmenta	0.50	0.61	0.07	0.95	0.57	(−0.59; 1.74)	0.47	0.66	0.05	0.97

Abbreviations: B, Bayley-III-NL; V, Vineland Screener 0-6 and E=ESSEON.

^aThe random coefficients model was reduced to a random intercept model since the variability in the slope was estimated to be zero for ‘all ages' and ‘age >36 months' and

^bfor ‘age >36 months' only. All ages n=25, Age >36 months n=21. The coefficient (C) is an estimate of the change in DAE in months per 6 months for the pre-treatment period (control rate) and treatment period (insulin effect). Observed insulin effects that show a clinical increase in DAE are underlined. The P-value (P) is calculated for the difference between the DAE at the beginning and the end of these respective periods. P<0.05 is considered statistically significant. Significant P-values of insulin effects are bold. The confidence interval (CI) represents the distribution of the individual coefficients.