Table 2.

Primary and secondary outcome measures (continuous)

Continuous outcomes	Total No of participants, adjusted mean (95% CI)		Adjusted mean difference (95% CI)	P
	CSII (n=144)	MDI (n=149)
HbA1c (mmol/mol) at 12 months (primary outcome)
Intention-to-treat analysis*†	143, 60.9 (58.5 to 63.3)	142, 58.5 (56.1 to 60.9)	2.4 (−0.4 to 5.3)	0.09
Per protocol†	87, 60.2 (56.4 to 63.9)	66, 59.3 (55.3 to 63.2)	0.9 (−3.2 to 5.0)	0.67
Change in body mass index SDS*‡	122, 0.6 (0.8)	122, 0.5 (0.8)	0.1 (0 to 0.3)	0.13
Change in height SDS*§	122, −0.1 (0.5)	122, 0 (0.4)	−0.1 (−0.2 to 0)	0.10
Insulin requirements (units/kg/day)*†	87, 0.7 (0.2)	64, 0.6 (0.3)	0.1 (0.0 to 0.2)	0.01

CSII=continuous subcutaneous insulin infusion; MDI=multiple daily injections; SDS=standard deviation score.

^*Intention-to-treat analysis.

^†Analysis adjusted for randomisation group (age category, fixed effects; centre, random effects).

^‡Analysis adjusted for randomisation group (age category, fixed effects; centre, random effects) and body mass index standard deviation score at baseline.

^§Analysis adjusted for randomisation group (age category, fixed effects; centre, random effects) and height standard deviation score at baseline.