Table 2.

Results of the meta-analyses for person-reported outcomes in randomised controlled trials and observational, pre-post studies.

	Studies and participants		Effect size			Heterogeneity
	Studies (N)	Observations	SMD	95% CI	p-value	I2	τ2	χ2 (p)
Randomised controlled trials
Diabetes distressb	13	1248	−0.159	−0.309; −0.010	0.0322a	23.0%	0.0142	15.58 (0.21)
Fear of hypoglycaemiab	14	1085	−0.339	−0.566; −0.111	0.0005a	42.6%	0.0860	22.66 (0.046)
Worry subscaleb	16	1376	−0.236	−0.355; −0.117	<0.0001a	0.0%	0.0	5.61 (0.99)
Behaviour subscaleb	12	983	−0.250	−0.435; −0.064	<0.0001a	32.1%	0.0266	16.20 (0.13)
Impaired awareness of hypoglycaemiab	4	434	−0.231	−0.424; −0.037	0.0193	0.0%	0.0	0.71 (0.87)
Quality of lifec	3	344	0.347	0.134; 0.560	0.0014	0.0%	0.0	1.11 (0.57)
Paediatric quality of lifec	5	529	0.249	0.050; 0.448	0.0081a	0.0%	0.0	2.33 (0.68)
Sleep qualityb	8	577	−0.109	−0.498; 0.280	0.4247a	68.4%	0.1396	22.18 (<0.01)
Treatment satisfactionc	8	642	0.184	−0.164; 0.532	0.2838a	67.2%	0.1162	21.34 (<0.01)
INSPIREc	3	264	0.199	−0.057; 0.456	0.1266a	52.5%	0.0555	4.21 (0.12)
Observational, pre-post studies
Diabetes distressb	21	1009	−0.217	−0.403; −0.031	0.0133a	68.5%	0.1028	63.42 (<0.01)
Fear of hypoglycaemiab	16	1029	−0.445	−0.540; −0.349	<0.0001a	0.0%	0.0	9.43 (0.85)
Worry subscaleb	17	862	−0.423	−0.527; −0.320	<0.0001a	0.0%	0.0	12.09 (0.74)
Behaviour subscaleb	12	622	−0.376	−0.584; −0.168	<0.0001a	31.2%	0.0463	15.99 (0.14)
Impaired awareness of hypoglycaemiab	5	338	−0.212	−0.419; −0.004	0.0066a	0.0%	0.0	3.73 (0.44)
Quality of lifec	4	1641	−0.049	−0.118; 0.019	0.1584	87.1%	0.1430	23.19 (<0.01)
Sleep qualityb	15	841	−0.158	−0.255; −0.061	0.0016a	0.0%	0.0	12.01 (0.61)
Treatment satisfactionc	6	214	0.668	−0.044; 1.381	0.0607	79.6%	0.3855	24.50 (<0.01)
INSPIREc	10	443	−0.028	−0.236; 0.179	0.8189a	42.9%	0.0304	15.77 (0.07)

SMD, standardised mean difference; 95% CI, 95% confidence interval; I², measure of heterogeneity; τ², measure of heterogeneity; χ², test statistic for heterogeneity.

^ap-value from hierarchical meta-analysis with study as random, level-2 factor.

^bNegative SMDs indicate improvement.

^cPositive SMDs indicate improvement.