Table 2.

Association of depression symptoms and diabetes distress with subsequent risk of GRADE primary metabolic outcome (HbA_1c ≥7% subsequently confirmed)

	Primary metabolic outcome (unadjusted)		Primary metabolic outcome (model 1*)		Primary metabolic outcome (model 2**)
	HR (95% CI)	P	HR (95% CI)	P	HR (95% CI)	P
Separate models
Depression symptoms
PHQ-8 total score	1.01 (1.00–1.03)	0.123	1.01 (1.00–1.03)	0.076	1.01 (1.00–1.03)	0.110
PHQ-8 total score (≥10 vs. <10)	1.03 (0.84–1.27)	0.747	1.09 (0.88–1.34)	0.422	1.13 (0.91–1.41)	0.272
PHQ-8 somatic depression score	1.09 (0.98–1.21)	0.105	1.10 (0.99–1.23)	0.080	1.10 (0.98–1.24)	0.113
PHQ-8 cognitive-affective depression score	1.06 (0.95–1.19)	0.266	1.09 (0.97–1.22)	0.146	1.09 (1.00–1.23)	0.193
Diabetes distress
DDS average score	1.13 (1.05–1.22)	0.001	1.04 (0.96–1.12)	0.351	1.10 (1.01–1.20)	0.027
DDS average score (≥2 vs. <2)	1.21 (1.06–1.38)	0.005	1.08 (0.94–1.23)	0.287	1.16 (1.00–1.33)	0.050
DDS emotional distress	1.11 (1.05–1.18)	0.001	1.03 (0.97–1.10)	0.303	1.07 (1.00–1.15)	0.071
DDS regimen-related distress	1.09 (1.02–1.15)	0.007	1.03 (0.97–1.09)	0.310	1.07 (1.01–1.15)	0.033
DDS physician-related distress	1.07 (1.00–1.14)	0.054	1.03 (0.96–1.10)	0.448	1.08 (1.00–1.16)	0.058
DDS interpersonal distress	1.08 (1.01–1.15)	0.016	1.00 (0.94–1.07)	0.957	1.04 (0.96–1.11)	0.334
Joint model
PHQ-8 total score	1.00 (0.99–1.02)	0.734	1.01 (1.00–1.03)	0.151	1.01 (1.00–1.02)	0.494
DDS average score	1.12 (1.04–1.22)	0.004	1.01 (0.93–1.10)	0.775	1.09 (0.99–1.19)	0.082

*Model 1, preplanned analyses, with adjustment for sex, race/ethnicity, randomized treatment group, and baseline values of age, duration of T2DM, BMI, and HbA_1c.

**Model 2, post hoc analyses, with model 1 adjustments plus education and income.

Bold type represents P < 0.01.