Table 2.

Mean changes in biomarkers between baseline and 1-year for participants receiving the CCI and UC

	Completers						All starters (dropouts imputed)d
	Unadjusted				Adjusted for baselinec		Unadjusted
	N	Difference (SD) or ± SE	1 Year	Significancee	Difference ±SE	Signif-icancee	Difference ± SE	1 Year	Significancee
Beta-hydroxybutyrate (mmol L−1)
CCI-all educationa	186	0.14 (0.36)	0.31 (0.35)	2.2 × 10−5	0.13 ± 0.02	2.8 × 10−7	0.12 ± 0.02	0.3 ± 0.02	5.8 × 10−7
Usual carea	59	0.04 (0.23)	0.18 (0.21)	0.24	0.06 ± 0.05	0.18	0.03 ± 0.04	0.18 ± 0.03	0.38
CCI-all vs. usual careb		0.1 (0.0)		0.01	0.06 ± 0.05	0.24	0.09 ± 0.04		0.04
Hemoglobin A1c (mmol mol−1)
CCI-all educationa	204	− 14.1 (14.43)	44.25 (10.28)	<10−16	− 14.43 ± 0.98	<10−16	− 14.21 ± 0.98	45.23 ± 0.77	<10−16
Usual carea	72	2.19 (14.76)	63.27 (19.89)	0.21	2.4 ± 1.75	0.17	2.19 ± 1.64	62.18 ± 2.08	0.18
CCI-all vs. usual careb		− 16.29 ± 1.97		4.4 × 10−16	− 16.83 ± 2.08	4.4 × 10−16	− 16.4 ± 1.86		<10−16
Hemoglobin A1c (%)
CCI-all educationa	204	− 1.29 (1.32)	6.20 (0.94)	<10−16	− 1.32 ± 0.09	<10−16	− 1.30 ± 0.09	6.29 ± 0.07	< 10−16
Usual carea	72	0.20 (1.35)	7.94 (1.82)	0.21	0.22 ± 0.16	0.17	0.20 ± 0.15	7.84 ± 0.19	0.18
CCI-all vs. usual careb		− 1.49 ± 0.18		4.4 × 10−16	− 1.54 ± 0.19	4.4 × 10−16	−1.50 ± 0.17		< 10−16
Fasting glucose (mmol L−1)
CCI-all educationa	202	− 1.96 (3.2)	6.84 (1.87)	<10−16	− 2.02 ± 0.26	6.0 × 10−15	− 1.95 ± 0.23	6.98 ± 0.17	< 10−16
Usual carea	71	0.59 (4.59)	9.3 (4.74)	0.28	0.81 ± 0.45	0.07	0.63 ± 0.49	9.29 ± 0.49	0.2
CCI-all vs. usual careb		− 2.55 ± 0.59		1.5 × 10−5	− 2.83 ± 0.53	7.9 × 10−8	− 2.58 ± 0.54		2.1 × 10−6
Insulin, all (pmol L−1)
CCI-all educationa	186	− 75.01 (178.49)	122.58 (169.6)	9.9 × 10−9	− 91.4 ± 12.15	5.5 × 10−14	− 73.62 ± 12.5	126.26 ± 12.5	4.3 × 10−9
Usual carea	59	12.15 (210.23)	218.91 (239.46)	0.66	36.88 ± 29.66	0.21	5.97 ± 24.52	206.27 ± 26.11	0.81
CCI-all vs. usual careb		− 87.23 (29.86)		0.004	− 127.58 ± 32.43	0.0009	− 79.59 ± 27.5		0.004
C-peptide (nmol L−1)
CCI-all educationa	185	− 0.36 (0.57)	1.11 (0.59)	<10−16	− 0.34 ± 0.05	1.1 × 10−13	− 0.33 ± 0.04	1.11 ± 0.04	2.2 × 10−16
Usual carea	59	0.08 (0.77)	1.43 (0.92)	0.41	0.02 ± 0.09	0.79	0.06 ± 0.09	1.44 ± 0.1	0.5
CCI-all vs. usual careb		− 0.44 ± 0.11		5.4 × 10−5	− 0.37 ± 0.1	0.0004	− 0.4 ± 0.1		5.3 × 10−5
HOMA-IR (insulin derived), all
CCI-all educationa	179	− 5.54 (12.19)	5.65 (8.71)	1.2 × 10−9	− 5.87 ± 0.92	2.2 × 10−10	− 5.58 ± 0.86	6.16 ± 0.69	7.5 × 10−11
Usual carea	56	1.65 (12.46)	12.96 (12.9)	0.32	2.4 ± 1.76	0.17	1.82 ± 1.49	12.2 ± 1.42	0.22
CCI-all vs. usual careb		− 7.19 (1.9)		0.0002	− 8.27±2.04	4.9 × 10−5	− 7.4 ± 1.72		1.6 × 10−5
HOMA-IR (insulin derived), e × cluding e × ogenous insulin users
CCI-all educationa	129	− 6.03 (10.67)	4.98 (5.69)	1.4 × 10−10	− 6.13 ± 0.98	4.2 × 10−10	− 6.82 ± 0.9	5.61 ± 0.51	3.2 × 10−5
Usual carea	25	3.99 (12.76)	13.35 (14.71)	0.12	4.1 ± 2.34	0.08	1.84 ± 1.96	13.3 ± 1.56	0.35
CCI-all vs. usual careb		− 10.01 ± 2.72		0.0002	− 10.23 ± 2.56	6.3 × 10−5	− 8.65 ± 2.16		6.0 × 10−5
HOMA-IR (C-peptide derived)
CCI-all educationa	170	− 3.53 (5.59)	7.9 (3.89)	2.2 × 10−16	− 3.53 ± 0.55	1.2 × 10−10	− 3.45 ± 0.46	8.25 ± 0.4	1.0 × 10−13
Usual carea	47	1.94 (10.54)	12.49 (10.46)	0.21	1.77 ± 1.12	0.11	1.65 ± 1.13	12.6 ± 1.11	0.14
CCI-all vs. usual careb		− 5.47 (1.6)		0.0006	− 5.29 ± 1.28	3.3  × 10−5	− 5.11 ± 1.22		3.0 × 10−5
Weight-clinic (kg)
CCI-all educationa	184	− 14.24 (10.29)	101.17 (22.06)	<10−16	− 13.81 ± 0.63	<10−16	− 13.8 ± 0.71	102.72 ± 1.5	< 10−16
Usual carea	69	0.04 (5.94)	106.82 (22.52)	0.95	− 1.11 ± 1.06	0.29	− 0.16 ± 0.84	107.31 ± 2.55	0.85
CCI-all vs. usual careb		− 14.29 ± 1.04		<10−16	− 12.7 ± 1.26	<10−16	− 13.65 ± 1.1		< 10−16
Systolic blood pressure (mmHg)
CCI-all educationa	187	− 6.77 (16.3)	125.84 (13.22)	1.3 × 10−8	− 6.52 ± 1.24	1.6 × 10−7	− 6.36 ± 1.12	125.57 ± 0.91	1.3 × 10−8
Usual carea	67	0.25 (17.8)	128.57 (11.82)	0.91	− 0.45 ± 2.15	0.83	− 0.9 ± 2.07	129.01 ± 1.72	0.67
CCI-all vs. usual careb		− 7.02 (2.4)		0.005	− 6.07 ± 2.55	0.02	− 5.46 ± 2.36		0.02
Diastolic blood pressure (mmHg)
CCI-all educationa	187	− 3.59 (9.33)	78.0 (7.55)	1.4 × 10−7	− 3.5 ± 0.7	6.2 × 10−7	− 3.51 ± 0.65	78.58 ± 0.56	7.2 × 10−8
Usual carea	67	− 0.12 (10.15)	80.99 (9.59)	0.92	− 0.39 ± 1.21	0.75	− 0.9 ± 1.2	81.12 ± 1.08	0.45
CCI-all vs. usual careb		− 3.47 ± 1.42		0.01	− 3.10±1.44	0.03	− 2.61 ± 1.37		0.06
Total cholesterol (mmol L−1)
CCI-all educationa	186	0.24 (0.93)	4.92 (1.18)	0.0004	0.24 ± 0.08	0.004	0.21 ± 0.07	4.97 ± 0.08	0.006
Usual carea	59	0.00 (1.60)	4.72 (1.62)	0.99	0.0 ± 0.16	0.98	− 0.04 ± 0.18	4.69 ± 0.18	0.83
CCI-all vs. usual careb		0.25 ± 0.22		0.26	0.25 ± 0.18	0.17	0.24 ± 0.19		0.2
LDL-C (mmol−1)
CCI-all educationa	172	0.28 (0.83)	2.87 (0.98)	7.7 × 10−6	0.28 ± 0.07	2.6 × 10−5	0.26 ± 0.06	2.94 ± 0.07	5.1 × 10−5
Usual carea	48	− 0.28 (0.97)	2.32 (0.8)	0.05	−0.28 ± 0.13	0.03	− 0.28 ± 0.12	2.32 ± 0.12	0.02
CCI-all vs. usual careb		0.56 ± 0.15		0.0003	0.56 ± 0.15	0.0002	0.54 ± 0.14		0.0001
Apo B (g L−1)
CCI-all educationa	186	− 0.01 (0.24)	1.03 (0.29)	0.69	− 0.0 ± 0.02	0.82	− 0.02 ± 0.02	1.04 ± 0.02	0.37
Usual carea	59	0.02 (0.37)	1.07 (0.39)	0.75	0.0 ± 0.04	0.9	0.0 ± 0.04	1.06 ± 0.04	0.95
CCI-all vs. usual careb		− 0.02 (0.05)		0.66	− 0.01 ± 0.05	0.83	− 0.02 ± 0.05		0.67
HDL-C (mmol L−1)
CCI-all educationa	186	0.20 (0.31)	1.29 (0.41)	<10−16	0.19 ± 0.02	<10−16	0.2 ± 0.02	1.29 ± 0.03	< 10−16
Usual carea	59	− 0.04 (0.23)	0.92 (0.32)	0.15	− 0.02 ± 0.04	0.69	− 0.03 ± 0.03	0.95 ± 0.04	0.41
CCI-all vs. usual careb		0.24 ± 0.04		1.7 × 10−10	0.2 ± 0.05	9.9 × 10−6	0.23 ± 0.04		1.3 × 10−8
Triglycerides (mmol L−1)
CCI-all educationa	186	− 0.56 (1.9)	1.71 (1.64)	<10−16	− 0.56 ± 0.18	9.3 × 10−15	− 0.54 ± 0.14	1.67 ± 0.13	< 10−16
Usual carea	59	0.34 (3.40)	3.7 (5.67)	0.22	− 0.35 ± 0.32	0.48	0.32 ± 0.37	3.45 ± 0.55	0.43
CCI-all vs. usual careb		− 0.9 ± 0.46		1.4 × 10−7	− 0.92 ± 0.38	7.5 × 10−6	− 0.86 ± 0.39		9.9 × 10−7
Total/HDL-cholesterol
CCI-all educationa	186	− 0.47 (1.41)	4.18 (1.71)	4.1  × 10−6	− 0.45 ± 0.16	0.005	− 0.53 ± 0.12	4.19 ± 0.13	1.7 × 10−5
Usual carea	59	0.52 (3.45)	5.96 (4.27)	0.24	0.44 ± 0.29	0.13	0.42 ± 0.36	5.73 ± 0.43	0.24
CCI-all vs. usual careb		− 1.00 ± 0.46		0.03	− 0.89 ± 0.33	0.008	− 0.95 ± 0.38		0.01
hsC−reactive protein (nmol L−1)
CCI-all educationa	193	− 31.71 (127.15)	53.81 (67.24)	<10−8	− 29.43 ± 9.14	<10−16	− 34.29 ± 10.0	52.86 ± 5.24	< 10−16
Usual carea	70	12.48 (126.86)	99.43 (139.91)	0.94	8.48 ± 16.1	0.88	12.48 ± 14.1	97.72 ± 14.76	0.93
CCI-all vs. usual careb		− 44.29 (17.14)		1.2 × 10−6	− 37.91 ± 18.55	3.0 × 10−5	− 46.76 ± 17.24		9.3 × 10−7
ALT (µkat L−1)
CCI-all educationa	201	− 0.16 (0.4)	0.36 (0.19)	9.5 × 10−9	− 0.16 ± 0.03	9.4 × 10−10	− 0.15 ± 0.02	0.36 ± 0.01	2.4 × 10−10
Usual carea	71	0.01 (0.28)	0.47 (0.34)	0.67	0.02 ± 0.05	0.67	0.01 ± 0.03	0.47 ± 0.04	0.77
CCI-all vs. usual careb		− 0.18 (0.04)		5.1 × 10−5	− 0.18 ± 0.05	0.0009	− 0.16 ± 0.04		4.6 × 10−5
AST (µkat L−1)
CCI-all educationa	201	− 0.09 (0.27)	0.32 (0.11)	2.8 × 10−6	− 0.09 ± 0.02	1.3 × 10−5	− 0.08 ± 0.02	0.32 ± 0.01	5.1 × 10−7
Usual carea	71	0.01 (0.32)	0.4 (0.27)	0.79	0.01 ± 0.04	0.69	0.01 ± 0.03	0.41 ± 0.03	0.72
CCI-all vs. usual careb		− 0.1 (0.04)		0.02	− 0.1 ± 0.04	0.02	− 0.09 ± 0.04		0.01
Alkaline phosphatase (µkat L−1)
CCI-all educationa	200	− 0.16 (0.24)	1.07 (0.35)	<10−8	− 0.17 ± 0.02	<10−16	− 0.16 ± 0.02	1.08 ± 0.02	< 10−16
Usual carea	71	0.0 (0.22)	1.31 (0.45)	0.94	0.02 ± 0.03	0.61	0.01 ± 0.03	1.3 ± 0.05	0.67
CCI-all vs. usual careb		− 0.17 (0.03)		6.3 × 10−8	− 0.18 ± 0.03	1.4 × 10−7	− 0.17 ± 0.03		3.1 × 10−8
Serum creatinine (µmol L−1)
CCI-all educationa	202	− 3.54 (14.14)	73.37 (18.56)	0.0001	− 3.54 ± 0.88	0.001	− 3.54 ± 0.88	74.26 ± 0.88	0.0001
Usual carea	71	− 0.88 (18.56)	77.79 (18.56)	0.56	− 2.65 ± 1.77	0.15	− 1.77 ± 1.77	78.68 ± 1.77	0.29
CCI-all vs. usual careb		− 2.65 ± 2.65		0.32	− 0.88 ± 2.65	0.73	− 1.77 ± 2.65		0.49
BUN (mmol L−1)
CCI-all educationa	202	0.76 (2.49)	6.82 (2.78)	1.5 × 10−5	0.75 ± 0.17	1.6 × 10−5	0.79 ± 0.17	6.81 ± 0.19	5.5 × 10−6
Usual carea	71	0.07 (2.15)	5.66 (2.11)	0.78	0.06 ± 0.3	0.85	− 0.01 ± 0.27	5.72 ± 0.26	0.97
CCI-all vs. usual careb		0.69 (0.29)		0.03	0.69 (0.32)	0.05	0.8 ± 0.32		0.01
eGFR (mL s−1 m−2)
CCI-all educationa	202	0.03 (0.15)	1.38 (0.2)	0.003	0.03 ± 0.01	0.009	0.03 ± 0.01	1.38 ± 0.01	0.005
Usual carea	71	0.01 (0.19)	1.34 (0.22)	0.51	0.02 ± 0.02	0.36	0.01 ± 0.02	1.34 ± 0.02	0.48
CCI-all vs. usual careb		0.03 ± 0.02		0.28	0.01 ± 0.02	0.61	0.02 ± 0.02		0.51
Anion gap (mmol L−1)
CCI-all educationa	201	0.29 (2.02)	7.08 (1.75)	0.04	0.28 ± 0.15	0.06	0.28 ± 0.14	7.13 ± 0.12	0.04
Usual carea	71	0.83 (2.44)	7.75 (1.97)	0.004	0.84 ± 0.26	0.001	0.81 ± 0.26	7.75 ± 0.22	0.002
CCI-all vs. usual careb		− 0.54 (0.3)		0.09	− 0.56 ± 0.31	0.07	− 0.53 ± 0.3		0.08
CO2 (mmol L−1)
CCI-all educationa	202	0.12 (2.26)	28.06 (2.29)	0.45	0.16 ± 0.18	0.38	0.18 ± 0.16	27.94 ± 0.16	0.27
Usual carea	71	0.17 (2.97)	28.23 (2.58)	0.63	− 0.2 ± 0.3	0.51	0.04 ± 0.33	28.12 ± 0.29	0.9
CCI-all vs. usual careb		− 0.05 (0.3)		0.9	0.36 ± 0.36	0.32	0.14 ± 0.37		0.71
Uric acid (µmol L−1)
CCI-all educationa	202	0.59 (70.79)	349.18 (91.01)	0.91	1.78 ± 4.76	0.72	1.78 ± 4.76	349.77 ± 5.95	0.67
Usual carea	71	− 10.71 (64.24)	320.03 (85.06)	0.15	− 16.66 ± 8.92	0.06	− 11.9 ± 7.73	322.41 ± 10.11	0.13
CCI-all vs. usual careb		11.3 ± 8.92		0.21	18.44 ± 10.11	0.07	13.68 ± 8.92		0.13
TSH (mIU L−1)
CCI-all educationa	200	− 0.41 (1.62)	1.9 (1.1)	0.0004	− 0.4 ± 0.11	0.0002	− 0.42 ± 0.1	1.91 ± 0.08	5.3 × 10−5
Usual carea	70	− 0.09 (0.99)	2.01 (0.99)	0.47	− 0.09 ± 0.19	0.64	0.0 ± 0.12	1.96 ± 0.12	0.98
CCI-all vs. usual careb		− 0.33 ± 0.16		0.05	− 0.31 ± 0.22	0.15	− 0.42 ± 0.16		0.01
Free T4 (pmol L−1)
CCI-all educationa	202	0.13 (2.32)	11.97 (2.45)	0.7	0.0 ± 0.26	0.83	0.13 ± 0.13	11.97 ± 0.13	0.58
Usual carea	71	0.26 (4.25)	11.58 (2.83)	0.7	0.26 ± 0.39	0.48	0.26 ± 0.39	11.46 ± 0.26	0.61
CCI-all vs. usual careb		− 0.13 (0.0)		0.8	− 0.26 ± 0.39	0.43	− 0.13 ± 0.51		0.78
Any diabetes medication, e × cluding metformin (%)
CCI-all educationa	218	− 27.52 (49.65)	27.98 ± 3.05	2.2 × 10−16	− 27.66 ± 3.21	<10−16	− 27.19 ± 3.14	29.68 ± 2.94	< 10−16
Usual carea	78	6.85 (34.68)	75.34 ± 5.08	0.09	7.54 ± 5.87	0.2	5.99 ± 4.31	72.66 ± 5.0	0.09
CCI-all vs. usual careb		− 34.37 ± 5.27		7.0 × 10−11	− 35.36 ± 6.83	2.3 × 10−7	− 33.19 ± 5.34		9.0 × 10−9
Sulfonylurea (%)
CCI-all educationa	218	− 24.31 (43.0)	0.0 ± 0.0	<10−16	− 24.23 ± 2.86	<10−16	− 23.67 ± 2.7	0.0 ± 0.0	< 10−16
Usual carea	78	2.74 (37.17)	26.02 ± 5.17	0.53	2.56 ± 5.24	0.63	1.91 ± 4.23	26.02 ± 5.17	0.65
CCI-all vs. usual careb		− 27.05 ± 5.23		2.4 × 10−7	− 26.85 ± 6.07	9.7 × 10−6	− 25.58 ± 5.02		3.3 × 10−7
Insulin (%)
CCI-all educationa	218	− 13.3 (35.37)	15.14 ± 2.43	2.8 × 10−8	− 15.5 ± 2.0	9.3 × 10−15	− 13.03 ± 2.22	16.74 ± 2.4	4.3 × 10−9
Usual carea	78	1.37 (31.15)	52.05 ± 5.89	0.71	8.46 ± 3.65	0.02	3.17 ± 3.68	49.18 ± 5.45	0.39
CCI-all vs. usual careb		− 14.67 ± 4.36		0.0008	− 23.89 ± 4.24	1.8  × 10−8	− 16.19 ± 4.3		0.0002
Thiazolidinedione (%)
CCI-all educationa	218	− 1.38 (15.12)	0.46 ± 0.46	0.18	− 1.47 ± 0.9	0.1	− 1.1 ± 0.91	0.42 ± 0.49	0.23
Usual carea	78	0.0 (0.0)	1.37 ± 1.37		0.26 ± 1.64	0.87	0.22 ± 0.51	1.27 ± 1.26	0.67
CCI-all vs. usual careb		− 1.38 ± 1.02		0.18	− 1.78 ± 1.91	0.35	− 1.31 ± 1.04		0.21
SGLT−2 (%)
CCI-all educationa	218	− 9.63 (29.57)	0.92 ± 0.65	1.5 × 10-6	− 9.96 ± 2.04	1.1 × 10−6	− 9.26 ± 1.88	0.92 ± 1.88	9.0 × 10−7
Usual carea	78	0.0 (28.87)	15.07 ± 4.22	1	1.13 ± 3.72	0.76	0.87 ± 3.17	15.07 ± 4.21	0.78
CCI-all vs. usual careb		− 9.63 ± 3.93		0.01	− 11.0 ± 4.32	0.01	− 10.13 ± 3.69		0.006
DPP−4 (%)
CCI-all educationa	218	− 3.67 (34.42)	6.42 ± 1.66	0.12	− 3.69 ± 2.21	0.09	− 3.52 ± 2.21	6.29 ± 1.66	0.11
Usual carea	78	2.74 (23.41)	10.96 ± 3.68	0.32	2.97 ± 4.05	0.46	2.64 ± 2.92	10.74 ± 3.51	0.37
CCI-all vs. usual careb		− 6.41 ± 3.6		0.07	− 6.64 ± 4.7	0.16	− 6.16 ± 3.66		0.09
GLP−1 (%)
CCI-all educationa	218	0.92 (34.6)	13.76 ± 2.34	0.7	1.15 ± 2.31	0.62	0.98 ± 2.3	14.4 ± 2.29	0.67
Usual carea	78	2.74 (33.22)	19.18 ± 4.64	0.48	2.09 ± 4.23	0.62	2.94 ± 3.84	17.02 ± 4.39	0.44
CCI-all vs. usual careb		− 1.82 ± 4.54		0.69	− 0.99 ± 4.91	0.84	− 1.96 ± 4.48		0.66
Metformin (%)
CCI-all educationa	218	− 7.34 (46.45)	64.22 ± 3.25	0.02	− 7.14 ± 3.0	0.02	− 6.34 ± 3.06	65.18 ± 3.14	0.04
Usual carea	78	0.0 (37.27)	61.64 ± 5.73	1	0.83 ± 5.5	0.88	− 0.08 ± 4.55	60.67 ± 5.61	0.99
CCI-all vs. usual careb		− 7.34 ± 5.38		0.17	− 7.95 ± 6.38	0.21	− 6.26 ± 5.48		0.25

See Table S2 (electronic supplemental material) for CCI-web, CCI-onsite, and additional comparisons

^aImputed values based on 700 iterations from multivariate normal regression

^bAdjusted for sex, age, baseline BMI, baseline insulin use (user vs. non-user), and African-American race

^cA significance level of P < 0.0017 ensures overall simultaneous significance of P ≤ 0.05 over the 30 variables using Bonferroni correction

^dMeans (standard deviations) are presented. Sample sizes, means, and significance levels refer to subjects with baseline and 1-year measurements for completers, and to 349 subjects (262 intervention and 87 usual care) for all starters. Significance levels for completers refer to one-sample t test with or without adjustment. Untransformed triglyceride and hsC-reactive protein values are presented; however, their statistical significances were based on their log-transformed values. CCI-all refers to the CCI-web and CCI-onsite combined

^eMean differences ± one standard error. Significance levels refer to two-sample t test or analysis of covariance for the differences