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Table 3 Relationship between TRIM-D overall and domain scores and the number of reduced injections from baseline to endpoint

From: Patient-reported outcomes in transition from high-dose U-100 insulin to human regular U-500 insulin in severely insulin-resistant patients with type 2 diabetes: analysis of a randomized clinical trial

TRIM-D Domain

Reduced Number of Injections

U-500R Treatment (n)

Mean Value (SD)

Change from Baseline

LSM Change from Baseline (SE)

Overall

0–2

TID (121)

67.78 (14.60)

5.74 (13.98)

6.15 (1.08)*

BID (58)

72.73 (12.56)

7.95 (13.37)

10.51 (1.60)*

3–4

TID (36)

70.54 (12.39)

11.32 (15.78)

8.48 (2.02)*

BID (85)

72.06 (12.89)

10.83 (13.71)

9.86 (1.29)*

>4

TID (2)

59.82 (16.41)

3.57 (6.31)

−1.22 (8.31)

BID (10)

74.02 (10.65)

10.27 (10.88)

9.89 (3.79)*

Treatment burden

0–2

TID (120)

68.65 (19.77)

5.36 (21.62)

7.09 (1.69)*

BID (58)

70.62 (21.93)

9.55 (25.43)

10.84 (2.47)*

3–4

TID (36)

70.37 (18.06)

8.91 (21.92)

6.61 (3.14)*

BID (85)

74.59 (18.91)

15.08 (21.02)

12.78 (2.00)*

>4

TID (2)

58.33 (17.68)

0.00 (11.79)

−3.42 (12.90)

BID (10)

72.92 (14.33)

9.58 (19.35)

10.17 (5.89)

Daily life

0–2

TID (121)

65.51 (18.76)

2.24 (19.05)

2.61 (1.50)

BID (58)

72.52 (17.34)

7.61 (19.99)

8.85 (2.22)*

3–4

TID (36)

68.89 (14.40)

9.17 (17.42)

6.75 (2.81)*

BID (85)

69.24 (17.33)

7.18 (19.02)

6.68 (1.79)*

>4

TID (2)

57.50 (3.54)

−7.50 (10.61)

−8.59 (11.54)

BID (10)

71.50 (21.61)

4.00 (16.12)

5.46 (5.27)

Diabetes management

0–2

TID (121)

56.46 (19.32)

12.33 (23.57)

12.95 (1.72)*

BID (58)

57.74 (20.00)

9.63 (24.48)

14.09 (2.55)*

3–4

TID (36)

59.44 (17.92)

19.83 (27.95)

15.08 (3.23)*

BID (85)

58.18 (20.15)

15.29 (25.55)

13.87 (2.06)*

>4

TID (2)

47.50 (10.61)

12.50 (17.68)

5.38 (13.29)

BID (10)

56.00 (16.30)

15.00 (16.83)

12.38 (6.06)*

Compliance

0–2

TID (121)

72.47 (17.61)

4.17 (15.47)

4.27 (1.24)*

BID (58)

77.51 (15.30)

8.76 (14.30)

9.77 (1.84)*

3–4

TID (36)

75.00 (14.56)

9.72 (22.43)

7.34 (2.33)*

BID (85)

78.09 (14.26)

9.12 (14.96)

9.16 (1.48)*

>4

TID (2)

68.75 (8.84)

3.13 (13.26)

0.13 (9.58)

BID (10)

81.88 (12.66)

7.50 (13.44)

9.27 (4.37)*

Psychological health

0–2

TID (121)

73.30 (20.56)

4.76 (17.85)

4.45 (1.38)*

BID (58)

81.51 (15.17)

5.60 (13.69)

9.39 (2.06)*

3–4

TID (36)

76.39 (17.12)

9.98 (15.79)

7.53 (2.59)*

BID (85)

77.61 (16.86)

8.01 (18.10)

7.28 (1.65)*

>4

TID (2)

65.63 (30.94)

7.81 (2.21)

0.78 (10.68)

BID (10)

83.75 (11.39)

13.13 (13.24)

11.32 (4.86)*

  1. Abbreviations: BID twice daily; LSM least-square mean; SD standard deviation; SE standard error; TID thrice daily; TRIM-D Treatment Related Impact Measure-Diabetes; U-500R human regular U-500 insulin
  2. *p < .05; p-value and LSM of change from baseline were from an ANCOVA model