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Table 2 Comparisons of TID and BID dosing algorithms using TRIM-D patient-reported outcomes

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

U-500R Treatment (n)

Mean Actual Value (SD)

Change from Baseline (MMRM) LSM (95 % CI)a

LSM Difference between Treatments (95 % CI) vs. U-500R TIDb

Overall

 Screening

TID (161)

60.28 (13.61)

−2.65 (−4.77,−0.53)*

0.50 (−2.57, 3.56)

BID (159)

60.77 (14.27)

−2.53 (−4.67,−0.38)*

 Baseline

TID (161)

61.35 (14.59)

 

1.09 (−2.05, 4.22)

BID (161)

62.44 (14.00)

 Endpoint

TID (159)

68.31 (14.14)

6.04 (3.81, 8.26)**

3.52 (0.93, 6.11)*

BID (153)

72.44 (12.57)

10.06 (7.82, 12.30)**

Treatment burden

 Screening

TID (160)

60.37 (18.40)

−2.75 (−6.12, 0.63)

−1.23 (−5.57, 3.11)

BID (159)

59.15 (20.91)

−2.63 (−6.01, 0.75)

 Baseline

TID (160)

62.69 (19.39)

−

−2.48 (−6.93, 1.97)

BID (160)

60.21 (21.02)

 Endpoint

TID (158)

68.91 (19.31)

6.23 (2.70, 9.75)*

5.03 (0.99, 9.06)*

BID (153)

72.97 (19.84)

12.24 (8.71, 15.77)**

Daily life

 Screening

TID (161)

63.72 (17.38)

−0.72 (−3.77, 2.32)

−0.50 (−4.52, 3.52)

BID (158)

63.22 (19.10)

−1.46 (−4.53, 1.62)

 Baseline

TID (161)

62.50 (17.69)

−

0.97 (−2.95, 4.89)

BID (161)

63.47 (18.07)

 Endpoint

TID (159)

66.17 (17.78)

1.75 (−1.44, 4.93)

4.01 (0.41, 7.62)*

BID (153)

70.63 (17.57)

6.58 (3.37, 9.79)**

Diabetes management

 Screening

TID (161)

40.18 (19.53)

−3.71 (−7.07,−0.35)*

4.27 (−0.15, 8.69)

BID (158)

44.45 (20.62)

0.13 (−3.26, 3.52)

 Baseline

TID (161)

43.15 (20.83)

−

0.91 (−3.67, 5.49)

BID (161)

44.07 (20.95)

 Endpoint

TID (159)

57.02 (18.92)

13.40 (9.89, 16.92)**

0.52 (−3.62, 4.65)

BID (153)

57.87 (19.75)

14.89 (11.35, 18.43)**

Compliance

 Screening

TID (161)

65.06 (17.34)

−3.04 (−5.79,−0.29)*

1.24 (−2.64, 5.11)

BID (158)

66.30 (17.84)

−2.58 (−5.37, 0.22)

 Baseline

TID (161)

67.43 (17.09)

−

2.02 (−1.76, 5.79)

BID (161)

69.45 (17.33)

 Endpoint

TID (159)

73.00 (16.87)

5.31 (2.43, 8.19)**

4.48 (1.50, 7.47)*

BID (153)

78.12 (14.52)

9.89 (6.98, 12.80)**

Psychological health

 Screening

TID (161)

68.09 (19.17)

−2.90 (−5.67,−0.13)*

−0.14 (−4.36, 4.08)

BID (159)

67.95 (19.20)

−5.00 (−7.80,−2.20)**

 Baseline

TID (161)

68.02 (19.07)

−

3.49 (−0.50, 7.47)

BID (161)

71.51 (17.23)

 Endpoint

TID (159)

73.90 (19.86)

4.57 (1.66, 7.47)*

3.22 (−0.11, 6.56)

BID (153)

79.49 (16.00)

7.50 (4.58, 10.43)**

  1. Abbreviations: BID twice daily; CI confidence interval; LSM least-square mean; MMRM mixed model for repeated measures; SD standard deviation; TID thrice daily; TRIM-D Treatment Related Impact Measure-Diabetes; U-500R human regular U-500 insulin
  2. a p-values and 95 % CI of difference of LSM of change from baseline were from the MMRM model
  3. b p-values and 95 % CI of difference of LSM of change from baseline were from the ANCOVA model
  4. *p < .05; **p < .001
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