Table 3.
Relationship between TRIM-D overall and domain scores and the number of reduced injections from baseline to endpoint
| 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)* |
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
*p < .05; p-value and LSM of change from baseline were from an ANCOVA model