Table 2.
Responsiveness of the TRIM-Diabetes and TRIM-Diabetes Device items and domains
| Baseline | Week 12 | Change score | ||||
|---|---|---|---|---|---|---|
| Abbreviated item content | Mean (SD) | Mean (SD) | Mean (SD) | t-stat | Effect sizea | ITSQ overall summary (Pearson r) |
| TRIM-Diabetes TOTAL SCORE (n = 226) | 65.9 (15.0) | 74.2 (13.0) | 8.3 (13.5) | 9.2*** | 0.55 | 0.72** |
| Treatment Burden (n = 225) | 54.7 (22.1) | 73.3 (19.2) | 18.6 (25.0) | 11.1*** | 0.84 | 0.58** |
| The ease and convenience of your medication | 3.4 (0.8) | 4.0 (0.9) | 0.6 (1.1) | 8.7*** | 0.75 | 0.53** |
| Carry your medication and supplies around with you | 2.8 (1.2) | 3.7 (1.0) | 1.0 (1.4) | 10.2*** | 0.75 | 0.48** |
| Store your medication | 3.2 (1.2) | 4.0 (1.0) | 0.8 (1.4) | 8.1*** | 0.67 | 0.44** |
| Take your medication at the right time | 3.3 (1.1) | 3.9 (0.9) | 0.65 (1.3) | 7.5*** | 0.55 | 0.44** |
| Prepare your medication for use | 3.4 (1.1) | 4.2 (0.9) | 0.8 (1.4) | 9.0*** | 0.73 | 0.51** |
| Monitor your blood sugar as often as necessary | 3.1 (1.1) | 3.7 (1.0) | 0.6 (1.2) | 7.9*** | 0.55 | 0.32** |
| Daily Life (n = 226) | 68.4 (18.5) | 75.6 (16.8) | 7.2 (17.9) | 6.0*** | 0.39 | 0.58** |
| Meal time planning | 3.6 (0.9) | 4.0 (0.9) | 0.4 (1.0) | 6.1*** | 0.44 | 0.45** |
| Social activities | 3.5 (1.1) | 4.0 (0.9) | 0.5 (1.1) | 6.3*** | 0.45 | 0.45** |
| Do you have to limit your daily activities? | 4.0 (0.8) | 4.2 (0.8) | 0.2 (1.0) | 2.5* | 0.25 | 0.39** |
| Do you accomplish less than you would like to? | 3.5 (1.1) | 3.8 (1.0) | 0.2 (1.1) | 3.3** | 0.27 | 0.37** |
| Do you feel tension in your relationships with friends or family? | 4.1 (0.9) | 4.3 (0.9) | 0.15 (1.0) | 2.4* | 0.22 | 0.39** |
| Diabetes Management (n = 226) | 52.5 (19.2) | 61.7 (17.9) | 9.3 (19.2) | 7.2*** | 0.48 | 0.43** |
| Help you control your diabetes | 3.3 (0.9) | 3.7 (0.8) | 0.35 (1.0) | 5.1*** | 0.44 | 0.38** |
| Help you avoid high blood sugar (hyperglycemia) | 3.2 (1.0) | 3.6 (0.9) | 0.4 (1.2) | 5.0*** | 0.40 | 0.34** |
| Help you avoid low blood sugar (hypoglycemia) | 3.4 (0.9) | 3.8 (0.8) | 0.35 (0.9) | 5.7*** | 0.44 | 0.31** |
| Help you manage your weight | 2.7 (1.2) | 3.0 (1.1) | 0.35 (1.1) | 4.8*** | 0.30 | 0.22** |
| Help you prevent feeling tired or a lack of energy | 2.8 (1.0) | 3.3 (1.1) | 0.4 (1.0) | 6.3*** | 0.50 | 0.31** |
| Compliance (n = 226) | 75.7 (17.0) | 79.3 (15.0) | 3.7 (15.1) | 3.7*** | 0.22 | 0.30** |
| Miss a dose | 4.3 (0.7) | 4.4 (0.7) | 0.1 (0.7) | 2.5** | 0.14 | 0.21** |
| Delay or postpone taking your medication | 3.9 (0.9) | 4.1 (0.8) | 0.2 (0.8) | 3.3** | 0.22 | 0.14* |
| Take your medication at a different time than prescribed | 3.9 (0.9) | 4.1 (0.8) | 0.1 (1.0) | 2.2* | 0.22 | 0.23** |
| Worry that you forgot to take/or missed your last dose of medication | 4.0 (0.9) | 4.2 (0.8) | 0.2 (1.0) | 2.5* | 0.22 | 0.25** |
| Psychological Health (n = 221) | 76.2 (18.6) | 79.2 (17.2) | 3.1 (16.9) | 2.7** | 0.17 | 0.59** |
| Depressed | 4.3 (0.9) | 4.4 (0.9) | 0.1 (0.8) | 1.5 (P = 0.137) | 0.11 | 0.36** |
| Worried that the medication is not helping to slow down or prevent complications from my diabetes | 3.9 (1.0) | 4.0 (1.0) | 0.1 (1.1) | 0.7 (P = 0.494) | 0.10 | 0.44** |
| Nervous or anxious | 4.2 (0.8) | 4.4 (0.8) | 0.1 (0.9) | 2.2* | 0.25 | 0.41** |
| Worried about my blood sugar control | 3.4 (1.1) | 3.5 (1.0) | 0.1 (1.1) | 1.7 (P = 0.084) | 0.09 | 0.47** |
| Unhealthy | 4.1 (1.0) | 4.1 (1.0) | 0.05 (1.0) | 0.8 (P = 0.434) | 0.00 | 0.40** |
| Angry | 4.3 (1.0) | 4.4 (0.9) | 0.05 (0.9) | 0.8 (P = 0.417) | 0.10 | 0.35** |
| Worried about side effects from my medication | 3.9 (1.1) | 4.2 (1.0) | 0.25 (1.1) | 3.2** | 0.27 | 0.38** |
| Feel embarrassed or awkward when taking your medication | 4.3 (0.9) | 4.5 (0.7) | 0.2 (0.9) | 3.8*** | 0.22 | 0.51** |
| TRIM-Diabetes Device TOTAL SCORE (n = 214) | 72.2 (17.1) | 81.8 (15.2) | 9.6 (20.6) | 6.9*** | 0.56 | 0.68** |
| Device Function (n = 214) | 71.6 (18.5) | 81.0 (17.0) | 9.4 (22.7) | 6.0*** | 0.51 | 0.56** |
| Learn how to use your device | 3.9 (0.9) | 4.4 (0.8) | 0.6 (1.1) | 7.3*** | 0.56 | 0.47** |
| Keep your device functioning properly | 4.1 (0.8) | 4.4 (0.8) | 0.3 (1.1) | 4.2*** | 0.38 | 0.42** |
| Adjust your medication for small dose changes | 3.8 (1.0) | 4.4 (0.9) | 0.6 (1.4) | 6.4*** | 0.60 | 0.51** |
| That your device delivers the correct, full dose of your medication | 3.7 (1.0) | 3.8 (1.1) | 0.2 (1.4) | 1.7 (P = 0.094) | 0.10 | 0.34** |
| That you are using the device properly | 4.0 (0.9) | 4.2 (1.0) | 0.2 (1.2) | 2.8** | 0.22 | 0.30** |
| Device Bother (n = 214) | 73.2 (23.3) | 83.3 (19.5) | 10.1 (26.1) | 5.6*** | 0.43 | 0.64** |
| Size of your device | 4.3 (0.9) | 4.4 (0.9) | 0.1 (1.2) | 1.8 (P = 0.076) | 0.11 | 0.40** |
| Physical discomfort related to using your device | 3.9 (1.0) | 4.4 (0.9) | 0.5 (1.2) | 5.5*** | 0.50 | 0.55** |
| Using your device in public | 3.6 (1.4) | 4.2 (1.1) | 0.6 (1.4) | 6.1*** | 0.43 | 0.57** |
TRIM Treatment Related Impact Measure, SD Standard deviation, ITSQ Insulin treatment satisfaction questionnaire
aEffect size = mean change in score divided by the standard deviation of mean baseline score
*** Correlation is significant at the 0.001 level (2-tailed)
** Correlation is significant at the 0.01 level (2-tailed)
* Correlation is significant at the 0.05 level (2-tailed)