TABLE 3.
Outcome measures in the same group: baseline vs week 4 and baseline vs week 16 in intervention group
| Variable | Baseline Mean (SD) | Week 4 Mean (SD) | Week 16 Mean (SD) | Difference Week 4—Baseline (CI 95%) | p‐value | Difference Week 16—Baseline (CI 95%) | p‐value |
|---|---|---|---|---|---|---|---|
| Haemoglobin A1c (%) | 9.69 (1.07) | 8.25 (0.78) | 7.31 (0.81) | −1.44 (−1.94–−0.94) | <.001 | −2.38 (−2.93–−1.83) | <.001 |
| Patients with A1c < 7% | 0 (0%) | 1 (10%) | 4 (40%) | 1 | 4 | ||
| Weight (pounds) | 212.68 (39.06) | 204.72 (35.61) | 196.3 (36.53) | −7.96 (−11.6–−4.32) | <.001 | −16.38 (−25.63–−7.13) | .003 |
| Systolic blood pressure (mmHg) | 127.2 (17.25) | 116.1 (20.82) | 111.2 (16.01) | −11.1 | .0248 | −16 (−33.37–1.37) | .0669 |
| Diastolic blood pressure (mmHg) | 77 (7.9) | 72.8 (7.22) | 69.8 (9.61) | −4.2 (−9.17–0.77) | .0880 | −7.2 (−18.24–3.84) | .1742 |
| eGFR (mL/min/1.73m2) | 85.4 (8.53) | 80.3 (15) | 81.1 (14.93) | −5.1 | .0579 | −4.3 | .2012 |
| Serum creatinine (mg/dl) | 0.71 (0.21) | 0.77 (0.33) | 0.75 (0.35) | 0.06 (−0.04–0.16) | .2172 | 0.04 (−0.08–0.16) | .462 |
| LDL cholesterol (mg/dl) | 72.4 (24.33) | 47.9 (22.46) | 56.7 (30.15) | −24.5 (−36.33–12.67) | .0011 | −15.7 (−30.29–−1.11) | .0378 |
| HDL cholesterol (mg/dl) | 40.6 (10.91) | 39.5 (9.72) | 39 (10.22) | −1.1 (−3.27–1.07) | .2813 | −1.6 (−5.8–2.6) | .4113 |
| Triglyceride (mg/dl) | 133.4 (55.36) | 115.4 (56.17) | 126.8 (50.13) | −18 (−41.52–5.52) | .1174 | −6.6 (−41.08–27.88) | .6752 |
| Total cholesterol (mg/dl) | 139.7 (30.79) | 110.4 (28.14) | 121.2 (33.63) | −29.3 (−44.61–−13.99) | .0019 | −18.5 (−35.79–−1.21) | .0386 |
| Haemoglobin (g/dl) | 14.21 (1.68) | 14.79 (1.53) | 14.29 (2.01) | 0.58 (0.21–0.95) | .0062 | 0.08 | .9527 |
| Serum sodium (mmol/L) | 137.6 (2.59) | 138.4 (2.41) | 137.7 (1.7) | 0.8 (−0.81–2.41) | .2901 | 0.1 (−1.85–2.05) | .9102 |
| Serum potassium (mmol/L) | 4.35 (0.29) | 4.26 (0.31) | 4.25 (0.4) | −0.09 | .4768 | −0.1 | .7211 |
| Serum bicarbonate (mmol/L) | 26.4 (1.78) | 26.2 (3.12) | 25.6 (2.59) | −0.2 (−1.74–1.34) | .7753 | −0.8 (−2.01–0.41) | .1679 |
| Total daily insulin dose (units) | 107.7 (64.14) | 55.1 (36.16) | 50.4 (38.03) | −52.6 (−77.31–−27.89) | <.001 | −57.3 (−81.18–−33.42) | <.001 |
| Metformin dose (mg) | 1500 (577.35) | 1750 (424.92) | 1750 (424.92) | 250 | .3711 | 250 | .3711 |
| DM‐SAT Total Score | 43.7 (19.45) | 80.33 (12.43) | 89 (8.59) | 34.78 (15.46–54.1) | .003 | 45.3 (28.19–62.41) | <.001 |
| DM‐SAT Subscale Score Wellbeing | 45.5 (19.84) | 83 (11.31) | 92.7 (5.7) | 36.56 | .0078 | 47.2 | .0091 |
| DM‐SAT Subscale Score Medical Control | 42.5 (20.71) | 81.33 (12.73) | 93.8 (5.05) | 36.67 (16.03–57.3) | .0034 | 51.3 (35.75–66.85) | <.001 |
| DM‐SAT Score Lifestyle | 45.6 (22.58) | 76.89 (14.94) | 81.4 (16.06) | 29.11 | .0273 | 35.8 (13.71–57.89) | .0052 |
| DM‐SAT Subscale Score Convenience | 45.7 (19.6) | 83.11 (15.69) | 80.98 (26.18) | 35 (14.37–55.63) | .0045 | 35.28 | .019 |