TABLE 2.
Outcome measures in the same group: baseline vs week 4 and baseline vs week 16 in control 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 (%) | 10.36 (0.88) | 9.7 (0.9) | 9.54 (1.11) | −0.38 (−0.96–0.19) | .1459 | −0.83 (−2.05–0.40) | .1558 |
| Patients with A1c < 7% | 0 (0%) | 0 (0%) | 0 (0%) | 0 | 0 | ||
| Weight (pounds) | 225.98 (52.82) | 236.1 (54.77) | 225 (47.98) | 1.13 (−1.08–3.34) | .2444 | −0.98 (−9.25–7.3) | .7885 |
| Systolic blood pressure (mmHg) | 121.5 (16.87) | 117.67 (16.51) | 136.5 (20.04) | −5 (−13.81–3.81) | .2042 | 15 (2.56–27.44) | .0247 |
| Diastolic blood pressure (mmHg) | 76 (10.35) | 71.33 (10.01) | 78.25 (8.01) | −5 (−11.26–1.26) | .0953 | 2.25 | .2033 |
| eGFR (mL/min/1.73m2) | 85.5 (6.63) | 82.17 (12.86) | 84.13 (10.11) | −1.5 | .7874 | −1.38 | .4227 |
| Serum creatinine (mg/dl) | 0.78 (0.18) | 0.85 (0.26) | 0.81 (0.22) | 0.03 (−0.09–0.16) | .5301 | 0.04 (−0.04–0.11) | .2849 |
| LDL cholesterol (mg/dl) | 84.5 (27.59) | 85.67 (38.24) | 105.5 (33.88) | 0.33 (−11.1–11.77) | .9432 | 21 (−9.9–51.9) | .152 |
| HDL cholesterol (mg/dl) | 43.25 (8.15) | 43.5 (10.15) | 43.25 (7.74) | −1.83 (−6.5–2.83) | .3588 | 0 (−7.11–7.11) | 1 |
| Triglyceride (mg/dl) | 186 (83.06) | 175.17 (92.19) | 176.13 (35.93) | 10.17 (−33.43–53.77) | .575 | −9.88 (−67.57–47.82) | .6977 |
| Total cholesterol (mg/dl) | 165.5 (35.09) | 163.83 (42.23) | 183.88 (39.38) | −0.67 (−14.02–12.68) | .9029 | 18.38 (−22.38–59.13) | .3217 |
| Haemoglobin (g/dl) | 13.78 (2.08) | 13.92 (1.42) | 14.25 (1.03) | 0.45 | .7874 | 0.48 (−0.79–1.74) | .4025 |
| Serum sodium (mmol/L) | 137.13 (2.36) | 136.67 (2.25) | 136.88 (3.14) | −0.67 (−2.38–1.05) | .3632 | −0.25 (−2.43–1.93) | .7939 |
| Serum potassium (mmol/L) | 4.25 (0.52) | 4.43 (0.69) | 4.36 (0.39) | 0.08 (−0.56–0.73) | .7545 | 0.11 (−0.15–0.37) | .3442 |
| Serum bicarbonate (mmol/L) | 37.75 (27.11) | 41.83 (31.8) | 37.13 (26.36) | 0.17 | 1 | −0.63 | .4403 |
| Total daily insulin dose (units) | 97.63 (54.04) | 111.67 (33.97) | 107.88 (45.82) | −1.83 (−45.55–41.88) | .9183 | 10.25 (−18.93–39.43) | .4336 |
| Metformin dose (mg) | 1750 (462.91) | 1750 (462.91) | 1875 (353.55) | 0 | – | 125 | 1 |
| DM‐SAT Total Score | 51.88 (16.92) | 61.83 (14.57) | 56.5 (15.45) | 9.67 (3.14–16.19) | .0125 | 4.63 (−0.83–10.08) | .085 |
| DM‐SAT Subscale Score Wellbeing | 53.75 (21.19) | 62.83 (23.15) | 60.75 (14.3) | 11.17 (−13.29–35.62) | .2933 | 7 | .7518 |
| DM‐SAT Subscale Score Medical Control | 40.12 (24.8) | 55 (18.79) | 48 (17.5) | 15.5 (1.27–29.73) | .038 | 7.88 (−4.28–20.03) | .1695 |
| DM‐SAT Score Lifestyle | 48.75 (13.6) | 57 (23.42) | 55.5 (15.52) | 7 (−6.06–20.06) | .2266 | 6.75 (−1.19–14.69) | .0843 |
| DM‐SAT Subscale Score Convenience | 61 (20.67) | 70.67 (15) | 59.5 (19.53) | 8.67 (−9.23–26.56) | .2682 | −1.5 (−10.25–7.25) | .6972 |