Table 2.
Between-group comparison of measures at baseline.
| pSMA group mean (SD) | Usual care group mean (SD) | P value | |
|---|---|---|---|
| Glycemic control and lipids | |||
| Hb1Ac-NGSP (%) | 7.92 (1.09) | 7.30 (0.44) | 0.117‡ |
| Hb1Ac-IFCC (mmol/mol) | 62.89 (11.90) | 56.25 (4.86) | 0.117‡ |
| Mean glucose (from CGMS) (mmol/L) | 11.56 (4.06) | 9.66 (2.01) | 0.392‡ |
| Time in range (from CGMS) (%) | 40.89 (22.84) | 60.71 (26.79) | 0.132† |
| Triglycerides (mmol/L) | 1.93 (0.63) | 1.71 (1.15) | 0.583‡ |
| Total Cholesterol (mmol/L) | 4.13 (0.61) | 3.95 (0.63) | 0.552† |
| Anthropometric measures and blood pressure | |||
| Height (cm) | 168.78 (5.17) | 166.19 (12.32) | 0.572† |
| Weight (kg) | 96.67 (19.91) | 81.67 (20.60) | 0.136† |
| Waist circumference (cm) | 112.39 (12.44) | 102.50 (9.80) | 0.091† |
| Hip circumference (cm) |
114.67 (17.71) | 108.63 (3.29) | 0.945‡ |
| BMI (kg/m2) | 34.08 (7.86) | 27.61 (2.99) | 0.167‡ |
| Waist/hip circumference ratio | 0.99 (0.08) | 0.94 (0.74) | 0.259† |
| Systolic BP (mm/Hg) | 139.11 (16.83) | 133.25 (11.00) | 0.416† |
| Diastolic BP (mm/Hg) | 84.99 (7.15) | 81.25 (4.65) | 0.239† |
| Beck Depression Inventory | 6.11 (4.83) | 9.63 (10.13) | 0.725‡ |
| State Anxiety Index | 33.11 (8.34) | 33.86 (10.67) | 0.877† |
| EQ5D5L | |||
| - anxiety | 1.44 (0.53) | 1.63 (0.92) | 1.000‡ |
| - mobility | 1.33 (0.50) | 1.38 (0.74) | 1.000‡ |
| - pain discomfort | 2.11 (0.93) | 1.88 (0.84) | 0.591† |
| - self-care | 1.00 (0.00) | 1.00 (0.00) | NA |
| - usual activity | 1.56 (0.53) | 1.50 (0.76) | 0.819‡ |
| - VAS | 74.00 (16.96) | 80.75 (15.66) | 0.409† |
| PAID | 23.06 (17.07) | 31.88 (30.66) | 0.468† |
| PROMIS29 | |||
| - pain intensity | 2.33 (2.55) | 2.00 (2.77) | 0.682‡ |
| - anxiety | 2.11 (1.69) | 3.25 (4.06) | 0.935‡ |
| - depression | 1.67 (2.24) | 2.38 (3.11) | 0.904‡ |
| - fatigue | 4.00 (4.03) | 4.88 (4.49) | 0.678† |
| - pain interference | 2.89 (3.59) | 2.00 (3.89) | 0.499‡ |
| - physical function | 1.78 (1.92) | 1.38 (1.77) | 0.636‡ |
| - sleep | 7.00 (1.12) | 7.00 (1.15) | 1.000† |
| - social | 11.67 (5.17) | 11.88 (3.64) | 0.867‡ |
†T2 test; ‡Mann-Whitney U test.
HbA1c, glycated haemoglobin; NGSP, National Glycohemoglobin Standardization Program; IFCC, International Federation of Clinical Chemistry.
EQ5DL, EuroQol-5D; PROMIS-29, Patient-Reported Outcomes Information System questionnaire; PAID, Problem Areas in Diabetes scale; BMI, Body Mass Index; BP, blood pressure; VAS, Visual Analogue Scale.