Baseline demographics and clinical information by study phase and arm
| Variable | Phase I (n=37, intervention=22) | Phase II (n=18) | Phase I intervention versus phase II p value | ||
| Intervention | Control | P value | Intervention | ||
| n (%) | n (%) | n (%) | |||
| Sex (male) | 9 (40.9) | 8 (53.3) | 0.470 | 9 (50.0) | 0.516 |
| Work | |||||
| Domestic | 10 (45.5) | 6 (40.0) | 0.470 | 7 (38.9) | 0.656 |
| Maintenance, construction | 3 (13.6) | 3 (20.0) | 5 (27.8) | ||
| Food service, transportation | 5 (22.7) | 1 (6.7) | 1 (5.5) | ||
| Unemployed/Unknown, other | 4 (18.2) | 5 (33.3) | 5 (27.8) | ||
| Legal status | |||||
| Documented | 14 (63.6) | 9 (60.0) | 0.829 | 11 (61.1) | 0.398 |
| Undocumented | 8 (36.4) | 6 (40.0) | 7 (38.9) | ||
| Diabetes therapy | |||||
| None (lifestyle only) | 2 (9.1) | 1 (6.7) | 0.798 | 2 (11.2) | 0.837 |
| Orals only | 18 (81.8) | 11 (73.3) | 0.551 | 9 (50.0) | 0.033 |
| Insulin only | 0 (0.0) | 0 (0.0) | 1.0 | 1 (5.5) | 0.274 |
| Orals+insulin | 2 (9.1) | 3 (20.0) | 0.354 | 6 (33.3) | 0.059 |
| Hypoglycemia* | 1 (4.5) | 1 (6.7) | 0.786 | 5 (22.8) | 0.042 |
| Medication non-adherence† | 5 (25.0) | 3 (21.5) | 0.848 | 11 (68.8) | 0.001 |
| Prevention (n)‡ | |||||
| B12 screening | 0 (0.0) | 0 (0.0) | 1.0 | 0 (0.0) | 1.0 |
| Statin therapy | 9 (40.9) | 10 (66.7) | 0.131 | 12 (66.7) | 0.369 |
| Foot exam | 4 (18.2) | 0 (0.0) | 0.085 | 0 (0.0) | 0.019 |
| Influenza vaccine | 3 (13.6) | 4 (26.7) | 0.334 | 8 (44.0) | 0.174 |
| Eye exam | 8 (36.4) | 7 (46.7) | 0.544 | 7 (38.9) | 0.425 |
| Urinary albumin | 20 (90.9) | 10 (66.7) | 0.068 | 5 (27.8) | <0.001 |
| Mean (±SD) | Mean (±SD) | Mean (±SD) | |||
| Diabetes duration (years) | 8.4±6.7 | 11.5±10.7 | 0.288 | 12.4±9.6 | 0.236 |
| Age (years) | 52.5±7.8 | 57.7±9.2 | 0.08 | 58.7±10.7 | 0.194 |
| HbA1c (%) | |||||
| All | 7.61±1.2 | 7.66±1.3 | 0.903 | 7.55±1.3 | 0.748 |
| Uncontrolled§ | 8.33±1.0 | 8.39±1.2 | 0.900 | 8.30±1.0 | 0.738 |
| Blood pressure (mmHg) | |||||
| Systolic | 132.6±14.3 | 137.9±21.0 | 0.369 | 140.1±29.3 | 0.517 |
| Diastolic | 75.9±12.4 | 74.0±8.0 | 0.651 | 81.1±11.6 | 0.458 |
| BMI (kg/m2) | 32.3±5.7 | 30.2±4.0 | 0.216 | 31.4±3.9 | 0.947 |
| Weight (lbs) | 182.8±35.6 | 170.9±23.5 | 0.285 | 179.0±24.8 | 0.725 |
| Cholesterol (mmol/L) | |||||
| Total | 179.1±40.5 | 181.8±39.3 | 0.872 | 171.9±46.6 | 0.293 |
| Triglycerides | 195.6±118.0 | 121.9±51.8 | 0.101 | 131.8±47.6 | 0.973 |
| HDL | 46.1±10.1 | 52.6±8.7 | 0.846 | 51.6±8.5 | 0.905 |
| LDL | 96.8±32.9 | 105.5±35.4 | 0.537 | 94.5±31.1 | 0.352 |
*>3 episodes <80 mg/dL weekly during the last month.
†Excludes individuals not receiving hypoglycemics: phase I intervention and phase II (n=2/arm); phase I control (n=1).
‡Guideline adherence as per American Diabetes Association. Data were gathered by chart review at the following time points: baseline (appropriately dosed statin; B12 screening), baseline to 1 year prior (annual screenings: retinal, foot, urine, influenza vaccination).25
§HbA1c >7% (or >7.5% if 65 years or older).
BMI, body mass index; HbA1c, hemoglobin A1c; HDL, high-density lipoprotein; LDL, low-density lipoprotein.