Table 1

Baseline demographics and clinical information by study phase and arm

VariablePhase I (n=37, intervention=22)Phase II (n=18)Phase I intervention versus phase II p value
InterventionControlP valueIntervention
n (%)n (%)n (%)
Sex (male)9 (40.9)8 (53.3)0.4709 (50.0)0.516
Work
 Domestic10 (45.5)6 (40.0)0.4707 (38.9)0.656
 Maintenance, construction3 (13.6)3 (20.0)5 (27.8)
 Food service, transportation5 (22.7)1 (6.7)1 (5.5)
 Unemployed/Unknown, other4 (18.2)5 (33.3)5 (27.8)
Legal status
 Documented14 (63.6)9 (60.0)0.82911 (61.1)0.398
 Undocumented8 (36.4)6 (40.0)7 (38.9)
Diabetes therapy
 None (lifestyle only)2 (9.1)1 (6.7)0.7982 (11.2)0.837
 Orals only18 (81.8)11 (73.3)0.5519 (50.0)0.033
 Insulin only0 (0.0)0 (0.0)1.01 (5.5)0.274
 Orals+insulin2 (9.1)3 (20.0)0.3546 (33.3)0.059
Hypoglycemia*1 (4.5)1 (6.7)0.7865 (22.8)0.042
Medication non-adherence†5 (25.0)3 (21.5)0.84811 (68.8)0.001
Prevention (n)‡
 B12 screening0 (0.0)0 (0.0)1.00 (0.0)1.0
 Statin therapy9 (40.9)10 (66.7)0.13112 (66.7)0.369
 Foot exam4 (18.2)0 (0.0)0.0850 (0.0)0.019
 Influenza vaccine3 (13.6)4 (26.7)0.3348 (44.0)0.174
 Eye exam8 (36.4)7 (46.7)0.5447 (38.9)0.425
 Urinary albumin20 (90.9)10 (66.7)0.0685 (27.8)<0.001
Mean (±SD)Mean (±SD)Mean (±SD)
Diabetes duration (years)8.4±6.711.5±10.70.28812.4±9.60.236
Age (years)52.5±7.857.7±9.20.0858.7±10.70.194
HbA1c (%)
 All7.61±1.27.66±1.30.9037.55±1.30.748
 Uncontrolled§8.33±1.08.39±1.20.9008.30±1.00.738
Blood pressure (mmHg)
 Systolic132.6±14.3137.9±21.00.369140.1±29.30.517
 Diastolic75.9±12.474.0±8.00.65181.1±11.60.458
BMI (kg/m2)32.3±5.730.2±4.00.21631.4±3.90.947
Weight (lbs)182.8±35.6170.9±23.50.285179.0±24.80.725
Cholesterol (mmol/L)
 Total179.1±40.5181.8±39.30.872171.9±46.60.293
 Triglycerides195.6±118.0121.9±51.80.101131.8±47.60.973
 HDL46.1±10.152.6±8.70.84651.6±8.50.905
 LDL96.8±32.9105.5±35.40.53794.5±31.10.352
  • *>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.