Baseine to 6-month clinical changes and comparisons of phase I, phase II, and phase I (intervention) versus phase II
| Variable | Phase I | Phase II | |||||||
| Baseline | 6 months | Mean change (95% CI) | Phase I p value* | Baseline | 6 months | Mean change (95% CI) | Phase II p value† | Phase I intervention versus phase II p value‡ | |
| Mean±SD or n (%) | Mean±SD or n (%) | ||||||||
| HbA1c (all) (%) | |||||||||
| Intervention | 7.61±1.2 | 6.99±0.7 | −0.73 (−1.1 to 0.3) | 0.016 | 7.55±1.3 | 6.77±0.7 | −0.78 (−1.3 to 0.3) | 0.006 | 0.60 |
| Control | 7.66±1.3 | 7.74±1.4 | 0.08 (−0.4 to 0.5) | ||||||
| HbA1c (uncontrolled)§ (%) | |||||||||
| Intervention | 8.33±1.0 | 7.30±0.7 | −1.03 (−1.5 to 0.5) | 0.011 | 8.30±1.0 | 6.96±0.6 | −1.34 (−2.0 to 0.7) | 0.001 | 0.43 |
| Control | 8.39±1.2 | 8.20±1.1 | 0.04 (−0.7 to 0.8) | ||||||
| Systolic BP (mmHg) | |||||||||
| Intervention | 132.6±14.3 | 124.4±8.8 | −10.84 (−18.3 to 3.4) | 0.50 | 140.1±29.3 | 133.5±14.3 | −7.18 (−19.1 to 4.7) | 0.23 | 0.80 |
| Control | 137.9±21.0 | 135.1±21.0 | −4.77 (−12.0 to 2.4) | ||||||
| Diastolic BP (mmHg) | |||||||||
| Intervention | 75.9±12.4 | 74.1±9.9 | −1.79 (−6.2 to 2.6) | 0.808 | 81.1±11.6 | 72.7±7.6 | −7.65 (−13.2 to 2.2) | 0.004 | 0.04 |
| Control | 74.0±8.0 | 73.0±7.9 | −0.97 (−6.3 to 4.3) | ||||||
| BMI (kg/m2) | |||||||||
| Intervention | 32.3±5.7 | 31.8±5.7 | −0.60 (−1.2 to 0.04) | 0.050 | 31.4±3.9 | 31.6±4.2 | −0.81 (−1.4 to 0.2) | 0.012 | 0.48 |
| Control | 30.2±4.0 | 30.5±3.6 | 0.28 (−0.3 to 0.8) | ||||||
| Weight (lbs) | |||||||||
| Intervention | 182.8±35.6 | 180.0±37.8 | −3.39 (−6.9 to 0.1) | 0.044 | 179.0±24.8 | 174.4±24.3 | −4.71 (−8.2 to 1.2) | 0.010 | 0.45 |
| Control | 170.9±23.5 | 173.4±21.8 | 1.71 (−1.6 to 5.0) | ||||||
| HbA1c target¶ | |||||||||
| Intervention | 9 (40.9) | 15 (68.2) | 0.3 (0.0 to 0.5) | 0.035 | 7 (38.9) | 12 (66.7) | 0.2 (0.0 to 0.5) | 0.100 | 0.60 |
| Control | 7 (46.7) | 6 (40.0) | −0.1 (−0.2 to 0.1) | ||||||
| Weight loss | |||||||||
| Intervention | N/A | 15 (68.2) | N/A | 0.094 | N/A | 14 (63.4) | N/A | N/A | 0.92 |
| Control | 6 (40.0) | N/A | |||||||
| Hypoglycemia** | |||||||||
| Intervention | 1 (4.5) | 0 (0.0) | −0.1 (−0.2 to 0.1) | 0.021 | 5 (27.8) | 0 (0.0) | −0.3 (−0.5 to 0.0) | N/A | 0.04 |
| Control | 1 (6.7) | 4 (26.7) | 0.2 (−0.1 to 0.5) | ||||||
| Prevention†† | |||||||||
| B12 screening | |||||||||
| Intervention | 0 (0.0) | 22 (1.0) | 1.0 (0.8 to 1.0) | <0.001 | 0 (0.0) | 18 (1.0) | 1.0 (0.8 to 1.0) | N/A | N/A |
| Control | 0 (0.0) | 0 (0.0) | 0 (−0.2 to 0.2) | ||||||
| Statin therapy | |||||||||
| Intervention | 9 (40.9) | 22 (1.0) | 0.6 (0.3 to 0.8) | 0.002 | 12 (66.7) | 18 (1.0) | 0.3 (0.1 to 0.6) | N/A | 0.10 |
| Control | 10 (66.7) | 11 (73.3) | 0.1 (−0.1 to 0.2) | ||||||
| Foot exam | |||||||||
| Intervention | 4 (18.2) | 22 (1.0) | 0.8 (0.6 to 0.9) | <0.001 | 0 (0.0) | 16 (88.9) | 0.9 (0.6 to 1.0) | N/A | 0.53 |
| Control | 0 (0.0) | 0 (0.0) | 0 (−0.2 to 0.2) | ||||||
| Influenza vaccine | |||||||||
| Intervention | 3 (13.6) | 19 (86.4) | 0.7 (0.4 to 0.8) | <0.001 | 8 (44.0) | 16 (88.9) | 0.4 (0.2 to 0.6) | 0.005 | 0.07 |
| Control | 4 (26.7) | 5 (33.3) | 0.1 (−0.2 to 0.3) | ||||||
| Eye exam | |||||||||
| Intervention | 8 (36.4) | 22 (1.0) | 0.6 (0.4 to 0.8) | <0.001 | 7 (38.9) | 16 (88.9) | 0.5 (0.2 to 0.7) | 0.007 | 0.51 |
| Control | 7 (46.7) | 7 (46.7) | 0 (−0.1 to 0.1) | ||||||
| Urinary albumin | |||||||||
| Intervention | 20 (90.9) | 22 (1.0) | 0.1 (−0.1 to 0.3) | 0.31 | 5 (27.8) | 17 (94.4) | 0.7 (0.4 to 0.8) | 0.0005 | 0.0001 |
| Control | 10 (66.7) | 9 (60.0) | −0.1 (−0.2 to 0.1) | ||||||
N/A: unable to calculate due to lack of variance for either baseline or 6-month scores.
*Baseline to 6-month changes, phase I between-group comparisons.
†Baseline to 6-month changes, phase II within-group comparisons.
‡Baseline to 6-month changes, phase I intervention versus phase II between-group comparisons.
§HbA1c >7.0% (>7.5% if >65 years of age) at baseline.25
¶HbA1c <7.0% (<7.5% if >65 years of age).25
**>3 episodes <80 mg/dL weekly during the last month.
††Guideline adherence as per American Diabetes Association, gathered at the following time points: baseline and month 6 (appropriately dosed statin; B12 screening), from baseline to 1 year prior and from month 6 to 1 year prior (annual screenings: retinal, foot, urine, influenza vaccination).25
Eligibility (eg, did not qualify for high-cost medication); patient (language barrier, self-titrate due to hypoglycemia); access (could not obtain refills at the pharmacy). Excludes individuals not on hypoglycemics: phase I intervention and phase II (n=2/arm); phase I control (n=1).
BMI, body mass index; BP, blood pressure; HbA1c, hemoglobin A1c.