Table 3 Secondary outcomes for Intent-to-Treat population

SOC + PMDC

SOC

OR (95% CI)

P-Value

HbA1c < 8.0 at 6 Months

(21 / 37) = 56.76%

(10 / 34) = 29.41%

3.15 (1.18, 8.42)

0.0222

HbA1c < 8.0 at 12 Months

(16 / 30) = 53.33%

(11 / 31) = 35.48%

2.08 (0.74, 5.81)

0.1630

Lipid Panel at 6 Months

(26 / 44) = 59.09%

(24 / 42) = 57.14%

1.08 (0.46, 2.55)

0.8548

Lipid Panel at 12 Months

(22 / 44) = 50.00%

(20 / 41) = 48.78%

1.05 (0.45, 2.46)

0.9105

Statin Therapy at 6 Months

(35 / 42) = 83.33%

(37 / 42) = 88.10%

0.68 (0.20, 2.33)

0.5346

Statin Therapy at 12 Months

(32 / 40) = 80.00%

(37 / 40) = 92.50%

0.32 (0.08, 1.33)

0.1172

Blood Pressure SBP < 140 and DBP < 90 at 6 Months

(20 / 40) = 50.00%

(27 / 39) = 69.23%

0.44 (0.18, 1.12)

0.0841

Blood Pressure SBP < 140 and DBP < 90 at 12 Months

(21 / 32) = 65.63%

(26 / 31) = 83.87%

0.37 (0.11, 1.22)

0.1027

Screening for Retinopathy at 6 Months

(35 / 44) = 79.55%

(35 / 42) = 83.33%

0.78 (0.26, 2.32)

0.6523

Screening for Retinopathy at 12 Months

(25 / 44) = 56.82%

(25 / 42) = 59.52%

0.90 (0.38, 2.11)

0.7993

Screening for Neuropathy at 6 Months

(38 / 44) = 86.36%

(39 / 42) = 92.86%

0.49 (0.11, 2.09)

0.3331

Screening for Neuropathy at 12 Months

(29 / 44) = 65.91%

(30 / 42) = 71.43%

0.77 (0.31, 1.93)

0.5818

Screening for Nephropathy at 6 Months

(34 / 44) = 77.27%

(35 / 42) = 83.33%

0.68 (0.23, 1.99)

0.4820

Screening for Nephropathy at 12 Months

(26 / 44) = 59.09%

(30 / 42) = 71.43%

0.58 (0.24, 1.42)

0.2321

Influenza vaccine at 6 Months

(24 / 44) = 54.55%

(25 / 42) = 59.52%

0.82 (0.35, 1.92)

0.6413

Influenza vaccine at 12 Months

(20 / 44) = 45.45%

(21 / 42) = 50.00%

0.83 (0.36, 1.95)

0.6732

PPSV23 vaccine at 6 Months

(27 / 44) = 61.36%

(33 / 42) = 78.57%

0.43 (0.17, 1.13)

0.0859

PPSV23 vaccine at 12 Months

(27 / 44) = 61.36%

(31 / 42) = 73.81%

0.56 (0.23, 1.41)

0.2205

SOC + PMDC

SOC

IRR (95% CI)

P-Value

Number of ER Visits at 6 Months

(n = 44) 0.68 (1.12)

(n = 42) 0.62 (0.99)

1.10 (0.55, 2.21)

0.7860

Number of ER Visits at 12 Months

(n = 44) 1.09 (1.65)

(n = 42) 1.05 (1.29)

1.04 (0.57, 1.89)

0.8944

Number of ER Visits for Hypo/Hyperglycemia at 6 Months

(n = 44) 0.00 (0.00)

(n = 42) 0.10 (0.37)

0.01 (0.01, 999)

0.9999

Number of ER Visits for Hypo/Hyperglycemia at 12 Months

(n = 44) 0.02 (0.15)

(n = 42) 0.12 (0.40)

0.19 (0.02, 1.84)

0.1521

Number of Inpatient Visits at 6 Months

(n = 44) 0.48 (0.85)

(n = 42) 0.38 (1.08)

1.25 (0.50, 3.16)

0.6335

Number of Inpatient Visits at 12 Months

(n = 44) 0.73 (1.13)

(n = 42) 0.71 (1.94)

1.02 (0.48, 2.18)

0.9630

Number of Outpatient Visits at 6 Months

(n = 44) 5.07 (2.97)

(n = 42) 4.55 (2.81)

1.11 (0.87, 1.43)

0.3972

Number of Outpatient Visits at 12 Months

(n = 44) 7.55 (4.25)

(n = 42) 7.60 (5.69)

0.99 (0.75, 1.31)

0.9626