Table 1

Baseline characteristics of patients and primary and secondary study outcomes

Group 1: UC (n = 56)Group 2: CO (n = 23)Group 3: CPP (n = 22)Group 4: CPDS (n = 62)
n% or mean ± SD*N% or mean ± SD*n% or mean ± SD*n% or mean ± SD*
Baseline characteristics
 Glycated hemoglobin (%)569.2 ± 1.7239.3 ± 1.8229.0 ± 1.8629.9 ± 2.1
  7.5–8.93562.51356.51359.12845.2
  ≥92137.51043.5940.93454.8
 Age (years)5653.2 ± 8.42352.8 ± 8.02253.7 ± 8.26252 ± 8.0
 Sex
  Male28501252.21045.53150
  Female28501147.81254.53150
 Race
  Black (non-Hispanic)2748.21043.51045.51727.4
  White (non-Hispanic)2646.41252.2940.93962.9
  Other35.414.3313.669.7
 Duration of diabetes diagnosis (years)569.0 ± 7.0237.7 ± 5.6226.8 ± 4.9628.2 ± 5.3
 Smoking status
  Current smokers1119.6626.1313.6812.9
  Former smokers11.814.300914.5
  Nonsmokers4478.61669.61986.44572.6
 Education
  High school/trade school or less1425730.4940.91930.6
  Some college or associates2035.71043.51045.52337.1
  Bachelors degree or higher2239.3626.1313.62032.3
 Depression (PHQ-9)
  Score564.7 ± 5.6235.2 ± 4.8225.5 ± 4.7625.5 ± 5.4
  Minimal to mild (0–9)4580.420871986.44877.4
  Moderate (10–14)58.914.329.1914.5
  Moderately severe (15–19)610.728.714.534.8
  Severe depression (20–27)00000023.2
 BMI
  BMI (kg/m2)5634.3 ± 6.32336.9 ± 7.52235.5 ± 10.36235.8 ± 7.1
  Underweight (16.5–18.4 kg/m2)11.80014.500
  Normal (18.5–24.9 kg/m2)000029.111.6
  Pre-obese (25–29.9 kg/m2)1119.6417.4731.81219.4
  Obese class 1 (30–34.9 kg/m2)2239.3626.114.51829
  Obese class 2 (35–39.9 kg/m2)1017.9521.7313.61727.4
  Obese class 3 (≥40 kg/m2)1221.4834.8836.41422.6
 Comorbidities
  Hypertension2951.81878.31359.14369.4
  Hypercholesterolemia3460.71147.81463.63658.1
  Coronary artery disease58.928.70058.1
  Microvascular complications, any814.314.329.169.7
Primary outcome, glycated hemoglobin (%)
  Baseline569.2 ± 1.7239.3 ± 1.8229.0 ± 1.8629.9 ± 2.1
  3 Months308.2 ± 1.2137.6 ± 1.297.5 ± 0.6417.8 ± 1.3
  6 Months278.6 ± 2.0157.6 ± 1.1117.6 ± 0.7307.5 ± 1.2
  9 Months238.2 ± 1.3137.7 ± 0.977.6 ± 0.8327.7 ± 2.1
  12 Months518.5 ± 1.8217.7 ± 1.0217.9 ± 1.4567.9 ± 1.7
  Change from baseline to 12 months (mean)−0.7−1.6−1.2−1.9
  Change from baseline to 12 months (95% CI)−1.1 to −0.3−2.3 to −1.0−1.8 to −0.5−2.3 to −1.5
Secondary outcomes, patient-reported outcomes
 Diabetes Distress Scale
  Baseline562.4 ± 0.9222.7 ± 0.9212.8 ± 0.7582.6 ± 0.9
  12 Months462.3 ± 0.9202.6 ± 0.9212.4 ± 0.8612.3 ± 0.8
  Change from baseline to 12 months (mean)−0.1−0.1−0.3−0.3
  Change from baseline to 12 months (95% CI)−0.4 to 0.1−0.4 to 0.3−0.7 to 0.0−0.5 to 0.0
 Diabetes symptom inventory
  Baseline5615.6 ± 5.62216.4 ± 5.72218.1 ± 6.46217 ± 5.6
  12 Months4614.6 ± 4.82115.5.0 ± 4.52116.2 ± 5.86216.7 ± 5.2
  Change from baseline to 12 months (mean)−2.3−2.8−4.3−1
  Change from baseline to 12 months (95% CI)−5.5 to 0.9−7.7 to 2.0−9.0 to 0.4−3.8 to 1.8
 Depression (PHQ-9)
  Baseline564.7 ± 5.6235.2 ± 4.8225.5 ± 4.7625.5 ± 5.4
  12 Months443.6 ± 4.1214.6 ± 5.0213.9 ± 5.3624.8 ± 4.8
  Change from baseline to 12 months (mean)−1.1−0.6−1.2−0.7
  Change from baseline to 12 months (95% CI)−3.2 to 3.0−2.7 to 1.4−3.3 to 0.8−1.9 to 0.5
Secondary outcomes, laboratory values
 Systolic blood pressure (mmHg)
  Baseline56130 ± 2223130 ± 1822133 ± 1462130 ± 14
  12 Months45133 ± 2021134 ± 2520134 ± 1651128 ± 19
  Change from baseline to 12 months (mean)+2+42−2
  Change from baseline to 12 months (95% CI)−3 to 7−4 to 11−6 to 10−6 to 3
 Diastolic blood pressure (mmHg)
  Baseline5678 ± 122379 ± 112279 ± 96279 ± 9
  12 Months4579 ± 132182 ± 112078 ± 95178 ± 10
  Change from baseline to 12 months (mean)+1+2−2−1
  Change from baseline to 12 months (95% CI)−2 to 4−2 to 7−6 to 3−4 to 2
 LDL (mg/dL)
  Baseline51102 ± 3623103 ± 2922103 ± 3355106 ± 33
  12 Months4291 ± 341994 ± 321594 ± 4745102 ± 32
  Change from baseline to 12 months (mean)−6−8−14−5
  Change baseline to 12 months (95% CI)−15 to 3−21 to 5−29 to 0−13 to 4
 HDL (mg/dL)
  Baseline5644 ± 112344 ± 112243 ± 115943 ± 11
  12 Months4445 ± 121642 ± 91544 ± 114845 ± 10
  Change from baseline to 12 months (mean)+100+2
  Change from baseline to 12 months (95% CI)−1 to 3−4 to 3−3 to 40 to 3
 Triglycerides (mg/dL)
  Baseline56185 ± 16723172 ± 10022164 ± 10559187 ± 145
  12 Months44169 ± 12416113 ± 4215151 ± 7448139 ± 91
  Change baseline to 12 months (mean)−23−53−12−31
  Change baseline to 12 months (95% CI)−58 to 12−110 to 4−71 to 47−65 to 3
 Total cholesterol (mg/dL)
  Baseline56182 ± 5123181 ± 3522177 ± 4259184 ± 41
  12 Months44168 ± 4016151 ± 3415168 ± 5248174 ± 42
  Change baseline to 12 months (mean)−11−24−14−9
  Change baseline to 12 months (95% CI)−22 to 1−43 to −5−35 to 5−21 to 2
  • n = 163.

  • *Unless otherwise indicated.

  • †Primary outcome, glycated hemoglobin change over 12 months; group 4 (P < 0.001) and group 2 (P = 0.003) have significantly larger changes than group 1. No other outcomes are significant.

  • ‡Mean change and CI values are from the mixed-effects model.