TABLE 1.
Baseline Demographic and Clinical Characteristics for the Overall Sample and Study Subgroups
| Characteristic | Overall | With Available 6-Month A1c | With Poor Glycemic Control (A1c ≥ 7%) at 6 Months | First Intensified by Increased Basal Insulin Dose | In Poor Glycemic Control (A1c ≥ 7%) After 6 Months of Increased Basal Insulin Dose | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| N = 23,260 | n = 427 | n = 346 | n = 231 | n = 151 | ||||||
| n | % | n | % | n | % | n | % | n | % | |
| Age (years) | ||||||||||
| Mean ± SD | 53.6 ± 8.0 | 53.9 ± 8.3 | 54.1 ± 8.0 | 54.7 ± 7.9 | 54.3 ± 7.7 | |||||
| Median | 55 | 55 | 55 | 55 | 55 | |||||
| Male gender | 13,603 | (58.5) | 253 | (59.3) | 204 | (59.0) | 139 | (60.2) | 96 | (63.6) |
| Ethnicity | 2,798 | (12.0) | 427 | (100.0) | 346 | (100.0) | 231 | (100.0) | 151 | (100.0) |
| Caucasian | 1,370 | (5.9) | 335 | (78.5) | 271 | (78.3) | 185 | (80.1) | 119 | (78.8) |
| Black | 91 | (0.4) | 19 | (4.4) | 14 | (4.0) | 7 | (3.0) | 6 | (4.0) |
| Asian | 17 | (0.1) | 5 | (1.2) | 5 | (1.4) | 0 | (0.0) | 0 | (0.0) |
| Other/unknown | 21,782 | (93.6) | 68 | (15.9) | 56 | (16.2) | 39 | (16.9) | 26 | (17.2) |
| Payer type | ||||||||||
| Commercial | 13,902 | (59.8) | 197 | (46.1) | 158 | (45.7) | 110 | (47.6) | 74 | (49.0) |
| Medicaid | 915 | (3.9) | 4 | (0.9) | 3 | (0.9) | 1 | (0.4) | 1 | (0.7) |
| Medicare risk | 408 | (1.8) | 23 | (5.4) | 19 | (5.5) | 13 | (5.6) | 5 | (3.3) |
| Self-insured | 7,953 | (34.2) | 203 | (47.5) | 166 | (48.0) | 107 | (46.3) | 71 | (47.0) |
| Unknown | 82 | (0.4) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) |
| Region | ||||||||||
| Northeast | 4,921 | (21.2) | 154 | (36.1) | 121 | (35.0) | 82 | (35.5) | 53 | (35.1) |
| Midwest | 6,818 | (29.3) | 107 | (25.1) | 87 | (25.1) | 61 | (26.4) | 46 | (30.5) |
| South | 8,715 | (37.5) | 119 | (27.9) | 96 | (27.7) | 61 | (26.4) | 39 | (25.8) |
| West | 2,806 | (12.1) | 47 | (11.0) | 42 | (12.1) | 27 | (11.7) | 13 | (8.6) |
| Basal insulin dose of the index prescription | ||||||||||
| Mean± SD | 35.7 ± 96.4 | 29.6 ± 38.8 | 29.2 ± 41.4 | 25.8 ± 12.3 | 25.3 ± 11.3 | |||||
| Median | 24 | 24 | 23 | 23 | 23 | |||||
| Physician specialty | ||||||||||
| Endocrinologist | 703 | (3.0) | 16 | (3.7) | 8 | (2.3) | 5 | (2.2) | 4 | (2.6) |
| Primary care (GP/FM/IM) | 9,802 | (42.1) | 146 | (34.2) | 118 | (34.1) | 78 | (33.8) | 51 | (33.8) |
| Hospitalist | 2,619 | (11.3) | 67 | (15.7) | 54 | (15.6) | 40 | (17.3) | 24 | (15.9) |
| Other | 10,136 | (43.6) | 198 | (46.4) | 166 | (48.0) | 108 | (46.8) | 72 | (47.7) |
| CCIa | ||||||||||
| Mean ± SD | 0.4 ± (1.0) | 0.4 ± (0.9) | 0.3 ± (0.8) | 0.4 ± (0.9) | 0.4 ± (0.9) | |||||
| Median | 0 | 0 | 0 | 0 | 0 | |||||
| DCSI | ||||||||||
| Mean ± SD | 0.3 ± (0.9) | 0.3 ± (0.9) | 0.3 ± (0.8) | 0.3 ± (0.9) | 0.2 ± (0.7) | |||||
| Median | 0 | 0 | 0 | 0 | 0 | |||||
| Frequent (≥ 10%) comorbidities of interest | ||||||||||
| Cardiovascular diseaseb | 16,006 | (68.8) | 301 | (70.5) | 246 | (71.1) | 161 | (69.7) | 113 | (74.8) |
| Coronary artery disease | 2,386 | (10.3) | 50 | (11.7) | 39 | (11.3) | 24 | (10.4) | 17 | (11.3) |
| Depression | 1,807 | (7.8) | 43 | (10.1) | 36 | (10.4) | 21 | (9.1) | 12 | (7.9) |
| Dyslipidemia | 15,240 | (65.5) | 311 | (72.8) | 255 | (73.7) | 171 | (74.0) | 115 | (76.2) |
| Hypertension | 15,380 | (66.1) | 289 | (67.7) | 236 | (68.2) | 154 | (66.7) | 109 | (72.2) |
| Frequent (≥ 10%) AHA classes | ||||||||||
| Biguanides | 14,901 | (64.1) | 289 | (67.7) | 237 | (68.5) | 157 | (68.0) | 106 | (70.2) |
| DPP-4 inhibitors | 5,757 | (24.8) | 147 | (34.4) | 127 | (36.7) | 82 | (35.5) | 63 | (41.7) |
| Fixed-dose combination orals | 4,090 | (17.6) | 77 | (18.0) | 69 | (19.9) | 48 | (20.8) | 30 | (19.9) |
| Sulfonylureas | 12,457 | (53.6) | 247 | (57.8) | 213 | (61.6) | 140 | (60.6) | 89 | (58.9) |
| TZDs | 3,517 | (15.1) | 68 | (15.9) | 53 | (15.3) | 35 | (15.2) | 26 | (17.2) |
| AHA classes used per patient | ||||||||||
| Mean ± SD | 1.8 ± (1.0) | 2.0 ± (1.0) | 2.1 ± (1.0) | 2.0 ± (0.9) | 2.1 ± (0.9) | |||||
| Median | 2 | 2 | 2 | 2 | 2 | |||||
| A1c (mmol/mol %) | 234 | (1.0) | 147 | (34.4) | 118 | (34.1) | 78 | (33.8) | 55 | (36.4) |
| 6.0-6.9 | 6 | (0.0) | 4 | (0.9) | 2 | (0.6) | 1 | (0.4) | 1 | (0.7) |
| 7.0-7.9 | 34 | (0.1) | 23 | (5.4) | 18 | (5.2) | 14 | (6.1) | 12 | (7.9) |
| 8.0-9.0 | 50 | (0.2) | 35 | (8.2) | 26 | (7.5) | 16 | (6.9) | 10 | (6.6) |
| > 9.0 | 144 | (0.6) | 85 | (19.9) | 72 | (20.8) | 47 | (20.3) | 32 | (21.2) |
| Mean ± SD | 9.7 ± (1.8) | 9.5 ± (1.8) | 9.6 ± (1.7) | 9.6 ± (1.8) | 9.5 ± (1.7) | |||||
| Median | 9 | 9 | 9 | 9 | 9 | |||||
| BMI (kg/m2) | 496 | (2.1) | 257 | (60.2) | 207 | (59.8) | 144 | (62.3) | 92 | (60.9) |
| Mean ± SD | 34.8 ± (7.1) | 35.2 ± (7.3) | 35.1 ± (7.3) | 34.7 ± (7.6) | 34.9 ± (7.8) | |||||
| Median | 34 | 35 | 35 | 34 | 34 | |||||
| Weight (kg) | 536 | (2.3) | 282 | (66.0) | 225 | (65.0) | 156 | (67.5) | 98 | (64.9) |
| Mean± SD | 103.2 ± (24.0) | 103.2 ± (24.1) | 103.9 ± (22.9) | 102.8 ± (22.6) | 103.9 ± (22.5) | |||||
| Median | 102 | 102 | 102 | 100 | 102 | |||||
aCCI excludes diabetes, as it is the exposure of interest.
bCardiovascular disease is not limited to but includes the separately reported categories of cardiac dysrhythmia, congestive heart failure, coronary artery disease, hypertension, and myocardial infarction.
A1c = hemoglobin A1c; AHA = antihyperglycemic agent; BMI = body mass index; CCI = Charlson Comorbidity Index; DCSI = Diabetes Complication Severity Index; DPP-4 = dipeptidyl peptidase-4; FP = family practice; GP = general practice; IM = internal medicine; SD = standard deviation; TZD = thiazolidinedione.