Table 1.
Baseline characteristics, by age group
| Characteristic | ≤65 years (n = 450) | >65 years (n = 270) |
|---|---|---|
| Age (years) median [range] | 56.6 [20.9;65.0] | 71.5 [65.1;89.2] |
| Sex (n, %) | ||
| Female | 224 (49.8) | 114 (42.2) |
| Male | 226 (50.2) | 156 (57.8) |
| Ethnicity (n, %) | ||
| Hispanic or Latino | 175 (38.9) | 87 (32.2) |
| Not Hispanic or Latino | 275 (61.1) | 183 (67.8) |
| Ethnicity | ||
| White | 356 (79.1) | 222 (82.2) |
| Black or African American | 65 (14.4) | 41 (15.2) |
| Native Hawaiian or other Pacific islander | 1 (0.2) | 0 (0) |
| American Indian or Alaska native | 4 (0.9) | 3 (1.1) |
| Asian | 19 (4.2) | 3 (1.1) |
| Other | 5 (1.1) | 1 (0.4) |
| Body weight (kg) | 93.8 (20.3) | 88.3 (17.6) |
| BMI (kg/m2) | 32.8 (5.8) | 31.2 (5.3) |
| Duration of diabetes (years), median [range] | 12 [1–40] | 15 [1–54] |
| Exposure to insulin >5 years (n, %) | 214 (47.6) | 142 (52.6) |
| Experience of at least one severe hypoglycaemic event during the previous yeara (n, %) | 79 (17.6) | 39 (14.4) |
| Impaired awareness of hypoglycaemia b (n, %) | 81 (18.0) | 48 (17.8) |
| Experience of at least one hypoglycaemic eventc within 12 weeks prior to visit 1 (screening) (n, %) | 298 (66.2) | 180 (66.7) |
| eGFR (mL/min/1.73 m2) | 87.0 (18.9) | 63.7 (16.8) |
| Moderate chronic renal failured (n, %) | 49 (10.9) | 110 (40.7) |
| Smoking status (n, %) | ||
| Never smoked | 230 (51.1) | 134 (49.6) |
| Previous smoker | 130 (28.9) | 115 (42.6) |
| Current smoker | 90 (20.0) | 21 (7.8) |
| HbA1c (%) | 7.7 (1.1) | 7.4 (1.0) |
| HbA1c (mmol/mol) | 60.3 (12.2) | 57.9 (11.2) |
| FPG (mmol/L) | 7.8 (2.9) | 7.2 (2.9) |
| FPG (mg/dL) | 140.9 (52.9) | 130.6 (51.4) |
Note. All values are mean (SD) unless otherwise specified.
Abbreviations: BMI, body mass index; CKD‐EPI, chronic kidney disease epidemiology collaboration; eGFR, estimated glomerular filtration rate; FPG, fasting plasma glucose; n, number of subjects; SD, standard deviation.
Event requiring assistance of another person to actively administer carbohydrate or glucagon, or to take other corrective action. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence.
History of impaired autonomic responses (tremulousness, sweating, palpitations and hunger) during hypoglycaemia.
Defined by symptoms of hypoglycaemia and/or event with low glucose measurement (≤70 mg/dL [≤3.9 mmol/L]).
Glomerular filtration rate 30–59 mL/min/1.73 m2 per CKD‐EPI by central laboratory analysis.