Introduction
Methods
Results
Characteristic | Low variability
n = 2528 | Medium variability
n = 2530 | High variability
n = 2528 |
---|---|---|---|
Age (years) | 64.7 ± 7.4a
| 65.0 ± 7.3b
| 65.3 ± 7.4 |
Patients aged ≥ 75 years | 261 (10.3) | 262 (10.4) | 284 (11.2) |
Men | 1617 (64.0) | 1621 (64.1) | 1515 (59.9) |
Ethnicity | |||
Hispanic or Latino | 310 (12.3) | 356 (14.1) | 465 (18.4) |
Race | |||
White | 1873 (74.1) | 1948 (77.0) | 1919 (75.9) |
Black or African-American | 199 (7.9) | 270 (10.7) | 355 (14.0) |
Asian | 389 (15.4) | 229 (9.1) | 155 (6.1) |
Other | 67 (2.7) | 83 (3.3) | 99 (3.9) |
Region | |||
North America | 1506 (59.6) | 1760 (69.6) | 1973 (78.0) |
Europe | 456 (18.0) | 278 (11.0) | 131 (5.2) |
South America | 143 (5.7) | 194 (7.7) | 247 (9.8) |
India | 204 (8.1) | 100 (4.0) | 51 (2.0) |
Asia excluding India | 136 (5.4) | 95 (3.8) | 60 (2.4) |
Africa | 83 (3.3) | 103 (4.1) | 66 (2.6) |
Diabetes duration (years) | 14.1 ± 8.1 | 16.3 ± 8.6 | 18.8 ± 9.3 |
Smoking status | |||
Current | 251 (9.9) | 276 (10.9) | 321 (12.7) |
Previous | 1096 (43.4) | 1147 (45.3) | 1093 (43.2) |
Never | 1181 (46.7) | 1107 (43.8) | 1114 (44.1) |
Trial eligibility stratum | |||
Age ≥ 50 years and established cardiovascular or chronic kidney diseasec
| 2147 (84.9) | 2148 (84.9) | 2172 (85.9) |
Age ≥ 60 years and risk factors for cardiovascular diseased
| 371 (14.7) | 377 (14.9) | 351 (13.9) |
Body weight (kg) | 95.9 ± 22.8 | 97.2 ± 23.3 | 95.3 ± 22.5 |
BMI (kg/m2) | 33.5 ± 6.7 | 33.8 ± 6.9 | 33.4 ± 6.9 |
Blood pressure | |||
Systolic (mmHg) | 134.7 ± 17.1 | 136.3 ± 18.1 | 135.6 ± 18.8 |
Diastolic (mmHg) | 76.9 ± 10.0 | 76.5 ± 10.3 | 75.1 ± 10.6 |
Pulse (beats/min) | 73.2 ± 11.2 | 73.1 ± 11.4 | 73.0 ± 11.4 |
HbA1c (%) | 8.1 ± 1.6 | 8.4 ± 1.6 | 8.8 ± 1.7 |
HbA1c (mmol/mol) | 65.4 ± 17.3 | 68.2 ± 17.5 | 72.2 ± 18.6 |
FPG (mmol/l) | 9.2 ± 3.5 | 9.5 ± 3.7 | 9.9 ± 4.4 |
eGFR (ml−1 min−1 [1.73 m]−2) based on CKD-EPI | 70.5 ± 21.1 | 68.7 ± 21.3 | 64.7 ± 21.8 |
Total cholesterol (mmol/l) | 4.3 ± 1.2 | 4.2 ± 1.2 | 4.3 ± 1.2 |
LDL-cholesterol (mmol/l) | 2.2 ± 0.9 | 2.2 ± 0.9 | 2.2 ± 1.0 |
HDL-cholesterol (mmol/l) | 1.1 ± 0.3 | 1.1 ± 0.3 | 1.2 ± 0.4 |
Triacylglycerolse (mmol/l) | 2.1 ± 2.0 | 2.1 ± 1.6 | 2.0 ± 1.8 |
Variability/HbA1c
| Low variability
n = 2528 | Medium variability
n = 2530 | High variability
n = 2528 |
---|---|---|---|
Variabilitya
| |||
Mean ± SD | 14 ± 3% | 23 ± 2% | 36 ± 9% |
Min, Max | 1%, 19% | 19%, 27% | 27%, 138% |
Mean number of monthly variancesb
| 22.2 ± 5.7 | 22.6 ± 5.3 | 22.2 ± 5.8 |
Mean number of blood glucose measurementsb
| |||
Week 1 | 2.9 ± 0.4 | 2.9 ± 0.4 | 2.9 ± 0.5 |
Month 12 | 2.9 ± 0.4 | 2.9 ± 0.3 | 2.9 ± 0.5 |
Month 24 | 2.8 ± 0.6 | 2.9 ± 0.6 | 2.8 ± 0.7 |
HbA1c at baselineb (%) | 8.1 ± 1.6 | 8.4 ± 1.6 | 8.8 ± 1.7 |
HbA1c at baselineb (mmol/mol) | 65.4 ± 17.3 | 68.2 ± 17.5 | 72.2 ± 18.6 |
HbA1c at 24 monthsb (%) | 7.2 ± 1.2 | 7.4 ± 1.2 | 7.8 ± 1.2 |
HbA1c at 24 monthsb (mmol/mol) | 55.5 ± 12.8 | 57.8 ± 12.7 | 61.7 ± 13.1 |
Change in HbA1c from baseline to 24 months (%) | −0.8 ± 1.4 | −0.9 ± 1.6 | −0.8 ± 1.6 |
Change in HbA1c from baseline to 24 months (mmol/mol) | −8.6 ± 15.8 | −10.0 ± 17.2 | −9.3 ± 17.5 |
Outcome | Low variability
n = 2528 | Medium variability
n = 2530 | High variability
n = 2528 | |||
---|---|---|---|---|---|---|
Events | Rate | Events | Rate | Events | Rate | |
Severe hypoglycaemia | 83 | 1.69 | 116 | 2.38 | 237 | 5.00 |
MACE | 187 | 3.84 | 219 | 4.49 | 267 | 5.48 |
Cardiovascular death | 75 | 1.50 | 83 | 1.65 | 116 | 2.30 |
Non-fatal MI | 90 | 1.83 | 104 | 2.11 | 117 | 2.37 |
Non-fatal stroke | 37 | 0.75 | 50 | 1.00 | 61 | 1.23 |
All-cause mortality | 115 | 2.30 | 131 | 2.61 | 171 | 3.40 |