Background
Methods
Patients and approvals
Overview of assessment procedures
Data collection
Statistical analysis
Results
Patient characteristics
FDS1 | FDS2 | Difference (95 % CI) |
P-value* | |
---|---|---|---|---|
Number | 1296 | 1509 | ||
Age (years) | 64.0 ± 11.3 | 65.4 ± 11.7 | 1.4 (0.6–2.3) | <0.001 |
Sex (% male) | 48.6 | 51.8 | 3.2 (−0.5 to 6.9) | 0.032 |
Ethnic background (%) | ||||
Anglo-Celt | 61.4 | 52.6 | −8.9 (−12.5 to −5.2) | <0.001 |
Southern European | 17.7 | 12.9 | −4.9 (−7.6 to −2.2) | <0.001 |
Other European | 8.5 | 7.4 | −1.1 (−0.9 to 3.1) | 0.20 |
Asian | 3.4 | 4.3 | 0.9 (−0.5 to 2.3) | 0.14 |
Aboriginal | 1.5 | 7.1 | 5.6 (4.2–7.1) | <0.00 |
Other | 7.5 | 15.8 | 8.4 (6.0–10.7) | <0.001 |
Age at diabetes diagnosis (years) | 57.9 ± 11.7 | 55.6 ± 12.4 | −2.3 (−3.2 to 1.4) | <0.001 |
Duration of diabetes (years) | 4.0 (1.0–9.0) | 8.0 (2.7–15.4) | 3.7 (3.2–4.3) | <0.001 |
Education beyond primary level (%) | 74.0 | 86.8 | 12.8 (9.8–15.7) | <0.001 |
Paid employment (%) | 17.5 | 31.0 | 13.6 (10.4–16.7) | <0.001 |
Married/de facto relationship (%) | 65.7 | 62.7 | −3.0 (−6.5 to 0.6) | 0.79 |
Alcohol use (standard drinks/day) | 0 (0–0.8) | 0.1 (0–1.2) | 0.2 (0.1–0.4) | 0.003 |
Smoking status (%) | ||||
Never | 44.7 | 45.4 | 0.7 (−3.0 to 4.4) | 0.054 |
Ex- | 40.2 | 43.9 | 3.6 (−0.03 to 7.3) | 0.29 |
Current | 15.1 | 10.7 | −4.5 (−7.0 to −2.0) | <0.001 |
BMI (kg/m2) | 29.6 ± 5.4 | 31.3 ± 6.1 | 1.7 (1.3–2.1) | <0.001 |
Obese by waist circumference (%)a
| 64.5 | 70.9 | 6.4 (2.9–9.9) | <0.001 |
Overweight/obese by waist:hip ratio (%)b
| 74.2 | 82.7 | 8.5 (5.4–11.6) | <0.001 |
Fasting serum glucose (mmol/L) | 8.0 (6.5–10.3) | 7.2 (6.2–8.9) | −0.8 (−1.0 to −0.6) | <0.001 |
HbA1c (%) | 7.2 (6.2–8.5) | 6.8 (6.2–7.7) | −0.3 (−0.4 to −0.2) | <0.001 |
HbA1c (mmol/mol) | 55 (44–69) | 51 (44–61) | −3.5 (−4.8 to −2.1) | <0.001 |
Diabetes treatment (%) | ||||
Diet | 31.9 | 24.6 | −7.3 (−10.7 to −4.0) | <0.001 |
Oral agents | 56.0 | 53.4 | −2.6 (−6.3 to 1.1) | 0.075 |
Insulin ± oral agents | 12.1 | 22.0 | 9.9 (7.2–12.7) | <0.001 |
Systolic blood pressure (mmHg) | 151 ± 24 | 146 ± 22 | −5.1 (−6.8 to −3.4) | <0.001 |
Diastolic blood pressure (mmHg) | 80 ± 11 | 80 ± 12 | −0.3 (−1.1 to 0.6) | 0.66 |
On antihypertensive therapy (%) | 50.9 | 72.6 | 21.7 (18.2–25.2) | <0.001 |
On renin-angiotensin blockers (%) | 21.8 | 64.3 | 42.4 (39.1–45.8) | <0.001 |
Total serum cholesterol (mmol/L) | 5.5 ± 1.1 | 4.4 ± 1.1 | −1.1 (−1.2 to −1.0) | <0.001 |
Serum HDL cholesterol (mmol/L) | 1.06 ± 0.3 | 1.24 ± 0.3 | 0.18 (0.15–0.20) | <0.001 |
Serum LDL cholesterol (mmol/L) | 3.3 ± 0.91 | 2.3 ± 0.9 | −1.0 (−1.1 to −0.9) | <0.001 |
Serum triglycerides (mmol/L) | 2.2 (1.2–3.9) | 1.5 (0.9–2.5) | −0.9 (−1.0 to −0.7) | <0.001 |
On lipid modifying treatment (%) | 10.5 | 67.5 | 56.9 (54.0–59.8) | <0.001 |
Taking aspirin (%) | 22.0 | 36.6 | 14.6 (11.3–17.9) | <0.001 |
Microalbuminuria or worse (%) | 56.4 | 40.0 | −16.4 (−20.0 to −12.7) | <0.001 |
eGFR <60 mL/min/1.73 m2 (%) | 24.2 | 16.5 | –7.8 (−10.8 to −4.8) | <0.001 |
Any retinopathy (%) | 16.4 | 22.4 | 6.0 (3.0–9.1) | 0.001 |
Peripheral sensory neuropathy (%) | 30.8 | 58.2 | 27.4 (23.9–31.0) | <0.001 |
Ischaemic heart disease (%) | 29.6 | 27.8 | −1.8 (−5.1 to 1.6) | 0.32 |
Cerebrovascular disease (%) | 10.0 | 8.5 | −1.4 (−3.6 to 0.8) | 0.21 |
Peripheral arterial disease (%) | 29.3 | 22.6 | −6.7 (−10.0 to −3.5) | <0.001 |
Intermittent claudication (%) | 14.0 | 9.2 | −4.8 (−7.2 to −2.4) | <0.001 |
Arterial bypass/revascularisation (%) | 1.3 | 3.0 | 1.7 (0.7–2.8) | 0.013 |
Past hospitalisation for/current foot ulcer | 1.6 | 2.8 | 1.2 (0.1–2.3) | 0.17 |
Diabetes-related LEA (%) | 1.2 | 1.0 | −0.2 (−0.9 to 0.6) | 0.22 |
Diabetes-related major LEA (%) | 0.6 | 0.3 | −0.3 (−0.8 to 0.2) | 0.07 |
Diabetes-related minor LEA (%) | 0.5 | 0.7 | 0.1 (−0.5 to 0.7) | 0.90 |
Baseline diabetes related amputation prevalence and associates
FDS1 | FDS2 | |||
---|---|---|---|---|
Odds ratio (95 % CI) |
P-value | Odds ratio (95 % CI) |
P-value | |
History or peripheral bypass or revascularisation | 40.15 (8.02–201.09) | <0.001 | 33.50 (6.93–161.86) | <0.001 |
Past hospitalisation for/current foot ulcer | 91.65 (19.40–433.08) | <0.001 | ||
Fasting serum glucose (increase of 1 mmol/L) | 1.36 (1.14–1.62) | 0.001 | ||
Ln (urinary albumin:creatinine ratio (mg/mmol)) | 2.04 (1.25–3.32) | 0.004 | ||
Cerebrovascular disease | 6.11 (1.28–29.16) | 0.023 | ||
Peripheral sensory neuropathy | 7.52 (1.16–49.01) | 0.035 |
No amputation | Amputation | P-value | |
---|---|---|---|
Number | 2775 | 30 | |
Age (years) | 64.8 ± 11.5 | 66.4 ± 10.5 | 0.45 |
Sex (% male) | 50.2 | 66.7 | 0.097 |
Ethnic background (%) | 0.020 | ||
Anglo-Celt | 56.8 | 46.7 | |
Southern European | 15.1 | 16.7 | |
Other European | 7.9 | 10.0 | |
Asian | 3.9 | 0.0 | |
Mixed/other | 12.0 | 6.7 | |
Aboriginal | 4.3 | 20.0 | |
Age at diabetes diagnosis (years) | 56.7 ± 12.0 | 50.5 ± 16.1 | 0.005 |
Duration of diabetes (years) | 5.0 (1.75–13.0) | 12.0 (9.0–28.0) | <0.001 |
Education beyond primary level (%) | 80.8 | 78.6 | 0.81 |
Paid employment (%) | 24.9 | 7.1 | 0.027 |
Married/de facto relationship (%) | 64.2 | 50.0 | 0.13 |
Alcohol use (standard drinks/day) | 0.11 (0.0–0.75) | 0.0 (0.0–1.13) | 0.65 |
Smoking status (%) | 0.093 | ||
Never | 45.2 | 26.7 | |
Ex | 41.9 | 63.3 | |
Current | 12.7 | 10.0 | |
BMI (kg/m2) | 30.5 ± 5.9 | 28.8 ± 5.3 | 0.14 |
Obese by waist circumference (%)a
| 67.9 | 69.6 | 1.0 |
Overweight/obese by waist:hip ratio (%)b
| 78.7 | 81.8 | 1.0 |
Fasting serum glucose (mmol/L) | 7.5 (6.2–9.6) | 7.6 (6.0–10.9) | 0.83 |
HbA1c (%) | 7.0 (6.2–8.1) | 7.1 (6.5–8.6) | 0.40 |
HbA1c (mmol/mol) | 53 (44–65) | 54 (48–70) | |
Diabetes treatment (%) | <0.001 | ||
Diet | 28.2 | 10.0 | |
Oral agents | 54.8 | 33.3 | |
Insulin ± oral agents | 17.0 | 56.7 | |
Systolic blood pressure (mmHg) | 148 ± 23 | 154 ± 33 | 0.33 |
Diastolic blood pressure (mmHg) | 80 ± 12 | 79 ± 13 | 0.61 |
On antihypertensive therapy (%) | 68 ± 19 | 75 ± 25 | 0.047 |
On renin-angiotensin blockers (%) | 16.9 | 23.3 | 0.33 |
Total serum cholesterol (mmol/L) | 4.9 ± 1.2 | 4.4 ± 1.2 | 0.034 |
Serum HDL cholesterol (mmol/L) | 1.16 ± 0.34 | 1.11 ± 0.32 | 0.46 |
Serum triglycerides (mmol/L) | 1.8 (1.0–3.2) | 1.8 (1.1–2.9) | 0.74 |
Urinary albumin:creatinine ratio | 4.0 (1.1–14.7) | 23.3 (4.5–121.6) | <0.001 |
On lipid modifying treatment (%) | 41.1 | 46.7 | 0.58 |
Taking aspirin (%) | 29.7 | 40.0 | 0.23 |
eGFR <60 mL/min/1.73 m2 (%) | 19.8 | 46.7 | 0.001 |
Any retinopathy (%) | 19.2 | 53.8 | <0.001 |
Peripheral sensory neuropathy (%) | 45.5 | 82.6 | <0.001 |
History of ischaemic heart disease (%) | 28.4 | 46.7 | 0.040 |
History of cerebrovascular disease (%) | 8.9 | 36.7 | <0.001 |
Peripheral arterial disease (%) | 24.9 | 100.0 | <0.001 |
Self-reported intermittent claudication (%) | 11.2 | 33.3 | 0.001 |
Arterial bypass/revascularisation (%) | 1.7 | 56.7 | <0.001 |
Past hospitalisation for/current foot ulcer (%) | 1.7 | 53.3 | <0.001 |
Odds ratio (95 % CI) |
P-value | |
---|---|---|
Ln (urinary albumin:creatinine ratio) | 1.74 (1.31–2.32) | <0.001 |
History of vascular bypass or revascularisation | 24.57 (8.22–73.48) | <0.001 |
Past hospitalisation for/current foot ulcer | 23.64 (7.80–71.70) | <0.001 |
FDS Phase 2 | 0.28 (0.09–0.84) | 0.023 |