Hypoglycemic events
| Hypoglycemic events and rates preindex and postindex by treatment group*† | ||||||||
|---|---|---|---|---|---|---|---|---|
| Treatment | Preindex rate‡ n (mean±SD) | 0–6 month postindex rate‡ n (mean±SD) | 0–6 month postindex versus preindex | 7–12 month postindex rate‡ n (mean±SD) | 7–12 month postindex versus preindex | 0–12 month postindex rate‡ n (mean±SD) | Change in annual rate (mean±SD) | 0–12 month postindex versus preindex |
| U-500R only (group A) | 16 (0.15±0.77) | 34 (0.33±1.23) | p=0.026 | 30 (0.29±1.00) | p=0.071 | 64 (0.31±0.99) | 0.15±0.95 | p=0.021 |
| U-500R with overlapping U-100 (group B) | 36 (0.31±1.23) | 57 (0.48±2.23) | p=0.062 | 54 (0.46±2.28) | p=0.199 | 111 (0.47±2.0) | 0.17±1.29 | p=0.051 |
| Total | 52 (0.23±1.04) | 91 (0.41±1.83) | p=0.005 | 84 (0.38±1.80) | p=0.045 | 175 (0.39±1.61) | 0.16±1.14 | p=0.003 |
| Group A versus group B | p=0.124 | p=0.364 | NA | p=0.318 | NA | p=0.284 | p=0.911 | NA |
| Patients with at least 1 hypoglycemic event in preindex or postindex | |||||||
|---|---|---|---|---|---|---|---|
| Treatment | preindex n (%) | 0–6 month postindex n (%) | 0–6 month postindex versus preindex | 7–12 month postindex n (%) | 7–12 month postindex versus preindex | 0–12 month postindex n (%) | 0–12 month postindex versus preindex |
| U-500R only (group A) | 10 (4.8) | 19 (9.1) | p=0.0005 | 19 (9.1) | p=0.0005 | 26 (12.4) | p=0.007 |
| U-500R with overlapping U-100 (group B) | 20 (8.5) | 23 (9.8) | p<0.0001 | 17 (7.2) | p<0.0001 | 27 (11.4) | p<0.0001 |
| Total | 30 (6.7) | 42 (9.4) | p<0.0001 | 36 (8.1) | p<0.0001 | 53 (11.9) | p<0.0001 |
| Group A versus group B | p=0.121 | p=0.814 | NA | p=0.466 | NA | p=0.745 | NA |
| Hypoglycemic events in preindex or postindex by visit type/setting | ||||
|---|---|---|---|---|
| Visit type | Preindex n (%) | 0–6 month postindex n (%) | 7–12 month postindex n (%) | 0–12 month postindex n (%) |
| Office or clinic | 40 (76.9) | 80 (87.9) | 72 (85.7) | 152 (86.9) |
| Emergency | 3 (5.8) | 1 (1.1) | 2 (2.4) | 3 (1.7) |
| Inpatient | 5 (9.6) | 7 (7.7) | 7 (8.3) | 14 (8.0) |
| Other | 1 (1.9) | 1 (1.1) | 2 (2.4) | 3 (1.7) |
| Not recorded/missing | 3 (5.8) | 2 (2.2) | 1 (1.2) | 3 (1.7) |
*Total: N=445; group A: n=209; group B: n=236.
†No hypoglycemic coma events were captured.
‡Annualized rate=hypoglycemic events per patient per year.
NA, not applicable; N/n, number of patients.