Table 1.
Tissue Histology Data
| CSII catheter | None | Mild | Moderate | Severe | ||
|---|---|---|---|---|---|---|
| Reticular fiber disruption | CC | 1 (2.8%) | 29 (80.6%) | 6 (16.7%) | 0 | *** |
| IC | 0 | 6 (16.7%) | 9 (25.0%) | 21 (58.3%) | ||
| Fibrin deposition in reservoir | CC | 1 (2.8%) | 10 (27.8%) | 15 (41.7%) | 10 (27.8%) | |
| IC | 0 | 8 (22.2%) | 21 (58.3%) | 7 (19.4%) | ||
| Collagen deposition at tip | CC | 4 (11.1%) | 26 (72.2%) | 6 (16.7%) | 0 | |
| IC | 1 (2.8%) | 23 (63.9%) | 11 (30.6%) | 1 (2.8%) | ||
| Fat necrosis | CC | 1 (2.8%) | 22 (61.1%) | 13 (36.1%) | 0 | *** |
| IC | 0 | 7 (19.4%) | 14 (38.9%) | 15 (41.7%) | ||
| Hemorrhage at tip base | CC | 1 (2.8%) | 27 (75.0%) | 8 (22.2%) | 0 | * |
| IC | 1 (2.8%) | 17 (47.2%) | 17 (47.2%) | 1 (2.8%) |
| Changes in tissue morphology | Regular | Intermediate | Irregular | |||
|---|---|---|---|---|---|---|
| Reservoir geometry | CC | 29 (82.9%) | — | 6 (17.1%) | *** | |
| IC | 11 (30.6%) | — | 25 (69.4%) | |||
| Topography of tissue planes along insertiona | CC | 30 (85.7%) | 5 (14.3%) | 0 | *** | |
| IC | 1 (2.8%) | 19 (52.8%) | 16 (44.4%) |
| Depth (mm) ± SD | ||||||
|---|---|---|---|---|---|---|
| Debris field (mean) | CC | 3.2 ± 1.1 | *** | |||
| IC | 4.9 ± 1.4 |
Values in brackets are a percent of 36 CCs and 36 ICs total.
a
Tissue morphology for Swine1-CC1 was not evaluated due to incomplete/superficial insertion of catheter; ***P < 0.001. *P < 0.05 significant difference between catheter types.
CC, commercial CSII catheter; CSII, continuous subcutaneous insulin infusion; IC, investigational CSII catheter.