Table 2.
Summary of Infusion Set Occlusions During the On-Treatment Period—Safety Population.
| SAR-Lis (n = 25) | Ly-Lis (n = 27) | |
|---|---|---|
| No. of patients with ≥1 ISO (%)a | 6 (24.0) | 4 (14.8) |
| Risk estimateb | 22.5% | 14.6% |
| 95% CI | 6.66 to 38.29 | 1.60 to 27.52 |
| Risk difference versus Ly-Lisb | 7.9% | |
| 95% CI | −1.90 to 17.73 | |
| No. of ISOsa | 14 | 9 |
| Rate of ISOs per month (SD) | 0.59 (1.25) | 0.36 (1.01) |
| Distribution of the no. of events by patient, n (%) | ||
| 1 | 2 (8.0) | 2 (7.4) |
| 2 | 1 (4.0) | 0 |
| 3 | 2 (8.0) | 1 (3.7) |
| >3 | 1 (4.0) | 1 (3.7) |
| Average interval of infusion set changes, days; mean (SD) [n]c | ||
| Any change | 3.09 (0.97) [25] | 2.95 (0.78) [26] |
| Scheduled infusion set change | 3.42 (0.95) [25] | 3.16 (0.86) [26] |
| Due to failure to correct hyperglycemia | 16.44 (10.05) [6] | 18.73 (11.90) [4] |
| Due to pump malfunction | 0 | 29.00 (NC) [1] |
| Based on AE | 25.88 (7.60) [4] | 29.00 (NC) [1] |
| Due to any occlusion (combined endpoint) | 18.46 (9.91) [8] | 20.78 (11.28) [5] |
| No. of patients (%) with pump (no delivery) alarm for ISO | 2 (8.0) | 0 |
| No. of patients (%) who identified ISOs | 1 (4.0) | 1 (3.7) |
| No. of patients (%) with any occlusion (combined endpointd) | 8 (32.0) | 5 (18.5) |
| ISOs by period | ||
| No. of patients with ≥1 ISO, (%)a | ||
| Period 1 | 3/13 (23.1) | 3/14 (21.4) |
| Period 2 | 3/12 (25.0) | 1/13 (7.7) |
| Total | 6/25 (24.0) | 4/27 (14.8) |
| No. of ISOsa | ||
| Period 1 | 6 | 6 |
| Period 2 | 8 | 3 |
| Total | 14 | 9 |
a
ISO defined as failure to correct hyperglycemia by insulin bolus via the insulin pump (excluding pump malfunction).
b
Repeated measures model using a binomial regression and an identity-link function, including fixed categorical effects for treatment, period, and sequence. Risks within each treatment group, risk difference, and their 95% CI provided using the adjusted least squares mean estimates of the treatment effect.
c
No. of patients with ≥≥1 changes.
d
ISO defined as failure to correct hyperglycemia by insulin bolus via the insulin pump (excluding pump malfunction), pump (no delivery) alarm for ISO, or patient-observed ISO.