Table 1.
Baseline, pre–PHPI transplant, and treatment covariates and subject disposition by CIT Consortium study
| Islet-alone transplantation (n = 48) | Islet-after-kidney transplantation (n = 24) | P | |
|---|---|---|---|
| Baseline covariates | |||
| Sex (n female/n male) | 29/19 | 11/13 | 0.36 |
| Age (years) | 47.8 ± 11.5 | 51.8 ± 11.1 | 0.17 |
| Weight (kg) | 71.9 ± 13.7 | 69.4 ± 8.8 | 0.35 |
| BMI (kg/m2) | 24.9 ± 3.1 | 24.6 ± 3.1 | 0.64 |
| Diabetes duration (years) | 31.5 ± 11.0 | 37.0 ± 10.0 | 0.04 |
| Pre–PHPI transplant covariates* | |||
| Daily insulin (units/day) | 33.6 ± 11.1 | 36.0 ± 12.2 | 0.43 |
| Daily insulin/kg (units/kg/day) | 0.47 ± 0.14 | 0.51 ± 0.14 | 0.32 |
| eGFR (mL/min/1.73 m2) | 100.3 ± 14.2 | 75.8 ± 19.3 | <0.001 |
| HbA1c (mmol/mol) | 57.3 ± 9.9 | 63.0 ± 13.0 | 0.06 |
| HbA1c (%) | 7.39 ± 0.91 | 7.92 ± 1.19 | 0.06 |
| HbA1c <7.0%, n (%) | 18 (38) | 5 (21) | |
| HbA1c ≤6.5%, n (%) | 8 (17) | 3 (13) | |
| Treatment covariates | |||
| Total IEQ/kg body wt of recipient† | 11,278 ± 3,935 | 12,585 ± 6,191 | 0.77 |
| Mean tacrolimus trough (ng/mL)† | 6.17 ± 1.53 | 7.63 ± 2.00 | 0.01 |
| Median follow-up and subject disposition | |||
| Median follow-up (months) | 65.8 | 39.3 | |
| Failed | 7 | 9 | |
| Withdrew with function | 15 | 7 | |
| Completed with function | 26 | 8 |
Data are means ± SD unless otherwise indicated.
*
Values obtained during the subject’s time on the islet transplant waiting list while on intensive insulin therapy.
†
IEQ/kg body wt and tacrolimus were log transformed for t tests. IEQ/kg body wt was entered as a time-dependent covariate.