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Lookup NU author(s): Dr George KourounisORCiD, Dr Sam Tingle, Dr Emily ThompsonORCiD, Dr Ruth Owen, Professor James ShawORCiD, Steven White, Colin Wilson
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
Copyright © 2025 Kourounis, Tingle, Maillo-Nieto, Wroe, Thompson, Owen, van Leeuwen, Holzner, Wadhera, Zeeshan Akhtar, Florman, Shaw, White and Wilson.Understanding which factors shape long-term pancreas graft outcomes after the critical first year post-transplantation is an ongoing challenge. This study assesses one-year HbA1c as a predictor of subsequent pancreas graft survival. A retrospective cohort study was conducted using the UNOS registry on all simultaneous pancreas-kidney (SPK) transplants between 2017 and 2023. Regression models with multiple imputations for missing data were used to evaluate predictors of long-term function. Non-linear relationships were modelled with restricted cubic splines (RCS). Among 2,917 SPK recipients (median follow-up 44 months, IQR: 25–60), one-year HbA1c was the strongest independent predictor of long-term graft survival. An HbA1c of 6.8% versus 4.4% (95th vs. 5th percentile) was associated with significantly worse graft survival (aHR = 2.48, 95% CI: 1.72–3.58). Simulated trial sample size calculations found that detecting a statistically and clinically significant reduction in one-year HbA1c from 7% to 6.5% would require 65 patients per group, whereas detecting a reduction in one-year graft loss from 12% to 9% would require 1,631 patients per group. HbA1c at 1 year is a robust, continuous marker of long-term graft function and may serve as a feasible, objective surrogate endpoint in future clinical trials, enabling smaller, more efficient study designs to evaluate interventions.
Author(s): Kourounis G, Tingle SJ, Maillo-Nieto A, Wroe C, Thompson ER, Owen R, van Leeuwen L, Holzner M, Wadhera V, Zeeshan Akhtar M, Florman S, Shaw J, White S, Wilson C
Publication type: Article
Publication status: Published
Journal: Transplant International
Year: 2025
Volume: 38
Online publication date: 06/08/2025
Acceptance date: 22/07/2025
Date deposited: 03/09/2025
ISSN (print): 0934-0874
ISSN (electronic): 1432-2277
Publisher: Frontiers Media SA
URL: https://doi.org/10.3389/ti.2025.14940
DOI: 10.3389/ti.2025.14940
Data Access Statement: The data analyzed in this study is subject to the following licenses/ restrictions: The data that support the findings of this study are available from UNOS upon reasonable request. Requests to access these datasets should be directed to https://optn.transplant.hrsa. gov/data/view-data-reports/request-data/
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