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. 2025 Aug 6;38:14940. doi: 10.3389/ti.2025.14940

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Copyright © 2025 Kourounis, Tingle, Maillo-Nieto, Wroe, Thompson, Owen, van Leeuwen, Holzner, Wadhera, Zeeshan Akhtar, Florman, Shaw, White and Wilson.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

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Graphs A and B show the required sample size per group on a logarithmic scale. Graph A (left) uses a red line to display sample sizes for continuous outcomes based on differences in mean HbA1c percentage. Graph B (right) uses a blue line for binary outcomes, showing relative risk reduction in graft loss percentage. Both graphs note calculations assume alpha equals 0.05 and power equals 0.8. — Sample sizes required to detect the desired minimum clinically important difference across the range of values on the x-axis (A) a change in one-year mean HbA1c from 7% (e.g., a reduction from 7% to 6.5% would require 65 patients per group) and (B) a relative risk reduction in graft loss from 20% at 1 year (e.g., a reduction from 20% to 16% would require 1,444 patients per group).