Randomised Controlled Feasibility Trial of Face‐To‐Face Diabetes Self‐Management Education Shows High Completion Rates Are Needed to Improve Patient‐Reported Outcomes

ABSTRACT Aims To examine the dose–response relationship between diabetes self‐management education (DSME) attendance and psychological outcomes in type 2 diabetes, assessing whether minimal attendance (10%) produces clinically meaningful improvements and comparing outcomes at the internationally adopted 60% completion benchmark with full (100%) completion. Materials and Methods This randomised feasibility trial enrolled 120 adults (≥ 18 years) due to attend a UK DSME programme. Participants were randomised to receive 100% (routine DSME), 60%, 10% or 0% (delayed DSME). Primary outcomes were changes in self‐management skills; secondary outcomes included health‐related quality of life (HRQoL) and diabetes distress. Results Participants had a mean age of 61 years, mean HbA 1c of 8.4% (68 mmol/mol) and median diabetes duration of 8 years. Significant between‐group differences were observed in change scores for self‐management skills ( F [3,109] = 6.914, p < 0.001) and diabetes distress ( F [3,108] = 7.369, p < 0.001). Education dose explained 16%–17% of the variance demonstrating a dose–response relationship (η p 2 = 0.16–0.17) with a moderate effect size ( n 2 = 0.16, 95% CI [0.04, 0.27]). Within‐group statistical improvements were observed for both 100% and 60% completion, but clinically meaningful improvements across all psychological domains occurred only with full (100%) completion. No significant between‐group differences were observed for HRQoL. Conclusions In this randomised feasibility trial, clinically significant psychological benefits from DSME required full (100%) programme completion. Attendance thresholds of ≤ 10% or partial completion (≥ 60%) did not yield meaningful improvements in diabetes distress or HRQoL. These findings suggest that existing performance indicators based on partial attendance may not reflect meaningful benefits and support 100% DSME attendance as the gold standard. Trial Registration Clinicaltrials.gov identifier: NCT06419907