Evaluating the impact of differing completion rates of a face‐to‐face DIABETES self‐management education programme on Patient Reported Outcome measures (DIABETES PRO): A feasibility trial protocol

Introduction Structured diabetes self‐management education (DSME) is internationally recommended for people with type 2 diabetes to support self‐management and to prevent associated long‐term complications. ‘Attendance’ at DSME is currently benchmarked as having completed a registration form and at least one active engagement with programme content, and ‘completion’ measured against ≥60% completion, despite landmark trials reporting outcomes based on the full completion of a programme. Little is known about the effectiveness of DSME on the psychological and emotional health of people with diabetes who complete less than the full DSME programme. We report a protocol for a single‐centre randomised feasibility study to assess the impact of differing completion rates of a face‐to‐face DSME programme on patient reported outcomes of self‐care, diabetes distress and quality of life in people with type 2 diabetes. Methods A randomised feasibility study in 120 people with type 2 diabetes due to attend a secondary care diabetes clinic in the North West UK for DSME. Participants will be randomised into one of the four groups: Group 1 full DSME programme, Group 2 60%, Group 3 10% and Group 4 0% (delayed education). Psychometric questionnaire scores will be evaluated at baseline and 3–4 months post‐intervention. Measures of feasibility (eligibility, recruitment and retention rates) will be reported. Ethics and Dissemination The DIABETES‐PRO study was approved by the London–Surrey Borders Research Ethics Committee (24/LO/0235). Results will be shared with study participants and published in peer‐reviewed journals. Trial Registration Clinicaltrials.gov NCT06419907.