Effect of an entry-to-care intervention on diabetes distress in individuals with newly diagnosed type 2 diabetes: A study protocol for a cluster-randomized trial.

Abstract Background Diabetes distress (DD) affects at least 36% of T2DM patients and is often associated with insufficient support and care. This study examines an intervention that targets DD through enhanced cross-sectoral collaboration and treatment during the first three months following diagnosis. The intervention aims to improve care, self-management, and to reduce DD. Methods & Intervention The study is designed as a cluster-randomized trial with the intervention focusing on four key elements of diabetes care: effective cross-sectoral communication and information sharing, systematic care, a "one-stop-shop" health screening and start-up conversation at the municipality, and improving patient insights into own care. This study requires 32 clusters (16/arm) to achieve 80% power and a 5% significance cut-off, with 270 patients required. GP recruitment occurred from May-Dec 2022. Patient recruitment is ongoing from May 2022 to Aug 2023. GPs were randomized 1:1 using computer-generated blocks of six. Participating GPs are located in Southern Denmark and are not participating in other trials. Patients must be 18+ years of age, have a T2DM diagnosis, and be fluent in spoken and written Danish. DD is the primary outcome and will be measured at baseline, at four months, and again at 12-month follow-up. Secondary outcomes include quality of care, self-management, quality of life, and clinical factors. Tertiary outcomes comprise depression, stress, resilience, sleep quality, and social network quality. Conclusion This study is among the first clinical trials exploring the development of DD from diagnosis to 12 months post-diagnosis. Many previous interventions did not directly target DD as the primary outcome. This research provides new insights into DD progression in patients newly diagnosed T2DM and examines an intervention designed to lower DD in early diabetes stages, contributing to a better understanding of the development of DD how this intervention affects patient well-being. Trial registration: ClinicalTrial.gov, NCT05571306. Registered 07 October 2022, https://beta.clinicaltrials.gov/study/NCT05571306