Digital Individualized and Collaborative Treatment of T2D in General Practice Based on Decision Aid

The purpose of this project is to improve life of patients with type 2 diabetes through an IT-supported lifestyle and treatment intervention. The intervention is based on combining and adapting existing and effective elements into the IT system of the general practitioner. In this way we will integrate specialist supervised treatment in general practice, individual patient coaching, and improved information exchange and data mining. The DICTA intervention consists of two integrated components: a patient-directed eHealth lifestyle coaching program delivered via the LIVA application, and a clinician-directed CDS tool embedded into the EPJ system. 1. eHealth lifestyle coaching: Individuals with T2D in the intervention group will receive individualized digital coaching from a health coach through the LIVA application. PROs are shared with GPs and health staff via the EPJ, enabling tailored, data-driven lifestyle support. 2. CDS: GPs receive real-time, individualized, algorithm-based pharmacological treatment recommendations for managing T2D, hypertension, and hypercholesterolemia, as appropriate. This is expected to facilitate use, assure individually tailored solutions, optimize treatment effects, and strengthen patient engagement. The study is a randomized controlled trial (RCT). It will include 400 patients with newly diagnosed type 2 diabetes. The patients will receive either treatment based on the intervention or usual care. After one year, we will assess quality of life and cardiovascular risk factors in both groups and evaluate if one group has improved management of their type 2 diabetes compared to the other. If the intervention proves effective, implementation on a national scale is highly feasible, and the intervention could probably be adapted to other lifestyle-related chronic diseases in Denmark and in other countries.

NCT Number	NCT04880005
Lead Sponsor	University of Southern Denmark Collaborators: Steno Diabetes Center Odense, Odense University Hospital, Steno Diabetes Center Sjaelland, Aalborg University, Holbaek Sygehus, Slagelse Sygehus
Conditions	Diabetes type2
Enrollment	400 participants
Start Date	2021-06-01
Primary Completion	2025-08-31 (estimated)
Study Completion	2025-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-02