LIVING - protocol for a pragmatic randomized controlled trial investigating the effect of three different levels of diabetes self-management programs

Abstract

Background

In Denmark, Type 2 Diabetes (T2D) care includes diabetes self-management programs (DSMPs) delivered by municipalities. Following a successful pilot study, a DSMP was expanded to include a digital platform and flexible educational materials. While exercise therapy is recognized as essential in T2D management, high-quality studies on DSMPs incorporating exercise are limited. This trial assesses the (cost)effectiveness of three interventions with escalating intensity, hypothesizing that higher intensity enhances diabetes management competence and reduces complication risk.

Methods/design

A pragmatic randomized controlled trial will assess three different DSMP interventions in six Danish municipalities acting as trial sites. Each site will implement one of three versions of Lev Livet: a short version (SLL), a full version (FLL), or the full version with high intensity exercise (FLL + H). At each site, 48 participants will be randomly assigned (2:1) to intervention or control groups. Primary outcome is perceived competence in diabetes (questionnaire). Other outcomes measure physical activity level (accelerometer),HbA1c, disease progression, physical function, and self-reported metrics. The trial is approved by the Danish National Center for Ethics (case no 1–10–72-107-23) and registered at ClinicalTrials.gov (NCT06091501).

Discussion

The LIVING trial has the potential to establish whether the Lev Livet program is effective and cost effective and how it can be implemented in municipalities. By analyzing dose-response relationships, the trial may refine intervention frequency and intensity, improve diabetes management, and inform both national and international guidelines for accessible, effective diabetes care.