Effect of emerging digital technologies and methodologies combined with incentives on HbA1c in patients with type 2 diabetes mellitus: study protocol for a parallel, open randomized controlled trial.

Background: Type 2 diabetes mellitus (T2DM) is a common metabolic disease that requires long-term management and treatment. Digital intervention, as an emerging medical model, has been widely used in the treatment of T2DM patients. Behavioral economics theory provides a favorable perspective for studying the effect of digital intervention because it can reveal the decision-making mechanisms behind human behavior and provide more effective interventions for digital intervention. The purpose of this trial is to evaluate the impact of behaviorally based digital intervention on T2DM patients' HbA1c, self-monitoring of blood glucose (SMBG) testing rate, diabetes self-efficacy, and other indicators compared to conventional treatment.

Methods: This trial is a prospective randomized controlled trial conducted at the First People's Hospital of Kunshan City from April 1, 2023, to December 31, 2024, with a follow-up period of 3 months. The specific randomization method was established and implemented through the EDC clinical trial center's randomization system. We will measure and collect baseline data from three groups, including Group A: digital intervention + virtual incentives + conventional treatment, Group B: digital intervention + physical incentives + conventional treatment, and Group C: conventional treatment. HbA1c, weight, SMBG testing rate, diabetes self-efficacy, and diabetes-related medical expenses will be recorded at baseline, 1 month, 2 months, and 3 months for all three groups. The Shapiro-Wilk test will be used to test for normality, and Pearson correlation analysis will be used for correlation analysis. Dropouts will be analyzed separately. Analysis of variance or exact probability calculation will be used to compare demographic data and other baseline indicators.

Discussion: This study is a novel clinical trial that integrates multiple disciplines (economics and medicine) and uses digital technology to deliver the intervention. Most published studies were offline interventions based on behavioral economics theory, but very few were on online interventions for T2DM patients. This study has both novelty and social value.

Trial Registration: Chinese Clinical Trial Registry ChiCTR2300070753. Registered on 2023/04/22.