JMIR Publications

ABSTRACT

Background:

Effective diabetes management requires a multimodal approach involving lifestyle changes, pharmacological treatment, and continuous patient education. Self-management demands can be overwhelming for patients, leading to lowered motivation, poor adherence and compromised therapeutic outcomes. In this context, digital health applications are emerging as vital tools to provide personalized support, enhance diabetes management and clinical outcomes.

Objective:

This study evaluated the impact of the digital health application Vitadio on glycemic control in patients with type 2 diabetes mellitus (T2DM). Secondary objectives included evaluating its effects on cardiometabolic parameters (weight, BMI, waist circumference, blood pressure, heart rate) and self-reported measures of diabetes distress and self-management.

Methods:

In this six-month, two-arm, multicentre, unblinded randomized-controlled trial, patients aged 18 years or older diagnosed with T2DM were randomly assigned (1:1) to an intervention group receiving standard diabetes care reinforced by the digital health application Vitadio or to a control group provided solely with standard diabetes care. Vitadio provided mobile-based self-management support tool featuring educational modules, motivational messages, peer support, personalized goal setting, and health monitoring. Personal consultant was available in the app to provide technical support for app-related issues. The primary outcome, assessed in the intention-to-treat population, was change in HbA1c levels at 6 months. Secondary outcomes included changes in cardiometabolic measures and self-reported outcomes. Data were collected in two study centres: diabetologist practice in Dessau-Roßlau and the University of Dresden.

Results:

Between November 2022 and June 2023, 276 patients were screened for eligibility, with 149 randomized into the trial (IG: 73, CG: 76). The majority of participants were male (61%). The dropout rate at month six was 19%. While both groups achieved significant HbA1c reduction at six months (intervention group: -0.8 ± 0.9%, p < 0.001; control group: -0.3 ± 0.7%, p = 0.001), the primary confirmatory analysis revealed statistically significant advantage of the intervention group (adjusted mean difference: -0.53%, 95% CI -0.24 to -0.82; p < 0.001, effect size d = 0.67 [0.33 to 1]). Significant between-group differences in favour of the intervention group were also observed for weight loss (p = 0.002), BMI (p = 0.001) and systolic blood pressure (p = 0.004). Additionally, Vitadio users experienced greater reduction in diabetes-related distress (p = 0.003) and obtained more pronounced improvements in self-care practices in the areas of general diet (p < 0.001), specific diet (p = 0.007), and exercise (p = 0.019).

Conclusions:

This trial provides evidence for superior efficacy of Vitadio in lowering the HbA1c levels in T2DM patients compared to standard care. Additionally, Vitadio contributed to the improvements in cardiometabolic health, reduced diabetes-related distress, and enhanced self-management, highlighting its potential as an accessible digital tool for comprehensive diabetes management. Clinical Trial: Registered in the German Clinical Trials Registry (DRKS00027405).