CLINICAL TRIAL article
Front. Digit. Health
Sec. Health Technology Implementation
Volume 7 - 2025 | doi: 10.3389/fdgth.2025.1644612
This article is part of the Research TopicDigital Medicine and Artificial IntelligenceView all 17 articles
Randomized Controlled Trial to evaluate an App-Based Multimodal Digital Intervention for people with Type 2 Diabetes in comparison to a Placebo App
Provisionally accepted
- 1University Hospital Carl Gustav Carus, Dresden, Germany
- 2Technische Universitat Dresden Paul Langerhans Institut Dresden, Dresden, Germany
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This multi-center, parallel-group randomized controlled trial evaluated the app-based intervention mebix, developed by Vision2b GmbH in Germany, for people with type 2 diabetes compared to a placebo app. A total of 153 participants were randomized in a 1:1 ratio to either intervention or control group, with allocation concealment ensured by a minimization procedure.. After sic months, participants using mebix achieved a statistically significant reduction in HbA1c levels by 0.82 percentage points (95% confidence interval: -1.20, -0.48, p = 0.003). This reduction was greater than in the control group (mean difference: 0.24 percentage points, 95% confidence interval: -0.44, 0.09). mebix users further experienced greater weight loss, lower diabetes-related distress, and reduced depression severity. Adherence to the app was high, with more than 75% of participants using mebix throughout the study period. These findings indicate that the digital pproach can meaningfully improve both glycemic control and psychological well-being in people with type 2 diabetes, supporting its potential integration into routine care.
Keywords: HbA1c reduction, digital health intervention, diabetes type 2 (T2D), dIgA, diabetes self-management, Well-being, lifestyle intervention
Received: 10 Jun 2025; Accepted: 21 Oct 2025.
Copyright: © 2025 Roth, Bretschneider and Schwarz. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Lena Roth, lena_maria_klara.roth@tu-dresden.de
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