Randomized controlled trial to evaluate an app-based multimodal digital intervention for people with type 2 diabetes in comparison to a placebo app

IntroductionThis 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.MethodA 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.ResultsAfter six 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.ConclusionThese findings indicate that the digital approach can meaningfully improve both glycemic control and psychological well-being in people with type 2 diabetes, supporting its potential integration into routine care.Clinical Trial Registrationhttps://www.evamebix.de, identifier DRKS00025719, DRKS00032395.