Evaluation of a Digital Lifestyle Intervention ("Vitadio") on Self-management and Diabetes Control: An Observational Study

Hypotheses The EDDY trial investigated whether the digital health application Vitadio is superior to standard diabetes care and has a clinically meaningful impact on HbA1c in patients with type 2 diabetes mellitus. Methods A three-month prospective, open-label trial with an intraindividual control group was conducted. The Intervention group received Vitadio, a digital lifestyle intervention. The intraindividual control group (consisting of the same patients) was treated with standard diabetes care. Metabolic parameters, patient reported outcomes and app-reported data (e.g., frequency of use, steps, meal logging) were observed at baseline and after 3 months of app use. HbA1c value was collected retrospectively 3 months before Vitadio use, at baseline and 3 months follow up of Vitadio use based on patient records. Repeated measures ANOVA was used to assess the significance of difference in HbA1c values. Results 42 participants completed the study (mean 57±7.4 years, 55% male). The mean baseline HbA1c was 7.9±1.0%. The Intervention group achieved an average HbA1c reduction of -0.9±1.1% (p<0.001) and significantly reduced body weight (-4.3±4.5kg), body mass index (-1.4±1.5kg/m2), waist circumference (-5.7±15cm) and fasting glucose (-0.6±1.3mmol/l). In the control group, the HbA1c decrease of 0.3±1.1% was not statistically significant. The difference between the intervention and control group was statistically significant [F (2, 78)=28.26, p<0.001]. Conclusion Vitadio achieved a significant HbA1c reduction and improvement in metabolic parameters. These results provide preliminary evidence on the impact of Vitadio on glycemic control and diabetes self-management for provisional listing as a DiGA by the BfArM. Publication History Article published online: 26 May 2022 © 2022. Thieme. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany