The aim of this study was to provide preliminary evidence on the impact of the digital health application Vitadio on improving glycemic control in patients with type 2 diabetes mellitus. This was a 3-month, prospective, multicenter, open-label trial with an intraindividual control group. Participants received a digital lifestyle intervention. HbA1c levels were observed at 3 time points: retrospectively, at 3 months before app use; at baseline, at the start of usage; and 3 months after the start of use. In addition, changes in other metabolic parameters (fasting glucose, body weight, and waist circumference), patient reported outcomes (quality of life, self-efficacy, and depression), and data generated within the app (frequency of use, steps, and photos of meals) were evaluated. Repeated measures analysis of variance with the Bonferroni correction was used to assess the overall difference in HbA1c values between the intervention and the intraindividual control group, with p < 0.05 considered significant. Participants (n = 42) were 57 ± 7.4 years old, 55% male, and with a mean baseline HbA1c of 7.9 ± 1.0%. An average HbA1c reduction of −0.9 ± 1.1% (p < 0.001) was achieved. The digital health application was effective in significantly reducing body weight (−4.3 ± 4.5 kg), body mass index (−1.4 ± 1.5 kg/m2), waist circumference (−5.7 ± 15 cm), and fasting glucose (−0.6 ± 1.3 mmol/L). The digital therapy achieved a clinically meaningful and significant HbA1c reduction as well as a positive effect on metabolic parameters. These results provide preliminary evidence that Vitadio may be effective in supporting patient diabetes management by motivating patients to adopt healthier lifestyles and improving their self-management.

1st Faculty of Medicine Charles University Prague Kateřinská 32 121 08 Prague Czech Republic

Department for Prevention and Care of Diabetes Department of Medicine 3 Faculty of Medicine Carl Gustav Carus Technische Universität Dresden Fetscherstrasse 74 01307 Dresden Germany

Department of Health Faculty of Medicine Masaryk University Kamenice 5 625 00 Brno Czech Republic

German Center for Diabetes Research Ingolstädter Landstraße 1 85764 Neuherberg Germany

Institute of Economic Studies Faculty of Social Sciences Charles University Prague Opletalova 26 110 00 Prague Czech Republic

Paul Langerhans Institute Faculty of Medicine Technische Universität Dresden Tatzberg 47 01307 Dresden Germany

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Evaluation of the Impact of Mobile Health App Vitadio in Patients With Type 2 Diabetes: Randomized Controlled Trial