In this study, we evaluated whether the digital program Vitadio achieves comparable results to those of an intensive in-person lifestyle intervention in obesity management. This is a 12-month prospective, randomized controlled trial. Obese patients with insulin resistance, prediabetes or type 2 diabetes were included. The intervention group (IG) used Vitadio. The control group (CG) received a series of in-person consultations. Body weight and various metabolic parameters were observed and analyzed with ANOVA. The trial is ongoing and the presented findings are preliminary. Among 100 participants (29% men; mean age, 43 years; mean BMI, 40.1 kg/m²), 78 completed 3-month follow-up, and 51 have completed the 6-month follow-up so far. Participants significantly (p < 0.01) reduced body weight at 3 months (IG: −5.9 ± 5.0%; CG: −4.2 ± 5.0%) and 6 months (IG: −6.6±6.1%; CG: −7.1 ± 7.1%), and the difference between groups was not significant. The IG achieved favorable change in body composition; significant improvement in TAG (−0.6 ± 0.9 mmol/l, p < 0.01), HDL (0.1 ± 0.1%, p < 0.05), HbA1c (−0.2 ± 0.5%, p < 0.05) and FG (−0.5 ± 1.5 mmol/l, p < 0.05); and a superior (p = 0.02) HOMA-IR reduction (−2.5 ± 5.2, p < 0.01). The digital intervention achieved comparable results to those of the intensive obesity management program. The results suggest that Vitadio is an effective tool for supporting patients in obesity management and diabetes prevention.

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.

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 apps are emerging as vital tools to provide personalized support and 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, and heart rate) and self-reported measures of diabetes distress and self-management. Methods: In this 6-month, 2-arm, multicenter, unblinded randomized controlled trial, patients aged 18 years or older diagnosed with T2DM were randomly assigned (1:1) to an intervention group (IG) receiving standard diabetes care reinforced by the digital health app Vitadio or to a control group (CG) provided solely with standard diabetes care. Vitadio provided a mobile-based self-management support tool featuring educational modules, motivational messages, peer support, personalized goal setting, and health monitoring. The 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 a change in glycated hemoglobin (HbA1c) levels at 6 months. Secondary outcomes included changes in cardiometabolic measures and self-reported outcomes. Data were collected in 2 study centers: diabetologist practice in Dessau-Roßlau and the University of Dresden. Results: Between November 2022 and June 2023, a total of 276 patients were screened for eligibility, with 149 randomized to in intervention group (IG; n=73) and a control group (CG; n=76). The majority of participants were male (91/149, 61%). The dropout rate at month 6 was 19% (121/149). While both groups achieved significant HbA1c reduction at 6 months (IG: mean –0.8, SD 0.9%, P<.001; CG: mean –0.3, SD 0.7%, P=.001), the primary confirmatory analysis revealed statistically significant advantage of the IG (adjusted mean difference: –0.53%, SD 0.15, 95% CI –0.24 to –0.82; P<.001; effect size [Cohen d]=0.67, 95% CI 0.33-1). Significant between-group differences in favor of the IG were also observed for weight loss (P=.002), BMI (P=.001) and systolic blood pressure (P<.03). In addition, Vitadio users experienced greater reduction in diabetes-related distress (P<.03) and obtained more pronounced improvements in self-care practices in the areas of general diet (P<.001), specific diet (P<.03), and exercise (P<.03). Conclusions: This trial provides evidence for the superior efficacy of Vitadio in lowering the HbA1c levels in T2DM patients compared to standard care. In addition, Vitadio contributed to improvements in cardiometabolic health, reduced diabetes-related distress, and enhanced self-management, highlighting its potential as an accessible digital tool for comprehensive diabetes management. Trial Registration: German Clinical Trials Registry DRKS00027405; https://drks.de/search/de/trial/DRKS00027405.

(1) Background: This study aimed at providing preliminary evidence for mebix, an app-based treatment program for patients with diabetes mellitus type II. The main target was to show a positive healthcare impact as defined by improved blood glucose control, i.e., reduced HbA1c values. (2) Methods: For this, a 3-month, prospective, open-label trial with an intraindividual control group was conducted. Participants received the mebix intervention for 3 months. HbA1c values were observed every 3 months: retrospectively, at baseline, and 3 months after the start of using the app. Additionally, weight and patients’ reported outcomes (well-being, diabetes-related distress, and self-management) were assessed. Data generated within the app were summarized and analyzed (steps, physical activity, fulfilled tasks, and food logs). (3) Results: After the usage of mebix for 3 months, participants significantly reduced their HbA1c levels (−1.0 ± 0.8%). Moreover, improvements in weight, well-being, and self-management as well as a reduction in diabetes-related distress were observed. App-generated data mainly supported the other main finding, that higher baseline HbA1c values lead to higher reductions. Overall, the study provided preliminary evidence that mebix can help patients improve metabolic and psychological health outcomes.

Background: Digital interventions are promising additions for both usual care and rehabilitation. Evidence and studies for the latter, however, are still rare. Objective: The aim of the study was to examine the app/web-based patient education program called “mebix” (previously called “Vision 2 – Gesundes Herz”) regarding its effectiveness in relation to the parameters of disease-specific quality of life (HeartQoL), cardiovascular risk profile (Cardiovascular Risk Management [CARRISMA]), and prognostic estimation of early retirement (Screening instrument work and occupation [SIBAR]) in 190 participants from a cardiological rehabilitation clinic. Methods: To evaluate mebix, 354 patients from the Roderbirken Clinic of the German Pension Insurance Rhineland (Germany) with a coronary heart diesase were recruited and randomized either to the intervention group (using mebix postrehabiliation for up to 12 months) or the control group (receiving standard care). The data collection took place at the end of inpatient rehabilitation (t0), as well as 6 months (t1) and 12 months (t2) after the end of rehabilitation. Analyses of variance are used to assess the overall significance of difference in outcome parameters between groups and over time. Results: The primary endpoint of disease-related quality of life shows a significant improvement of 7.35 points over the course of the intervention that is also more pronounced in the intervention group. Similarly, the 10-year risk of cardiovascular death and myocardial infarction showed significant improvements in the cardiovascular risk profile over time and between groups, indicating better results in the intervention group (ie, a reduction of −1.59 and −5.03, respectively). Secondary outcomes like the body weight and cholesterol levels were significantly reduced in the intervention group, also in comparison with the control group. In addition, the SIBAR was significantly lower/better at the end of the observation period than at the beginning of the observation for both groups. Conclusions: Overall, the digital training program represents an effective follow-up offer after rehabilitation that could be incorporated into standard care to further improve disease-related quality of life and cardiovascular risk profiles.

Background: In the treatment of diabetes mellitus, the challenge is to integrate adequate self-management into clinical care. Customization including goal setting, monitoring, and feedback could be achieved through digitization. Digital linking between different devices could simplify and promote self-management. The aim of this study is to evaluate the outcome of diabetes treatment assisted by a digital health application compared with standard diabetes therapy. Methods: The DAVOS study is a 6-month-period prospective, multicentric, randomized controlled trial. In total, 154 diabetes patients (age ≥18; treated with insulin) will be recruited and randomized into control group or intervention group. Both groups will receive standard diabetes care. The intervention group will additionally use a diabetes app. HbA1c value will be monitored on three separate defined visits. Primary endpoint is the overall reduction of HbA1c value. Secondary endpoints (eg, usability of the app) will be determined through patient-reported outcome questionnaires. Discussion: Through enhanced interaction of health care professionals, providers of the app, and patients, the study aims to demonstrate improvement in the self-management of diabetes. As part of the closure management, all patients will be invited to use the examined application after completion of the study. The DAVOS study will be conducted in accordance with the valid version of the present study protocol and the internationally recognized International Conference on Harmonization–Good Clinical Practice (ICH-GCP) Guidelines. Special attention will be paid to European, national, and regional requirements for the approval, provision, and use of medical devices. The study was registered in the German Register of Clinical Trials (DRKS) with number DRKS00025996.