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.
ZUSAMMENFASSUNGStand Oktober 2022 sind bereits 2 Diabetes-DiGAs zugelassen – HelloBetter (Zulassung Dezember 2021) und Vitadio (Zulassung April 2022). Des Weiteren gibt es mit zanadio (Zulassung November 2020) und Oviva Direkt (Zulassung Oktober 2021) 2 Adipositas-DiGAs, welche ebenfalls Patientinnen und Patienten mit Diabetes mellitus unterstützen. Viele weitere DiGAs sind in den Startlöchern und werden im Laufe des nächsten halben Jahres das DiGA-Verzeichnis füllen. Die Entwicklung erfolgt einerseits von ärztlichen Kolleginnen und Kollegen, andererseits von Start-Ups oder Konsortien gemeinsam mit Universitäten. Neben der ambulanten und stationären Therapie haben DiGAs das Potenzial, die dritte Säule in der Gesundheitsversorgung darzustellen. Die rasante Entwicklung wird von einigen Kolleginnen und Kollegen kritisch oder mit Skepsis gesehen, andere hingegen integrieren DiGAs bereits in die Praxis und sammeln erste Erfahrungen mit dem Einsatz dieser. Das Zulassungsverfahren von DiGAs ist vergleichbar mit dem neuer Medikamente und zusätzlich zum Therapieindikator muss auch ein positiver Versorgungseffekt nachgewiesen werden. Informationen darüber, wie die erstattungsfähigen DiGAs verordnet werden, finden sich im DiGA-Verzeichnis unter Informationen für Fachkreise. DiGAs ermöglichen ein besseres Empowerment der Patientinnen und Patienten für ein optimiertes Selbstmanagement und weisen den Weg zu einem patientenzentrierten Behandlungsansatz.
Stand Februar 2023 sind 2 Adipositas DiGAs zugelassen, welche Patientinnen und Patienten mit Diabetes mellitus unterstützen: zanadio (vorläufige Zulassung 2020, endgültige Zulassung 2022) und Oviva Direkt (vorläufige Zulassung Oktober 2021). In diesem Artikel der DiGA-Serie wird die DiGA zanadio 1 unter die Lupe genommen, die wichtigsten Informationen präsentiert, sowie kleine Einblicke in die App gewährt.
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