Bretschneider Maxi Pia, Kolasińska Agnieszka Barbara, Šomvárska Lenka, Klásek Jan, Mareš Jan, Schwarz Peter Eh
Department of Prevention and Care of Diabetes, Department of Medicine III, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
Vitadio s.r.o., Prague, Czech Republic.
J Med Internet Res. 2025 May 9;27:e68648. doi: 10.2196/68648.
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.
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.
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 (HbA) 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.
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 HbA 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).
This trial provides evidence for the superior efficacy of Vitadio in lowering the HbA 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.
German Clinical Trials Registry DRKS00027405; https://drks.de/search/de/trial/DRKS00027405.
有效的糖尿病管理需要多模式方法，包括生活方式改变、药物治疗和持续的患者教育。自我管理的要求对患者来说可能不堪重负，导致动力降低、依从性差和治疗效果受损。在这种背景下，数字健康应用程序正成为提供个性化支持、改善糖尿病管理和临床结果的重要工具。
本研究评估了数字健康应用程序Vitadio对2型糖尿病（T2DM）患者血糖控制的影响。次要目标包括评估其对心脏代谢参数（体重、BMI、腰围、血压和心率）以及自我报告的糖尿病困扰和自我管理指标的影响。
在这项为期6个月的双臂、多中心、非盲随机对照试验中，将年龄在18岁及以上、诊断为T2DM的患者随机（1:1）分配到干预组（IG），接受由数字健康应用程序Vitadio强化的标准糖尿病护理，或分配到仅接受标准糖尿病护理的对照组（CG）。Vitadio提供了一个基于移动设备的自我管理支持工具，具有教育模块、激励信息、同伴支持、个性化目标设定和健康监测功能。应用程序中有个人顾问，可提供与应用程序相关问题的技术支持。在意向性分析人群中评估的主要结局是6个月时糖化血红蛋白（HbA）水平的变化。次要结局包括心脏代谢指标和自我报告结局的变化。数据在2个研究中心收集：德绍-罗斯劳的糖尿病专家诊所和德累斯顿大学。
在2022年11月至2023年6月期间，共有276名患者接受了资格筛查，其中149名被随机分配到干预组（IG；n = 73）和对照组（CG；n = 76）。大多数参与者为男性（91/149，61%）。6个月时的脱落率为19%（121/149）。虽然两组在6个月时HbA均显著降低（IG：平均 -0.8，标准差0.9%，P <.001；CG：平均 -0.3，标准差0.7%，P =.001），但主要验证性分析显示IG具有统计学显著优势（调整后平均差异：-0.53%，标准差0.15，95%置信区间 -0.24至 -0.82；P <.001；效应大小[Cohen d] = 0.67，95%置信区间0.33 - 1）。在体重减轻（P =.002）、BMI（P =.001）和收缩压（P <.03）方面，也观察到有利于IG的显著组间差异。此外，Vitadio用户的糖尿病相关困扰减少更多（P <.03），并且在总体饮食（P <.001）、特定饮食（P <.03）和运动（P <.03）等自我护理实践方面有更明显的改善。
本试验为Vitadio在降低T2DM患者HbA水平方面优于标准护理提供了证据。此外，Vitadio有助于改善心脏代谢健康、减少糖尿病相关困扰并增强自我管理，凸显了其作为一种可及的数字工具用于全面糖尿病管理的潜力。
德国临床试验注册中心DRKS00027405；https://drks.de/search/de/trial/DRKS00027405 。
