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.