Design of the DAVOS Study: Diabetes Smartphone App, a Fully Automatic Transmission of Data From the Blood Glucose Meter and Insulin Pens Using Wireless Technology to Enhance Diabetes Self-Management-A Study Protocol for a Randomized Controlled Trial.

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.