Skin Reaction Report Form: Development and Design of a Standardized Report Form for Skin Reactions Due to Medical Devices for Diabetes Management

Background: Skin reactions due to medical devices for diabetes management have become a common problem in diabetes technology. There is a varying degree in how detailed skin reactions are described in scientific literature and diabetes practice, and no uniform structured documentation is given. Whereas most articles only describe findings, some others already document final diagnoses, such as contact dermatitis. Furthermore, inconsistent wordings for comparable issues were used. Methods: A more detailed and standardized documentation, possibly facilitated by a generally accepted guideline for structured descriptions, of skin reactions could be helpful to enable better differentiations between the described skin reactions. Therefore, a report form to assess skin reactions due to medical devices in diabetes therapy was developed and will be presented in this article. Results: The one-page report form is divided into four categories and a separate instruction paper. Beside general information the form includes the location, size, severity and duration of skin appearances, the grading of itching, and suspected diagnoses. Conclusion: A consistent use of the form in daily practice and clinical trials could facilitate a fast and standardized documentation and help to evaluate the occurrence and severity of different skin reactions due to medical devices in diabetes management.