Sound Evidence Generation for DiGA is Possible

The evaluation process for digital health apps is particularly challenging for start-ups. Obtaining data from high-quality studies to prove a positive care effect of an app requires extensive knowledge of clinical research methods. In addition, DiGA studies must generate convincing data in the shortest possible time and with limited budgets. Contract research organizations for clinical research can provide crucial support here. This is demonstrated by the successful launch of the first gastroenterology app in Germany.

(March, 2024) CSG was an operational partner in the launch of the first and so far only gastroenterology DiGA for the treatment of irritable bowel syndrome in Germany. Together with the manufacturer, HiDoc Technologies, the "Cara Care for Irritable Bowel Syndrome" app was permanently included in the Federal Institute for Drugs and Medical Devices' (BfArM) list of reimbursable DiGAs. This allows doctors to prescribe the application at the expense of statutory health insurance. Currently, 33 DiGAs have achieved this (as of March 2024).
CSG supported the manufacturer in the implementation of the decisive study for the evaluation procedure: a prospective, multi-centre, two-arm, randomized study with almost 400 patients. The University Hospital Brandenburg an der Havel was also involved in the clinical trial. The study showed that the app reduces symptoms and improves the quality of life of those affected. The study concept was developed by the IGES Institute.

For more information, please contact CSG’s team: csg@csg-germany.com