Evaluation of a Digital Health Application for Diabetics Under Real-World Conditions: Superior Outcomes Compared to Standard Care in an Observational Matched Case–Control Study

Background: The present study aims to evaluate the effectiveness of ESYSTA® (Emperra GmbH E-Health Technologies, Germany), a CE-certified digital health application made to support insulin-treated diabetes patients to improve their disease management through better self-empowerment. Methods: To evaluate the effectiveness of ESYSTA®, data from patients who used ESYSTA® for at least 12 months and participated in an originally prospective one-arm study were evaluated. This study was conducted in cooperation with the German health insurance company AOK Nordost (2012–2015). From a real-world data pool of insured AOK Nordost patients, a control group was matched to mimic a controlled trial that allows the use of ESYSTA® to be compared with standard care in the context of a disease management program (DMP). Results: The study results show significant and clinically relevant reductions in HbA1c values of at least 0.4% in ESYSTA® users after 6 months. After 12 months, users achieved, on average, an HbA1c reduction of approximately 0.7%. These reductions are more pronounced compared to the matched control group. Conclusions: The present study shows the effectiveness of the digital health application ESYSTA®. Using a matched control group further increased the internal and external validity of the study results.