Evaluation of a Remote Monitoring Application in the Follow-up of Patients With Active Inflammatory Bowel Diseases

Telemonitoring is of definite theoretical interest for patients suffering from chronic diseases and could help to improve monitoring of treatment efficacy and tolerance, and hence remission and quality of life. Reimbursement is now planned in France for devices that have demonstrated a positive effect on patient intake. However, available studies testing different tools in IBD have shown no significant improvement in disease control or quality of life. Nevertheless, major secondary endpoints such as reduced hospitalization, complications and healthcare costs have been demonstrated. Several biases have been identified to explain these disappointing results, such as the heterogeneity of the tools/applications tested, methodological limitations concerning the main objective and technological limitations of the tools evaluated. We propose here to evaluate the impact of a tight remote monitoring through digital tool on disease control, in patients with active IBD, thanks to the MedicWise platform. The technology of the MedicWise solution enables the automatic collection of a wide range of biological and healthcare consumption data, thus limiting the need for patient input. MedicWise has obtained the CE label and is already used and reimbursed in France in other chronic diseases. The SECURITY trial proposes to evaluate the impact of a tight remote monitoring through digital tool on time spent in remission. Improvement of IBD related disability is also a major secondary objective of the study. It also has the following secondary objectives to analyze the impact of this tool on the organization of care teams caring for patients with IBD.

NCT Number	NCT06742385
Lead Sponsor	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives Collaborators: AbbVie, Semeia
Conditions	Crohn Disease, Ulcerative Colitis
Enrollment	290 participants
Start Date	2025-09-18
Primary Completion	2027-09-18 (estimated)
Study Completion	2028-09-18 (estimated)
Updated on ClinicalTrials.gov	2025-09-24