RecruitingNot ApplicableNCT06742385

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

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


Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Enrollment

290 participants

Start Date

Sep 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether a smartphone app called SEMEIA can help doctors monitor patients with inflammatory bowel disease (IBD — including Crohn's disease and ulcerative colitis) remotely when their disease is active and their treatment is being changed. **You may be eligible if...** - You are over 18 years old - You have a confirmed diagnosis of Crohn's disease or ulcerative colitis - Your IBD is currently active and your doctor is changing or starting a new treatment - You have a smartphone and are willing to use the app for 12 months **You may NOT be eligible if...** - You are under 18 years old - You are pregnant - You have had major bowel surgery (such as colostomy, removal of most of the colon, or extensive intestinal resection) - You had part of your small intestine removed less than 6 months ago - You are enrolled in another clinical trial involving an experimental treatment - You don't have access to a smartphone or email Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMedicWise

* Both arms are equipped with the application, data are collected via the application and telemonitoring with alerts to the care team are activated in the active telemonitoring arm. * Data are collected in both arms at baseline, M3, M6, M9 and M12 * Each center defines who handles alerts internally (physicians, IBD nurses, others, etc.) according to its internal organization. The application does not impose an internal operation. * the alert thresholds are identical and fixed for all centers during the study. Within the framework of the study, alerts are defined according to the study's modalities but cannot be modified by the centers. * Participating sites will have no obligation to respond to alerts. * Randomization will be stratified by centers and by diseases (Crohn and UC) with unbalanced blocks of randomization


Locations(1)

Institut des MICI

Neuilly-sur-Seine, France, France

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NCT06742385


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