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

NCT ID: NCT06742385

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-18
• Study Completion Date: 2028-09-18

Brief 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.

Detailed Description

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.

Main objective: To evaluate whether tight control through remote monitoring device improves disease activity compare to standard of care in patients with active Inflammatory Bowel Disease (IBD).

Conditions

Crohn Disease; Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Active arm

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.

Group Type: EXPERIMENTAL

MedicWise

Intervention Type: DEVICE

• 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

Control arm

Both arms are equipped with the application, data are collected via the application and telemonitoring with alerts to the care team are inactivated in the active control arm.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MedicWise

• 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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• CD/UC patients with a validated diagnosis
• Patients age > 18 years
• IBD with clinical signs of PRO2 activity leading to modification of medical treatment: introduction of a new treatment, or change of dose or addition of a treatment (corticoids, ASA, IS, biotherapy (a 4 week induction phase is authorized
• Patients willing and able to participate in the collection of data via SEMEIA App on their smartphone
• Patients agreeing to participate for 12 months

Exclusion Criteria

• Patients with an inability to use a smartphone and email
• Patients < 18 years old
• Digestive surgery expected within 3 months
• Pregnancy at baseline
• Patients with an history of sub-total colectomy, coloproctectomy, digestive ostomy, extensive or multiple intestinal resections with sequelae of diarrhoea, short bowel syndrome.
• Patients who have had recent digestive surgery (ileal resection < 6 months) Patients with any other uncontrolled somatic or psychiatric pathology
• Patients enrolled in a trial with an investigational treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: collaborator

Semeia

INDUSTRY

Sponsor Role: collaborator

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut des MICI

Neuilly-sur-Seine, France, France

Site Status: RECRUITING

Countries

France

Central Contacts

Xavier TRETON, Pr

Role: CONTACT

projet@getaid.org

+ 33 (0) 9 72 57 61 60

GETAID GETAID

Role: CONTACT

projet@getaid.org

+ 33 (0) 9 72 57 61 60

Facility Contacts

Xavier TRETON, Professeur

Role: primary

xavier.treton@institutdesmici.fr

Other Identifiers

GETAID-2023-02

Identifier Type: -

Identifier Source: org_study_id