Evaluation of a Remote Monitoring Application in the Follow-up of Patients With Active Inflammatory Bowel Diseases
Crohn Disease · Ulcerative Colitis
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - 80 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 290 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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).
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
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.
Device: MedicWise
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.
MedicWise 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
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Percentage of cumulative time spent in symptomatic remission within 12 months
Time frame: 12 months
Percentage of cumulative time spent in symptomatic remission within 12 months
Time spent in symptomatic remission defined by (PRO2):
MC: abdominal pain ≤ 1 and stool frequency ≤ 3 defined clinical remission in CD, both not worsening compared from inclusion
UC: absence of rectal bleeding (score 0) and stool frequency score ≤ 1, both not worsening compared with inclusion
Secondary measures
Average value of IBD disk change from baseline over 12 months (M3, M6, M9 and M12)
Time frame: 12 months
Average value of IBD disk change from baseline over 12 months (M3, M6, M9 and M12)
Average value of IBD disk change from baseline over 12 months
Time frame: 12 months
Average value of IBD disk change from baseline over 12 months
Patient report outcomes (PR02), questionnaire to assess this outcome measure at M6 and M12
Time frame: 6 and 12 months
Patient report outcomes (PR02), questionnaire to assess this outcome measure at M6 and M12
Short Inflammatory Bowel Disease (S-IBDQ) delta mean value between inclusion and M12 (The total score ranges from 10 to 70, with the higher the score, the better the quality of life.)
Time frame: 12 months
Short Inflammatory Bowel Disease (S-IBDQ) delta mean value between inclusion and M12
Average value of Short Inflammatory Bowel Disease (S-IBDQ) delta mean value between inclusion and M12 (The total score ranges from 10 to 70, with the higher the score, the better the quality of life.) change from baseline over 12 months
Time frame: 12 months
Average value of Short Inflammatory Bowel Disease (S-IBDQ) delta mean value between inclusion and M12 (The total score ranges from 10 to 70, with the higher the score, the better the quality of life.) change from baseline over 12 months
Number of contacts / consultations / hospitalizations during 12 months
Time frame: 12 months
Number of contacts / consultations / hospitalizations during 12 months
Medication and care compliance/consumption over 12 months
Time frame: 12 months
Medication and care compliance/consumption over 12 months
number of complications (AE/SAE, hospitalizations, surgeries) over 12 months
Time frame: 12 months
number of complications (AE/SAE, hospitalizations, surgeries) over 12 months
Satisfaction questionnaires (patients/care team) at M12
Time frame: 12 months
Satisfaction questionnaires (patients/care team) at M12
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Institut des MICINeuilly-sur-Seine, France, FranceStatus unknown
Study team and timeline
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Study start
- Sep 18, 2025 Actual
- Primary completion
- Sep 18, 2027 Estimated
- Study completion
- Sep 18, 2028 Estimated
- First posted
- Dec 19, 2024 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Evaluation of a Remote Monitoring Application in the Follow-up of Patients With Active Inflammatory Bowel Diseases: The SECURITY Trial
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026