MedicWise remote monitoring for active inflammatory bowel disease follow-up
Evaluation of a Remote Monitoring Application in the Follow-up of Patients With Active Inflammatory Bowel Diseases: The SECURITY Trial
This project will test whether the MedicWise remote monitoring app helps adults with active Crohn's disease or ulcerative colitis spend more time in remission.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 290 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives Academic / other |
| Locations | 1 site (Neuilly-sur-Seine, France) |
| Trial ID | NCT06742385 on ClinicalTrials.gov |
What this trial studies
This interventional project enrolls adults with active Crohn's disease or ulcerative colitis who require a change in medical therapy and can use a smartphone. Participants use the MedicWise platform and the SEMEIA app, which automatically collects biological data and healthcare consumption information to limit manual patient input, and are followed for 12 months. The primary outcome is time spent in remission, with key secondary outcomes including IBD-related disability, hospitalizations, complications, and healthcare costs. MedicWise is CE-marked and reimbursed in France for other chronic diseases, but prior telemonitoring studies in IBD have shown mixed results for disease control.
Who should consider this trial
Good fit: Adults (≥18) with a validated diagnosis of Crohn's disease or ulcerative colitis experiencing clinical activity that prompts a treatment change and who can use a smartphone and commit to 12 months of follow-up are ideal candidates.
Not a fit: Patients who cannot use a smartphone or email, are pregnant at baseline, have impending or recent major digestive surgery, short bowel syndrome, or uncontrolled comorbidities are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this approach could increase time spent in remission and reduce hospitalizations and overall IBD-related healthcare costs.
How similar studies have performed: Previous telemonitoring trials in IBD have generally not improved disease control or quality of life though they have reduced hospitalizations and costs, so the approach is partially supported but not conclusively proven in IBD.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Neuilly-sur-Seine, France
- Institut des MICI — Neuilly-sur-Seine, France, France (Recruiting)
Study contacts
- Study coordinator: Xavier TRETON, Pr
- Email: projet@getaid.org
- Phone: + 33 (0) 9 72 57 61 60
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.