Evaluation of a Remote Monitoring Application in the Follow-up of Patients With Active Inflammatory Bowel Diseases
Not applicable · Testing MedicWise · 1 site · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing MedicWise (a device). Condition(s) listed: Crohn Disease and Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 80
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 2 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 290 participants are expected to take part.
- Start date: 2025-09-18.
- Main results expected around 2027-09-18 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- Percentage of cumulative time spent in symptomatic remission within 12 months (12 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease; Ulcerative Colitis |
| Lead sponsor | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
| Collaborators | AbbVie; Semeia |
| Enrollment | 290 (estimated) |
| Start date | 2025-09-18 |
| Primary completion (est.) | 2027-09-18 |
| First posted | 2024-12-19 |
| Last updated | 2025-09-24 |
| Official title | Evaluation of a Remote Monitoring Application in the Follow-up of Patients With Active Inflammatory Bowel Diseases: The SECURITY Trial |
| ClinicalTrials.gov ID | NCT06742385 |
Interventions
- 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 …
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Institut des MICI | Neuilly-sur-Seine, France | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.