Cure8 trial brief
Remote monitoring could let care teams detect worsening disease sooner and tailor treatment changes, which might increase time spent in remission and reduce disability or hospital use.
This trial directly tests whether a CE-marked digital tool (MedicWise) improves time in symptomatic remission for people with active IBD.
Adults with Crohn's disease or ulcerative colitis, IBD clinicians and nurses, researchers studying digital health/telemonitoring, and health systems evaluating reimbursement for remote-monitoring tools.
This is a registered interventional trial (SECURITY) testing a remote monitoring digital tool (MedicWise) versus usual care in adults with active Crohn’s disease or ulcerative colitis.
The study will randomize patients to an active telemonitoring arm (alerts enabled to the care team) or a control arm (alerts disabled) and follow participants for 12 months, with the primary outcome defined as percentage of cumulative time spent in symptomatic remission over 12 months using PRO2-based definitions.
The MedicWise platform collects biological and healthcare-consumption data automatically and has CE marking; the trial will examine whether tighter remote monitoring increases time in remission and reduces IBD-related disability, and will also assess impacts on care-team organization.
Planned enrollment is 290 adults; randomization is stratified by center and disease (CD vs UC). Alerts have fixed thresholds for the study, and participating sites are not obligated to respond to alerts. If you are considering the implications: this trial tests a telemonitoring workflow and a specific commercial platform rather than a new drug.
Results, when available, may inform whether routine remote monitoring with automated data capture can change disease control or health-care usage in IBD.
This is a trial record (ACTIVE_NOT_RECRUITING) describing planned study design and outcomes; it does not report results. Prior studies of varied telemonitoring tools in IBD have had mixed results, with some secondary benefits reported. MedicWise is CE-marked and used in other chronic diseases in France, but trial outcomes are needed to show benefit for IBD.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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