System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Studies

Interventional Active not recruiting Phase 4

NCT05780151 on ClinicalTrials.gov

Remote And Decentralised Innovative Approaches to Clinical Trials (RADIAL)

Official title: Pan-European Proof-of-concept Study Comparing Decentralised Clinical Trial (DCT) and Hybrid Approaches to Conventional Clinical Trial Approaches in Patients With Type 2 Diabetes Mellitus Treated With Toujeo®

  • Sponsor: MIRA (United Kingdom)
  • Collaborators: IMI Trials@Home consortium, Innovative Medicines Initiative, Sanofi
  • Enrollment: 107 (Actual)
  • Study start: 2023-07-10 (Actual)
  • Primary completion: 2024-11-01 (Estimated)
  • Study completion: 2025-11-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Parallel-group, open-label, multi-centre study
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

Pan-European proof-of-concept study comparing Decentralised Clinical Trial (DCT) and hybrid approaches to conventional clinical trial approaches in patients with Type 2 diabetes mellitus treated with Toujeo®.

Conditions

  • Diabetes Mellitus, Type 2

Intervention / Treatment

  • Other: Methodological intervention
  • Drug: Toujeo

Primary Outcome Measures

  • Enrolment rates (32 weeks)
    Time to enrolment from Site activation until last participant enrolled
  • Retention rates (6 months)
    Proportion of participants completing the study period
  • Diversity (10 weeks)
    Various diversity aspects such as race, ethnicity, socioeconomic status, digital literacy, distance to health care professional, mobility.
  • Participant satisfaction (6 months)
    Participant satisfaction measured using a questionnaire just after V2 (baseline), V6 and V9 (EOT)
  • Site staff satisfaction (6 months)
    Site staff satisfaction measured using a questionnaire (after study initiation visit \[SIV\]), after 3 enrolled participants, after 3 participants completed Week 12 and after last patient last visit (LPLV).
  • Study cost (complete trial duration)
    Absolute cost per participant using a combination of prospective and retrospective measurements
  • Time of AE (Adverse Event)/ SAE (Serious Adverse Event) occurence to collection (6 months)
    Time from event occurrence to collection AE/SAE in the eDiary or eCRF (electronic Case Report Form), whichever is applicable.
  • Treatment adherence (6 months)
    Adherence to the daily insulin injection by means of eDiary analysis in percentage of days of documented intake until participant's EOT.
  • Missing data (9 months)
    Proportion of missing data on the critical data points (Hb1Ac, Fasting Glucose, Participant satisfaction questionnaire)
  • Query rate (9 months)
    Number of queries (both manual and automatic) per participant per arm.

Countries

Denmark, Germany, United Kingdom

Locations and Investigators

  • Steno Diabetes Centre Odense, Odense, Denmark
  • Syddansk Universitet, Odense, Denmark
  • Studienzentrum Diabetespraxis Dr. Braun, Berlin, Germany
  • Klinische Forschung Dresden GmbH, Dresden, Germany
  • Velocity Clinical Research Leipzig GmbH, Leipzig, Germany
  • FutureMeds Soho Health Centre, Birmingham, United Kingdom
  • Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, United Kingdom
  • University Hospitals Leicester NHS Trust, Leicester, United Kingdom
  • NIHR Patient Recruitment Centre Newcastle, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, United Kingdom

Study Officials

  • Mira GP Zuidgeest, PhD (Principal Investigator) — UMC Utrecht