drugset / Trial / NCT05780151
Remote And Decentralised Innovative Approaches to Clinical Trials (RADIAL)
Phase 4
Completed
107 enrolled
Mira Zuidgeest
IMI Trials@Home consortium · collabInnovative Medicines Initiative · collabSanofi · collab
RandomizedParallel-groupOpen-labelOther
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®.
Timeline
- Start
- 2023-07-10
- Primary completion
- 2025-01-21
- Completion
- 2025-01-21
Publications
- Kopanz J, Zuidgeest MGP, Rutgrink L, Keighron C, Grobbee DE, Lagerwaard B; Trials@Home consortium. Participant satisfaction across three trial arms with varying degrees of decentralisation in the RADIAL proof-of-concept trial. Trials. 2026 Mar 12;27(1):311. doi: 10.1186/s13063-026-09616-4.
- Weitlaner T, Giannikopoulos D, Lagerwaard B, Hilberger H, Neumayer B, Zuidgeest MGP, Hanke S; Trials@Home Consortium. Toward Effective Technology Support in DCTs: Insights from the Trials@Home Proof-of-Concept Trial RADIAL. J Med Syst. 2026 Mar 5;50(1):28. doi: 10.1007/s10916-026-02352-x.
- Zuidgeest MGP, Heath M, Lagerwaard B, van Weelij DR, Rutgrink L, Hanke S, Vedenkannas T, Kosonen T, Collamati S, Fons-Martinez J, Veen D, Gardarsdottir H, Mackenzie IS, Dupont S, Grobbee DE; Trials@Home consortium. Bringing Trial Activities to Participants-The Trials@Home RADIAL Proof-of-Concept Trial Investigating Decentralization of Trials. Clin Pharmacol Ther. 2025 Nov;118(5):1037-1045. doi: 10.1002/cpt.70025. Epub 2025 Sep 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Toujeo | Unknown | — | Other |