NCT05780151: RADIAL

Remote And Decentralised Innovative Approaches to Clinical Trials (RADIAL)

Completed Phase 4 Last updated 29 May 2025

What this trial tests

Phase 4 trial testing Methodological intervention in Diabetes Mellitus, Type 2 in 107 participants. Completed in 21 January 2025.

Timeline

10 July 2023

Primary endpoint
21 January 2025

21 January 2025

Quick facts

Lead sponsor	Mira Zuidgeest
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	107
Start date	10 July 2023
Primary completion	21 January 2025
Estimated completion	21 January 2025
Sites	9 locations across Denmark, United Kingdom, Germany

Drugs / interventions tested

• Methodological intervention
• Toujeo

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Mira Zuidgeest — full company profile →

Who can join

18 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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®.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bringing Trial Activities to Participants-The Trials@Home RADIAL Proof-of-Concept Trial Investigating Decentralization of Trials.
   Zuidgeest MGP, Heath M, Lagerwaard B, van Weelij DR, et al · · 2025 · cited 6× · PMID 40888335 · DOI 10.1002/cpt.70025
2. Selecting and Preparing Clinical Sites for the Successful Conduct of Decentralized Clinical Trial Activities-Findings From the Trials@Home RADIAL Proof-of-Concept Trial.
   Lipinska K, van Weelij D, Lagerwaard B, Rutgrink L, et al · · 2025 · cited 4× · PMID 41035203 · DOI 10.1002/cpt.70075
3. Recruiting and Consenting Decentralized Clinical Trial Participants-Learnings from the Trials@Home RADIAL Proof-of-Concept Trial.
   Lagerwaard B, Rutgrink L, van Weelij D, Lipinska K, et al · · 2025 · cited 4× · PMID 40906242 · DOI 10.1002/cpt.70042
4. Operationalizing Decentralized Clinical Trials: Technology Insights from the Trials@Home RADIAL Proof-of-Concept Trial.
   Hanke S, Giannikopoulos D, Neumayer B, Vedenkannas T, et al · · 2025 · cited 3× · PMID 40970561 · DOI 10.1002/cpt.70070
5. The Supply of Investigational Medicinal Product and Management of Study Materials for Decentralized Participants-Insights from the Trials@Home RADIAL Proof-of-Concept Trial.
   Heath M, de Jong AJ, Magorrian-Spence S, Jin C, et al · · 2025 · cited 2× · PMID 40988634 · DOI 10.1002/cpt.70072
6. Participant satisfaction across three trial arms with varying degrees of decentralisation in the RADIAL proof-of-concept trial.
   Kopanz J, Zuidgeest MGP, Rutgrink L, Keighron C, et al · · 2026 · PMID 41814361 · DOI 10.1186/s13063-026-09616-4
7. Toward Effective Technology Support in DCTs: Insights from the Trials@Home Proof-of-Concept Trial RADIAL.
   Weitlaner T, Giannikopoulos D, Lagerwaard B, Hilberger H, et al · · 2026 · PMID 41781790 · DOI 10.1007/s10916-026-02352-x
8. Decentralized Clinical Trials in the Era of Real-World Evidence: A Critical Assessment of Recent Experiences.
   Wang H, Daizadeh N, Shen YL, Chen J, et al · · 2025 · PMID 40920390 · DOI 10.1111/cts.70328