Remote And Decentralised Innovative Approaches to Clinical Trials (RADIAL)

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

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®.

It had three arms (groups): Conventional (active comparator), Hybrid (active comparator) and Remote (active comparator).

In RADIAL, the main study intervention is a methodological intervention with patients being recruited into three arms with different level of decentralization. Additionally, participants in all arms are switching from their previously used basal insulin to Toujeo®, which is the clinical intervention, in the protocol defined as the study drug. The conventional arm is modelled after a previous clinical trial with a similar indication and intervention and aims to represent current state-of-the art clinical trial conduct.

In RADIAL, the main study intervention is a methodological intervention with patients being recruited into three arms with different level of decentralization. Additionally, participants in all arms are switching from their previously used basal insulin to Toujeo®, which is the clinical intervention, in the protocol defined as the study drug. The remote arm is fully decentralised and aims to represent future decentralised clinical trial practice using a decentralised recruitment model, intervention period and data collection.

The registry classes the interventions as drug and other.

More on the Plan

The proposed study has been designed to compare the scientific and operational quality of fully decentralised and hybrid approaches to a conventional clinical trial approach and evaluate the feasibility of such approaches.

The study consists of 2 parts with 3 different arms.

Part A has site-based recruitment followed by a 1:1 randomization into a conventional arm and a hybrid arm.

Part B has decentralised recruitment, no randomization and consists of a fully remote arm.

Who Took Part

Enrollment: 107 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participant with T2DM diagnosed for at least 1 year before the screening visit (V1). Participant treated with a stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection), for at least 3 months before the screening visit. Signed written informed consent or e-consent depending on the arm. Willing and able to permit home visits (only for Part A of the study). Willing and able to comply with study drug receipt, accountability, and return processes and procedures.

The full record lists 10 inclusion and 15 exclusion criteria; among the exclusions: age \<18 years; patient not willing to self-manage insulin titration algorithm; type 1 diabetes mellitus.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2023-07-10 with completion listed for 2025-01-21.

It ran at 9 sites in United Kingdom (4), Germany (3) and Denmark (2).

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Enrolment rates (time frame: 32 weeks). Retention rates (time frame: 6 months). Diversity (time frame: 10 weeks).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 107 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.