Remote And Decentralised Innovative Approaches to Clinical Trials (RADIAL)

NCT05780151 | Completed Phase 4

• 2 other identifiers: EU-CT number 2022-500449-26-001006010
• Study Type: interventional
• Target: 107
• Locations: 3 countries
• Sites: 9

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

Keywords

decentralised clinical trial approach; proof-of-concept study

Outcome Measures

Primary Outcomes (10)

• Enrolment rates

  Time to enrolment from Site activation until last participant enrolled

  32 weeks

• Retention rates

  Proportion of participants completing the study period

  6 months

• Diversity

  Various diversity aspects such as race, ethnicity, socioeconomic status, digital literacy, distance to health care professional, mobility.

  10 weeks

• Participant satisfaction

  Participant satisfaction measured using a questionnaire just after V2 (baseline), V6 and V9 (EOT)

  6 months

• Site staff satisfaction

  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).

  6 months

• Study cost

  Absolute cost per participant using a combination of prospective and retrospective measurements

  complete trial duration

• Time of AE (Adverse Event)/ SAE (Serious Adverse Event) occurence to collection

  Time from event occurrence to collection AE/SAE in the eDiary or eCRF (electronic Case Report Form), whichever is applicable.

  6 months

• Treatment adherence

  Adherence to the daily insulin injection by means of eDiary analysis in percentage of days of documented intake until participant's EOT.

  6 months

• Missing data

  Proportion of missing data on the critical data points (Hb1Ac, Fasting Glucose, Participant satisfaction questionnaire)

  9 months

• Query rate

  Number of queries (both manual and automatic) per participant per arm.

  9 months

Study Arms (3)

Conventional

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.

Other: Methodological intervention; Drug: Toujeo

Hybrid

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 hybrid trial design is defined as a trial containing conventional trial elements, such as site-based recruitment and screening visits, as well as decentralised trials elements, such as a remote follow-up period and data collection

Other: Methodological intervention; Drug: Toujeo

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 remote arm is fully decentralised and aims to represent future decentralised clinical trial practice using a decentralised recruitment model, intervention period and data collection.

Other: Methodological intervention; Drug: Toujeo

Interventions

Methodological intervention OTHER

All three arms will receive the same clinical intervention but will differ in their level of decentralisation, the methodological intervention.

Conventional; Hybrid; Remote

Toujeo DRUG

All participants in the study will receive Toujeo® (insulin glargine 300 U/mL). During the treatment period, Toujeo® injection will be administered once daily at the same time as the participant's previous basal insulin was injected, for participant previously treated with once daily injection. In case of previous insulin treatment administered twice a day, the time of injection of Toujeo® will have to be agreed between the physician and the participant before first administration.

Also known as: insulin glargine 300 U/ml

Conventional; Hybrid; Remote

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• 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.
• The total daily basal insulin dose should be stable (±20%) for at least 1 month before the screening visit.
• Participant treated with ≥1 noninsulin antidiabetic drugs at stable dose in the 3 months before the screening visit.
• Signed written informed consent or e-consent depending on the arm.
• Participant's mental and physical status allows them to be able to perform their activities of daily living with no or minimal assistance, including the ability to administer injectable insulin and measure their blood glycaemic level.
• 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.
• Access to tablet/smartphone with Bluetooth functionality.
• Access to internet connection that allows remote data entry and, for part B, video conferencing.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Age \<18 years.
• HbA1c at screening visit: \<7.0% or \>10.0%.
• Patient not willing to self-manage insulin titration algorithm.
• Type 1 diabetes mellitus.
• Treatment with mixed insulin (premixes), short-acting insulin, fast acting insulin analogues or Toujeo® during the 3 months before the screening visit.
• Use of systemic glucocorticoids (excluding topical application or inhaled forms) for two weeks or more within 8 weeks prior to the time of screening.
• Any clinically significant abnormality identified at the time of screening, or any condition (including known substance or alcohol abuse, or psychiatric disorder) that in the opinion of the Investigator or any sub-Investigator would make implementation of the protocol or interpretation of the study results difficult or would preclude the safe participation of the participant in this study.
• Use of any investigational drug within 1 month or 5 half-lives, whichever is longer, prior to screening visit.
• Participant is the Investigator or any Subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
• Participant whom the investigator deems otherwise ineligible (e.g. unable to understand and follow instructions). Reason for ineligibility will be documented.
• Pregnant or breastfeeding woman at the time of screening.
• Woman of childbearing potential not protected by acceptable method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy (see Section 10.3).
• Known hypersensitivity / intolerance to insulin glargine or any of Toujeo® excipients.
• Participant who withdraws consent during the screening (participant who is not willing to continue or fails to return).

Sponsors & Collaborators

• Mira Zuidgeest: lead
• IMI Trials@Home consortium: collaborator
• Innovative Medicines Initiative: collaborator
• Sanofi: collaborator

Study Sites (9)

Steno Diabetes Centre Odense

Odense, Denmark

Location

Syddansk Universitet

Odense, Denmark

Location

Studienzentrum Diabetespraxis Dr. Braun

Berlin, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, Germany

Location

Velocity Clinical Research Leipzig GmbH

Leipzig, Germany

Location

FutureMeds Soho Health Centre

Birmingham, United Kingdom

Location

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, United Kingdom

Location

University Hospitals Leicester NHS Trust

Leicester, United Kingdom

Location

NIHR Patient Recruitment Centre Newcastle, The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40888335 DERIVED

Related Links

• Website Trials@Home project

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Mira GP Zuidgeest, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Parallel-group, open-label, multi-centre study

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 22, 2023
• Study Start: July 10, 2023
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: May 29, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4); DE (3); DK (2)