Diabetes Mellitus, Type 2Phase 4RADIALNCT05780151

Remote And Decentralised Innovative Approaches to Clinical Trials (RADIAL)

A Phase 4 study testing Methodological intervention and Toujeo in people with Diabetes Mellitus, Type 2, run by Mira Zuidgeest at 9 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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®. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Methodological intervention and Toujeo
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 107 participants
Where: 9 sitesin 3 countries
Study dates: 10 Jul 2023to 21 Jan 2025
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 11Show fewer

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.

Who cannot join

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.

Show all 16Show fewer

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).
Despite screening of the participant, enrolment is stopped at the study level.

Trial locations and contacts

9 sites in 3 countries.

Country

City, postcode or hospital

9 sites in 3 countries

United Kingdom4 sites

FutureMeds Soho Health Centre
Birmingham
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool
University Hospitals Leicester NHS Trust
Leicester
NIHR Patient Recruitment Centre Newcastle, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle

Other trials in United Kingdom

Germany3 sites

Studienzentrum Diabetespraxis Dr. Braun
Berlin
Klinische Forschung Dresden GmbH
Dresden
Velocity Clinical Research Leipzig GmbH
Leipzig

Other trials in Germany

Denmark2 sites

Steno Diabetes Centre Odense
Odense
Syddansk Universitet
Odense

Other trials in Denmark

About this study

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®

Read the detailed description

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 primary study objectives are to (1) assess potential benefits of a DCT approach on participant recruitment, retention, diversity, site and participant satisfaction, and cost and (2) to determine acceptability of a DCT approach by measuring variables related to safety oversight, treatment adherence and data quality (missing data and query rate) within the arms that have a different degree of decentralisation.

The secondary study objective is to determine whether the efficacy of treatment with Toujeo® (insulin glargine 300 U/mL) is within the accepted range within the arms with different degree of decentralisation.

The design is a parallel-group, open-label, multi-centre study in Europe for patients with Type 2 diabetes mellitus ( T2DM) with glycated haemoglobin (HbA1c) between 7% and 10% and treated with basal insulin as part of their glucose-lowering treatment. 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.

The study will enrol approximately 150 adults in each site-based arm (conventional and hybrid) and approximately 300 in the remote arm, for a total of 600 participants in approximately 5-6 countries. Both Part A and Part B will consist of a screening period (3-6 weeks), a treatment period with open-label Toujeo® (24 weeks) and a follow-up period (2-4 days after end of treatment [EOT]).

Conditions: Diabetes Mellitus, Type 2
Being tested: Methodological intervention, Toujeo
Keywords: decentralised clinical trial approach, proof-of-concept study
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Methodological interventionOther
All three arms will receive the same clinical intervention but will differ in their level of decentralisation, the methodological intervention.
ToujeoDrug
Also called insulin glargine 300 U/ml
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.

Study groups in NCT05780151
Study group	Role	What they receive
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. Receives: 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 Receives: 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. Receives: Other: Methodological intervention; Drug: Toujeo

What is being measured

The primary outcome is the main question the study is designed to answer.

Enrolment rates
Time to enrolment from Site activation until last participant enrolled
Measured: 32 weeks
Retention rates
Proportion of participants completing the study period
Measured: 6 months
Diversity
Various diversity aspects such as race, ethnicity, socioeconomic status, digital literacy, distance to health care professional, mobility.
Measured: 10 weeks
Participant satisfaction
Participant satisfaction measured using a questionnaire just after V2 (baseline), V6 and V9 (EOT)
Measured: 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).
Measured: 6 months
Study cost
Absolute cost per participant using a combination of prospective and retrospective measurements
Measured: 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.
Measured: 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.
Measured: 6 months
Missing data
Proportion of missing data on the critical data points (Hb1Ac, Fasting Glucose, Participant satisfaction questionnaire)
Measured: 9 months
Query rate
Number of queries (both manual and automatic) per participant per arm.
Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 202321 Jan 2025

First posted22 Mar 2023
Study start10 Jul 2023
Primary completion21 Jan 2025
Study completion21 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel-group, open-label, multi-centre study
Masking: None (open label)
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05780151
Sponsor's protocol ID: EU-CT number 2022-500449-26-00
Other IDs: 1006010
Acronym: RADIAL
Status last verified: Jun 2024
First submitted: 8 Mar 2023
Last updated: 29 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 41814361
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.
PubMed 41781790
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.
PubMed 40888335

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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®
ClinicalTrials.gov ID: NCT05780151
Acronym / sponsor ID: RADIAL / EU-CT number 2022-500449-26-00
Conditions: Diabetes Mellitus, Type 2
Keywords: decentralised clinical trial approach, proof-of-concept study
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: Mira ZuidgeestUniversity, hospital or other
Collaborators: IMI Trials@Home consortium, Innovative Medicines Initiative, Sanofi
Study start: 10 Jul 2023 (actual)
Primary completion: 21 Jan 2025 (actual)
Study completion: 21 Jan 2025 (actual)
First posted: 22 Mar 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Parallel-group, open-label, multi-centre study

Arm	Type	Receives
Conventional	Active comparator	Other: Methodological intervention, Drug: ToujeoIn 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.
Hybrid	Active comparator	Other: Methodological intervention, Drug: ToujeoIn 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
Remote	Active comparator	Other: Methodological intervention, Drug: ToujeoIn 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Methodological interventionAll three arms will receive the same clinical intervention but will differ in their level of decentralisation, the methodological intervention.	Other	Conventional, Hybrid, Remote
ToujeoAlso: insulin glargine 300 U/mlAll 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.	Drug	Conventional, Hybrid, Remote

Primary outcome

Enrolment rates
Time frame: 32 weeks
Time to enrolment from Site activation until last participant enrolled
Retention rates
Time frame: 6 months
Proportion of participants completing the study period
Diversity
Time frame: 10 weeks
Various diversity aspects such as race, ethnicity, socioeconomic status, digital literacy, distance to health care professional, mobility.
Participant satisfaction
Time frame: 6 months
Participant satisfaction measured using a questionnaire just after V2 (baseline), V6 and V9 (EOT)
Site staff satisfaction
Time frame: 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
Time frame: 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
Time frame: 6 months
Time from event occurrence to collection AE/SAE in the eDiary or eCRF (electronic Case Report Form), whichever is applicable.
Treatment adherence
Time frame: 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
Time frame: 9 months
Proportion of missing data on the critical data points (Hb1Ac, Fasting Glucose, Participant satisfaction questionnaire)
Query rate
Time frame: 9 months
Number of queries (both manual and automatic) per participant per arm.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
Derived from this study: PubMed 41814361Kopanz 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.
Derived from this study: PubMed 41781790Weitlaner 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.
Derived from this study: PubMed 40888335Zuidgeest 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.
Website Trials@Home projectLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mira GP Zuidgeest, PhD principal investigator

UMC Utrecht

9 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Methodological intervention and Toujeo in people with Diabetes Mellitus, Type 2, run by Mira Zuidgeest at 9 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United Kingdom, Germany, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enrolment rates (time frame: 32 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05780151, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.