Remote And Decentralised Innovative Approaches to Clinical Trials (RADIAL)

Diabetes Mellitus, Type 2 Clinical Trial

— RADIAL  

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®

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05780151
• Other study ID #: EU-CT number 2022-500449-26-00
• Secondary ID: 1006010
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 10, 2023
• Est. completion date: November 2025

Study information

• Verified date: June 2024
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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®.

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]).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 107
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Participant with T2DM diagnosed for at least 1 year before the screening visit (V1).

2. 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.

3. The total daily basal insulin dose should be stable (±20%) for at least 1 month before the screening visit.

4. Participant treated with =1 noninsulin antidiabetic drugs at stable dose in the 3 months before the screening visit.

5. Signed written informed consent or e-consent depending on the arm.

6. 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.

7. Willing and able to permit home visits (only for Part A of the study).

8. Willing and able to comply with study drug receipt, accountability, and return processes and procedures.

9. Access to tablet/smartphone with Bluetooth functionality.

10. Access to internet connection that allows remote data entry and, for part B, video conferencing.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

1. Age <18 years.

2. HbA1c at screening visit: <7.0% or >10.0%.

3. Patient not willing to self-manage insulin titration algorithm.

4. Type 1 diabetes mellitus.

5. Treatment with mixed insulin (premixes), short-acting insulin, fast acting insulin analogues or Toujeo® during the 3 months before the screening visit.

6. Use of systemic glucocorticoids (excluding topical application or inhaled forms) for two weeks or more within 8 weeks prior to the time of screening.

7. 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.

8. Use of any investigational drug within 1 month or 5 half-lives, whichever is longer, prior to screening visit.

9. 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.

10. Participant whom the investigator deems otherwise ineligible (e.g. unable to understand and follow instructions). Reason for ineligibility will be documented.

11. Pregnant or breastfeeding woman at the time of screening.

12. 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).

13. Known hypersensitivity / intolerance to insulin glargine or any of Toujeo® excipients.

14. Participant who withdraws consent during the screening (participant who is not willing to continue or fails to return).

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Drug:
• Toujeo
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.

Locations

Country	Name	City	State
Denmark	Steno Diabetes Centre Odense	Odense
Denmark	Syddansk Universitet	Odense
Germany	Studienzentrum Diabetespraxis Dr. Braun	Berlin
Germany	Klinische Forschung Dresden GmbH	Dresden
Germany	Velocity Clinical Research Leipzig GmbH	Leipzig
United Kingdom	FutureMeds Soho Health Centre	Birmingham
United Kingdom	Blackpool Teaching Hospitals NHS Foundation Trust	Blackpool
United Kingdom	University Hospitals Leicester NHS Trust	Leicester
United Kingdom	NIHR Patient Recruitment Centre Newcastle, The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle

Sponsors (4)

Lead Sponsor	Collaborator
Mira Zuidgeest	IMI Trials@Home consortium, Innovative Medicines Initiative, Sanofi

Countries where clinical trial is conducted

Denmark,  Germany,  United Kingdom, 

Outcome

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

External Links

•   Website Trials@Home project