We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Louise
Sollis
Louise.Sollis@sanofi.com
Sandra
Mawdesley
s.mawdesley@nhs.net
Dr
Martin
Johnson
martin.johnson@futuremeds.com
Angela
Birt
angela.birt@nihr.ac.uk
Diabetes mellitus
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Traditionally,clinical trials take place in hospitals or other research sites,often requiring
participants to attend several face-to-face study visits. In the absence of broad internet access,home computing and mobile (smart) phones,conventional clinical trials relied upon paper
advertising,physician awareness of clinical trials and the physician’s network of patients and
medical colleagues to recruit clinical trial participants and on face-to-face study visits to conduct
trial procedures. This ‘conventional’ clinical trial model often faces difficulties,including slow
patient recruitment,low retention and selective participation not reflective of the population of
interest,putting pressure not only on the efficiency but also on the generalisability to clinical
practice of the findings of conventional clinical site-centred approaches.
There is a growing body of evidence supporting the use of broadband internet,home computing
and smartphones as well as newly available wearable and non-wearable digital technologies,medical devices and biosensor technology to conduct telehealth audiovisual interactions and to
allow a more robust monitoring and support of clinical trial participants and management of such
trials in general. This operational strategy of technology-enhanced trials,also known as
Decentralised Clinical Trials (DCTs),is expected to make clinical trials more accessible to
participants by moving trial activities to the participant’s home or to other local settings and
minimising or eliminating physical visits to a clinical trial centre,reducing the burden on clinical
trial participants. Additionally,the increased decentralisation in trials could allow for a more
diverse participant population,as centring the trial around the participant eliminates the need to
travel and allows individuals more flexibility to fit the trial activities into their daily lives,expanding the potential trial accessibility beyond of what was previously possible. Moreover,a
decentralised approach to recruitment,e.g. by use of social media and liaising with advocacy
groups,could make trials more visible and accessible to participants independent of referring
physicians. The increased,possibly more diverse,potential population might alleviate some of
the difficulties clinical trials face such as slow patient recruitment. Furthermore,the increased
opportunities for active and passive collection of participant-generated data can provide data that
more closely reflects patients’ daily lives,norms,and values,and thereby provide better insight
into disease progression and effectiveness of treatment strategies (Real World Evidence).
The already increasing decentralisation of clinical trials has been further advanced by the
COVID-19 pandemic,which forced the implementation of innovative technologies and solutions
to ensure trial continuation and maintain safety monitoring and oversight (McDermott et al.
2020). Nevertheless,despite the increase in DCTs and trials adopting DCT elements,often
referred to as a hybrid trial,little is known on the effect of these clinical trial approaches on
important trial aspects,or Key Performance Indicators (KPIs),such as treatment adherence,safety oversight and data quality. Furthermore,the potential benefits of DCTs regarding,for
example,enrolment,retention,costs,participant and site satisfaction and diversity have not been
previously explored in a head-to-head comparison with the conventional site-based approach.
Therefore,this protocol describes a proof-of-concept study that has been designed to compare
the scientific and operational quality of a fully decentralised and a hybrid trial approach to a
conventional trial approach and evaluate the feasibility of such approaches. To meet this aim,the
CONFIDENTIAL
v. 2.1 RADIAL Protocol
15 / 80
RADIAL study will compare three trial arms that will receive the same clinical intervention but
will differ in the degree of decentralisation of the trial approach (the methodological
intervention). The conventional arm is modelled after a previous clinical trial with a similar
indication and intervention and aims to mirror current state-of-the-art clinical trial conduct. The
hybrid arm contains conventional trial elements,such as conventional recruitment and screening
visits,as well as decentralised trial elements,such as a decentralised treatment period and data
collection. The fully decentralised,or remote arm,is intended to mimic future fully decentralised
clinical trial practice,including a decentralised recruitment method,treatment period and data
collection.
The proposed study design allows to give insights into whether data from fully decentralised
and/or hybrid approaches (if such a trial approach is suitable based on the research question,study population and type of interventions) could be acceptable to all stakeholders with the same
trust in the data and the same confidence regarding participant safety as conventional trial
approaches. To provide these insights the study has been designed to evaluate if decentralised
and hybrid approaches meet the same KPIs (see Section 3) as conventional trial approaches for
generating valid and appropriate data to allow drawing appropriate conclusions from the study
results,thus supporting the feasibility of DCTs. Therefore,this study will focus on the
characterisation and evaluation of recognised KPIs which reflect scientific and operational
quality of clinical trials. Furthermore,this proof-of-concept study will help to identify possible
legal,regulatory,technological,operational and psychosocial barriers to implementation of DCT
approaches for future clinical trials. The findings of this study will allow us to better understand
the benefits and challenges of decentralised elements and will support the formulation of
recommendations regarding the adoption of DCTs.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;Education or Self-Management;Management of Care;Other;
You can take part if:
You may not be able to take part if:
1) Age <18 years 10.0%. 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),rapid 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.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Angela
Birt
angela.birt@nihr.ac.uk
Louise
Sollis
Louise.Sollis@sanofi.com
Sandra
Mawdesley
s.mawdesley@nhs.net
Dr
Martin
Johnson
martin.johnson@futuremeds.com
The study is sponsored by University Medical Centre Utrecht (Netherlands) and funded by European Commission .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 53661
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
