RADIAL
Research type
Research Study
Full 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®
IRAS ID
1006010
Contact name
Mira Zuidgeest
Contact email
Sponsor organisation
University Medical Center Utrecht
Clinicaltrials.gov Identifier
Research summary
The RADIAL study will compare three clinical trial models: decentralised, hybrid and conventional. The study will include 600 (150 conventional, 150 hybrid and 300 in decentralised model) adult type 2 diabetes mellitus patients who are on basal insulin from 6 countries. All patients will have a period of 3 to 6 weeks in which their suitability will be assessed and a treatment period with Toujeo® of 24 weeks. By taking part in this study patients will contribute to testing different models of clinical trials. This study will assess the acceptability and potential benefits of these models. The results of this study may change the way clinical trials are designed and conducted in the future. Decentralisation of clinical trials is expected to reduce the burden of participation in clinical trials.
Participation in this study may improve the control of participants' blood sugar levels. The insulin to be used, Toujeo®, has already been investigated, approved and used by diabetic patients. We already know a lot about the possible risks, which are considered to be small. This is also one of the reasons why Toujeo® is used in this trial, as it is considered safe to switch to, even in a decentralised way. Moreover, it may have advantages over other types of insulins. The researchers will be able to monitor the patients’ progress throughout the study. In addition, both the patient and the researchers have the possibility to contact each other in case of questions or clarifications or safety issues.
The study procedures are low risk and have low inconvenience. The burden on patients is considerable: daily diary entries for dose and time data, periodic questionnaire and four visits (online or at the research centre, depending of the trial model). However, the burden is considered to be acceptable, taking into account the potential benefits for the patient and the learnings obtained from this study. This study could lead to more effective study in the future.REC name
East of England - Essex Research Ethics Committee
REC reference
22/EE/0184
Date of REC Opinion
25 Oct 2022
REC opinion
Further Information Favourable Opinion