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The RADIAL study: A clinical trial to learn more about the benefits and the acceptability of trials that include technology to centre the trial around the participant, known as decentralised, and hybrid clinical trials compared to standard clinical trials that take place in hospitals or in research centres, in patients with type 2 diabetes mellitus treated with Toujeo®, a drug to help manage blood sugar levels.
EU CTIS ID: 2022-500449-26-00
What this study is testing
1. To assess potential benefits of a DCT approach on participant recruitment, retention, diversity, site and participant satisfaction, and cost. 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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1) Participant with T2DM diagnosed for at least 1 year before the screening visit (V1).
- 2) Participant treated as part of their treatment with a basal insulin (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) Signed written informed consent or e-consent depending on the arm.
- 5) 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.
- 6) Willing and able to permit home visits (only for Part A of the study).
You likely can't join if
- 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) 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.
See the full eligibility criteria
Who can join
- 1) Participant with T2DM diagnosed for at least 1 year before the screening visit (V1).
- 2) Participant treated as part of their treatment with a basal insulin (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) Signed written informed consent or e-consent depending on the arm.
- 5) 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.
- 6) Willing and able to permit home visits (only for Part A of the study).
- 7) Willing and able to comply with study drug receipt, accountability, and return processes and procedures.
- 8) Access to tablet/smartphone with Bluetooth functionality.
- 9) Access to internet connection that allows remote data entry and, for part B, video conferencing.
What rules you out
- 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) 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.