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®.
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 \[EOT\]).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
107
All three arms will receive the same clinical intervention but will differ in their level of decentralisation, the methodological intervention.
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.
Steno Diabetes Centre Odense
Odense, Denmark
Syddansk Universitet
Odense, Denmark
Studienzentrum Diabetespraxis Dr. Braun
Berlin, Germany
Klinische Forschung Dresden GmbH
Dresden, Germany
Enrolment rates
Time to enrolment from Site activation until last participant enrolled
Time frame: 32 weeks
Retention rates
Proportion of participants completing the study period
Time frame: 6 months
Diversity
Various diversity aspects such as race, ethnicity, socioeconomic status, digital literacy, distance to health care professional, mobility.
Time frame: 10 weeks
Participant satisfaction
Participant satisfaction measured using a questionnaire just after V2 (baseline), V6 and V9 (EOT)
Time frame: 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).
Time frame: 6 months
Study cost
Absolute cost per participant using a combination of prospective and retrospective measurements
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Velocity Clinical Research Leipzig GmbH
Leipzig, Germany
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, United Kingdom
Time frame: 6 months
Missing data
Proportion of missing data on the critical data points (Hb1Ac, Fasting Glucose, Participant satisfaction questionnaire)
Time frame: 9 months
Query rate
Number of queries (both manual and automatic) per participant per arm.
Time frame: 9 months