The University of Birmingham, Dexter* and Cegedim Health Data have partnered in a trial of a new approach that automates finding and recruiting patients for randomised clinical trials (RCTs) and evaluates a specific intervention to improve the uptake of testing for type 2 diabetes amongst women at risk of the disease.
The RADIANT** trial is funded by the National Institute for Health and Care Research (NIHR) Research for Patient Benefit programme.
It will focus on gestational diabetes mellitus (GDM), which is diagnosed in over 30,000 women a year in the UK. Although GDM commonly resolves after giving birth, some 50% of women who have had GDM go on to develop type 2 diabetes, so all women diagnosed with it are advised to have yearly diabetes tests. However, few of them do.1
RADIANT will use Dexter’s new software platform, which was developed at the University’s Institute for Applied Health Research, to identify women who are suitable for inclusion in the trial from Cegedim Health Data’s real-world database, The Health Improvement Network (THIN), which is an anonymised database of primary care records.
Cegedim will then use its own software to check eligibility, randomise women to the intervention or control group, and send a text message reminder to women in the intervention group. This will include a link to an animation developed at the University that details the purpose of the test, what it involves, and encourages them to book a diabetes test with their GP.
Dr Francesca Crowe, Lecturer in Epidemiology and Health Informatics, is leading the trial. She said: “Standard randomised controlled trials (RCTs) rely on manual methods to identify and include patients, which makes the process time-consuming and costly. Our aim in this trial is to validate that a data-driven approach offers better outcomes as well as time and cost savings, and we will also find out whether the text message and animation are acceptable and good value for money.”
Samir Dhalla, Head of THIN, Cegedim Healthcare Solutions, commented: “As a long-standing partner of both the University of Birmingham and the NHS at large, we are delighted to be involved in their exemplar RADIANT study, which we also hope will mark a new era for data-driven, randomised controlled trials.”
Dr Crowe added: “We are using just a small subset of the wealth of data that is captured in electronic patient records, and we hope that this first study is one of many more to come.”
Participants in the RADIANT trial have been selected and NHS Ethics approval is in process to progress the active invention arm of the study.
* Dexter is an Operating Division managed by the University of Birmingham Enterprise Limited. Operating Divisions are an innovative model whereby University of Birmingham academics can set up their own commercial entity to operate in the commercial market, much like a limited company, but with the legal management, insurance and financial management being carried out by UoB Enterprise.
**RADIANT stands for impRoving testing for cardiometabolic diseases in those with previous gestational diabetes mellitus: an exemplar study on implementation and evaluation of a novel dAta-DrIven rANdomised clinical Trial platform in primary care