iDiabetes platform-enhanced phenotyping of patients with diabetes for precision diagnosis, prognosis and treatment: study protocol for a cluster-randomised controlled study in Tayside, Scotland.

INTRODUCTION AND AIM

Diabetes is a global health emergency with increasing prevalence and diabetes-associated morbidity and mortality. One of the challenges in optimising diabetes care is translating research advances in this heterogeneous disease into clinical care. A potential solution is the introduction of precision medicine approaches into diabetes care.We aim to develop a digital platform called 'intelligent Diabetes' (iDiabetes) to support a precision diabetes care model in Scotland and assess its impact on the primary composite outcome of all-cause mortality, hospitalisation rate, renal function decline and glycaemic control.

METHODS AND ANALYSIS

The impact of iDiabetes will be evaluated through a cluster-randomised controlled study, recruiting up to 22 500 patients with diabetes. Primary care general practices (GPs) in the National Health Service (NHS) Scotland Tayside Health Board are the units (clusters) of randomisation. Each primary care GP will form one cluster (approximately 400 patients per cluster), with up to 60 clusters recruited. Randomisation will be to ), or (control arm). Patients of participating primary care GPs are automatically enrolled on the study when they attend for their annual diabetes screening or are newly diagnosed with diabetes. A composite hierarchical primary outcome, evaluated using Win-Ratio statistical methodology, will consist of (1) all-cause mortality, (2) all-cause hospitalisation rate, (3) proportion with >40% estimated glomerular filtration rate [eGFR] reduction from baseline or new development of end-stage renal disease, (4) proportion with absolute HbA1C reduction >0.5%. Outcomes will be evaluated after a 2-year median follow-up period. Comprehensive qualitative and health economic analyses will be conducted, assessing the cost-effectiveness, budget impact and user acceptability of the iDiabetes platform.

ETHICS AND DISSEMINATION

This study was reviewed by the NHS Health Research Authority and approved by the East of Scotland Research Ethics Committee (reference: 23/ES/0008). Study findings will be disseminated via publications, presented at scientific conferences and shared with patients and the public on the study website and social media.

TRIAL REGISTRATION NUMBER

ISRCTN18000901.