The iDiabetes Platform: Enhanced Phenotyping of Patients with Diabetes for Precision Diagnosis, Prognosis and Treatment- study protocol for a cluster-randomised controlled study

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 heterogenous disease into routine 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 (GP) in the National Health Service 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 iDiabetes (guideline support), iDiabetesPlus or usual diabetes care (control arm). Patients of participating primary care GPs are automatically enrolled to 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 consists of (I) all-cause mortality, (II) all-cause hospitalisation rate, (III) proportion with >40% eGFR reduction from baseline or new development of end-stage renal disease, (IV) proportion with absolute HbA1C reduction >0.5%. 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 HRA and given a favourable opinion by a Research Ethics Committee (reference:23/ES/0008). Study findings will be disseminated via publications and presented at scientific conferences. Findings will be shared with patients and the public on the study website and social media. Study registration ISRCTN18000901 Study Sponsor University of Dundee, no. 2-026-22. Contact: tascgovernance{at}dundee.ac.uk Protocol version V3.0, 22/09/2023 Strengths Limitations ### Competing Interest Statement YYL, DL, MA, RB, TC, JFD, PTD, AF, RH, SMcK, SM, MR, GT, HW and MW have no competing interests. ERP has received honoraria for speaking from Novo Nordisk, Lilly and Illumina. SB has received consultancy fees from Astra Zeneca, Bayer and GSK. SGC is a director and employee of MyWay Digital Health. CL has received consultancy fees from Amarin, Aztra Zeneca, Boehringher Ingelheim, Novartis and Vifor; and research grants from Applied Therapeutics, Anacardia, Astra Zeneca, British Heart Foundation, Boehringer Ingelheim, Chief Scientist Office, Eli Lilly, Horizon 2020 EU funding, JDRF, Moderna, NIHR-HTA, Roche Diagnostics, Novo Nordisk, Novartis, and UKRI. HCM has received honoraria from Novo Nordisk and Astra Zeneca. IRM has received honoraria from Astra Zeneca and Boehringer Ingelheim. DJW is a shareholder and cofounder of MyWay Digital Health. ### Clinical Trial ISRCTN18000901 ### Funding Statement This work was funded by Chief Scientist Office, Scotland (grant number: PMAS-21-01). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The East of Scotland Research Ethics Committee (NHS Scotland) gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Individual level patient data will not be made publicly available due to data privacy/GDPR regulations. Additional access to the final study dataset on Health Informatics Centre Trusted Research Environment (University of Dundee) will be approved by the chief investigator with an appropriate data sharing agreement in place.