The 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

Abstract

ABSTRACTIntroduction and AimDiabetes 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 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 AnalysisThe 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 toiDiabetes (guideline support),iDiabetesPlusorusual 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%. 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 DisseminationThis study was reviewed by the NHS HRA and approved by 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.Study registrationISRCTN18000901Study SponsorUniversity of Dundee, no. 2-026-22. Contact:tascgovernance@dundee.ac.ukProtocol version:V3.0, 22/09/2023ARTICLE SUMMARYStrengthsiDiabetes is a novel precision medicine platform which is the first of its kind to evaluate a precision diabetes care model in a controlled trialReal-world application in an existing healthcare system, with the entire regional diabetes population eligible for enrolment – results are therefore likely to be generalisable and the approach could be scaled up to a national levelThe study analysis utilises a mixed-method approach allowing a comprehensive evaluation of all aspects of the precision medicine platform including impact on clinical outcomes, usability for both patients and clinicians, cost-effectiveness analysis, budget impact analysis and patient preferences.LimitationsStudy enrolment takes place when patients attend their routine clinical diabetes review - consequently a subpopulation of patients with limited healthcare access may be excludedThe patient-facing platform is only available in an English version and can only be accessed digitally, therefore patients with limited English or digital illiteracy may not benefit from the intervention to its full potential