University of Dundee, Dundee, UK.
Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.
BMJ Open. 2024 Nov 28;14(11):e086594. doi: 10.1136/bmjopen-2024-086594.
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.
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.
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.
ISRCTN18000901.
糖尿病是一种全球性的健康紧急情况，其患病率不断上升，与糖尿病相关的发病率和死亡率也在上升。优化糖尿病护理的挑战之一是将这种异质性疾病的研究进展转化为临床护理。一种潜在的解决方案是将精准医学方法引入糖尿病护理。我们旨在开发一个名为“智能糖尿病”（iDiabetes）的数字平台，以支持苏格兰的精准糖尿病护理模式，并评估其对全因死亡率、住院率、肾功能下降和血糖控制的主要复合结局的影响。
通过一项整群随机对照研究评估 iDiabetes 的影响，该研究将招募多达 22500 名糖尿病患者。苏格兰泰赛德卫生局国民保健服务（NHS）的基层医疗全科医生（GP）是随机分组的单位（群）。每个基层医疗 GP 将形成一个群（每个群约 400 名患者），最多招募 60 个群。随机分组将为 、 或 （对照组）。当参加年度糖尿病筛查的患者或新诊断为糖尿病的患者到参与的基层医疗 GP 就诊时，他们将自动被纳入研究。使用 Win-Ratio 统计方法评估的综合分层主要结局将包括（1）全因死亡率，（2）全因住院率，（3）与基线相比 eGFR 下降 >40%[eGFR]或新发展为终末期肾病的比例，（4）绝对 HbA1C 降低 >0.5%的比例。在中位 2 年随访期后评估结局。将进行全面的定性和健康经济学分析，评估 iDiabetes 平台的成本效益、预算影响和用户接受度。
该研究由国民保健服务健康研究管理局审查，并获得苏格兰东部研究伦理委员会批准（参考号：23/ES/0008）。研究结果将通过出版物、科学会议报告以及在研究网站和社交媒体上与患者和公众分享进行传播。
ISRCTN85533256。
