Patient pathway and therapeutic inertia in newly diagnosed T2DM patients with multimorbidity

Date of ISAC Approval: 
Lay Summary: 
In the UK, the National Institute for Health and Care Excellence (NICE) provides guidance for the care and management of type 2 diabetes (T2DM) in adults. The guidance includes first educating patients on staying active and eating healthy, then escalates to managing the level of sugar in the blood by prescribing medications. Additional considerations include managing the risk of diseases of the heart and blood vessels and other potential complications through medication. We are interested in determining whether these guidelines are followed in primary care practice in the UK. We will use data collected in hospital and from general practices contributing to the Clinical Practice Research Datalink (CPRD). We will examine whether having additional chronic diseases (comorbidities) changes the patient's care pathway, risk of diseases of the heart and blood vessels, prescribed medications, and frequency of doctor's appointments. Therapeutic inertia is the failure to step-up treatment, despite no improvement in disease management. Therefore, we also want to understand factors that may lead to therapeutic inertia in people with T2DM. Understanding these factors will allow doctors to identify and target patients that are likely to experience therapeutic inertia, putting them at higher risk for complications from T2DM.
Technical Summary: 
In the UK, the National Institute for Health and Care Excellence (NICE) provides guidance for the care and management of type 2 diabetes (T2DM) in adults (aged 18 and over). The guideline, NG28, focuses on educating patients on physical activity and dietary considerations as a first point of intervention, and then intensifies to managing cardiovascular risk, blood glucose levels, and long-term complications through progressively stronger therapeutic regiments. However, the uptake of these guidelines in the real-world primary care setting is unknown. It is also unknown whether additional comorbidities affect a patient's therapeutic pathway. Therefore, in the first part of this study, we want to determine the prevalence of comorbidities in patients with T2DM and describe how comorbidities affect primary care resource utilisation and costs, outcomes, and glucose lowering treatment pathways. We will use data collected in primary and secondary care for a cohort of patients w ith a first recorded T2DM diagnosis during 01/01/2000-31/12/2018. Therapeutic inertia is the failure to establish appropriate targets and escalate treatment to achieve treatment goals. There is a gap in understanding what factors drive therapeutic inertia in patients with T2DM. Therefore, in the second part of this study, we will examine potential points of therapeutic inertia, determine drivers of treatment intensification, as well as identify factors that impact the early lines of glucose lowering therapy for patients with T2DM. We will use time to event flexible parametric modelling to examine factors associated with therapeutic inertia, treatment intensification, and early lines of therapy.
Health Outcomes to be Measured: 
Part 1: - time to event: fatal/non-fatal cardiovascular event; all-cause mortality; cardiovascular-related mortality - 1st line therapies, 2nd line therapies, 3rd line therapies, etc. - time to treatment initiation - time to treatment intensification - consultation rates - estimated health care costs Part 2: - treatment intensification - treatment pathway (1st line therapy, 2nd line therapy, 3rd line therapy, etc.) - HbA1c control - transition from an oral glucose-lowering medications to insulin or other injectable glucose-lowering medication - early lines of therapy

Ms Briana Coles - Chief Investigator - University of Leicester
Ms Briana Coles - Corresponding Applicant - University of Leicester
Mr Christian Hvid - Collaborator - Novo Nordisk
Dr Clare Gillies - Collaborator - University of Leicester
Dr Francesco Zaccardi - Collaborator - University of Leicester
Professor Kamlesh Khunti - Collaborator - University of Leicester
Ms Sophia Abner - Collaborator - University of Leicester

HES Admitted;ONS;Patient IMD