Type 2 diabetes is a common lifelong condition characterised by high blood sugar. People with type 2 diabetes are at risk of developing long-term problems affecting the heart, kidneys, eyes and nerves. Type 2 diabetes can be managed by improving diet and increasing exercise, but medication to lower blood sugar is frequently also required.
It is unclear to what extent improvements in diabetes care have improved the health of people with type 2 diabetes. This, combined with the introduction of new drug treatments, warrants further research into the condition. The aim of this research is to help us to understand the association between having type 2 diabetes and the risk of death and developing the long-term problems listed above and whether this has changed in recent years. In addition, we aim to investigate the association between different treatments for type 2 diabetes and the occurrence of these problems. We hope our findings will be used to support results from clinical trials elsewhere and to inform further investigation.
The aim is to investigate the association between type 2 diabetes and the development of complications of diabetes and death. We will also investigate the association between glucose-lowering therapies and the same outcomes in people with type 2 diabetes.
Patients will be selected from the Clinical Practice Research Datalink (CPRD) GOLD and Aurum datasets if they have a record of one or more of the following: a product code indicative of a glucose-lowering therapy; or a medical code indicative of diabetes in CPRD or linked Hospital Episode Statistics (HES) Admitted Patient Care (APC) and Outpatient data. Patients will be classified as having type 2 diabetes by applying a series of previously published decision rules based on diagnoses, prescriptions for glucose-lowering therapies, body mass index (BMI) and haemoglobin A1c (HbA1c).
The following outcomes will be investigated using CPRD, linked HES APC and Outpatient data and Office for National Statistics (ONS) Death Registration data: eye disease related to diabetes; nephropathy; revascularisation; major adverse cardiac events (MACE); myocardial infarction; stroke; neuropathy, all-cause mortality, time-to-initiation of a glucose-lowering therapy. The date of death recorded in the ONS death registration data will take precedence over the CPRD-derived date of death where available. Cases of type 2 diabetes will be compared with a matched control group without a record of diabetes. In a subgroup analysis, glucose-lowering therapies will be compared. Time to endpoint will be evaluated using Cox proportional hazards modelling. If the proportional hazards assumption is not met, we will use a parametric survival model.
This study will provide valuable information on the impact of type 2 diabetes and the effectiveness of glucose-lowering therapies on long term diabetes related outcomes and could be used in addition to randomised controlled trials to help support healthcare decision-making.
Eye disease related to diabetes; Nephropathy; revascularisation; Major adverse cardiac events (MACE); Myocardial infarction; Stroke; Neuropathy; All- cause mortality; Time to initiation of a glucose-lowering therapy.
Note to reviewer: This section should clearly list the primary and key secondary outcomes of interest in a concise list, separated by semicolons. Therefore, we cannot elaborate on the outcome definitions in this section. All outcome definitions are included in the ‘Exposures, Outcomes and Covariates’ section.
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Sarah Holden - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Aron Buxton - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Benjamin Heywood - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Bethan Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Chris Shepherd - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Christian Bannister - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Elgan Mathias - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Harry Fisher - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
James Bateman - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Lauren Riddick - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Leah Fisher - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Rhiannon Thomason - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Thomas Berni - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data